Evidence Report/Technology Assessment 

Number 181 

Outcomes of Community Health Worker Interventions 

Prepared for: 

Agency for Healthcare Research and Quality 

U.S. Department of Health and Human Services 

540 Gaither Road 

Rockville, MD 20850 

www.ahrq.gov 

Contract No. 290 2007 10056 I 

Prepared by: 

RTI International–University of North Carolina Evidence-based Practice Center 

Research Triangle Park, North Carolina 

Investigators 

Meera Viswanathan, Ph.D. 

Jennifer Kraschnewski, M.D. 

Brett Nishikawa, M.D. 

Laura C. Morgan, M.A. 

Patricia Thieda, M.A. 

Amanda Honeycutt, Ph.D. 

Kathleen N. Lohr, Ph.D. 

Dan Jonas, M.D., M.P.H. 

AHRQ Publication No. 09-E014 

June 2009 
This report is based on research conducted by the RTI International – University of North Carolina 

at Chapel Hill, North Carolina (RTI-UNC) Evidence-based Practice Center (EPC) under contract 

to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290 

2007 10056 I). The findings and conclusions in this document are those of the author(s) who are 

responsible for its contents; the findings and conclusions do not necessarily represent the views of 

AHRQ. Therefore, no statement in this report should be construed as an official position of the 

Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human 

Services. 

The information in this report is intended to help clinicians, employers, policymakers, and others

make well-informed decisions about the provision of health care services. This report is intended 

as a reference and not as a substitute for clinical judgment. 

This report may be used, in whole or in part, as the basis for development of clinical practice 

guidelines and other quality enhancement tools, or a basis for reimbursement and coverage 

policies. AHRQ or U.S. Department of Health and Human Services endorsement of such 

derivative products may not be stated or implied. 
This document is in the public domain and may be used and reprinted without permission except 

those copyrighted materials noted for which further reproduction is prohibited without the 

specific permission of copyright holders. 

Suggested Citation: 

Viswanathan M, Kraschnewski J, Nishikawa B, Morgan LC, Thieda P, Honeycutt A, Lohr 

KN, Jonas D. Outcomes of Community Health Worker Interventions. Evidence Report/Technology 

Assessment No. 181 (Prepared by the RTI International–University of North Carolina Evidence-based 

Practice Center under Contract No. 290 2007 10056 I.) AHRQ Publication No. 09-E014. Rockville, MD: 

Agency for Healthcare Research and Quality. June 2009. 

No investigators have any affiliations or financial involvement (e.g., employment, 

consultancies, honoraria, stock options, expert testimony, grants or patents received or 

pending, or royalties) that conflict with material presented in this report.
Preface 

 The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based 

Practice Centers (EPCs), sponsors the development of evidence reports and technology 

assessments to assist public- and private-sector organizations in their efforts to improve the 

quality of health care in the United States. The reports and assessments provide organizations 

with comprehensive, science-based information on common, costly medical conditions and new 

health care technologies. The EPCs systematically review the relevant scientific literature on 

topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to 

developing their reports and assessments. 

 To bring the broadest range of experts into the development of evidence reports and health 

technology assessments, AHRQ encourages the EPCs to form partnerships and enter into 

collaborations with other medical and research organizations. The EPCs work with these partner 

organizations to ensure that the evidence reports and technology assessments they produce will 

become building blocks for health care quality improvement projects throughout the Nation. The 

reports undergo peer review prior to their release. 

 AHRQ expects that the EPC evidence reports and technology assessments will inform 

individual health plans, providers, and purchasers as well as the health care system as a whole by 

providing important information to help improve health care quality. 

 We welcome comments on this evidence report. They may be sent by mail to the Task Order 

Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, 

Rockville, MD 20850, or by e-mail to epc@ahrq.gov. 

Jean Slutsky, P.A., M.S.P.H. 

Director, Center for Outcomes and Evidence 

Agency for Healthcare Research and Quality 

Carolyn M. Clancy, M.D. 

Director 

Agency for Healthcare Research and Quality 

 Beth Collins Sharp, R.N., Ph.D. 

 Director, EPC Program 

 Agency for Healthcare Research and Quality 

Margaret Coopey, R.N., M.G.A., M.P.S. 

EPC Program Task Order Officer 

Agency for Healthcare Research and Quality 
Structured Abstract

Objectives. To conduct a systematic review of the evidence on characteristics of community 

health workers (CHWs) and CHW interventions, outcomes of such interventions, costs and costeffectiveness of CHW interventions, and characteristics of CHW training. 

Data sources. We searched MEDLINE®, Cochrane Collaboration resources, and the 

Cumulative Index to Nursing and Allied Health Literature for studies published in English from 

1980 through November 2008. 

Review methods. We used standard Evidence-based Practice Center methods of dual review 

of abstracts, full-text articles, abstractions, quality ratings, and strength of evidence grades. We 

resolved disagreements by consensus. 

Results. We included 53 studies on characteristics and outcomes of CHW interventions, 6 on 

cost-effectiveness, and 9 on training. CHWs interacted with participants in a broad array of 

locations, using a spectrum of materials at varying levels of intensity. We classified 8 studies as 

low intensity, 18 as moderate intensity, and 27 as high intensity, based on the type and duration 

of interaction. 

Regarding outcomes, limited evidence (five studies) suggests that CHW interventions can 

improve participant knowledge when compared with alternative approaches such as no 

intervention, media, mail, or usual care plus pamphlets. We found mixed evidence for CHW 

effectiveness on participant behavior change (22 studies) and health outcomes (27 studies): some 

studies suggested that CHW interventions can result in greater improvements in participant 

behavior and health outcomes when compared with various alternatives, but other studies 

suggested that CHW interventions provide no statistically different benefits than alternatives. 

Low or moderate strength of evidence suggests that CHWs can increase appropriate health care 

utilization for some interventions (30 studies). The literature showed mixed results of 

effectiveness when analyzed by clinical context: CHW interventions had the greatest 

effectiveness relative to alternatives for some disease prevention, asthma management, cervical 

cancer screening, and mammography screening outcomes. CHW interventions were not 

significantly different from alternatives for clinical breast examination, breast self-examination, 

colorectal cancer screening, chronic disease management, or most maternal and child health 

interventions. 

Six studies with economic and cost information yielded insufficient data to evaluate the costeffectiveness of CHW interventions relative to other community health interventions. 

Limited evidence described characteristics of CHW training; no studies examined the impact 

of CHW training on health outcomes. 

Conclusions. CHWs can serve as a means of improving outcomes for underserved 

populations for some health conditions. The effectiveness of CHWs in numerous areas requires 

further research that addresses the methodological limitations of prior studies and that 

contributes to translating research into practice. 

Contents 

Executive Summary........................................................................................................................ 1 

Evidence Report 

Chapter 1. Introduction ..................................................................................................................11

Background................................................................................................................................... 11

Health Disparities in the United States ..................................................................................11

Role of the Community Health Worker in Addressing Health Disparities ...........................11

History of Community Health Workers.................................................................................12

Key Questions and Analytic Framework...................................................................................... 14

Key Questions........................................................................................................................14

Analytic Framework for Outcomes of Community Health Worker Interventions....................... 14

Production of This Evidence Report............................................................................................. 15

Organization...........................................................................................................................15

Technical Expert Panel (TEP) ...............................................................................................15

Uses of This Report ...................................................................................................................... 16

Chapter 2. Methods........................................................................................................................17

Literature Review Methods........................................................................................................... 17

Inclusion and Exclusion Criteria............................................................................................17

Literature Search and Retrieval Process ................................................................................18

Literature Synthesis ...................................................................................................................... 21

Development of Evidence Tables and Data Abstraction Process..........................................21

Quality Rating of Individual Studies .....................................................................................22

Strength of Available Evidence .............................................................................................22

Applicability of the Evidence ................................................................................................23

External Peer Review.................................................................................................................... 23

Chapter 3. Results ..........................................................................................................................25

KQ 1: Interaction of Community Health Workers and Participants............................................. 25

Overview of Interaction Between Community Health Workers and Participants.................26

Intensity of Interaction...........................................................................................................27

Community Health Worker-Participant Interaction by Clinical Context ..............................27

KQ 2: Outcomes of Community Health Worker Interventions.................................................... 37

Outcomes for Health Promotion and Disease Prevention......................................................38

Outcomes for Injury Prevention.............................................................................................46

Outcomes for Maternal and Child Health..............................................................................49

Outcomes for Cancer Screening ............................................................................................60

Outcomes for Chronic Disease Management ........................................................................84

KQ 3: Cost-Effectiveness of Community Health Worker Interventions...................................... 99

Overview of Economic Analyses...........................................................................................99

KQ 4: Training of Community Health Workers......................................................................... 106

Characteristics of Training for Community Health Workers ..............................................106

Patient Outcomes of Community Health Worker Training .................................................110

Chapter 4. Discussion ..................................................................................................................111
Interactions between Community Health Workers and Clients (KQ 1) ..................................... 111

Outcomes of Community Health Worker Interventions (KQ 2) ................................................ 112

Knowledge ...........................................................................................................................114

Behavior...............................................................................................................................115

Satisfaction...........................................................................................................................118

Health Outcomes..................................................................................................................118

Health Care Utilization ........................................................................................................121

Applicability of Findings about Outcomes..........................................................................124

Summary Findings by Clinical Context...............................................................................125

Cost-Effectiveness of Community Health Worker Interventions (KQ 3) .................................. 127

Training of Community Health Workers (KQ 4) ....................................................................... 129

Limitations of this Review.......................................................................................................... 130

Limitations of the Evidence Base ........................................................................................130

Limitations of the Review....................................................................................................131

Future Research Directions......................................................................................................... 132

Conclusion .................................................................................................................................. 134

References....................................................................................................................................137

Figures 

Figure 1. Outcomes of community health worker interventions: conceptual framework.....15

Figure 2. Results of literature search.....................................................................................21

Tables 

Table 1. Inclusion/exclusion criteria....................................................................................18

Table 2. MEDLINE search strategy and unduplicated results for April 2008.....................19

Table 3. Overall unduplicated results and sources of all searches.......................................20

Table 4. Strength of evidence grades and definitions ..........................................................23

Table 5. CHW-participant interactions for health promotion and disease prevention.........28

Table 6. CHW-participant interactions for injury prevention..............................................30

Table 7. CHW-participant interactions for maternal and child well-being..........................31

Table 8. CHW-participant interactions for cancer screening...............................................33

Table 9. CHW-participant interactions for chronic disease management ...........................35

Table 10. CHWs and health promotion and disease prevention: pediatric immunization 

interventions...........................................................................................................39

Table 11. CHWs and health promotion and disease prevention: Latina health promotion 

interventions...........................................................................................................41

Table 12. CHWs and health promotion and disease prevention: disease prevention 

interventions...........................................................................................................43

Table 13. CHW injury prevention interventions and home safety ........................................47

Table 14. CHW injury prevention interventions and workplace safety.................................48

Table 15. CHW maternal and child interventions and prenatal care and perinatal 

outcomes ................................................................................................................50

Table 16. CHW maternal and child interventions and child development ............................53
Table 17. CHW maternal and child interventions and environment conducive to child 

health......................................................................................................................56

Table 18. CHW cancer screening: improving knowledge .....................................................62

Table 19. CHW cancer screening: changing planned behaviors ...........................................63

Table 20. CHW cancer screening: changing breast self-examination behavior ....................64

Table 21. CHW cancer screening: Pap smears ......................................................................67

Table 22. CHW cancer screening: mammography ................................................................72

Table 23. CHW cancer screening: clinical breast examination .............................................81

Table 24. CHW cancer screening: colorectal cancer screening.............................................84

Table 25. CHW chronic disease management: diabetes mellitus ..........................................85

Table 26. CHW chronic disease management: hypertension ................................................88

Table 27. CHW chronic disease management: infectious diseases .......................................91

Table 28. CHW chronic disease management: back pain......................................................92

Table 29. CHW chronic disease management: mental health ...............................................93

Table 30. CHW asthma interventions and behavior ..............................................................95

Table 31. CHW asthma interventions and health outcomes ..................................................96

Table 32. CHW asthma interventions and health care utilization..........................................98

Table 33. Summary of economic analyses of CHW interventions......................................105

Table 34. CHW training and evaluation results...................................................................107

Table 35. Number of studies, by clinical focus and intensity of interventions....................112

Table 36. Summary of studies reporting on outcomes by primary clinical context and 

subtopic................................................................................................................113

Table 37. Effect of CHW interventions on knowledge: strength of evidence .....................115

Table 38. Effect of CHW interventions on behavior: strength of evidence.........................116

Table 39. Effect of CHW interventions on participant satisfaction: strength of 

evidence ...............................................................................................................118

Table 40. Effect of CHW interventions on health outcomes: strength of evidence.............119

Table 41. Effect of CHW intervention on health care utilization: strength of evidence......121

Table 42. Cost and cost-effectiveness of CHW interventions: strength of evidence...........128

Appendixes 

Appendix A: Exact Search Strings 

Appendix B: Sample data abstraction forms 

Appendix C: Evidence tables 

Appendix D: List of Excluded Studies 

Appendix E: Acknowledgements 

Appendixes cited in this report are available at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/comhealthwork/comhwork.pdf. 
Executive Summary 

Introduction 

The United States has experienced remarkable improvements in public health and medical 

progress throughout much of the twentieth century, including major advances in pharmaceutical 

and medical device innovation and gains in life expectancy. These improvements, however, have 

not been accessible to all parts of U.S. society. Substantial disparities in life expectancy, health, 

and health care persist. Although many actors—including health care systems, insurers, health 

care providers, and patients—contribute to these disparities, bias, discrimination, and 

stereotyping during the clinical encounter also explain health care disparities. Experts 

recommend reducing fragmentation in health care systems, improving awareness on the part of 

health care providers of these problems, strengthening culturally competent approaches to the 

delivery of health care, and increasing the diversity of the health care workforce, as strategies to 

reduce health care disparities. A core component in recommendations to address healthcare 

disparities is the involvement of the community: specifically, the involvement of community 

health workers (CHWs). 

The RTI International–University of North Carolina at Chapel Hill Evidence-based Practice 

Center (RTI-UNC EPC) conducted a systematic review on outcomes of CHW interventions. The 

review addressed four key questions (KQs): 

KQ 1. How do CHWs interact with participants? Specifically, what is the place of service, type 

of service, type of educational materials used, duration of interaction with participants, 

and length of followup? 

KQ 2. What is the impact of CHWs on outcomes, particularly knowledge, behavior, satisfaction, 

health outcomes, and health care utilization? 

KQ 3. What is known about the cost-effectiveness of CHWs for improving health outcomes? 

KQ 4a. What are characteristics of training for CHWs in the outpatient setting? 

KQ 4b. Are particular training characteristics associated with improved outcomes for patients? 

Methods 

We searched MEDLINE®, Cochrane Collaboration resources, and the Cumulative Index to 

Nursing and Allied Health Literature for studies published in English from 1980 through 

November 2008 in the United States. We refined KQs in collaboration with a panel of technical 

experts. We searched data sources using more than 10 terms for CHWs, including the Medical 

Subject Heading term “community health aides.” We used standard Evidence-based Practice 

Center methods of dual review of abstracts, full-text articles, abstractions, quality ratings, and 

strength of evidence grades. We resolved disagreements by consensus. We identified 53 studies 

addressing KQ 1 and KQ 2, 6 studies addressing KQ 3, and 9 studies addressing KQ 4.

1 
Results 

KQ 1: Characteristics of Community Health Worker Interaction with 

Participants 

KQ 1 asks for descriptions of the interaction between CHWs and participants; specifically, 

we examined place of service, type of service, type of educational materials used, duration of 

interaction with participants, and length of follow-up. CHWs interacted with participants in a 

broad array of locations, using a spectrum of materials at varying levels of intensity. Studies 

usually described the place of service and type of intervention in some detail. Across the studies, 

one-on-one interventions generally occurred in the home, over the telephone, or in a medical 

setting; by contrast, group interventions tended to take place in a community setting. Studies 

described types of educational materials poorly or not at all. Studies inconsistently reported 

duration of interaction with participants and length of followup (the number and length of 

sessions), and studies did not always clarify whether their reporting was based on protocol or on 

actual experience. 

We synthesized the variety of ways in which CHWs can interact with participants into a 

single measure of intensity that serves as a proxy of resource allocation. We classified 

interactions that reported at least four of six elements suggesting a higher resource utilization 

(one-on-one, face-to-face, 1 hour per session or more, 3 or more months’ duration, three or more 

interactions, and tailored materials) as high intensity; interventions with two or three elements as 

moderate intensity; and interventions with only one or none of the elements as low intensity. Of 

the total of 53 studies, we classified 27 as high intensity, 18 as moderate intensity, and 8 as low 

intensity. The intensity of CHW interventions varied by clinical context: maternal and child 

health and chronic disease management interventions were all moderate or high intensity, 

whereas prevention and screening studies were more likely to include low-intensity 

interventions. 

KQ 2: Outcomes of Community Health Worker Interventions 

KQ 2 asks about the impact of CHWs on outcomes, with specific attention to the following 

five domains: knowledge, behavior, satisfaction, health outcomes, and health care utilization. In 

addition, we summarize results by a key source of heterogeneity, the clinical context of the CHW 

intervention. 

Summary by Outcomes 

Knowledge. The five studies reporting information on knowledge together provided 

moderate strength of evidence that CHW interventions improve the knowledge of participants on 

disease prevention and cancer screening, compared with other alternatives, and provided low 

strength of evidence that CHW interventions improve knowledge of label reading among 

diabetics, compared with usual care, but these studies gave insufficient evidence for knowledge 

of other issues related to the management of diabetes. This literature did not compare CHWs 

with a comprehensive range of usual care providers; we cannot therefore conclude that CHWs 

outperform all alternatives in improving participant knowledge. For the small subset of 

comparators and outcomes included in this literature, the studies together suggest that CHW 

2 
interventions can improve participant knowledge when compared with alternative approaches 

such as no intervention, media, mail, or usual care plus pamphlets. 

Behavior. Twenty-two studies reported on the effect of CHW interventions on participant 

behavior. The evidence for workplace safety, diabetes mellitus, and the use of bedding 

encasements for asthma, from five studies, suggested that CHW interventions result in 

improvements in participant behavior when compared with alternatives such as a community 

intervention, a lower-intensity CHW intervention, and usual care combined with a pamphlet. The 

strength of evidence is moderate for the use of bedding encasements for asthma and low for 

workplace safety and diabetes mellitus. The evidence for disease prevention, improving the 

environment for child well-being, planned use of cancer screening tests, and breast selfexamination, from 14 studies, is mixed, with some studies demonstrating a statistically 

significant benefit of the CHW arm, and others demonstrating a lack of significant difference. 

The strength of evidence for these outcomes is low. The evidence for health promotion among 

Latinas, injury prevention at home, and smoking cessation to reduce asthma, from five studies, 

failed to demonstrate that CHW interventions resulted in significantly different outcomes than 

alternatives; the strength of evidence for these outcomes is low. 

Together these studies suggest that CHW interventions can, in some instances, result in 

greater positive changes in participant behavior when compared with a range of alternatives 

(including no intervention, community intervention, usual care plus a newsletter, media, print, a 

less intense or delayed CHW arm, or a combination of interventions). In other instances, CHW 

interventions provided no statistically different benefit when compared with a range of 

alternatives. When the alternative requires greater resource allocation, as with the use of health 

care professionals, the absence of statistically significant differences may favor the use of 

CHWs. 

Satisfaction. A single study, focusing on mental health among the homeless, found no 

differences between study arms in participant satisfaction; the strength of evidence for this 

outcome is low. 

Health outcomes. The literature examined CHW effectiveness on a range of outcomes: 27 of 

53 studies reported health outcomes. Moderate strength of evidence exists that CHW 

interventions improve health outcomes for two clinical areas (improving back pain and 

improving psychosocial outcomes among caregivers of children with asthma) when compared 

with either a lower-intensity CHW intervention or a delayed-intervention control group (three 

studies). The evidence for other outcomes (pediatric immunizations, prenatal care and perinatal 

outcomes, child development, environment conducive to child well-being, mental health, 

diabetes, and asthma symptoms), from 22 studies, is mixed, with some studies suggesting that 

CHW interventions are more effective than alternatives (including no intervention, usual care, 

and nurses), and other studies showing no difference between CHW interventions and 

alternatives. For disease prevention (specifically, reduction in body mass index), hypertension, 

and mental health, the evidence from five studies suggests no difference between CHW 

interventions and alternative approaches, including the use of CHWs in a lesser capacity, nurses, 

and print materials; the strength of evidence for these outcomes is low. 

Together these studies showed that CHW interventions had a greater effect on some health 

outcomes when compared with alternatives such as no intervention, usual care, and nurses, but 

these findings were not consistent across all studies; several studies found no statistically 

significant benefit of the CHW arm when compared with alternative approaches. 

3 
Health care utilization. More than one-half of the identified studies reported on health care 

utilization. Fifteen studies provided moderate strength of evidence that CHW interventions 

increase appropriate health care utilization for disease prevention, mammography, infectious 

diseases, and asthma when compared with a range of alternatives such as no intervention, mail, 

print, or a less intense CHW arm. Two studies offered low strength of evidence that CHW 

interventions provide statistically significant benefits in health care utilization for two outcomes: 

prenatal and perinatal care (when compared with nurses) and hypertension (when compared with 

usual care). For Pap smears, six studies provided mixed evidence, with some studies suggesting a 

statistically significant benefit for the CHW arm, and other studies suggesting no significant 

differences; the strength of evidence for this outcome is low. For health promotion among 

Latinas, child well-being, clinical breast examination, colorectal cancer screening, and mental 

health, evidence from nine studies suggested no difference between the CHW intervention and 

alternatives; the strength of evidence for these outcomes is low. 

Together these studies provided low to moderate evidence that CHW interventions increase 

appropriate health care utilization (e.g., more use of cancer screening tests, less use of emergency 

services) when compared with a range of alternatives for disease prevention (specifically, 

medical follow-up for elevated blood pressure), mammography, infectious diseases, and asthma; 

for other reported outcomes, the evidence was mixed or does not show a statistically significant 

benefit of the CHW arm. 

Summary Findings by Clinical Context 

Health promotion and disease prevention. Eleven studies addressed health promotion and 

disease prevention, including pediatric immunizations, cardiovascular disease, diabetes 

prevention, HIV prevention, secondhand smoke exposure, colorectal cancer prevention, and 

general preventive care. Two studies on disease prevention found that CHW interventions versus 

print or no intervention were more effective in changing knowledge. Results for CHW 

interventions on behavior outcomes were mixed, with one-half of the studies favoring CHW 

intervention versus control groups, which consisted of no intervention, media, print, or a 

combination of interventions. None of the studies evaluated outcomes in the area of satisfaction. 

Results for CHW interventions on health outcomes, available from four studies, were also mixed. 

The results suggest that CHW interventions may serve as an effective means of improving 

knowledge outcomes and possibly other outcomes related to preventing disease in underserved, 

minority populations. 

Injury prevention. Three studies assessed injury prevention measures and associated 

behavioral outcomes: two focused on home injury prevention, and one considered workplace 

injury prevention. One study found improvements in behavior associated with CHW 

interventions when compared with a minimal community intervention, and one found mixed 

results with CHW interventions showing a statistically significant benefit in some measures but 

controls (with no intervention) showing a statistically significant benefit over CHW interventions 

for other measures. One study showed no significant difference in behavior between CHW 

interventions and health care professionals. The mixed results preclude any firm conclusions 

regarding the benefit of CHW interventions for injury prevention behaviors. 

Maternal and child health. Fifteen studies meeting our inclusion criteria involved primarily 

maternal health, child health, or both and reported mainly on health outcomes. A statistically 

significant benefit of CHWs over standard care was shown most prominently in rapidity of 

metabolic control for mothers with phenylketonuria (PKU) and in the mental development of 

4 
infants of mothers with PKU. CHW interventions were associated with a greater likelihood of 

initiating breastfeeding among African Americans, more frequent use of nonviolent discipline 

methods by parents, and higher parenting efficacy scores when compared with videointervention or no-intervention controls. CHWs were also associated with significant attenuation 

in the decline of cognitive and motor development among infants with failure to thrive and with 

a lesser degree of increase in depressive symptoms among postpartum women when compared 

with no intervention. No significant advantage to CHW intervention was seen for improvements 

in incidence of low birth weight, presence of neonatal or infant health problems, language 

development, maternal stress or self-esteem, continuation of breastfeeding beyond 1 week, 

tobacco exposure for children of smokers, continued drug use among mothers with known prior 

drug use, growth of children with failure to thrive, or incidence of child maltreatment when 

compared with nurse interventions, multidisciplinary specialty clinical care, video or print 

intervention, routine health care, or no intervention. 

Most studies involving CHWs for maternal and child health have been concerned with highrisk populations. For maternal and child health, CHWs appear to be most beneficial when 

addressing existing health conditions instead of potential conditions (i.e., primary prevention). 

Of the 15 studies that were evaluated, 8 studies reported statistically significant benefit to CHWs, 

compared with nurse interventions, multidisciplinary specialty clinical care, video or print 

intervention, routine health care, or no intervention. CHWs have not yet been shown to improve 

key health outcomes relating to maternal and child health such as prematurity, low birth weight, 

sustained breastfeeding, or child maltreatment relative to other alternatives such as video or print 

intervention, routine health care, or no intervention. The lack of such findings suggests that 

either further research is needed to demonstrate benefits or that there is a true lack of benefit for 

CHWs in this domain. 

Cancer screening. Fifteen studies examining knowledge or health care utilization outcomes 

of CHW interventions for improving breast, cervical, or colorectal cancer screening met 

inclusion criteria for this systematic review. Together the 15 studies suggest limited evidence of 

improvement in knowledge in the CHW arm, compared with alternative approaches such as 

media or mail, and these studies also suggest conflicting findings on the effect of CHWs on 

planned or actual behavior changes—specifically, breast self-examination—when compared with 

no intervention, delayed intervention, mail, minimal CHW, or usual care. The volume of 

evidence on these outcomes is limited; the quality and design of the studies limit the 

interpretation of available evidence. Regarding health care utilization, our findings from limited 

evidence suggest that CHW interventions are not effective in comparison with other alternatives 

(such as no intervention, mail, tailored print and video, and minimal CHW) in raising the rates of 

clinical breast examination or colorectal cancer screening. More substantial evidence exists on 

Pap smears and mammography. The evidence suggests that the CHW arm is at least as effective 

as other alternatives (such as mail or lower-intensity CHW interventions) in improving Pap 

smear rates, but more effective than other alternatives (such as no intervention, media, print, 

community interventions, and usual care) only with low- and moderate-intensity interventions 

(rather than high-intensity interventions). Studies demonstrated significantly greater 

improvements in the CHW arm, compared with the alternative (no intervention, mail, print, or 

minimal CHW) in the main analysis or in subgroup analysis among low-income, minority, or 

other underserved subsamples. 

CHW interventions were not demonstrated to be more effective than alternatives for 

increasing the utilization of breast self-examination, clinical breast examination, or colorectal 

5 
cancer screening. CHWs can serve as a means of improving utilization of Pap smear tests and 

mammograms for underserved populations; the effectiveness of CHWs for other outcomes 

requires further research. 

Chronic disease management. Thirteen studies addressed disease management, including 

diabetes mellitus, hypertension, asthma, back pain, mental health, and tuberculosis. Only one of 

the studies in the area of chronic disease management addressed knowledge outcomes. Two of 

four CHW interventions on diabetes and two asthma studies addressed behavior changes, 

comparing the CHW arm with usual care or a less intense CHW arm. These studies found that 

CHW interventions provided statistically significant benefit for diabetes and for use of bedding 

encasements in asthma, but not for smoking cessation. Only the mental health study addressed 

satisfaction outcomes, and this study did not demonstrate a difference between the CHW group 

and the control. Regarding health outcomes, two of four studies focusing on diabetes 

management found that a CHW intervention was more effective than usual care in decreasing 

hemoglobin A1c. None of the studies addressing hypertension management showed a significant 

difference in blood pressure control between groups. Two asthma studies demonstrated that 

CHW interventions were more effective than alternatives in reducing unscheduled health care 

services, improving psychological outcomes, and changing behavior, although symptom 

measures improved equally in each group. With the exception of asthma, the majority of CHW 

interventions for chronic disease management (specifically, diabetes, hypertension, and mental 

health) failed to show consistently greater improvement in health outcomes than usual care. By 

contrast, four of five studies on chronic disease management found that a CHW intervention was 

more effective than usual care or a less intense CHW arm in improving health care utilization. 

KQ 3: Cost-Effectiveness of Community Health Worker Interventions 

We identified six studies in the literature providing economic analyses of CHW 

interventions. All of the studies included in our review estimated intervention program costs, but 

not all reported the specific components of those costs or the year for which costs were 

estimated. None of the CHW intervention evaluations that included an economic analysis 

reported a standard measure of costs per quality-adjusted life year saved, as recommended in 

recent guides for performing economic evaluations. One study did report on the costs per lifeyear saved of the CHW intervention, but potential biases in measurement limit the interpretation 

of results. We found insufficient evidence to evaluate whether CHW interventions are a costeffective alternative to clinical interventions to promote health and prevent disease. 

KQ 4: Training of Community Health Workers 

We found only nine studies meeting our inclusion criteria that described the training of 

CHWs. All included studies reported evidence of improvement in knowledge or skills, and many 

focused on aspects of training relevant to the specific health concern. Few reported on training 

for cultural competence, recruitment and retention process skills, intake and assessment, or 

protocol delivery. The failure to report on these elements presents a roadblock to identifying 

critical elements of a standardized curriculum applicable to all CHWs. 

No studies reported on the effects of CHW training on health outcomes. The question of how 

to tailor CHW training to improve health outcomes is a significant gap for future studies to 

address. 

6 
7 

Discussion 

CHW interventions have the potential to address two fundamental imperatives for improving 

health care in the United States: the need to address substantial and persistent health care 

disparities, and the need to translate more research into practice. CHWs, by virtue of their role as 

a bridge to the health care system, can help to disseminate widely efficacious interventions to 

populations that rarely benefit from health care advances. 

Evidence about the effectiveness of CHWs relative to other choices is, however, mixed. 

Some studies demonstrated statistically significant benefits of the CHW approach, compared 

with other choices; other studies showed mixed results or no statistically significant differences 

between study arms. For the latter studies, one explanation is a lack of true benefit of the CHW 

arm relative to other choices. In addition, the choice of controls (including health professionals 

and CHWs in a lesser capacity), inadequate study power, and the Hawthorne effect may explain 

the lack of significant differences between CHWs and alternatives. The variation in and 

inadequate reporting on components of CHW interventions limit assessments of whether highintensity interventions deliver greater value than low- or moderate-intensity interventions. 

We found limited evidence that suggests that CHW interventions can improve participant 

knowledge when compared with alternative approaches such as no intervention, media, mail, or 

usual care plus pamphlets. We found mixed evidence for CHW effectiveness on participant 

behavior change and health outcomes: some studies suggested that CHW interventions can result 

in greater improvements in participant behavior and health outcomes when compared with 

various alternatives, but other studies suggested that CHW interventions provide no statistically 

different benefits. Low or moderate strength of evidence suggests that CHWs can increase 

appropriate health care utilization for some interventions. The literature showed mixed results of 

effectiveness when analyzed by clinical context: CHW interventions had the greatest 

effectiveness relative to alternatives for some disease prevention, asthma management, cervical 

cancer screening, and mammography screening outcomes. CHW interventions were not 

significantly different from alternatives for clinical breast examination, breast self-examination, 

colorectal cancer screening, chronic disease management, or most maternal and child health 

interventions. We found insufficient evidence to evaluate the cost-effectiveness of CHW 

interventions relative to other public health interventions. 

Our review suggests that CHWs may serve as a means of improving outcomes for 

underserved populations for some health conditions, as described above. Other health concerns 

require further research that addresses the methodological limitations of prior studies to fully 

evaluate the effectiveness of CHW interventions. 

Evidence Report 

Chapter 1. Introduction 

Background 

Health Disparities in the United States 

The United States experienced remarkable improvements in public health and medical 

progress throughout much of the twentieth century. These advances, which have continued into 

the twenty-first century, have been accompanied by significant increases in medical spending. In 

2003, total health care spending reached approximately $1.7 trillion, accounting for nearly 16 

percent of the gross domestic product.1

 An estimated 5.6 percent of total health care spending 

was on biomedical research, a proportion unmatched by any other country.2

 Some experts note 

associations between US expenditures on biomedical research and major advances in 

pharmaceutical and medical device innovation2

 and accompanying improvements in life 

expectancy.3 

These improvements have not been accessible to all parts of US society. Substantial 

disparities in life expectancy,4

 health, and health care persist.5-9 Repeated measures of disparities 

in quality of care and access to care since 2003 demonstrate, at best, only minor improvements.5-

9

 According to an Institute of Medicine (IOM) committee report, Unequal Treatment, these 

seemingly intractable differences cannot be explained by clinically appropriate care, differing 

needs of patients, or patient preferences.10 Moreover, access-related factors such as insurance 

status and income also cannot alone explain differences in quality of care or outcomes.10 

Although many actors, including health care systems, insurers, health care providers, and 

patients, contribute to these disparities, bias, discrimination, and stereotyping during the clinical 

encounter also explain health care disparities.10 Recommendations of the IOM report, echoed by 

other publications,11,12 focus on reducing fragmentation in health care systems, improving 

awareness on the part of health care providers of these problems, strengthening culturally 

competent approaches to the delivery of health care, and increasing the diversity of the health 

care workforce.10 

Role of the Community Health Worker in Addressing Health 

Disparities 

A core component in recommendations to address health disparities is the involvement of the 

community, specifically the involvement of community health workers (CHWs).10 Models of 

care using CHWs vary from making them an integral part of the care delivery team to involving 

them as community navigators, education providers, or outreach agents.13 

A key variable along this spectrum is the extent to which CHWs operate within their own 

social networks. For example, CHW interventions using natural helpers rely on the specialized 

knowledge and expertise of CHWs working within their own social networks, whereas an 

outreach worker model may operate across social networks.14 The nomenclature for CHWs 

reflects this variation; it includes terms such as natural helpers, lay health advisors, patient 

navigators, and community health aides, among others. The disease conditions that CHWs help 

to address also reflect a wide spectrum, from AIDS prevention to smoking cessation, 

hypertension management to pediatric immunization, and asthma management to maternal and 

child care. 

11 
Common attributes across CHWs, regardless of nomenclature, health condition, or 

intervention include: (1) their role as health workers who share a relationship with their 

community (e.g., shared language, ethnicity, geography, race, or disease condition) and (2) the 

absence of professional training. The relationship that CHWs share with the community in which 

they work has long identified them as a natural bridge to the health care system. 

Explanations for the anticipated outcomes of CHW interventions typically cite theories of 

individual behavior change.15-23 Theories of individual behavior change draw upon many ideas. 

Among them are the stages of change or the transtheoretical model (a framework for 

understanding motivational readiness to address problem behaviors24), social learning or social 

cognitive theory (an explanation of individual learning as operating through the observation of 

others within the context of behavioral, environmental, and personal factors25), and the health 

belief model (an explanation of individual health behaviors through attitudes and beliefs toward 

perceived susceptibility, severity, benefits, and barriers26). 

Less frequently, authors acknowledge that these interventions also operate within the context 

of community change.27-29 According to Minkler and Wallerstein, collaborative models of 

community change range from community organizing (externally driven and motivated by 

community needs) to community building (internally generated and drawing upon community 

strengths) with variants in between.30 Several ideas help explain the drivers and mechanisms of 

community change: theories of social justice and human rights (the idea of health as a human 

right that CHWs can help to achieve in the interest of social justice28,31), collaborative 

empowerment (grantmakers, support organizations, local leaders, and individuals working 

together in a reciprocal manner32), and critical consciousness (the process of critical awareness 

by which community members become aware of their own agency and create spaces to work 

with others to bring about changes in individual and community health33,34). 

CHW engagement is expected to diffuse community change to individuals; in addition, 

CHWs are postulated to reduce disparities through improving access to care, providing culturally 

competent health education, counseling, and sometimes rendering direct health services. 

Additionally, as trusted members of the community, CHWs may help to minimize barriers to 

care resulting from health beliefs and health values.10 

History of Community Health Workers 

The history of CHWs supports the role that they continue today in providing services to 

marginalized populations. Perez and Martinez28 note that the earliest records of CHWs date back 

to a shortage of doctors in early 17th century Russia, when lay people, called “feldshers,” 

received training to provide basic medical care to military personnel.35 Later a similar model 

arose in China, where farmers with minimal medical training served as “barefoot doctors” to 

provide basic primary care, including vaccinations and treatment of minor illnesses, to rural 

underserved regions.28 Today, thousands of health programs employ CHWs worldwide for 

similar reasons.36

Internationally, a global shortage of medical workers has increased the call for these types of 

personnel. Significant health care workforce shortages are present in 57 countries, including 

countries in sub-Saharan Africa, Bangladesh, India, and Indonesia.37 Figures for the number of 

physicians per 100,000 people range from a low of 2 in Malawi to a high of 591 in Cuba; the 

number in the United States is 256.37 These figures represent overall physician proportions; the 

proportion of primary care physicians is far lower worldwide. 

12 
The AIDS epidemic in developing countries that already face a critical shortage of 

professional health care workers has strengthened the need to make greater use of CHWs. Task 

shifting allows CHWs to take on jobs that were previously performed by nurses; this 

phenomenon holds promise for rapidly filling the health care workforce deficit. One advantage 

of employing CHWs is the relatively short amount of training time they need, ranging from 

hours to weeks. This quick turnaround in training allows CHWs to be ready to provide services 

years before new nurses or doctors can complete their own training. Ultimately, the hope is that 

task shifting will improve access to primary care and, thus, serve to strengthen health care 

systems around the world.37 

In the United States, despite the relatively high ratios of physicians to patients in this country, 

a significant percentage of the population remains underserved, particularly for primary care. An 

estimated one in five Americans are medically disenfranchised due to the shortage of primary 

care physicians, meaning they have inadequate or even no access to these physicians.38 The need 

to reduce health disparities among the underserved has led to an interest in CHW interventions 

within the United States. The 2007 Community Health Worker National Workforce Study 

suggests that the development of the CHW workforce in the United States occurred over four 

important time periods: early documentation (1966-1972), utilization of CHWs in special 

projects (1973-1989), state and federal initiatives (1990-1998), and public policy options (1999-

2007).13 Few references to CHW interventions appear in the literature before the mid-1960s. 

During the period of early documentation (1966-1972), CHWs were used to address 

problems of the poor rather than in specific health improvement models. The New York City 

Health Department first documented CHW use in a 1960s-era tuberculosis program that involved 

“neighborhood health aides.”39 One early effectiveness study on CHWs (published in 1970) 

consisted of a CHW intervention with nurses and physicians to improve compliance in treating 

pediatric infections.40 

Public and private funding of projects involving CHWs continued to grow from 1973 to 

1989, in turn prompting more publications.13 Further attention was brought to CHWs as a result 

of a World Health Organization (WHO) declaration in 1978, proposing the development of 

national CHW programs as important for promoting primary health care.41 Another significant 

step for dissemination of CHW programs occurred when the “Resource Mothers” curriculum, 

prepared for the Virginia Task Force on Infant Mortality during the 1980s, became one of the 

early CHW curricula distributed nationally.42 

From 1990 to 1998, several state and federal bills proposed CHW interventions; none, 

however, was enacted. Despite this lack of legislative support, training centers dedicated to 

CHWs opened in Boston43 and San Francisco.44 Support remained high for the promise of CHW 

interventions with the expectation that the widespread incorporation of CHWs into the health 

delivery system would offer opportunities to improve the delivery of preventive and primary 

health care in the United States.45

The state of Texas passed the first legislation addressing the CHW workforce in 1999, 

starting the public policy options period (1999-2006).13,46 During this time, several associations 

called for expansion of CHW roles and projects, including the National Rural Health 

Association, the American Association of Diabetes Educators, and the American Public Health 

Association. As noted earlier, the 2003 IOM report also made recommendations regarding the 

role of CHWs in addressing health care disparities.10 Finally, during this same period the first 

national legislation on CHWs was passed: The Patient Navigator Outreach and Chronic Disease 

13 
Prevention Act of 2005. Additionally, the state of Minnesota passed legislation allowing for 

Medicaid coverage of CHW services in December of 2007.47

In 2000, an estimated 86,000 CHWs were supporting American communities.13 The number 

of CHWs has continued to grow since then to an estimated 121,000 CHWs in 2005, representing 

a 41 percent increase from 2000.13

Key Questions and Analytic Framework 

Key Questions 

Numerous recent reviews have examined the effectiveness of CHWs, but their scope has 

often been limited to specific disease conditions,48,49 subpopulations,50,51 or study designs.52,53

The Agency for Healthcare Research and Quality (AHRQ) commissioned the RTI International–

University of North Carolina Evidence-based Practice Center (RTI-UNC EPC) to conduct a 

systematic review on outcomes of CHW interventions. The nominator for this work was the 

Minnesota Department of Human Services (MDHS). 

The EPC received and revised key questions (KQs) after discussions with internal technical 

staff, AHRQ staff, MDHS staff, and our Technical Expert Panel (TEP, see below). The final 

KQs are as follows: 

KQ 1. How do community health workers interact with participants? Specifically, what is the 

place of service, type of service, type of educational materials used, duration of 

interaction with participants, and length of followup? 

KQ 2. What is the impact of community health workers on outcomes, particularly knowledge, 

behavior, satisfaction, health outcomes, and health care utilization? 

KQ 3. What is known about the cost-effectiveness of community health workers for improving 

health outcomes? 

KQ 4a. What are characteristics of training for community health workers in the outpatient 

setting? 

KQ 4b. Are particular training characteristics associated with improved outcomes for patients? 

Analytic Framework for Outcomes of Community Health 

Worker Interventions 

Based on our discussion with TEP members, we used the following operational definition of 

CHWs: A CHW: 

• Performs health-related tasks to create a bridge between community members, 

especially hard-to-reach populations, and the health care system (i.e., performs tasks 

extending beyond peer counseling or peer support alone). 

• Has health training associated with the intervention; training is shorter than that of a 

professional worker (i.e., training does not form part of a tertiary education 

certificate). 

• Is recognized (or can be identified) as a member of the community in which he or she 

works, defined by but not limited to, geographic location, race or ethnicity, and 

exposure or disease status. 

14 
As reflected in Figure 1, KQ 1 and KQ 4a are descriptive questions. The information 

obtained through KQ 1 will inform KQ 2. KQ 3 evaluates cost information for the subset of 

evidence identified in KQ 1 as effective. The heterogeneity of health conditions, CHW 

intervention types, and comparators will be explicitly addressed in all KQs. 

Figure 1. Outcomes of community health worker interventions: conceptual framework 

CHW Characteristics: Motivation, setting, ethnic concordance, integration with health care 

system

Training (KQ4)

Intervention 

with CHW 

Component

CHW-Client 

Interaction

Health Care 

and Utilization 

Outcomes

Population with 

Health Concern

Patient Characteristics: Demographics (age, sex, race, education), cointerventions, income, 

 immigration status

Population Characteristics: Appropriateness of intervention, eligibility of population

Societal Characteristics: Socio-economic policy, insurance, cultural barriers, availability of 

 services, health benefits

CostEffectiveness

(KQ3)

KQ1 KQ2

Production of This Evidence Report 

Organization 

Chapter 2 describes our methods, including our search strategies and inclusion/exclusion 

criteria; we also document our approach to grading the quality of articles and rating the strength 

of evidence. In Chapter 3, we report the results of literature searches and synthesis of retained 

articles for KQs 1, 2, 3, and 4. Chapter 4 presents our conclusions and offers our 

recommendations for future research. 

References and included studies follow Chapter 4. Appendixes include a detailed description 

of our search strings (Appendix A*

), data collection forms (Appendix B), detailed evidence 

tables (Appendix C), excluded studies (Appendix D), and acknowledgments (Appendix E). 

Technical Expert Panel (TEP) 

In designing the study questions and methodology at the outset of this report, we consulted 

several technical and content experts, seeking broad expertise and perspectives. We identified 

 

*

 Appendixes are cited in this report and provided electronically at

http://www.ahrq.gov/downloads/pub/evidence/pdf/comhealthwork/comhwork.pdf 

15 
16 

seven technical experts to provide assistance throughout the project (Appendix E); two were 

employed by the Minnesota Department of Human Services (the nominator for this topic). The 

TEP contributed to AHRQ’s broader goals of (1) creating and maintaining science partnerships 

as well as public-private partnerships and (2) meeting the needs of an array of potential 

customers and users of its products. Thus, the TEP was both an additional resource and a 

sounding board during the project. 

Divergent and conflicting opinions are common; we perceive them as healthy scientific 

discourse that contributes to a thoughtful, relevant systematic review. Nonetheless, in the end, 

study questions, design, and/or methodologic approaches do not necessarily represent the views 

of individual technical and content experts. 

To ensure robust, scientifically relevant work, we called on the TEP to provide reactions to 

work in progress and advice on substantive issues or possibly overlooked areas of research. 

Specifically, TEP members participated in conference calls and discussions through e-mail to: 

• refine the analytic framework and KQs at the beginning of the project; 

• discuss the preliminary assessment of the literature, including inclusion/exclusion 

criteria; and 

• provide input on the information and categories included in evidence tables. 

Because of their extensive knowledge of the literature, including numerous articles authored 

by TEP members themselves, and their active involvement in the field, we also asked TEP 

members to participate in the external peer review of the draft report. 

Uses of This Report 

We anticipate that this report will be useful to primary care and public health practitioners; 

community health workers; national, state, and local health policy makers; Medicaid and other 

public and private insurers; and community-based researchers. As noted above, we will explicitly 

consider CHW effectiveness by clinical concern; specialists in these areas may also find this 

report to be of use in designing and allocating resources for future CHW interventions. 
Chapter 2. Methods 

In this chapter, we document the procedures that the RTI International–University of North 

Carolina Evidence-based Practice Center (RTI–UNC EPC) used to develop this comprehensive 

evidence report on community health workers (CHWs). The team was led by a senior health 

services researcher (Meera Viswanathan, Ph.D., Study Director), and included a physician 

trained in internal medicine and pediatrics (Dan Jonas, M.D., M.P.H.), a general internist 

(Jennifer Kraschnewski, M.D.), a preventive medicine physician (Brett Nishikawa, M.D.), an 

economist (Amanda Honeycutt, Ph.D.), and two EPC staff members, Laura Morgan, M.A., and 

Patricia Thieda, M.A. 

We describe our inclusion and exclusion criteria, search and retrieval process, and methods 

of abstracting relevant information from the eligible articles to generate evidence tables. We also 

discuss our criteria for grading the quality of individual articles and for rating the strength of the 

evidence as a whole. 

Literature Review Methods 

Inclusion and Exclusion Criteria 

Our inclusion and exclusion criteria are documented in Table 1. As noted in Chapter 1, this 

systematic review focuses on characteristics, outcomes, cost-effectiveness, and training of 

CHWs. We restricted our searches to the United States so that we could have data relevant to 

domestic health care concerns. We also restricted our searches to studies published in 1980 or 

thereafter to ensure that results had relevance to current practice. 

We excluded studies that (1) were published in languages other than English (given the 

available time and resources); (2) did not report information pertinent to the key clinical 

questions; (3) had fewer than 40 subjects for randomized controlled trials (RCTs) or 

nonrandomized cohorts with comparisons; and (4) were not original studies. 

A key criterion for inclusion was the requirement that the effect of the CHW had to be 

abstractable. As a result of this criterion, our review is limited to studies for which the effect of 

the CHW intervention can be isolated; we excluded 38 studies in which the outcome of the 

intervention could not be attributed to the CHW. These studies often compared usual care to a 

combination of interventions that may have included CHWs as one of several components and 

did not distinguish between the effect of the CHW and other components. Another key criterion 

was the requirement that the intervention included CHWs. As a result, we excluded studies that 

relied on peer counselors (13 studies). 

For key questions (KQs) 1, 2, and 3, we required that the CHW intervention be compared 

with an alternative; we excluded 70 studies without comparison arms. For KQ 4, we required 

that the description of training for CHWs be supported by pre- and post-training evaluation data; 

we excluded 34 studies without such data. 

17 
Table 1. Inclusion/exclusion criteria 

Category Criteria 

Populations All study populations with a CHW intervention 

Interventions Intervention must be delivered by CHWs, not peer counselors or health 

care professionals. A CHW: 

• Performs health-related tasks to create a bridge between 

community members, especially hard-to-reach populations, and 

the health care system (i.e., performs tasks extending beyond 

peer counseling or peer support alone). 

• Has health training associated with the intervention; training is 

shorter than that of a professional worker (i.e., training does not 

form part of a tertiary education certificate). 

• Is recognized (or can be identified) as a member of the 

community in which he or she works, defined by but not limited 

to, geographic location, race or ethnicity, and exposure or 

disease status. 

Comparisons KQs 1, 2, 3: CHW intervention must have a comparison arm; all 

comparisons admissible as long as the effect of the CHW intervention 

can be abstracted 

KQ 4: No comparisons required 

Outcomes KQ 1: Interaction with clients 

KQ 2: Knowledge, satisfaction, behavior, health outcomes, and health 

care utilization 

KQ 3: Cost data 

KQ 4: Training characteristics 

Time period 1980 to November 14, 2008 

Study settings and geography United States 

Publication languages English only 

Admissible evidence (study design and 

other criteria) 

Admissible designs

controlled trials (n ≥ 40), nonrandomized controlled trials (n ≥ 40), 

systematic reviews, meta-analyses, prospective trials with historical 

controls (n ≥ 40) 

Other criteria 

• Original research studies must provide sufficient detail 

regarding methods and results to enable use and adjustment 

of the data and results 

• Relevant outcomes must be able to be abstracted from data 

presented in the papers 

• Effect of CHW intervention must be abstractable 

• KQ 4: CHW interventions must provide pre-training and posttraining evaluation of CHW knowledge or skills 

Literature Search and Retrieval Process 

Databases. We searched three electronic databases—MEDLINE®, Cochrane Collaboration 

resources, and Cumulative Index to Nursing and Allied Health Literature (CINAHL). We also 

hand-searched the reference lists of relevant articles to make sure that we did not miss any 

18 
relevant studies. We consulted with our Technical Expert Panel (TEP) about any studies or trials 

that were currently under way or that had not yet been published. 

Search terms. Based on the inclusion/exclusion criteria above, we generated a list of 

Medical Subject Heading (MeSH) search terms (Table 2 and Appendix A†). Our TEP also 

reviewed these terms to ensure that we were not missing any critical areas, and this list 

represents our collective decisions as to the MeSH terms used for all MEDLINE searches. 

Table 2. MEDLINE search strategy and unduplicated results for April 2008 

Search 

number 

Search Term Yield

#2 Search "Community Health Aides"[MeSH] OR "health advisor" OR "health worker" OR "health 

advocate" OR "health paraprofessional" OR "community health representative" OR "outreach 

worker" OR dumas OR promotoras OR embajadores OR consejeras 

6,051

#3 Search "Community Health Aides"[MeSH] OR "health advisor" OR "health worker" OR "health 

advocate" OR "health paraprofessional" OR "community health representative" OR "outreach 

worker" OR dumas OR promotoras OR embajadores OR consejeras Limits: Humans, English 

3,031

#6 Search (("Outcome Assessment (Health Care)"[MeSH] OR "Pregnancy Outcome"[MeSH])) OR 

("Treatment Outcome"[MeSH] OR "Outcome and Process Assessment (Health Care)"[MeSH] 

OR "Fatal Outcome"[MeSH]) Limits: Humans, English 

369,350

#7 Search #3 AND #6 Limits: Humans, English 175

#17 Search ("Patient Education as Topic"[MeSH] OR "Patient Education Handout "[Publication 

Type]) OR "Professional-Patient Relations"[MeSH]) OR "Office Visits"[MeSH] Limits: Humans, 

English 

109,582

#18 Search #3 AND #17 Limits: Humans, English 90

#26 Search ("Costs and Cost Analysis"[MeSH] OR "Economics"[MeSH] OR "economics 

"[Subheading] OR "Cost-Benefit Analysis"[MeSH] OR "Cost Allocation"[MeSH] OR "Cost of 

Illness"[MeSH] OR "Cost Control"[MeSH] OR "Cost Sharing"[MeSH] OR "Cost Savings"[MeSH] 

OR "Health Care Costs"[MeSH] OR "Direct Service Costs"[MeSH] OR "Hospital Costs"[MeSH] 

OR "Employer Health Costs"[MeSH] OR "Drug Costs"[MeSH]) Limits: Humans, English 

257,114

#27 Search #3 AND #26 Limits: Humans, English 254

#28 Search United States Limits: Humans, English 606,881

#29 Search #27 AND #28 Limits: Humans, English 71

#33 Search (("Education"[MeSH] OR "education "[Subheading])) OR "Education, 

Professional"[MeSH] OR training Limits: Humans, English 

370,579

#34 Search #3 AND #33 Limits: Humans, English 1,013

#35 Search #34 AND #28 Limits: Humans, English 241

#41 Search ("Randomized Controlled Trials as Topic"[MeSH] OR "Randomized Controlled Trial 

"[Publication Type]) OR "Single-Blind Method"[MeSH]) OR "Double-Blind Method"[MeSH]) OR 

"Random Allocation"[MeSH] Limits: Humans, English 

303,728

#42 Search #3 AND #41 Limits: Humans, English 165

#44 Search control OR controlled Limits: Humans, English 1,368,901

#45 Search #3 AND #44 Limits: Humans, English 908

#46 Search #45 AND #28 Limits: Humans, English 154

Total unduplicated PubMed records 640

 

†

 Appendixes cited in this report are available at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/comhealthwork/comhwork.pdf 

19 
Our initial searches in MEDLINE produced 640 unduplicated records. Searches in other 

databases (CINAHL, Cochrane, and Cochrane Clinical Trials Registry) yielded 169 new records 

(unduplicated across all databases) for a total of 809 records. We conducted update searches in 

all databases in November, 2008 and supplemented electronic searches with manual searches of 

reference lists. In addition, we received recommendations for studies of interest from the TEP 

and conducted a supplemental search on patient navigators after peer review. In all, we identified 

1,076 unduplicated references from all searches (Table 3). 

Table 3. Overall unduplicated results and sources of all searches 

Original search of MEDLINE, Cochrane, 

Cochrane Clinical Trials Registry, CINAHL (April 

2008) 

809 

Update search of MEDLINE, Cochrane, 

Cochrane Clinical Trials Registry, CINAHL 

(November 2008) 

59 

TEP recommended references 10 

Handsearches of reference lists 173 

Supplemental search (Patient Navigator) of 

MEDLINE, Cochrane, Cochrane Clinical Trials 

Registry, CINAHL 

25 

TOTAL 1,076 

Figure 2 presents the yield and results from our searches, which we conducted from April 

through November 2008. Beginning with a yield of 1,076 articles, we retained 89 articles that we 

determined were relevant to address our KQs and met our inclusion/exclusion criteria (Figure 2). 

We reviewed titles and abstracts of the articles against the basic inclusion criteria above; we 

retained relevant articles and used them as appropriate in the discussion in Chapter 4. 

Article selection process. Once we had identified articles through the electronic database 

searches, review articles, and reference lists, we examined abstracts of articles to determine 

whether studies met our criteria. Each abstract was independently, dually reviewed for inclusion 

or exclusion, using an Abstract Review Form (Appendix B).‡

 If one reviewer concluded that the 

article should be included in the review, we retained it. 

Of this entire group of 1,076 citations, 590 required full review. For the full article review, 

one team member read each article and decided whether it met our inclusion criteria, using a 

Full-Text Inclusion/Exclusion Form (Appendix B). Reasons for article exclusion are listed in 

Appendix D. 

 

‡

 Appendixes cited in this report are available at

http://www.ahrq.gov/downloads/pub/evidence/pdf/comhealthwork/comhwork.pdf 

20 
Figure 2. Results of literature search 

Literature Synthesis 

Development of Evidence Tables and Data Abstraction Process 

The team jointly developed the evidence tables. We designed the tables to provide sufficient 

information to enable readers to understand the studies and to determine their quality; we gave 

particular emphasis to essential information related to our KQs. We based the format of our 

evidence tables on successful designs that we have used for prior systematic reviews. 

We trained abstractors by having them abstract several articles into evidence tables and then 

reconvening as a group to discuss the utility of the table design. The abstractors repeated this 

process through several iterations until they decided that the tables included the appropriate 

categories for gathering the information contained in the articles. 

Four members of the team (Jennifer Kraschnewksi, Brett Nishikawa, Laura Morgan, and 

Patricia Thieda) shared the task of initially entering information into the evidence tables. Authors 

21 
of individual sections reviewed the articles and edited all initial table entries for accuracy, 

completeness, and consistency. Abstractors reconciled all disagreements concerning the 

information reported in the evidence tables. The full research team met regularly during the 

article abstraction period and discussed global issues related to the data abstraction process. 

The final evidence tables are presented in their entirety in Appendix C. Studies are presented 

in the evidence tables alphabetically by the last name of the first author. A list of abbreviations 

and acronyms used in the tables appears at the beginning of that appendix. 

Quality Rating of Individual Studies 

Quality rating forms for RCTs have been validated and in use for several years; a similarly 

well-validated form for observational studies does not exist. RTI has been developing a form to 

rate observational studies.54 This form, which can be used to rate the quality of a variety of 

observational studies, was based on a review of more than 90 AHRQ systematic reviews that 

included observational studies; we supplemented this review with other key articles identifying 

domains and scales.55,56 We structured the resultant form largely on the basis of the domains and 

subdomains suggested by Deeks and colleagues;55 we then adapted it for use in this systematic 

review (Appendix B).§ 

The form currently includes review of nine key domains for observational studies: 

background, sample selection, specification of exposure, specification of outcome, soundness of 

information, followup, analysis comparability, analysis of outcome, and interpretation. An 

additional domain for RCTs is the quality of randomization. We used these dimensions of quality 

to assess the overall quality of the study. We did not attempt to construct a quantitative scale for 

quality. Previous scales have been critiqued for their lack of inter-rater reliability. An additional 

concern is scales do not account for a single flaw that may substantially bias results, despite 

meeting standards for all other aspects of study quality. Each study was dually evaluated for 

quality; abstractors reconciled all disagreements. 

Strength of Available Evidence 

We evaluated the strength of evidence based on the AHRQ Comparative Effectiveness 

Methods Guide.57 The strength of evidence for each outcome incorporates risk of bias, 

consistency, directness, precision, and the presence of other modifying factors. As described in 

Owens et al., the evaluation of risk of bias includes assessment of study design and aggregate 

quality of studies.57 We judged good quality studies with strong designs to result in evidence 

with low risk of bias. We graded evidence as consistent when effect sizes across studies were in 

the same direction and had a narrow range. When the evidence linked the interventions directly 

to health outcomes, we graded the evidence as being direct. We graded evidence as being precise 

when results had low degree of uncertainty. When considering the effect of confounders, we 

evaluated whether the degree of intensity of interventions in both arms could have explained the 

effects (or absence of effects); additionally we considered whether other sources of effect 

modification or confounding had been accounted for. We dually evaluated the overall strength of 

evidence for each outcome based on a qualitative assessment of strength of evidence for each 

 

§

 Appendixes cited in this report are available at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/comhealthwork/comhwork.pdf 

22 
23 

domain and reconciled all disagreements. The levels of strength of evidence are shown in Table 

4. 

Table 4. Strength of evidence grades and definitions 

Grade Definition 

High High confidence that the evidence reflects the true effect. Further research is very 

unlikely to change our confidence in the estimate of effect. 

Moderate Moderate confidence that the evidence reflects the true effect. Further research may 

change our confidence in the estimate of effect and may change the estimate. 

Low Low confidence that the evidence reflects the true effect. Further research is likely to 

change our confidence in the estimate of effect and is likely to change the estimate. 

Insufficient Evidence either is unavailable or does not permit estimation of an effect. 

Applicability of the Evidence 

We evaluated the applicability of the evidence based on a qualitative assessment of the 

population, intensity, or quality of treatment, choice of the comparator, outcomes, and timing of 

followup. We based our parameters for evaluation on guidance provided by AHRQ’s 

Comparative Effectiveness Methods Guide.58 Specifically, we consider whether enrolled 

populations differ from target populations and how this might affect risk of benefits or harms, 

whether studied interventions compare to those in routine use and how this might affect risk of 

benefits or harms, whether comparators reflect best alternative treatment and how this may 

influence treatment effect size, whether measured outcomes are known to reflect the most 

important clinical benefits and harms, and whether followup is sufficient to detect clinically 

important benefits. 

External Peer Review 

AHRQ’s Scientific Resource Center requested review of this report from a wide array of 

outside experts. We received three external reviews and revised the report as appropriate. 

Chapter 3. Results 

This chapter presents the results of our evidence review for the following four key questions 

(KQs): KQ 1, interaction of CHWs with participants; KQ 2, outcomes of community health 

worker (CHW) interventions; KQ 3, cost-effectiveness of CHW interventions; and KQ 4, 

training of CHWs and the relationship between CHW training and patient health outcomes. We 

note that KQ 3, on cost-effectiveness of CHW outcomes, is derivative of KQ 2 and is limited to 

studies demonstrating effectiveness. As noted in Chapter 2, a total of 53 studies qualified for 

inclusion for KQ 1 and KQ 2, 6 for KQ 3, and 9 for KQ 4. 

Appendix C-1** provides the detailed evidence tables for KQs 1, 2, and 3. Appendixes C-2 

and C-3 present individual quality ratings for randomized clinical trials (RCTs) and 

observational studies, respectively. Appendix C-3 provides detailed abstractions for KQ 4. All 

evidence tables are presented in alphabetical order by last name of the first author. 

As noted in earlier chapters, an overall assessment of the effectiveness of CHW outcomes 

requires evaluation of sources of heterogeneity, including clinical context, intensity of interaction 

between CHWs and participants, and type of comparator. CHW interventions operate in a variety 

of clinical contexts; summarizing the effects of these interventions on varied outcomes requires 

an explicit consideration of the clinical context. For this reason, we have organized the results for 

KQs 1, 2, and 3 by the clinical context of the interventions identified. These are, specifically, 

health promotion and disease prevention, injury prevention, maternal and child health, cancer 

screening, and chronic disease management. 

An additional source of heterogeneity is the degree of intensity of the intervention, which can 

vary by clinical context. We synthesize the evidence from KQ 1 to develop a measure of the 

intensity (low, moderate, or high) of the interaction between CHWs and participants, and we 

then include the measure in describing results for KQ 2 and KQ 3. We also record other sources 

of heterogeneity such as the type of comparator. Chapter 4 discusses the effectiveness of CHW 

interventions and the potential impact of sources of heterogeneity on effectiveness more fully. 

This literature is characterized by several articles together constituting a single study. We 

refer to studies in the text and cite all relevant articles for each study; article and study counts, 

therefore, frequently do not match. Our summary tables below feature groups of studies 

addressing each outcome. Unless otherwise stated, these tables are organized alphabetically by 

the last name of the first author. The summary tables for KQ 2 and KQ 3 provide information to 

identify the study (author, and date of publication), study design, population and setting, sample 

size, study quality, intervention and comparators, and results. 

KQ 1: Interaction of Community Health Workers and 

Participants 

KQ 1 focuses on how CHWs interact with participants, specifically the place of service, type 

of service, type of educational materials used, duration of interaction with participants, and 

length of contact. We categorize place of service as over the telephone or based in the clinic, the 

community, home, or workplace. Interventions often employed multiple settings to interact with 

 

** Appendixes cited in this report are available at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/comhealthwork/comhwork.pdf 

25 
participants. The type of services ranged from one-on-one interactions to group interactions. All 

CHW interventions included some element of education; we sought to understand the degree to 

which these materials were standardized or tailored for each participant. We identified three 

elements of duration of interaction: the number of sessions, time per session, and the length of 

time from the first interaction to the last interaction (length of contact). We report summary 

findings below, for each descriptor, of the interaction between CHWs and participants across all 

studies and clinical contexts. These characteristics vary greatly across CHW interventions, but a 

common element is the overall intensity of the intervention. Interventions of lower intensity will 

require fewer resources than interventions of moderate or high intensity. As a proxy measure of 

resource allocation, we employ characteristics of the CHW-participant intervention to develop a 

measure of intensity of interaction. As noted earlier, a key organizing principle for understanding 

the effectiveness of CHW interventions is clinical context; we conclude this section by 

describing characteristics of CHW-participant interactions and their intensity by clinical context. 

Summary tables describing the characteristics of CHWs are provided by clinical context; within 

each table, studies are presented in order of intensity and then in alphabetical order, by the last 

name of the first author. 

Overview of Interaction Between Community Health Workers and 

Participants 

Place of service. CHWs interacted with participants over the telephone or provided services 

in one or more of four locations: home, community, clinic, or workplace. CHWs provided home, 

telephone, and clinic interventions on a one-on-one basis; community interventions were more 

likely to be oriented toward groups than to individuals. Thirty-two studies had at least one home 

visit but may have involved telephone and community components as well.15,17,18,23,59-102

Interventions in five studies occurred primarily by telephone.19-22,69,70,103-106 In nine studies, 

interventions included at least one meeting in a community setting and were primarily grouporiented.27,59,60,107-115 Interventions taking place in the community generally occurred in 

churches59,60,107,108 or in other neighborhood or community locations.27,102,109-114,116-122 Eight 

studies involved community interventions but did not specify the location;27,109-115,118-120 of these, 

only two were one-on-one interventions.118-121 One intervention occurred in a neighborhood 

beauty salon,116 and four occurred on the street or in shelters.117-122 Five studies took place within 

clinics or health care settings.23,77,99,123-125 One intervention occurred in the workplace.

126 We 

could not determine the place of service for one intervention.16,127

Type of service. The type of services varied greatly across included studies. CHWs provided 

a wide range of services including one-on-one counseling (face-to-face and by telephone), 

education, support, information on health and community resources, transportation, appointment 

reminders, and other forms of assistance. The type of service ranged from brief one-time 

interactions to intensive one-on-one interactions over a span of years. The minimal service 

provided was a brief, one-time interaction such as distributing condoms and providing 

prevention literature117 or a single telephone call to promote cancer screening.103 At the other end 

of the spectrum, many interventions had multiple face-to-face counseling sessions, often in the 

home, to address specific needs. 

Type of educational materials used. The least described characteristic of the interaction 

between CHWs and clients is the type of educational material used. As many as twenty-seven 

studies did not report any details on the type of educational materials utilized.16,19-23,67-74,78,79,83,85-

26 
92,96,97,99,101,104-108,117,120-122,124,125,127 Several studies did not describe educational materials per se 

but did report that they distributed “materials” as part of the intervention (e.g., safety glasses, 

materials to reduce exposure to asthma triggers, smoke detectors). The remainder provided 

minimal descriptions that ranged from the use of a postcard66 to complex systems, including 

audio and written formats to appeal to the broadest range of subjects.63

Duration of interaction (time per session and number of sessions). The duration of 

interaction varied broadly overall. Interactions lasted from quite brief (5 minutes to an hour) onetime meetings to extensive multiple interactions totaling several hours in all. 

Length of contact. The length of contact—that is, the length of time that CHWs were 

directly involved with participants (which may have differed from the length of the study, or the 

length of time between measurement of pre- and postintervention health outcomes)—was 

inadequately reported in many cases. Length of contact ranged from 1 day15,103,108,116,117 to 2.5 

years.98 

Intensity of Interaction 

Based on the type of interaction, the duration of interaction (time per session, number of 

sessions, and length of interaction), and the tailoring of CHW interactions, we classified the 

intensity of an intervention into three categories: low, moderate, or high. Interactions that had at 

least four of six elements suggesting a higher intensity (one-on-one, face-to-face, an hour per 

session or more, 3 or more months’ duration, three or more interactions, and tailored materials) 

were classified as high intensity. Interventions with two or three elements were classified as 

moderate intensity. Interventions with only one or none of the elements were classified as low 

intensity. 

In making these classifications, we relied, whenever possible, on the protocol intentions 

rather than what actually occurred. When no information was available for the protocol, we 

relied on reported interactions in the field. When interactions in the field were also not reported, 

we assumed lower intensity for that aspect for the intervention. For instance, when studies did 

not report the time spent in each session, we assumed that the time per session did not exceed an 

hour on average. Similarly, if studies did not report specifically that the materials were tailored 

for each participant, we assumed that the interventions used generic materials for all participants. 

Low-intensity interventions were generally one-time interactions, usually in a group setting. 

Moderate-intensity interventions occurred in a variety of settings but typically involved only one 

or two interactions with CHWs over shorter periods of time. High-intensity interventions 

included multiple interactions, face-to-face, for 3 months or more. Each category varies 

internally: for instance, within the high-intensity interventions, the number of interactions could 

vary from 3 to more than 20 in a year, depending on the nature of the intervention. Of the total of 

53 studies, we classified 8 studies as low intensity,19-22,59,60,103,104,107,108,113,117,126 18 as moderate 

intensity106,125,

15,23,63,66,69,70,99,101,102,105,109-112,114,116,118,119,122-124 and 27 as high 

intensity.16-18,27,61,62,64,65,67,68,71-98,100,120,121,127,128 

Community Health Worker-Participant Interaction by Clinical Context 

Community health worker-participant interactions for health promotion and disease 

prevention intervention. We included 11 studies on health promotion and disease prevention 

(Table 5). Six studies occurred in the home and by telephone;64-71 one additional study was by 

telephone and mail.105 Three studies were conducted in community settings—one in a 

27 
nonclinical site,118,119 one in churches,107 and one on community streets.117 For one study, the 

place of service was not reported.16,127 The majority of studies did not report the educational 

materials used; one of these studies provided condoms as part of the intervention.117 Only four 

studies provided some description of the educational materials used during the 

intervention.64-66,117-119 

Table 5. CHW-participant interactions for health promotion and disease prevention 

Author, Date 

of Publication 

Place of 

Service Type of Service 

Educational and 

Other Materials 

Provided 

Number of 

Sessions, Time 

per Session, and 

Length of Contact 

with Participants 

Intensity—

Low, 

Moderate, 

High 

Auslander et 

al., 200216

Williams et al., 

2001127

NR Counseling adults for 

diabetes prevention: group 

and individual sessions 

NR 6 group sessions 

and 6 individual 

sessions weekly, 

45-90 minutes per 

session, over 3 

months 

High 

Barnes et al., 

199968 Home and 

telephone 

Information and assistance, 

referral, transportation to 

clinic if needed for childhood 

immunizations 

NR Unspecified 

number of calls 

and visits, over 6 

months (time per 

session NR) 

High 

Barnes-Boyd 

et al., 200171

Nacion et al., 

200072

Home Family-focused care plan; 

support, model problemsolving skills, promote selfdevelopment of mother, 

provide instruction in infant 

care; transportation; find 

community resources for 

childhood immunizations 

NR 12 monthly visits, 

over 1 year (time 

per visit NR) 

High 

Conway et al., 

200467 Home and 

telephone 

Problem-solving techniques 

to reduce environmental 

tobacco smoke exposure to 

children 

NR 6 home and 

telephone visits 

over 4 months 

(time per session 

NR) 

High 

Elder et al., 

200564

Elder et al., 

200665

Home and/or 

telephone 

Home visits or phone calls 

for Latinas to make healthful 

dietary behavior changes 

Tailored 

newsletters with 

homework 

assignments 

12 home visits or 

telephone calls 

over a 12-week 

period, 12 weekly 

tailored newsletters 

(time per session 

NR) 

High 

Becker et al., 

2005118

Cene et al., 

2008119

Community--

nonclinical 

site 

Counseling for adults with 

risk factors for 

cardiovascular disease 

Written, culturally 

sensitive 

Multiple (number 

unspecified) 30-

minute sessions 

over 1-year period 

Moderate 

Hunter et al., 

200466 Home Facilitated appointment 

scheduling for annual 

preventive exams for Latinas

Postcard 1 initial home visit 

and 1 final followup 

visit 8 weeks after 

postcard mailing to 

begin intervention 

(time per session 

NR) 

Moderate 

NR, not reported. 

28 
Table 5. CHW-participant interactions for health promotion and disease prevention (continued) 

Author, Date 

of Publication 

Place of 

Service Type of Service 

Educational and 

Other Materials 

Provided 

Number of 

Sessions, Time 

per Session, and 

Length of Contact 

with Participants 

Intensity—

Low, 

Moderate, 

High 

Krieger et al., 

1999105 Telephone 

and mail 

Referral to medical care; 

appointment scheduling 

assistance; appointment 

reminder letter; followup to 

determine whether the 

appointment was kept; a 

new appointment for each 

missed appointment (up to 

3); and assistance in 

reducing barriers to care 

through referral to 

community transportation, 

child care, or other services 

NR Various, brief 

interactions over 3 

months (time per 

session NR) 

Moderate 

Rask et al., 

200169

LeBaron et al., 

200470

Home and 

telephone 

Appointment reminder, 

assistance in overcoming 

barriers to appointment for 

pediatric immunizations if 

needed 

NR At least 1 

telephone call, 

followed by repeat 

calls and home 

visit if no telephone 

contact, over 15 

months or less 

(time per 

interaction NR) 

Moderate 

Campbell et 

al., 2004107 Community – 

churches 

Provide information through 

existing networks; organize 

and conduct at least three 

church-wide activities 

focused on spreading 

information for colorectal 

cancer prevention 

NR 3 church- based 

activities during 12 

months (time per 

session NR) 

Low 

Wendell et al., 

2003117 Community

— streets 

Interview on sexual disease 

risk factors and prevention in 

at-risk adults; survey 

interaction 

Condoms Brief one-time 

interaction handing 

out condoms and 

prevention 

literature (time of 

interaction NR) 

Low 

Five studies were of high intensity,16,64,65,67,68,71,127 four of moderate intensity,66,69,70,105,118,119

and two of low intensity.107,117 

Community health worker-participant interactions for injury prevention interventions. 

We included three studies in injury prevention (Table 6).101,102,126 Two took place primarily in 

the home101,102 and one on farms.126 Two studies involved the distribution of materials to 

improve safety;102,126 one study did not report the educational materials used.101 Two studies 

were of moderate intensity;101,102 one was of low intensity.126

29 
Table 6. CHW-participant interactions for injury prevention 

Author, 

Date of 

Publication 

Place of 

Service Type of Service 

Educational and 

Other Materials 

Provided 

Number of Sessions, 

Time per Session, 

and Length of 

Contact with 

Participants 

Intensity—

Low, 

Moderate, 

High 

Gielen et al., 

2002101 Home Assessed home for 

injury hazards such as 

falls, burns, and 

poisonings; made 

recommendations about 

appropriate safety 

products and practices; 

referred families to the 

Child Safety Center 

NR 1 home-safety visit 

sometime between the 

patient’s 6- and 9-

month well-infant visits 

(time of session NR) 

Moderate 

Schwarz et 

al., 1993102 Home and 

community 

Recruitment of volunteer 

representative from 

each block to identify 

neighborhood 

resources, facilitate 

contacts with residents, 

and reinforce safety 

messages through 

monthly block meetings. 

Home safety inspections 

in the presence of 

residents consisting of 

provision of safety 

materials; instruction on 

correcting safety 

hazards, simple 

household repairs, use 

of ipecac and bathwater 

thermometer, safety 

behaviors; identification 

of community resources 

Safety materials: 

smoke detectors, 

batteries, bathwater 

thermometer, 

nightlight, ipecac, 

sticker for telephone 

with emergency 

numbers, and a 

poster with 

information on 

preventing burns, 

poisonings, falls, and 

injury from domestic 

violence 

1 home visit and 

monthly block meetings 

over 18-month period 

(time per session NR) 

Moderate 

Forst et al., 

2004126 Workplace 

(farms) 

Distribution of eyewear, 

training on use and on 

eye health and safety 

Reference manual 

on agricultural eye 

illness and injury; 

enlarged photos and 

fotonovelas; tool kit 

to demonstrate eye 

injuries and hazards; 

protective eyewear 

At least 1 individual 

and at least 1 group 

session during farming 

season (time per 

session NR) 

Low 

NR, not reported. 

Community health worker-participant interactions for maternal and child health 

interventions. Overall we included 15 studies in maternal and child health (Table 7). All of the 

studies occurred primarily in the home, but 1 had opportunities for interactions in health care 

clinics.77 Only 4 studies provided some description of educational materials used during the 

intervention;75-77,80-82,84 the remaining 11 did not report any details.67,68,71-74,78,79,83,85-87,128 All the 

maternal and child health studies were of high intensity. 

30 
Table 7. CHW-participant interactions for maternal and child well-being 

Author, 

Date of 

Publication 

Place of 

Service Type of Service 

Educational 

and Other 

Materials 

Provided 

Number of Sessions, 

Time per Session, and 

Length of Contact with 

Participants 

Intensity—

Low, 

Moderate, 

High 

BarnesBoyd et al., 

200171

Home Family-focused care plan; 

support, model problemsolving skills, promote selfdevelopment of mother, 

provide instruction in infant 

care; transportation; find 

community resources 

NR Monthly visits over 12 

months (time per session 

NR) 

High 

Barnes et 

al., 199968 Home and 

telephone 

Information and assistance, 

referral, transportation to clinic 

if needed for childhood 

immunizations 

NR Unspecified number of 

calls and visits over 6 

months (time per session 

NR) 

High 

Barth et al., 

198873 Home Task-directed approach to 

reduce risk of parenting 

problems including 

transportation, support and 

assistance with participant 

needs, advocating on 

participant’s behalf, modeling 

positive parenting and 

homecare skills 

NR ≈2 visits per month, ≈ 4 

hours per session, over 6 

months 

High 

Barth et 

al.,199174 Home Task-directed approach to 

reduce the risk of parenting 

problems 

NR On average 11 visits 

(range 5-20) over 6 

months (time per session 

not reported but ≈ 4 hours 

implied) 

High 

Black et al., 

199575

Hutcheson 

et al., 199776

Home Develop individualized family 

service plan with specific 

goals; support mother’s 

needs; promote maternal-child 

relationship 

Handouts, 

developmental 

assessment 

toys 

Weekly visits (≈ 1 hour 

per visit) for 1 year 

High 

Caulfield et 

al., 199877 Community (WIC 

clinics), 

home or 

telephone 

One-on-one counseling on 

participants’ attitudes toward 

infant feeding, correcting 

misconceptions, group 

support sessions on infant 

feeding 

Breastfeeding 

motivational 

video, posters 

and 

pamphlets 

3 or more meetings 

during pregnancy (from 

24 weeks of gestation) 

and then weekly up to 16 

weeks postpartum if they 

continued breast feeding 

(time per meeting NR) 

High 

Conway et 

al., 200467 Home and 

telephone 

Problem-solving techniques to 

reduce environmental tobacco 

smoke exposure to children 

NR 6 home and telephone 

visits over 4 months (time 

per session NR) 

High 

Duggan et 

al., 199978

Duggan et 

al., 2000128

Home Building relationships with 

families; active assistance to 

address existing crises; model 

problem-solving skills and 

effective parent-child 

interaction; link families with 

needed resources; provide 

parenting education; ensuring 

presence of medical home for 

children 

NR ≈22 visits (1 hour each) 

over 2 years 

High 

≈, approximately; NR, not reported; WIC, Special Supplemental Nutrition Program for Women, Infants, and Children. 

31 
Table 7. CHW-participant interactions for maternal and child well-being (continued) 

Author, 

Date of 

Publication 

Place of 

Service Type of Service 

Educational and 

Other Materials 

Provided 

Number of 

Sessions, Time 

per Session, and 

Length of Contact 

with Participants 

Intensity—

Low, 

Moderate, 

High 

Graham et 

al., 199279 Home Psychosocial support; 

educate family about 

pregnancy; advocate; link to 

community services for 

stress reduction; information 

on health risks during 

pregnancy and on nutrition 

NR 4 visits (1 hour 

each) at 2-4 week 

intervals for 2-5 

months (until birth 

of child) 

High 

Nacion et 

al., 200072 Home Intensive home visits for 

assessment, problemsolving, emotional support, 

and information 

NR NR High 

Olds et al., 

200280

Korfmacher 

et al., 199981

Olds et al., 

200482

Home Intensive home visitation: 

promoting healthy 

behaviors, competent child 

care, pregnancy planning, 

education, employment, 

linking to social and health 

services; promoting healthy 

family/friend relationships 

Visit-specific 

protocol, adapted 

to individual needs 

of mother 

Every other week 

(except for weekly 

visits during the 

first 4 weeks after 

enrollment and the 

first 6 weeks after 

delivery) through 

the child's 21st 

month, followed by 

monthly visits 

during the final 3 

months, ≈ 75 

minutes per 

session 

High 

St. James et 

al., 199983 NR (most 

likely home, 

based on 

activities like 

cooking) 

Counseling, meal planning, 

pregnancy education, 

shopping, discuss medical 

recommendations 

NR ≈20 sessions of 2 

hours each (weekly 

in beginning then 

less frequently) 

throughout 

pregnancy 

High 

Schuler et 

al., 200084 Home Teaching and counseling on 

infant development, health 

education, mother-infant 

interaction 

Activity sheets Weekly visits 

(mean duration 

30.1 minutes per 

visit) for 6 months 

High 

Silver et al., 

199785 Home Counseling; share 

information on child health 

and behavior; link families 

with existing community 

resources 

NR 6 meetings (1 hour 

each) with at least 

biweekly telephone 

calls and 3 group 

social activities 

over 12 months 

High 

Tessaro et 

al., 199786

NavaieWaliser et 

al., 200087

Home Counseling, assistance in 

applying for government 

benefits, housing, 

employment, education, 

general advocacy for 

families 

NR One visit per 

month (more if 

needed) for 

approximately 14 

months (time per 

visit NR) 

High 

32 
Community health worker-participant interaction for cancer screening interventions. 

Overall 15 studies concerned cancer screening: 7 took place primarily in the home (visits or 

telephone )15,17-22,61-63,103,104,106 and 8 in community locations59,60,107-113,116,125 (Table 8). 

Nine studies described some of the materials used during the intervention;15,17,18,59-63,103,109-113

six did not report the educational materials used.19-22,104,106-108,116,125 We found two studies of high 

intensity,17,18,61,62 seven of moderate intensity.15,63,106,109-112,116,125 and six studies of low 

intensity.19-22,59,60,103,104,107,108,113

Table 8. CHW-participant interactions for cancer screening 

Author, 

Date of 

Publication 

Place of 

Service Type of Service 

Educational and 

Other Materials 

Provided 

Number of 

Sessions, Time 

per Session, 

and Length of 

Contact with 

Participants 

Intensity—

Low, 

Moderate, 

High 

Paskett et 

al., 200617

Katz et al., 

200718

Home and 

telephone 

Education and barrierspecific counseling to 

promote screening; 

scheduling assistance 

Individualized 

health education 

program 

2 visits at 45-60 

minutes and 30-

45 minutes, 2 

intervening 

telephone calls, 

and a final visit 

(time of final visit 

NR) over 9 to 12 

months 

High 

Sung et al., 

199761

Sung et al., 

199262

Home Education on breast and 

cervical cancer, breast 

self-exam, educational 

materials on screening, 

facilitation to address 

logistical barriers to 

screening 

Video of Pap and 

breast exam; 

printed materials 

3 visits (months 

1, 2, 4) over 4-

month period, 

visits 1 and 2 for 

1.5 hours each, 

time for visit 3 

NR 

High 

Dignan et 

al., 200515 Home Barrier-specific counseling 

to promote screening 

Tailored brochure One-time 

session of 20-90 

minutes 

Moderate 

Hiatt et al., 

1995125 Community 

(various 

locations) 

One-on-one support; 

education: contact with 

clients was ongoing and 

personal 

NR Unspecified # of 

interactions 

(time per 

interaction NR) 

over 2 years 

Moderate 

Jandorf et 

al., 2005106 Telephone One-on-one support and 

education on screening 

techniques and barriers to 

screening; assistance 

scheduling procedures 

NR At least 3 

telephone calls 

(time per call 

NR) over 6 

months 

Moderate 

Mock et al., 

2007109 Community 2 small group gatherings 

and individual direct 

contacts to help access 

medical services and 

schedule appointments 

Languagespecific flip charts 

and booklets 

2 sessions of 90 

or 120 minutes 

each over 3 to 4 

months 

Moderate 

NR, not reported. 

33 
Table 8. CHW-participant interactions for cancer screening (continued) 

Author, 

Date of 

Publication 

Place of 

Service Type of Service 

Educational and 

Other Materials 

Provided 

Number of 

Sessions, Time 

per Session, 

and Length of 

Contact with 

Participants 

Intensity—

Low, 

Moderate, 

High 

Navarro et 

al., 1995, 

1998, 

2000110-112

Community 12 weekly small group 

educational sessions 

Pamphlets, 

worksheets, 

posters 

developed for 

project and 

pamphlets from 

other 

organizations 

12 sessions of 

90 minutes each 

over 3 months 

Moderate 

Taylor, et 

al., 200263 Home and 

telephone 

Tailored responses to 

individual barriers to 

cervical cancer screening, 

clinic referral and 

scheduling assistance, 

translation services, 

transportation assistance 

Video, 

motivational 

pamphlet, 

educational 

brochure, fact 

sheet, tailored 

counseling 

One-time visit 

with followup 

telephone call 

(time per 

interaction NR) 

Moderate 

Wilson et al., 

2008116 Community—

beauty salon 

Education, counseling, 

and information on 

location of screening 

services during salon 

appointment 

Written materials 

(not described) 

1 visit (time of 

session NR) 

Moderate 

Andersen et 

al., 2000103 Telephone Barrier-specific telephone 

counseling to promote 

screening 

Standardized 

script 

1 interaction 

(time of 

interaction NR) 

Low 

Campbell et 

al., 2004107 Community—

churches 

Provide information 

through existing networks; 

organize and conduct at 

least 3 church-wide 

activities focused on 

spreading information 

NR 3 church-based 

activities during 

12 months (time 

per session NR) 

Low 

Derose et al., 

200019

Duan et al., 

200020

Derose et al., 

200021

Fox et al., 

1998104

Stockdale et 

al., 200022

Telephone Barrier-specific telephone 

counseling to promote 

screening, discussion of 

resources for free- and 

reduced-cost 

mammograms, translation 

services, transportation, 

and childcare assistance 

NR 2 telephone calls 

(1 per year over 

2 years), time 

per session 7-11 

minutes on 

average 

Low 

Earp et al., 

2002113 Community Presentations to 

community groups and 

events; one-on-one 

conversations; use of 

informational/ motivational 

materials 

Brochures, 

posters, church 

fans, holiday 

cards 

2 community 

activities per 

month; one-onone 

conversations 

once a week 

over a 24-month 

period, time per 

session NR 

Low 

34 
Table 8. CHW-participant interactions for cancer screening (continued) 

Author, 

Date of 

Publication 

Place of 

Service Type of Service 

Educational and 

Other Materials 

Provided 

Number of 

Sessions, Time 

per Session, 

and Length of 

Contact with 

Participants 

Intensity—

Low, 

Moderate, 

High 

Erwin et al., 

1997108 Church Motivational speeches 

based on cancer survivor 

experience of CHWs, 

breast self-exam lessons 

using a breast model, 

discussion of resources for 

free- and reduced-cost 

mammograms 

NR 1 presentation, 

time NR 

Low 

Sauaia et al., 

200759

Welsh et al., 

200560

Community 

(church) and 

home 

Personal education 

sessions to deliver health 

promotion messages 

Newsletter At least 

bimonthly 

meetings (time 

per meeting NR) 

over 5 years 

Low 

Community health worker–participant interactions for chronic disease management 

interventions. Overall, 13 studies focused on chronic disease management (Table 9). Seven took 

place primarily in the home,23,88-100 2 in health care settings123,124 and 4 in community 

locations.27,114,120-122 Eight described some of the materials used during the intervention;27,93-

98,100,114,123 five did not report the educational materials used.23,88-92,99,120-122,124 Two studies 

provided materials to households to reduce exposure to asthma triggers (bedding, vacuum 

cleaners, etc.).96,97,100 Eight were of high intensity27,88-98,100,120,121 and five studies were of 

moderate intensity.23,99,114,122-124 

Table 9. CHW-participant interactions for chronic disease management 

Author, Date of 

Publication 

Place of 

Service Type of Service 

Educational 

and Other 

Materials 

Provided 

Number of Sessions, 

Time per Session, and 

Length of Contact with 

Participants 

Intensity—

Low, 

Moderate, 

High 

Batts et al., 

200188

Gary et al., 

200389

Gary et al., 

200590

Gary et al., 

200091

Vetter et al., 

200492

Home and 

telephone 

Offer to schedule 

appointments and visits, 

provide education, 

mobilize social support 

for adults with diabetes 

mellitus 

NR 3 visits (45-60 minutes 

each) per year over 2 

years (and additional 

contacts as needed) 

High 

Beckham et al., 

200893 Home or clinic 

(site chosen by 

participant; 

majority 

preferred home) 

Diabetes selfmanagement education; 

referrals to registered 

dieticians, healing center

Visual aids 

(majority of 

participants 

illiterate) 

Up to 15 home visits over 

1 year, lasting 1-1.5 

hours per visit 

High 

NR, not reported. 

35 
Table 9. CHW-participant interactions for chronic disease management (continued) 

Author, Date of 

Publication 

Place of 

Service Type of Service 

Educational 

and Other 

Materials 

Provided 

Number of Sessions, 

Time per Session, and 

Length of Contact with 

Participants 

Intensity—

Low, 

Moderate, 

High 

Frate et al., 

198594

Frate et 

al.,198395

Home or 

community 

Monitor blood pressure; 

provide health education 

and support; selfmanagement of 

hypertension for adults 

Pamphlets, 

scale, low-salt 

cookbook, AHA 

and NHLBI 

pamphlets 

Monthly visits over 18 

months (time per session 

NR) 

High 

Krieger et al., 

200596

Krieger et al., 

200297

Home Environmental 

assessment; 

individualized action 

plan; education and 

social support; deliver 

materials to reduce 

trigger exposure for 

asthma 

Materials to 

reduce 

asthma-trigger 

exposure 

4 to 9 visits over 12 

months (time per session 

NR) 

High 

Levine et al., 

200398 Home Education, counseling, 

referrals, providing 

information on access to 

health care, answered 

questions for adults with 

hypertension 

Wallet-sized 

blood pressure 

tracking card, 

educational 

pamphlet 

6 visits 

over 2.5 years (time per 

visit NR) 

High 

Lujan et al., 

200727 Community 

(classroom), 

telephone, and 

mail 

Deliver participative 

classes for adults with 

diabetes mellitus, 

answered questions, 

reinforce education, 

promote behavior 

change, send biweekly 

postcards 

Audiovisual 

teaching aids 

(flip charts, 

food models, 

food labels) 

and handouts 

8 weekly 2-hour classes 

+ biweekly telephone 

calls for 8 weeks followed 

by biweekly postcards for 

16 weeks 

24 weeks’ total duration 

of interaction with 

participants 

High 

Morse et al., 

1997120

Wolfe et al., 

1997121

Community—

unspecified 

locations 

(homeless 

population) 

Assistance with activities 

of daily living and leisure 

activities for homeless 

people with psychiatric 

diseases 

NR Face-to-face meetings 

(time per meeting and 

number NR) over 18 

months 

High 

Parker et al., 

2008100 Home Environmental 

assessment; asthma 

action plan based on 

allergy tests; education 

and social support; 

mattress covers, pillows, 

vacuum, cleaning 

supplies; counseling on 

environmental tobacco 

smoke; integrated pest 

management services 

Asthma 

booklet; 

materials to 

reduce asthma 

trigger 

exposure 

At least 9 visits over 12 

months (time per session 

NR) 

High 

36 
Table 9. CHW-participant interactions for chronic disease management (continued) 

Author, Date of 

Publication 

Place of 

Service Type of Service 

Educational 

and Other 

Materials 

Provided 

Number of Sessions, 

Time per Session, and 

Length of Contact with 

Participants 

Intensity—

Low, 

Moderate, 

High 

Bone et al., 

1989123 Emergency 

room and 

telephone 

Measured pulse and 

blood pressure (in 

emergency room 

session); provided 

educational counseling; 

identified barriers related 

to referrals, appointment 

keeping, and adherence 

to the treatment plan for 

adults with hypertension 

Wallet-sized 

BP record card

1 face-to-face session 

(≈20 minutes) and at 

least 1 pre-followup 

appointment reminder 

telephone call (5-10 

minutes) (time period 

over which this occurred 

NR) 

Moderate 

Corkery et al., 

1997124 Hospital clinic Liaison between patients 

and health care 

providers for adults with 

diabetes mellitus; 

attended clinic sessions 

with patient; provided 

translation, appointment 

reminders; rescheduled 

missed appointments; 

reinforced self-care 

instructions 

NR Varied (mean = 3.4 

months, range: 0.9-5.4), 

time per session equal to 

clinic visit duration 

Moderate 

Morisky et al., 

200223

Ward et al., 

200099

Home and/or 

clinic 

Counseling regarding 

lifestyle, medicationtaking, and appointmentkeeping; tailored to 

patient need for adults 

with hypertension 

NR Number of visits, time per 

session, time period over 

which interactions 

occurred NR 

Moderate 

Pilote et al., 

1996122 Community—

shelters 

(homeless 

population) 

Transported participants 

to clinic appointment for 

homeless people with 

tuberculosis; assisted 

with paperwork and 

doctor’s 

recommendations 

None Met participants and went 

to clinic within a 3 week 

period (time per session 

NR) 

Moderate 

Von Korff et al., 

1998114 Community—

unspecified 

locations 

Led classes on selfmanaging back pain, 

discussed strategies and 

barriers to achieve goals 

for managing pain 

Book, 

pamphlets, 

videotapes, 

flipcharts 

4, 2-hour classes held 

once a week for 1 month 

Moderate 

KQ 2: Outcomes of Community Health Worker Interventions 

KQ 2 asks about the impact of CHWs on outcomes, particularly knowledge, behavior, 

satisfaction, health outcomes, and health care utilization. As noted earlier, the effect of CHW 

interventions will vary by clinical context (e.g., diagnosis or health concern), so as with KQ 1, 

we present results by clinical context for each of the outcomes described above. The areas of 

37 
clinical concern are health promotion and disease prevention, injury prevention, maternal and 

child health, cancer screening, and chronic disease management. 

We also assessed each study for quality; in general, we present results for higher quality 

studies first, followed by findings for moderate and then lower quality studies. We also give the 

level of intensity of the interaction between CHWs and participants and the type of comparator 

for each study, using the three intensity categories introduced in KQ 1. As noted there, the 

intensity of the interaction between CHWs and participants varied by clinical context. For 

example, maternal and child health interventions were solely high intensity whereas cancer 

screening studies ranged across high, medium, and low intensity. Because of this variation for 

cancer screening, we discuss those studies categorized first by intensity, then by quality. For all 

other clinical contexts, we did not find meaningful patterns by intensity of intervention, either 

because of lack of variation in intensity, or because the number of studies was insufficient to 

draw conclusions. 

Variation in aims and clinical contexts of the studies, populations and settings, measures of 

health outcomes, and health care utilization information precluded quantitative synthesis of the 

results of studies. As with other questions, the number of articles exceeds the number of distinct 

studies. In all cases, tables list studies by quality (good, fair, then poor) and then alphabetically 

by last name of the first author of the article(s). 

Outcomes for Health Promotion and Disease Prevention 

Health promotion and disease prevention: pediatric immunizations. Study 

characteristics. Two RCTs, one good69,70 and one fair quality,68 and one poor-quality prospective 

cohort study (REACH-Futures71,72) examined outcomes of CHW interventions to improve 

pediatric immunization rates in inner cities (Table 10). The RCTs used moderate-intensity 

interventions and the cohort study used a high-intensity intervention. 

Both RCTs used CHWs to provide reminder telephone calls for upcoming clinic 

appointments. The good-quality RCT, targeting children < 12 months of age in a county public 

health clinic in metropolitan Atlanta, had CHWs make home visits only if a child remained 

behind on his or her immunization schedule.69,70 Additionally, this study compared four groups 

of children receiving: (1) automated telephone call reminders, (2) CHW outreach, (3) a 

combination of a CHW and automated telephone call reminders, and (4) a control group defined 

by normal clinic procedure.69,70 Outcomes were assessed after 22 months.69,70 

The fair-quality trial, targeting low-income children in Manhattan, also used CHWs to 

provide basic immunization education and referral, in addition to assisting in obtaining 

immunization services through a combination of telephone and home visits.68 It compared 

outcomes after 6 months for children receiving the CHW intervention with those for a control 

group comprising parents who were informed of their child’s immunization status at enrollment 

and instructed to reschedule the missed appointment.68 

38 
Table 10. CHWs and health promotion and disease prevention: pediatric immunization interventions 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Rask et al.,, 2001;69

LeBaron et al., 200470

RCT 

Pediatric Immunizations 

Children <12 months in a 

county public health clinic 

in metropolitan Atlanta, 

Georgia 

N: 3,050 

Good 

Moderate G1: Autodial – automated telephone call 

delivered recorded message from health 

department medical staff; if no number or 

nonworking – then postcard to remind 

families 7 calendar days before child was 

due to be immunized 

G2: Outreach – Following standardized 

protocol, outreach worker contacted 

patient within 1 week and made reminder 

call before appointment; if child still not up 

to date, monthly home visits attempted 

G3: Combination of G1 and G2 

G4: Normal clinic procedure (control) 

Vaccine series completed 

per immunization registry 

after 22 months: 

No statistical difference 

between CHW and control 

groups 

Barnes et al., 199968

RCT 

Pediatric Immunizations 

Low-income children in 

Manhattan, New York 

N: 434 

Fair 

Moderate G1: Basic immunization education and 

referral. During subsequent contacts 

(home visits or telephone calls) 

throughout the remainder of followup, 

families were reminded of upcoming 

vaccinations and were recontacted to 

ensure that requisite vaccines were 

received. Contact with the clinic or escort 

to appointments provided if a family 

required support or assistance to obtain 

immunization services. 

G2: Informed of their child’s immunization 

status at the enrollment visit by the control 

group interviewer and were instructed to 

reschedule the missed appointment. 

Up-to-date on 

immunizations after 6 

months: 

G1: 75% 

G2: 54% (P = 0.03) 

Late for immunization: 

G1: 18% 

G2: 38% (P < 0.05) 

Barnes-Boyd et al., 200171

Prospective Cohort 

Pediatric Immunizations 

Low-income inner-city 

African-American women 

and infants in Chicago, 

Illinois 

N: 1,922 

Poor 

High G1: Monthly home visits over 1 year; 

visits at prenatal, 1, 6, and 12 months 

teamed with a nurse. 

G2: Historic controls with nurse home 

visits. 

Percent fully immunized at 

12 months: 

G1: 77% 

G2: 63% (P <0.001) 

CHW, community health worker; G, group; N, number; RCT, randomized controlled trial. 

REACH-Futures, a prospective cohort study, compared a group receiving a high-intensity 

intervention of CHW and nurse visits with historic controls of nurse-only home visits.71,72

39 
Monthly home visits started prenatally and ended at 1 year.71,72 We rated this study poor because 

of high potential for secular trends, given the time difference between the two groups, and for 

other confounding problems.71,72

Overview of results. These three studies68-72 evaluated the impact of CHWs on vaccine series 

completion rates and showed different CHW effectiveness. The good-quality study found no 

difference between groups receiving the CHW intervention and the control group.69,70 In 

contrast, the fair-quality study demonstrated that children in the CHW group were more up-todate and less likely to be late for their immunizations than the controls.68 The control group for 

this study received more intervention directed at improving immunization rates, which would 

diminish the apparent effectiveness of the CHW. This study was more intensive than either of the 

other two projects (regular home visits or telephone calls over 6 months to ensure that requisite 

vaccines were received); this factor may have produced the difference in effectiveness between 

studies. REACH-Futures71,72 also found that the CHW-intervention group had a higher 

proportion of fully immunized participants at 12 months than did the historic controls who had 

received a nurse-only home visit. 

Knowledge. No study reported outcomes for improved knowledge of pediatric immunization. 

Behavior. No study reported outcomes for behavior changes. 

Satisfaction. No study reported outcomes for satisfaction. 

Health outcomes. All three studies evaluated immunization rates. The good-quality trial 

evaluated vaccine series completion rate from an immunization registry and found no difference 

between the CHW and control groups.69,70 The fair-quality trial found that children in the CHW 

arm were more up-to-date on immunizations than in the control arm (75 percent versus 54 

percent, P = 0.03) and that fewer children were late for immunizations (18 percent versus 38 

percent, P < 0.5).68 The poor-quality study evaluated vaccine series completion rates at 12 

months and found that a higher proportion of children receiving the CHW and nurse home visits 

were up-to-date than historical controls (P < 0.001).71,72

Health care utilization. No study reported outcomes for health care utilization. 

Health promotion and disease prevention: health promotion – Latina health. Study 

characteristics. Two RCTs, one fair66 and one poor quality,64,65 examined outcomes of CHW 

interventions in comparison with mailings for health promotion in Latinas (Table 11). The fairquality study used a moderate-intensity CHW intervention in uninsured Hispanic women age 40 

years and older living at the US-Mexico border (Agua Prieta, Sonora, Mexico, and Douglas, 

Arizona, United States) with the aim of increasing return to clinic for an annual preventive 

examination.66 It compared a group receiving CHW home visits in addition to reminder 

postcards with a group getting reminder postcards alone. 

The poor-quality study, Secretos de la Buena Vida, used a high-intensity CHW model in the 

same target population living in San Diego County, California.64,65 It evaluated the effectiveness 

of weekly CHW home visits and telephone calls in addition to tailored print materials against 

that of tailored materials alone or off-the-shelf materials for changing dietary behavior. We rated 

this a poor-quality study because of a high potential for selection bias, measurement bias, and 

confounding.64,65 

40 
Table 11. CHWs and health promotion and disease prevention: Latina health promotion interventions 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Hunter et al., 

200466

RCT 

Annual preventive 

exams 

Uninsured 

Hispanic women, 

aged 40 and 

older, living at the 

US-Mexico border 

N: 103 

Fair 

Moderate G1: Received postcards in the mail 2 

weeks before the month their annual 

exams were due, printed in language 

used to complete original 

questionnaire 

G2: Received G1 intervention and 

were visited by a promotora 2 weeks 

after the postcard had been mailed. 

Promotora facilitated appointment 

scheduling and contacted them to 

facilitate rescheduling if appointment 

was missed. 

Return to clinic for a second 

comprehensive annual exam: 

G1: 48% (n = 24) 

G2: 65% (n = 33) 

RR, 1.35; 95% CI, 0.95-1.92 

Elder et al., 

2006;65

Elder et al., 

200564

RCT: Secretos de 

La Buena Vida 

Dietary behavior, 

changes 

Latinas in San 

Diego County, 

California 

N: 357 

Poor 

High G1: CHW home visits and/or 

telephone calls + tailored print 

materials 

G2: 12 weekly tailored newsletters 

and homework 

G3: 12 weekly off-the-shelf dietary 

printed material 

Total fat gm, total fiber gm 

(Nutrition Data System 24-hour 

dietary recall interview) (validated):

No significant difference between 

groups at 6 and 12 months 

postintervention 

CHW, community health worker; CI, confidence interval; G, group; N, number; RCT, randomized controlled trial; RR, risk ratio. 

Overview of results. The fair study found that a moderate-intensity CHW intervention was 

more effective than a reminder postcard in increasing preventive exam appointments.66 The 

poor-quality study demonstrated that a high-intensity CHW intervention group was different 

from those receiving weekly tailored dietary printed material in terms of dietary intake 

immediately post-intervention. This difference was no longer apparent after 6 months, although 

all three groups improved.64,65

Knowledge. Neither study reported outcomes for improved knowledge of health promotion. 

Behavior. The Secretos de la Buena Vida project examined behavioral changes.64,65 The 

CHW arm and the tailored print arm did not differ significantly at 6 and 12 months 

postintervention in dietary intake of fat or fiber, based on a validated measure for 24-hour diet 

recall. 

41 
Satisfaction. Neither study reported outcomes for satisfaction. 

Health outcomes. Neither study reported outcomes for improved health. 

Health care utilization. The fair-quality, moderate-intensity CHW study reported on the 

percentage of women returning to clinic for a second annual preventive examination.66 The 

CHW arm had a higher percentage of women returning than the postcard-only arm (65 percent 

versus 48 percent; RR, 1.35; 95percent CI, 0.95-1.92), but the difference was not statistically 

significant. 

Health promotion and disease prevention: disease prevention. Study characteristics. Six 

studies, five RCTs16,67,105,107,118,119,127 and one prospective cohort study,117 examined outcomes of 

CHW interventions for disease prevention in underserved populations throughout the United 

States (Table 12). Two studies were both high intensity and fair quality;16,67,127 two studies were 

moderate intensity, one fair105 and one poor quality;118,119 and two studies were low intensity, one 

fair117 and one poor quality.107 Studies focused on a broad range of disorders, including 

cardiovascular disease prevention,105,118,119 diabetes prevention,16,127 HIV prevention,117colorectal 

cancer prevention,107 and second-hand smoke exposure.67 Of the five RCTs, three were of fair 

quality16,67,105,127 and two were poor.107,118,119

The Missouri study was a fair-quality RCT evaluating a high-intensity CHW intervention 

focused on diabetes prevention in a low-income, African-American female population.16,127 This 

study compared 3 months of weekly sessions, alternating between group and individual sessions, 

targeting stages of change to tailor dietary patterns, with a control group that received a book to 

read.16,127 The San Diego study was a fair-quality RCT evaluating a high-intensity CHW 

intervention focused on decreasing secondary tobacco smoke exposure in Latino neighborhoods 

in San Diego County, California.67 The intervention consisted of six home and/or telephone 

visits by CHWs over 4 months using culturally tailored behavioral problem-solving techniques to 

reduce secondary tobacco smoke exposure; controls received no intervention.67 The Seattle, 

Washington, study was a fair-quality RCT evaluating moderate-intensity CHW assistance with 

medical followup against verbal advice to see a medical provider in low-income neighborhood 

participants who were found to have elevated blood pressure.105 

The sole prospective cohort study, rated fair quality, evaluated the effectiveness of a lowintensity CHW intervention in HIV prevention by street outreach to at-risk community members 

in Louisiana compared with a control group in a neighborhood receiving no intervention.117 

The poor-quality Baltimore, Maryland, trial evaluated a moderate-intensity intervention 

consisting of a nurse practitioner and CHW team at a nonclinical site with exercise equipment; 

CHWs provided dietary, smoking cessation, and exercise counseling.118,119 This strategy was 

compared with “enhanced” primary care, in which the same risk-specific materials and 

information on local programs were given to the intervention group and results and 

recommendations were provided to the patients’ primary care physicians. We rated it poor 

because of a high potential for measurement bias.118,119 The WATCH trial was a poor-quality 

RCT of low intensity conducted in rural, predominantly African-American churches in North 

Carolina.107 This study had four arms: (1) control churches offered a health education session 

and speakers not related to study objectives; (2) CHW intervention, consisting of organization 

and presentation of at least three church-wide activities on educating and enhancing support for 

healthy lifestyle and colorectal cancer screening; (3) four personalized computer-tailored 

newsletters and four targeted videotapes focused on healthy lifestyle and colorectal screening 

mailed bimonthly to participants’ homes; and (4) both the CHW and the videotape 

components.107 

42 
Overview of results. These six disease prevention studies reported on outcomes of 

knowledge, behavior, health outcomes, and health care utilization. Overall, four studies found 

that a CHW intervention was more effective in achieving outcomes than the respective control 

group.16,105,117-119,127 Two fair-quality studies (the Missouri trial16,127 and the prospective cohort 

study117) reported improved knowledge of the respective diseases in the CHW intervention as 

compared to respective controls. Two fair-quality studies (the Missouri trial16,127 and the 

prospective cohort study117) and one poor-quality study (the Baltimore trial118,119) demonstrated 

that moderate- and low-intensity CHW interventions were more effective than controls in 

changing health behaviors. 

Table 12. CHWs and health promotion and disease prevention: disease prevention interventions 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of CHW 

Intervention Study Groups Results 

Auslander et al., 

2002;16 

Williams et al., 

2001127

RCT 

Diabetes 

prevention 

Low-income 

African-American 

women in a large 

city (unspecified) 

in Missouri 

N: 294 

Fair 

High G1: 6 group sessions (approximately 

6 to 8 participants per group) and 6 

individual sessions targeting stages of 

change to tailor, dietary pattern with a 

peer educator, meeting weekly over a 

3-month period 

G2: A book (control) 

Food Frequency Questionnaire – 

Validated: 

Intervention was effective in 

reducing fat intake, as measured 

by percentage of calories from total 

fat (baseline/6 months): 

G2: 36.0/34.5 

G1: 35.9/32.3 (P < 0.05) 

BMI: No significant difference 

between groups 

Knowledge of Label Reading 

Questionnaire (unvalidated) 

baseline/6 months: 

G2: 5.4/5.7 

G1: 5.5/6.3 (P > 0.0001) 

Conway, 200467

RCT 

Secondary 

tobacco smoke 

Latino 

neighborhoods in 

San Diego 

County, California 

N: 143 

Fair 

High G1: Culturally relevant home and 

telephone visits on problem-solving 

techniques to reduce ETS exposure 

G2: No intervention (control) 

RIA of child's hair for nicotine and 

cotinine (validated): 

No significant difference between 

groups 

BMI, body mass index; CBC, community-based care; CHW, community health worker; CI, confidence interval; EPC, enhanced 

primary care; ETS, environmental tobacco smoke; LHA, lay health advisor; MET, metabolic equivalent; N, number; NP, nurse 

practitioner; OR, odds ratio; PCP, primary care physician; RCT, randomized controlled trial; RIA, radioimmunoassay; SE, 

standard error; YMCA, Young Men’s Christian Association. 

43 
Table 12. CHWs and health promotion and disease prevention: disease prevention interventions (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of CHW 

Intervention Study Groups Results 

Krieger, 1999105

RCT 

Hypertension 

Low-income 

neighborhoods in 

Seattle, Washington 

N: 421 

Fair 

Moderate G1: CHW assistance with medical 

followup related to a date when 

blood pressure was determined to 

be elevated 

G2: Advice to see medical provider, 

list of public and community clinics 

Self-report of completed followup 

appointment within 90 days 

(validated by medical provider 

report): 

G1: 65.1% 

G2: 46.7% (P = 0.001) 

Wendell, 2003117

Prospective cohort 

study 

HIV prevention 

At-risk 

neighborhoods in 

Louisiana 

N: 6,547 

Fair 

Low G1: Discussions with community 

members during which they 

assessed the client’s needs, 

imparted a risk- or harm-reduction 

message, answered questions, 

made referrals, and negotiated and 

reinforced behavior change 

G2: No intervention (control) 

Condom use (intervention vs. 

comparison): 

OR, 1.37 (95% CI, 1.20 to 1.56; 

P < 0.001) 

Becker et al., 

2005;118

Cene et al., 2008119

RCT 

Cardiovascular 

disease prevention 

Baltimore, Maryland 

N: 267 

Poor 

Moderate G1: EPC- received risk-specific 

materials (same as intervention 

group), PCP received results and 

recommendations, sent info on 

local programs (e.g., YMCA) 

G2: CBC - received care in 1 

nonclinical site in the community 

from a NP and CHW. CHW 

provided dietary counseling, 

smoking cessation, and exercise 

counseling lasting 30 minutes. 

Smoking cessation (self-report): 

G1: 7% reduction 

G2: 16.2% reduction (P < 0.001) 

44 
Table 12. CHWs and health promotion and disease prevention: disease prevention interventions (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of CHW 

Intervention Study Groups Results 

Campbell, 2004107

RCT 

Colorectal cancer 

screening 

African-American 

rural churches in 

North Carolina 

NR (12 churches; 

completers/dropouts 

of individual 

participants from 

each church not 

reported) 

Poor 

Low G1: Control churches were offered 

health education sessions and 

speakers on topics of their choice 

not directly related to study 

objectives 

G2: Organize and conduct at least 

3 church-wide activities on 

spreading info and enhancing 

support for healthy lifestyle and 

CRC screening (LHA) 

G3: 4 personalized computertailored newsletters and 4 targeted 

videotapes corresponding to the 

same behaviors mailed to 

participants' homes bimonthly for 

first 6 months after baseline data 

collection; 4th mailing was 9 

months baseline 

G4: LHA + targeted print and 

videotape 

Dietary change—daily fruit and 

vegetable servings 

(baseline/followup): 

G1: 3.3/3.4 

G2: 3.5/3.5 

G3: 3.3/3.9 

G4: 3.4/3.7 

No significant change across 

arms for LHA interventions 

Physical activity—recreational 

(moderate-vigorous) activity MET 

hours/week, M (SE) 

(baseline/followup): 

G1: 9.3(0.88)/8.4(0.69) 

G2: 10.5(0.9)/10.6(0.70) 

G3: 9.5(0.80)/10.9(0.61) 

G4: 9.7(0.76)/9.7(0.60) 

No significant change across 

arms for LHA interventions 

The two studies that targeted tobacco cessation found opposing results regarding CHW 

effectiveness.67,118,119 The fair-quality study (San Diego trial67) found no difference in smoking 

cessation between a high-intensity CHW intervention group and a group receiving nothing based 

on validated radioimmunoassay (RIA) of children’s hair for nicotine and cotinine. The poorquality study (Baltimore trial118,119) found a significant difference between a moderate-intensity 

CHW intervention and enhanced usual care; however, this outcome was based on self-report. 

The fair-quality Seattle trial measured health care utilization and demonstrated that a moderateintensity CHW intervention increased medical followup compared with only verbal advice to 

seek medical care for elevated blood pressure.105

Overall, most (four of the six) disease prevention studies demonstrated that various levels of 

CHW intervention intensity (low, moderate, or high) were more effective than the comparator, 

which ranged from nothing to enhanced usual clinical care, in changing a variety of outcomes. 

Knowledge. Two fair-quality studies16,117,127 reported outcomes for improved knowledge of 

the respective diseases. The Missouri study16,127 found that participants in the high-intensity, 

diabetes-oriented CHW intervention, compared with a control group receiving a book to read, 

had an improved knowledge of label reading as assessed by an unvalidated questionnaire 

(P < 0.0001); this improvement remained statistically significant at 6-month followup. The 

prospective cohort study117 demonstrated that a low-intensity CHW street outreach program was 

effective at increasing knowledge of where to obtain free condoms as determined by an 

unvalidated questionnaire (90 percent versus 74 percent, odds ratio [OR], 3.2, P = 0.001). 

45 
Behavior. Five RCTs, three fair16,67,105,127 and two poor quality,107,118,119 examined a variety 

of behavioral changes. Three demonstrated CHW effectiveness16,105,118,119,127 and two67,107

showed no difference compared with their respective controls. The Missouri trial on diabetes 

prevention evaluated dietary change following high-intensity, CHW-led group and individual 

sessions;16,127 it found a reduction in fat intake with a validated food frequency questionnaire 

compared with intake in a control group (P < 0.0001). The San Diego trial, a high-intensity 

CHW intervention of home and telephone visits to reduce second-hand tobacco smoke exposure 

to children, found no difference from baseline by self-report or validated RIA of children’s hair 

for nicotine and cotinine.67 In contrast, the Baltimore trial evaluated a CHW intervention and 

found a difference in self-reported smoking cessation as compared to a standard of care group 

(16.2 percent reduction versus 7.0 percent, P < 0.001).118,119 Both groups reported less smoking, 

confirmed by measures of hair cotinine. The North Carolina trial did not show a difference in 

either fruit and vegetable intake or increased physical activity between intervention and control 

groups.107 The prospective cohort low-intensity study targeting HIV prevention demonstrated an 

increase in condom use reported in the intervention group (OR, 1.37; 95 percent CI, 1.20-

1.56).117

Satisfaction. No study for health promotion evaluated outcomes focused on satisfaction. 

Health outcomes. The Missouri trial found no difference within or between arms when 

comparing the high-intensity CHW intervention and the control group in terms of body weight 

and body mass index (BMI) at baseline (BMI 35.7 versus 35.3) and after 6 months (BMI 35.7 

versus 35.4).16,127

Health care utilization. The Seattle trial evaluated self-reported medical provider followup 

within 90 days of determined elevated blood pressure.105 It demonstrated a higher rate of 

completed medical followup in the CHW group than in the control group (65.1 percent versus 

46.7 percent, P = 0.001). The number needed to treat in order to bring 1 person to medical care 

was 5 (95 CI, 3-13).105 

Outcomes for Injury Prevention 

Injury prevention: home safety. Study characteristics. One fair-quality RCT101 and one 

poor-quality RCT randomized at the community level (called the Safe Block Project)102 assessed 

the effect of low-intensity CHW interventions on injury prevention in homes, either for 

children101 or for all ages.102 Both studies involved CHW home visits. The fair-quality RCT 

consisted of assessment of safety hazards and recommendations for appropriate products and 

practices compared with safety counseling in a pediatric clinic.101 The poor-quality RCT also 

included direct implementation of several safety features into homes compared with no 

intervention in control households; we rated this trial poor because of its high potential for 

measurement bias and not masking those who assessed outcomes.102

Overview of results. The fair-quality RCT showed no benefit to CHW intervention,101 but the 

poor-quality trial had mixed results102 (Table 13.). Significant benefit was seen for household 

features that did not require participants to change behaviors (e.g., continued presence of a 

smoke detector, as installed in intervention homes); conversely, no benefit was observed for 

other household features that did require behavior change (e.g., maintaining a working light bulb 

in stairways). 

Knowledge. Neither study assessed knowledge-related outcomes. 

46 
Table 13. CHW injury prevention interventions and home safety 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Gielen et al., 2002101

Parents and infants 6 

months or younger in large 

urban teaching hospital 

pediatric clinic 

Baltimore, Maryland 

N: 187 

Fair 

Moderate G1: Safety counseling and 

referral by pediatrician to 

children’s safety center 

G2: Standard care plus 

offer of CHW home visit; 

assessed injury hazards; 

made recommendations 

about appropriate safety 

products and practices; 

referred families to the 

children’s safety center; 1 

visit between 6 and 9 

months 

No significant difference between groups in home 

safety practices: 

Hot water temperature controlled: 

Pre/Post G1: 39%/47%; G2: 39%/47% 

Working smoke alarm: Pre/Post G1: 92%/84%; 

G2: 92%/81% 

Safety gates used: Pre (planned use)/Post (actual 

use) G1: 84%/23%; G2: 84%/27% 

Poisons latched/locked: Pre/Post G1: 26%/12%; 

G2: 26%/10% 

Ipecac present: Pre/Post G1: 12%/27%; G2: 

12%/31% 

Schwarz et al., 1993102

(Safe Block Study) 

Inner city residents in 

neighborhoods with high 

injury rates 

Philadelphia, Pennsylvania 

N: 2,722 

Poor 

Moderate G1: Safety inspections, 

home modifications and 

education; myriad safety 

devices (e.g., smoke 

detectors, ipecac, 

emergency telephone 

numbers, light bulbs) 

G2: Control (details NR) 

G1 more likely than G2 to retain intervention 

modifications such as presence of ipecac 

(P < 0.001), hot water temperature control 

(P < 0.001) 

No difference between groups for adequate 

lighting at stairs 

CHW, community health worker; G, group; N, number. 

Behavior. In the fair-quality RCT,101 groups did not differ significantly in maintaining 

adequate stairway lighting (83.1 percent versus 80.1 percent; adjusted odds ratio [AOR], 0.90; 95 

percent CI, 0.69-1.16) or in following any of the home safety practices assessed. Hot water 

temperature control and presence of ipecac increased from baseline in both groups, but presence 

of a working smoke alarm, use of safety gates on stairs, and latching or locking of poisons 

declined from baseline. In the poor-quality trial,102 following the CHW intervention a 

significantly higher proportion of households continued to have ipecac (which was 

recommended at the time of the study for households with young children) (81.0 percent versus 

9.8 percent; AOR, 0.04; 95 percent CI, 0.02 to 0.07) and smoke detectors (96.0 percent versus 77 

percent; AOR, 0.14; 95 percent CI, 0.09 to 0.20) than did controls. These interventions were 

provided by the CHWs and required no behavior change by participants. In contrast, intervention 

households were actually less likely than control households to have retained hot water 

temperature controls (63.2 percent versus 73.2 percent; AOR, 1.73; 95 percent CI, 1.39 to 2.15). 

Satisfaction. Neither study assessed satisfaction. 

Health outcomes. Neither study assessed direct health outcomes. 

47 
Health care utilization. Neither study assessed health care utilization. 

Injury prevention: workplace safety. Study characteristics. One prospective cohort study, 

rated poor quality for high potential for selection and measurement bias and lack of description 

of baseline characteristics, examined the effect of a low-intensity CHW intervention for migrant 

farm workers to prevent work-related eye injury. The CHW intervention involved distribution of 

protective eyewear either with or without specific training provided by the CHWs; it was 

compared to distribution of eye protection not involving CHWs. Outcomes were assessed during 

the same growing season in parts of the Midwest. 

Overview of results. The CHW intervention increased the likelihood of protective eyewear 

use, particularly when coupled with CHW-led training (Table 14).126

Table 14. CHW injury prevention interventions and workplace safety 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Forst et al., 2004126

Latino migrant and seasonal 

farm workers 

Southeast Michigan and 

northeast Illinois 

N: 786 

Poor 

Low intensity G1: CHW distributed protective 

eyewear, conducted at least 1 

each individual and group training 

sessions 

G2: CHW distributed eyewear, 

did not provide training 

G3: No CHW component 

G1 were more likely to increase 

use of protective eyewear 

compared with G2 (P < 0.0001) 

and with G3 (P = 0.03) 

Any CHW intervention increased 

likelihood of protective eyewear 

use vs. no CHW (P = 0.0004) 

CHW, community health worker; G, group; N, number. 

Knowledge. Knowledge was not assessed. 

Behavior. The presence of any CHW component related to receiving protective eyewear was 

significantly associated with increased self-report of continued use of the eyewear on a 5-point 

Likert scale compared with having received the eyewear without CHW involvement (difference 

in average change in Likert scale value 0.6452, P < 0.01). Incorporation of CHW-led training 

was associated with greater self-reported eyewear use compared with CHW eyewear distribution 

alone (difference in average change 0.7663, P < 0.01) and with no CHW involvement (difference 

in average change 0.5241, P = 0.03). Observed use of eyewear increased in all groups during the 

study period (CHW trained 1.1 to 36 percent; CHW distributed 0 to 5.2 percent; no CHW 0 to 14 

percent, 

P-value not reported). 

Satisfaction. Satisfaction was not assessed. 

Health outcomes. Although the investigators measured the incidence of pterygium, they did 

not compare groups on this variable and in fact reported it as only inadequately identified. 

Health care utilization. No measure of health care utilization was reported. 

48 
Outcomes for Maternal and Child Health 

Maternal and child health: overview. We identified 15 studies that met inclusion criteria 

and involved maternal or child health outcomes (or both). All the studies utilized high-intensity 

interventions, usually involving some series of home visits. All but 1 study were rated either fair 

(8 studies) or poor (6 studies). The 1 good-quality study found no significant differences 

associated with interventions employing CHWs. Among the other studies, results were mixed, 

some showing benefit of CHW interventions and some showing no effect attributable to CHWs. 

This distribution was found in both fair- and poor-quality studies. Significant associations were 

most commonly found for existing conditions (e.g., phenylketonuria [PKU] or failure to thrive) 

rather than primary prevention and in the area of health care utilization (e.g., immunization rates) 

and behavior (e.g., parenting measures). 

Maternal and child health: prenatal care and perinatal outcomes. Study characteristics.

Six studies assessed prenatal care and perinatal outcomes associated with CHWs.71,72,77,79,83,86,87

Of these, three were rated fair quality: one RCT involving prenatal care in Cleveland79 and two 

cohort studies (one on the Resource Mothers Program for Maternal PKU83 and one evaluating 

REACH-Futures72). The remaining three studies, rated poor, included one RCT on promotion of 

breastfeeding in African-American mothers in Baltimore,77 rated poor for high attrition and lack 

of specific or validated outcome measures; one cohort study (the Baby Love Maternal Outreach 

Worker study31,32), rated poor for high attrition, high potential for selection bias and 

confounding, and lack of specific or validated outcome measures; and a second study on 

REACH-Futures71 rated poor for high potential for secular trend and other confounding. 

Most studies focused on interventions for low-income families, usually from racial or ethnic 

minority groups. Most CHW interventions involved home visits. The Resource Mothers Program 

for Maternal PKU83 involved coaching in activities of daily living unique to mothers with PKU 

infants including meal planning and medical recommendations concerning pregnancy. The 

Maternal Outreach Worker program also provided direct assistance to families for obtaining 

benefits and services.86,87 

Studies generally compared outcomes for families receiving CHW interventions with 

outcomes for those receiving usual clinical care (Table 15). The Baltimore breastfeeding study 

compared CHW intervention with video and other literature and against both interventions 

combined;77 the Resource Mothers Program83 used as controls mothers who had completed 

pregnancy in the 5 years before the start of the program; and REACH-Futures71,72 used historic 

controls of nurse home visits. Outcomes were typically assessed months to years after the 

interventions. 

Overview of results. Improvements over usual care were demonstrated to be associated with 

CHWs in breastfeeding,77 maternal control of PKU,83 and prenatal care.86,87 However, birth 

outcomes in mothers with PKU,83 low birth weight incidence,86,87 continuation of 

breastfeeding,77 and overall presence of infant health problems71 were not significantly improved 

by use of CHWs compared with usual care77,83,86,87 or with health professional intervention.71

Knowledge. No study measured knowledge-related outcomes. 

Behavior. No study assessed behavior change. 

Health outcomes. Peer CHW counseling in the Baltimore study was associated with greater 

initiation of breastfeeding than standard care (OR, 3.84; 95 percent CI, 1.44-10.21), but the 

statistically significant difference between groups in the proportion of participants still 

breastfeeding by 7 to 10 days disappeared.77 For the Resource Mothers Program,83 mothers 

49 
receiving the CHW intervention needed less time to reach metabolic control (blood 

phenylalanine level consistently below 10 mg/dL) than those who had not received the 

intervention (8.5 weeks versus 16 weeks, P < 0.05). The head circumference of infants born to 

participating mothers did not differ significantly between cohorts (mean Z-score of head 

circumference: intervention -0.56; 95 percent CI, -0.88 - -0.24 versus control -1.4; 95 percent CI, 

-1.56 - -1.2; P = 0.08). The Maternal Outreach Workers program 

Table 15. CHW maternal and child interventions and prenatal care and perinatal outcomes 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of CHW 

Intervention Study Groups Results 

Graham et al., 199279

RCT 

Pregnant inner-city 

African-American women 

Cleveland, Ohio 

N: 145 

Fair 

High G1: Home visits with 

psychosocial support 

and encouragement, 

education, link to 

community resources, 

information on health 

risks; 4 visits of 1 hour 

each at 2-4 week 

intervals 

G2: Routine prenatal 

obstetric care (control) 

No statistically significant difference 

between groups in incidence of low birth 

weight: 12.9% intervention, 7.5% controls 

(P = 0.51) 

Nacion et al., 200072

Cohort 

REACH-Futures 

Low-income inner-city 

African-American 

pregnant women and 

infants 

Chicago, Illinois 

N: 213 

Fair 

High G1: Home visits by 

CHW 

G2: Home visits by 

nurse (historic control) 

G1 more likely than G2 to receive problemsolving services (P < 0.01) and to have 

problems identified in women’s health 

(P = 0.01), well-child health care deficits 

(P = 0.02), parenting (P = 0.02), and 

socioeconomic issues (P < 0.01) 

G1 less likely than G2 to receive emotional 

support services (P < 0.01), to have 

referrals placed for women’s health 

(P = 0.01), well-woman (P = 0.02), 

emotional/interpersonal (P < 0.01), parental 

support (P < 0.01), or for socioeconomic 

issues (P < 0.01) 

St. James et al., 199983

Cohort 

Mothers with PKU 

New England 

N: 69 

Fair 

High G1: Historic control; 

women who completed 

pregnancy in the 5 

years prior to project 

onset 

G2: Resource mothers 

Metabolic control achieved in 8.5 weeks for 

G2 vs. 16 weeks for G1 (P < 0.05) 

Infant mental scale on Bayley 

Developmental Quotient was 108 for G2 vs. 

95 for G1 (P < 0.05) 

No difference in head circumference at birth 

(P = 0.08) 

CHW, community health worker; PKU, phenylketonuria; WIC, Special Supplemental Nutrition Program for Women, Infants, 

and Children. 

50 
Table 15. CHW maternal and child interventions and prenatal care and birth outcomes (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of CHW 

Intervention Study Groups Results 

Barnes-Boyd et al., 200171

Cohort 

REACH-Futures 

Low-income inner-city 

African-American 

pregnant women and 

infants 

Chicago, Illinois 

N: 1,922 

Poor 

High G1: Monthly home visits 

over 1 year; visits at 

prenatal, 1, 6, and 12 

months teamed with nurse

G2: Historic controls with 

nurse home visits 

Proportion fully immunized at 12 months: 

CHW 77%, nurse 63% (P < 0.001) 

No significant difference between groups 

in presence of neonatal or postneonatal 

health problems (27% CHW vs. 25% 

nurse) 

Caulfield et al., 199877

RCT 

African-American women 

receiving prenatal care 

Baltimore, Maryland 

N: 548 

Poor 

High G1: Standard WIC 

services only 

G2: WIC plus video and 

literature 

G3: WIC plus peer 

counseling 

G4: WIC plus peer 

counseling plus video and 

literature 

Initiation of breastfeeding: 

G1: 26% (referent) 

G2: 50% (OR, 1.36; 95% CI, 0.52-3.54) 

G3: 62% (OR, 3.84; 95% CI, 1.44-10.21) 

G4: 52% (OR, 1.92; 95% CI, 0.78-4.76) 

Breastfeeding at 7-10 days: 

G1: 14% (referent) 

G2: 30% (OR, 0.79; 95% CI, 0.25-2.52) 

G3: 38% (OR, 1.11; 95% CI, 0.34-3.61) 

G4: 38% (OR, 1.52; 95% CI, 0.50-4.59) 

Tessaro et al., 199786,87

Cohort 

Maternal Outreach 

Workers 

Medicaid-eligible pregnant 

women with 1 or more 

pregnancy risk factors 

North Carolina 

N: 705 

Poor 

High G1: CHW intervention 

G2: Matched controls, not 

otherwise defined 

Maternal depression score increased by 

2.1 in G1 vs. 5.1 in G2 (P = 0.01) 

Prenatal care, African Americans: 

G1: 60.7% adequate, 32.6% 

intermediate, 6.7% inadequate 

G2: 63.8% adequate, 31.5% 

intermediate, 4.7% inadequate 

Prenatal care, Whites: 

G1: 77.4% adequate, 19.7% 

intermediate, 2.9% inadequate 

G2: 75.1% adequate, 22.8% 

intermediate, 2.1% inadequate 

No difference between groups in 

maternal self-esteem (P = 0.19) or 

perceived stress (P = 0.75) 

No difference in observed vs. expected 

incidence of low birth weight or very low 

birth weight: African Americans -13 

(P = 0.12), Whites +1 (P = 0.58) 

51 
demonstrated a trend toward lower incidence of adequate prenatal care for African-American 

women receiving CHW intervention than for controls (significance not reported);86,87 neither the 

observed nor the expected incidences of low birth weight or very low birth weight infants 

differed significantly. REACH-Futures found no difference between CHW intervention and 

controls in incidence of neonatal or postneonatal infant health problems.71

Health care utilization. The Cleveland study showed a significant increase in the ratio of 

actual to expected numbers of prenatal visits for women receiving CHW intervention (P = 

0.029);79 the investigators did not compare the intervention findings to those from women in the 

control group. 

Other. The fair-quality analysis from REACH-Futures found that CHW home visits were 

more likely than nurse home visits to include identification of problems in women’s health (P = 

0.01), deficits in well-child care (P = 0.02), parenting issues (P = 0.02), and socioeconomic 

issues (P < 0.01) and that participants were more likely to receive problem-solving services (P < 

0.01).72 However, CHWs were less likely than nurses to provide emotional support services (P < 

0.01) or to place referrals for women’s health (P = 0.01), well-woman care (P = 0.02), 

emotional/interpersonal support (P < 0.01), parental support (P < 0.01), or socioeconomic issues 

(P < 0.01). 

Maternal and child health: Child development. Study characteristics. Four studies 

considered the impact of CHWs on child development (Table 16). Three were rated fair quality 

and one poor quality; all used high-intensity interventions. One RCT focused on children with 

nonorganic failure to thrive in Baltimore, Maryland;75,76 another RCT examined the Home 

Visitation 2000 program in Denver, Colorado;80-82 and a cohort study involved the Resource 

Mothers Program for Maternal PKU in New England.83 The RCT assessing the Hawaii Healthy 

Start Program78,128 was rated poor for high potential for site-specific bias. 

Overview of results. Variation in timing and specific outcomes among studies precludes 

much summarization of results. Two of the studies demonstrated some significant benefit of 

CHW intervention over usual care; the other two showed no significant difference between 

CHW intervention and controls. The failure-to-thrive study demonstrated that the CHW home 

visiting program was effective in mitigating declines in cognitive and motor development, but 

not language, if implemented during the first year of life (Table 16).75,76 The PKU Resource 

Mothers Program study found higher mental development for infants born to mothers who 

participated than for those born to historic controls.83 By contrast, the Home Visitation 2000 trial 

showed more improvement in language development with nurse visits rather than CHWs,80-82

and the Hawaii trial found no difference in mental or psychomotor development between 

children receiving CHW intervention and controls. 

Knowledge. No study assessed knowledge about child development issues. 

Behavior. No study included health behaviors in the outcomes measured. 

Satisfaction. No study considered satisfaction outcomes. 

52 
Table 16. CHW maternal and child interventions and child development 

Author, Year 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Black et al., 1995;75

Hutcheson et al., 199776

Low-income urban 

children with nonorganic 

failure to thrive 

Baltimore, Maryland 

N: 130 

Fair 

High G1: Weekly CHW home visits with 

community health nurse supervision for 

1 year, addressing various child health 

and development needs, nutrition 

intervention, and concerns raised by 

mothers 

G2: Clinic-based multidisciplinary 

services; no CHW intervention 

Smaller postintervention decline 

in cognitive and motor 

development for G1 vs. G2 only 

for children recruited in infancy 

Bayley cognitive development 

(SD): 

G1: 96.9 (SD 15.8) to 89.3 (17.4) 

G2: 96.2 (12.1) to 86.1 (18.7) 

Bayley motor development: 

G1: 91.1 (18.7) to 92.0 (14.6) 

G2: 95.3 (17.7) to 91.5 (18.7) 

(P = 0.02) 

No significant differences 

between groups for language 

development 

Korfmacher et al., 1999;81

Olds et al., 2002;80

Olds et al., 200482

Home Visitation 2000 

Medicaid-eligible pregnant 

women 

Denver, Colorado 

N: 735 

Fair 

High G1: Developmental screening plus 

intensive home visitation: promoting 

healthy behaviors, competent child 

care, pregnancy planning, education, 

employment; linking to social and 

health services; promoting healthy 

family/friend relationships; variable 

frequency from weekly to monthly up to 

24 months of age 

G2: Developmental screening plus 

nurse home visits 

G3: Developmental screening and 

referrals 

Preschool Language Scales at 21 

months (G3 mean 99.49): 

G1 vs. G3 +0.40 (95% CI, -1.94 

to +2.74) 

G2 vs. G3 +1.73 (95% CI, -0.64 

to +4.11) 

Mental Development Index at 24 

months (G3 mean 89.38): 

G1 vs. G3 +0.07 (95% CI, -2.39 

to +2.53) 

G2 vs. G3 +0.75 (95% CI, -1.77 

to +3.28) 

St. James et al., 199983

Mothers with PKU 

(PKU Resource Mothers 

Program) 

New England 

N: 69 

Fair 

High G1: Historic control; women who 

completed pregnancy in the 5 years 

before project onset 

G2: Resource mothers 

Infant mental scale on Bayley 

Developmental Quotient was 

G1: 95 

G2: 108 (P < 0.05) 

CHW, community health workers; CI, confidence interval; G, group; PKU, phenylketonuria; SD, standard deviation.

53 
Table 16. CHW maternal and child interventions and child development (continued) 

Author, Year 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Duggan et al., 1999;128

Duggan et al., 200078

Families at high risk for 

child maltreatment 

Oahu, Hawaii 

N: 730 

Poor 

High G1: Home visiting with individualized 

service plans, child developmental 

screenings, and mother-child 

interaction assessments; family support 

plan within 45 days of initial visit, 

reviewed every 6 months, revised 

annually; periodic screening for 

developmental delays, observational 

assessment of parent-child interaction 

and home environment; ensure 

existence of medical home, link to 

other needed resources 

G2: Control (details NR) 

All outcome measures at 2 years 

postintervention 

Bayley Scales of Infant 

Development – 

Mental Development Index: 

G1: 90.0 

G2: 89.2 (P = 0.60) 

Psychomotor Development Index:

G1: 92.1 

G2: 90.4 (P = 0.12) 

Health outcomes. All four studies examined various health outcomes. In the Baltimore, 

Maryland, failure-to-thrive study, the decline in cognitive development over 1 year as measured 

by the Bayley Scales of Infant Development was less severe for the home intervention group 

than for the clinic-only group (P = 0.02) for children recruited during infancy. Groups of 

children recruited at older ages did not differ using the Battelle Developmental Inventory, 

although all groups demonstrated some degree of decline in cognitive function. Whether this 

decline was attributable to failure to thrive or to some other factor was not assessed in the study. 

Children in the intervention group showed less severe decline in receptive and expressive 

language than did age-matched controls (P = 0.05), but all groups experienced relative declines 

in language over the course of the study. All groups showed significant improvements in weight 

for age, weight for height, and height for age, but the groups did not differ significantly. 

The Home Visitation 2000 study in Denver, Colorado, found slightly greater improvement 

over controls with nurse home visits than with CHW visits for the Preschool Language Scales at 

21 months and the Mental Development Index at 24 months.80-82

Infants in the intervention cohort of the Resource Mothers Program in New England had 

higher mean Bayley Developmental Quotient (mental scale) values than those in the control 

cohort (108 versus 95) at 12 months of age (P < 0.05).83

At 2 years postintervention, children in the Hawaii Healthy Start Program78,128 who received 

CHW intervention had a mean Bayley Mental Development Index score of 90.0 versus 89.2 for 

controls (P = 0.60) and a Psychomotor Development Index score of 92.1 versus 90.4 for controls 

(P = 0.12). 

Health care utilization. No study assessed health care utilization. 

Maternal and child health: Environment conducive to child well-being. Study 

characteristics. Factors contributing to an environment conducive to the health and well-being of 

children were assessed directly in 10 studies; 6 rated as fair quality and 4 as poor quality. The 

five fair-quality RCTs covered the following populations and interventions: smokers in San 

Diego;67 low-income urban children with nonorganic failure to thrive;75,76 the Parent to Parent 

Network for mothers of children with chronic conditions;85 a trial targeting children in New York 

54 
with missed immunization visits;68 a trial involving drug-using mothers in Maryland;84 and the 

Home Visitation 2000 RCT.80-82 Finally, of the four poor-quality studies, two RCTs (both 

involving the Child-Parent Enrichment Project, or CPEP73,74) were rated poor for lack of relevant 

outcome measures; the Hawaii Healthy Start Program78,128 was rated poor for high potential for 

site-specific bias; and on the REACH-Futures trial71 was rated poor because of high potential for 

secular trend and for other confounding. 

Overview of results. The variety of outcomes assessed by the studies precludes much 

summary of results. Of the 10 studies in this category, only 4 reported significantly beneficial 

outcomes for CHWs over usual care. 

The New York study68 and REACH-Futures trial71 did find CHW-associated improvements 

in immunization status. Home Visitation 2000 showed greater improvement with nurse than with 

CHW interventions for mother-infant interaction, home environment, and tobacco smoke 

exposure.80-82 The Hawaii study found that CHW intervention significantly increased appropriate 

parental coping and discipline methods and decreased injuries from partner-related violence.78,128

As to the remaining studies: the San Diego study found no significant impact by CHWs on 

exposure to environmental tobacco smoke among children of smokers.67 The failure-to-thrive 

study found no effect of CHWs on outcomes related to home environment or parenting 

behavior.75,76 The Parent to Parent Network study showed no significant difference between 

intervention and control groups for maternal psychiatric well-being postintervention;85 however, 

the results were potentially confounded by differences at baseline. No differences were found in 

the Maryland study84 for maternal drug use or mother-child interaction. Other studies on 

substance abuse, child maltreatment, and improving psychiatric outcomes among caregivers of 

children with chronic diseases also did not report significant differences between study arms.74,84 

Knowledge. No study assessed measures of knowledge. 

Behavior. The failure-to-thrive study found no differences between groups for parent-child 

interaction behavior during feeding using a modified Parent Child Early Relational 

Assessment.75,76 It did show improved interactive communication with parents during feeding 

among children over time for all groups (P < 0.001), but no differences were apparent according 

to intervention status. Developmental appropriateness of the home environment, as assessed 

postintervention by the Home Observation for Measurement of the Environment Scales, was 

slightly higher for the CHW intervention group than for the clinic-only group (31.6 [SD 3.6] 

versus 29.3 [SD 4.2] for infants; 32.4 [SD 5.1] versus 30.3 [SD 5.7] for older children; P = 0.05 

[significance not reported by age strata]). However, no baseline scores were reported for this 

measure to ascertain the true effect of CHWs. 

In the Maryland study on substance-abusing mothers, self-reported postintervention 

substance use was similar for mothers receiving CHW interventions and for those in the control 

group (65 percent versus 68 percent for alcohol, 46 percent versus 44 percent for cocaine and/or 

heroin, and 25 percent versus 38 percent for marijuana; P ≥ 0.1).84 

The Hawaii study found that parents who received CHW intervention had a greater 

postintervention use of nonviolent discipline strategies (see Table 16), reported less parentingrelated stress, and had higher parenting efficacy scores than those receiving usual care alone.78,128

Satisfaction. No study assessed satisfaction outcomes. 

Health outcomes. Among children of smokers in the San Diego study,67 no reduction was 

seen in parental report of children’s tobacco exposure or in nicotine or cotinine levels in 

children’s hair for either CHW or control participants. The Parent to Parent Network

demonstrated no difference between groups in postintervention Psychiatric Symptom Index 

55 
scores (intervention 22.1 versus control 20.1).85 However, the baseline score for the intervention 

group was significantly higher than for the control group (24.1 versus 20.3, respectively; P < 

0.05). Adjustment for this baseline difference revealed a greater degree of improvement in the 

intervention group than in controls, except for the depression subscale, which was improved in 

both groups. However, whether this reflected true improvement attributable to CHWs or was 

simply a regression to the mean could not be determined. The New York study showed that 

children receiving CHW intervention were more likely than control children to be current on 

their immunizations (P = 0.03) and less likely to have received immunizations behind schedule 

(P < 0.05) (Table 17).68

Table 17. CHW maternal and child interventions and environment conducive to child health 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Barnes et al., 199968

Low-income immigrant 

children from Dominican 

Republic 

NW Manhattan, New York 

N: 434 

Fair 

High G1: Basic immunization education 

and referral; home visits with 

reminders of immunizations due, 

followup to ensure compliance 

G2: Information provided on child’s 

missed immunizations, encouraged 

to reschedule missed appointments 

(control) 

Immunizations up to date: 

G1: 75% 

G2: 54% (P = 0.03) 

Late for immunizations: 

G1: 18% 

G2: 38% (P < 0.05) 

Conway et al., 200467

Latino families with 

smokers and children 

between 1 and 9 years old 

San Diego County, 

California 

N: 143 

Fair 

High G1: Home and telephone visits on 

problem-solving techniques to 

reduce environmental tobacco 

smoke exposure; 6 visits over 4 

months 

G2: Participated in surveys but 

received no other intervention 

(control) 

No difference between groups for 

parent report of child’s tobacco 

exposure or child’s hair nicotine or 

cotinine levels (no reduction in either 

group) 

Black et al., 199575; 

Hutcheson et al., 199776

Low-income urban 

children with nonorganic 

failure to thrive 

Baltimore, Maryland 

N: 130 

Fair 

High G1: Weekly CHW home visits with 

community health nurse 

supervision for 1 year, addressing 

various child health and 

development needs, nutrition 

intervention, and concerns raised 

by mothers 

G2: Clinic-based multidisciplinary 

services; no CHW intervention 

No significant differences between 

groups for parent-child interaction 

HOMES home environment scores 

not reported pre-intervention 

CHW, community health worker; CI, confidence interval; G, group; N, number; ng/dL, nanograms/deciliter; SD, standard 

deviation. 

56 
Table 17. CHW maternal and child interventions and environment conducive to child health (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Korfmacher et al., 1999;81

Olds et al., 2002;80

Olds et al., 200482 

(Home Visitation 2000) 

Medicaid-eligible pregnant 

women 

Denver, Colorado 

N: 735 

Fair 

High G1: Developmental screening plus 

intensive home visitation: 

promoting healthy behaviors, 

competent child care, pregnancy 

planning, education, employment; 

linking to social and health 

services; promoting healthy 

family/friend relationships; variable 

frequency from weekly to monthly 

up to 24 months of age 

G2: Developmental screening plus 

nurse home visits 

G3: Developmental screening and 

referrals (control) 

Greater improvement in mother-infant 

interaction and home environment 

with intervention vs. controls for nurse 

home visits (least squares mean 

1.32, P ≤0.05) than for CHW visits 

(least squares mean 1.16, P < 0.1) 

Urine cotinine among smoking 

mothers reduced in all groups, more 

so for nurse intervention: 

CHW vs. control -76.19 ng/dL (95% 

CI, -302.21 to -149.82) 

Nurse vs. control -246.68 ng/dL (95% 

CI, -466.19 to -27.16; P ≤ 0.05) 

Schuler et al., 200084

Women with known history 

of drug use plus their 

infants 

Unspecified inner city, 

Maryland 

N: 192 

Fair 

High G1: 9 visits of 30 minutes each to 

enhance mothers’ ability to manage 

self-identified problems by using 

existing services and family and 

social supports; modeling infant 

development behavior/activities 

G2: 3 monthly visits of 17 minutes 

each for tracking purposes only 

No difference between groups in selfreported maternal drug use or in 

infant warmth on observed motherchild interactions 

65% of intervention and 68% of 

controls reported alcohol use 

postintervention, 46% of intervention 

and 44% of controls reported cocaine 

and/or heroin use, 25% of 

intervention and 38% of controls 

reported marijuana use (P ≥ 0.1) 

Silver et al., 199785

Inner-city, low-income, 

minority women with 

children who have a 

chronic disease 

Bronx or Lower 

Westchester, New York 

N: 365 

Fair 

High G1: Intervention 

G2: Usual care (control) 

Psychiatric Symptom Index scores 

higher at baseline in G1 than G2 (P < 

0.05), but no difference between 

groups postintervention 

Barnes-Boyd et al., 200171

(REACH-Futures) 

Low-income inner-city 

African-American pregnant 

women and infants 

Chicago, Illinois 

N: 1,922 

Poor 

High G1: Monthly home visits over 1 

year; visits at prenatal, 1, 6, and 12 

months teamed with nurse 

G2: Nurse home visits (historic 

controls) 

Proportion fully immunized at 12 

months: CHW 77%, nurse 63% 

(P < 0.001) 

57 
Table 17. CHW maternal and child interventions and environment conducive to child health (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Barth et al., 198873

Families referred for high 

risk of child maltreatment 

Contra Costa County, 

California 

N: 65 

Poor 

High G1: Twice-monthly home visits over 

6 months with links to other 

community resources 

G2: Usual care 

Child Abuse Potential Inventory prevs. postintervention: 

G1: 116.33 (SD 47.75) to 88.54 

(SD 53.09) 

G2: 103.50 (SD 43.26) to 92.44 

(SD 51.44) (P ≥ 0.05 between 

groups) 

Barth et al., 199174

Families referred for high 

risk of child maltreatment 

Contra Costa County, 

California 

N: 240 

Poor 

High G1: Home visits 

G2: Usual care 

Increase in total child maltreatmentrelated reports and court actions: 

G1: +40 families to +65 total reports 

G2: +41 families to +74 total reports 

(no significance testing reported) 

Duggan et al., 1999;128

Duggan et al., 200078

Families at high risk for 

child maltreatment 

Oahu, Hawaii 

N: 730 

Poor 

High G1: Home visiting with 

individualized service plans, child 

developmental screenings, and 

mother-child interaction 

assessments; family support plan 

within 45 days of initial visit, 

reviewed every 6 months, revised 

annually; periodic screening for 

developmental delays, 

observational assessment of 

parent-child interaction and home 

environment; ensure existence of 

medical home, links to other 

needed resources 

G2: Control (details NR) 

All outcome measures at 2 years 

postintervention 

Reported frequent use of nonviolent 

discipline strategies: 

G1: 39% 

G2: 34% (P = 0.03) 

Reported parenting-related stress: 

G1: 77.7% 

G2: 80.7% (P = 0.08) 

Parenting efficacy (Parenting Sense 

of Confidence Scale): 

G1: 76.1 

G2: 74.1 (P = 0.03) 

Maternal life skills (Community Life 

Skills Scale): 

G1: 23.9 

G2: 23.9 (P = 0.84) 

Maternal social support (Maternal 

Social Support Index): 

G1: 21.4 

G2: 21.7 (P = 0.48) 

Maternal substance use: 

G1: 18% 

G2: 20% (P = 0.55) 

58 
Table 17. CHW maternal and child interventions and environment conducive to child health (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Duggan et al., 1999;128

Duggan et al., 200078

(continued) 

Maternal depressive symptoms: 

G1: 23% 

G2: 26% (P = 0.49) 

Poor, general maternal mental 

health: 

G1: 36% 

G2: 39% (P = 0.43) 

Home learning environment (Total 

Home Observation for Measurement 

of the Environment Scale): 

G1: 34.6 

G2: 34.1 (P = 0.47) 

Mother-child interaction (Nursing 

Child Assessment Satellite Training 

scales): 

G1: Caregiver total 15.0, child total 

7.2 

G2: Caregiver total 14.6 (P = 0.28), 

child total 7.2 (P = 0.83) 

Partner-related violence in household 

resulting in injury: 

G1: 16% 

G2: 24% (P = 0.03) 

Confirmed Child Protective Services 

reports: 

G1: 2% 

G2: 3% (P = 0.40) 

Presence of primary care provider: 

G1: 91% 

G2: 86% (P = 0.09) 

Adequate number of well-child visits: 

G1: 60% 

G2: 55% (P = 0.95) 

Immunizations up to date: 

G1: 87% 

G2: 85% (P = 0.45) 

The Maryland study found infant warmth (on a 5-point scale) to be equal for those receiving 

CHW interventions and controls (2.5, SD 0.4 for both groups).84

Home Environment 2000 demonstrated more improvement over controls in mother-infant 

interaction and in home environment for nurse home visits (least squares mean 1.32, P ≤ 0.05) 

59 
than for CHW visits (least squares mean 1.16, P < 0.1).80-82 Among participating families with 

mothers who smoked, maternal urine cotinine was reduced in all groups; those receiving nurse 

home visits had a significantly greater degree of reduction than those receiving CHW visits 

(nurse versus control -246.68 ng/dL; 95 percent CI, -466.19 to -27.16); CHW versus control -

76.19 ng/dL; 95 percent CI, -302.21 to -149.82; P ≤ 0.05). 

The studies from Contra Costa, California, found no significant difference between groups on 

the Child Abuse Potential Inventory postintervention (Table 17); both groups showed 

improvement and no difference in reported cases of child maltreatment.73,74

The Hawaii study78,128 demonstrated no difference between groups for maternal life skills 

(Table 17), maternal social support, maternal substance use, maternal depressive symptoms, or 

incidence of poor general mental health among mothers at 2 years postintervention. Neither 

home learning environment nor parent-child interactions differed between groups at 2 years. The 

investigators did not report how each of these measures compared with baseline values. The 

study did show lower incidence of injuries attributable to partner-related violence among 

families receiving CHW intervention (P = 0.03), but no differences in reported or confirmed 

cases of child maltreatment. 

Health care utilization. Children receiving CHW intervention in the Hawaii study were no 

more likely than those receiving usual care to have a primary care provider (P = 0.09) (Table 

17), to have received the recommended number of well-child visits (P = 0.95), or to be current 

on immunization status (P = 0.45).78,128

Outcomes for Cancer Screening 

Cancer screening. Study Characteristics. A total of 15 studies (24 citations) examined 

outcomes of CHW interventions for improving breast, cervical, or colorectal cancer 

screening.15,17-22,59-63,103,104,106-113,116,125 Information on these studies is spread across multiple 

tables, depending on the specific focus: improving knowledge, changing behavior, breast selfexamination, Pap smears, mammography, clinical breast examination, and colorectal cancer 

screening. 

Of these studies, 10 are RCTs15,17-22,61-63,103,104,106-113 and 5 are observational 

studies.59,60,108,113,116,125 The RCTs include three randomized by communities103 or churches.19-

22,104,107 Of the five observational studies, one was a quasi-experimental controlled cohort,125 two 

were prospective cohorts,108,113 one used retrospective records,59,60 and one used repeated crosssectional survey of women attending beauty salons randomly assigned to experimental and 

control groups.116 The studies spanned the quality range as well: two were of good quality,17,18,103

seven of fair quality,59-63,106,108,109,125 and six of poor quality.15,19-22,104,107,110-113,116 

As noted in our section on KQ 1, seven studies used low-intensity CHW models, 6 used 

moderate-intensity interventions, and two used high-intensity interventions. Six studies included 

more than two arms. Studies compared the CHW arm with a variety of alternatives, including no 

intervention or usual care (6 studies), mail (3 studies), community interventions (4 studies), 

CHWs in a lesser capacity (2 studies), and CHWs in combination with other interventions (2 

studies). 

With the exception of two studies on colorectal cancer screening,106,107 all other studies focus 

on women. All studies focused mainly on minority or underserved communities. 

Studies used varied definitions of outcomes. The greatest commonality was reporting on 

utilization of cancer screening tests such as mammography, clinical breast examination, Pap 

smears, and colorectal cancer screening. Of the 15 studies, 13 reported on changes in rates of 

60 
utilization, but they varied in their specific definitions (ever use, use in the past 3 months, 1 year, 

2 years, and so on).15,17-22,59-63,104,106-113,125 With the exception of 3 studies examining Medicaid or 

medical records for mammography use,17,18,59,60,63 all relied solely on self-report. 

Overview of results. Together, the 15 studies suggest limited evidence of improvement in 

knowledge in the CHW arm compared with alternative approaches; they present conflicting 

findings on the effect of CHWs on planned and actual health behaviors, specifically breast selfexamination. The volume of evidence on these outcomes is limited; the quality and design of the 

studies limits the interpretation of available evidence. 

Unlike most of the other subsections dealing with other purposes for CHW strategies, cancer 

screening studies used high-, moderate-, and low-intensity interventions. Enough studies and 

evidence are available to permit some analysis by the intensity variable as it relates to Pap 

smears and mammography. Summary tables for these two outcomes are therefore presented by 

intensity (low, then moderate, then high), followed by quality, and then alphabetical order, by 

last name of first author(s); for all other sections, we present studies by quality, and then 

alphabetical order, by last name of first author(s). 

Regarding health care utilization, our findings from this limited evidence do not support the 

conclusion that CHW interventions are more effective in comparison with other alternatives in 

raising the rates of clinical breast examination or colorectal cancer screening. More substantial 

evidence exists on Pap smears and mammography. The CHW approach is at least as effective as 

the alternative in improving Pap smear rates, but it is more effective than the alternative only in 

limited circumstances of low- and moderate-intensity interventions. With respect to 

mammography rates, studies demonstrated significantly greater improvements in the CHW arm 

compared with the alternative (no intervention, mail, print, or minimal CHW) in either the entire 

sample or in subsamples. 

Knowledge. Two studies (three articles; Table 18) examined changes in knowledge and 

found limited evidence of improvement for the CHW arm.17,18,109 A good-quality, high-intensity 

study in North Carolina measured knowledge for 12 individual measures on breast cancer and a 

composite score.17,18 The studies together suggest improvements in the CHW arm, although the 

results are not consistent on the relative benefit of the CHW arm versus the alternative. Although 

differences between the CHW and the comparison arm (mail intervention) were not statistically 

significant for the composite measure of knowledge, the study reported significant different 

improvements favoring the CHW arm on two individual items measuring knowledge. Both arms 

demonstrated improvements in other measures, but these improvements were not statistically 

significantly different. A second study, of fair quality and moderate intensity in California, found 

significantly different improvements on two measures of knowledge, favoring the CHW arm 

compared with the media intervention arm.109

61 
Table 18. CHW cancer screening: improving knowledge 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Paskett et al., 2006;17

Katz et al., 200718

RCT 

Community health 

centers, Robeson 

County, North 

Carolina 

820 

Good 

High G1: Letter and NCI brochure sent about 

the need for regular cervical cancer 

screening 6 months after random 

assignment, followed by letter and NCI 

brochure about the need for 

mammography 3 months after followup 

assessment (control) 

G2: Individualized health education 

program that was culturally acceptable and 

tailored to meet the needs of each woman, 

intensive face-to-face interactive 

educational program administered over a 

9- to 12-month period, consisting of 3 inperson visits, with educational materials 

provided at each visit and followup 

telephone calls and mailings thereafter 

Composite knowledge score: 

not statistically significantly higher in 

CHW group 

Mock et al., 2007109

RCT 

Vietnamese-American 

women, Santa Clara 

County, California 

968 

Fair 

Moderate G1: CHW small group meetings; direct 

contact with subjects; Vietnamese 

language ads for TV, radio, newspaper; 

booklets and printed materials in various 

community locations 

G2: Vietnamese-language ads for TV, 

radio, newspaper; booklets and printed 

materials in various community locations; 

delayed educational session 

Reported awareness of need for 

Pap test by women 18+ years old 

(baseline/followup): 

G1: 68.4%/93.9% (P < 0.001) 

G2: 68.5%/70.2% (P = 0.55) 

Z-test P < 0.001 

Heard of Pap test: 

G1: 81.8%/99.6% (P < 0.001) 

G2: 87.2%/95.2% (P < 0.001) 

Z-test P < 0.001 

CHW, community health workers; G, group; NCI, National Cancer Institute; RCT, randomized controlled trial; TV, television. 

Behavior: planned testing. Two studies, one of fair quality and low intensity63 and the other 

of poor quality and moderate intensity,116 provide contradictory findings on the effect of CHWs 

on planned behavior Table 19). The fair-quality study compared a CHW arm with direct and 

usual care; differences in the rate of planned Pap smear tests favoring the CHW arm were 

statistically significant compared with either direct mail or usual care.63 The poor-quality study 

reported no differences among study arms. However, the design of the study, which involved 

repeated cross-sections in salons randomly assigned to experimental and control status in which 

experimental salons offered barrier-specific counseling, was not measuring changes in intent 

over time; rather, it was concerned with differences in a cross-sectional sample. Low penetration 

combined with contamination across the samples (as suggested by the 37 percent and 10 percent 

of the sample reporting breast health messages at control sites and experimental sites, 

respectively) could have diluted the effects of the intervention.116

62 
Table 19. CHW cancer screening: changing planned behaviors 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Taylor, et al., 200263

RCT 

Chinese-American 

women, Seattle, 

Washington, and 

Vancouver, British 

Columbia 

402 (181 Seattle, 221 

Vancouver) 

Fair 

Low G1: Introductory mailing, CHW visit 

with multimedia and tailored 

counseling, telephone followup and 

tailored counseling, logistic assistance 

as needed 

G2: Direct mail multimedia materials 

G3: Usual care at local clinics and 

doctors' offices (control) 

Pap testing planned within 2 

years: 

G1: 72% 

G2: 59% 

G3: 48% 

(G1 vs. G3 P < 0.001, G2 vs. G3 

P = 0.05, G1 vs. G2 P = 0.03) 

Wilson et al., 2008116

Repeated crosssectional survey of 

women attending 

salons randomly 

assigned to 

experimental and 

control groups 

Neighborhood hair 

salons, Brooklyn, 

New York 

40 salons/1,210 

respondents 

Poor 

Moderate G1: Control, before intervention 

G2: Stylist group, before intervention 

G3: Control, after intervention 

G4: Stylist group, after intervention 

Intervention consisted of education, 

counseling, and information on 

location of screening services during 

salon appointment 

Intention to receive clinical 

breast examination in next year:

G3: 90% 

G4: 89% 

AOR, 0.9; adjusted 95% CI, 0.6-

1.2 

Intention to receive mammogram 

in next year: 

G3: 70% 

G4: 74% 

AOR, 1.3; adjusted 95% CI, 0.9-

1.2 

CHW, community health worker; CI, confidence interval; G, group; AOR, adjusted odds ratio. 

Behavior: breast self-examination. Five studies (eight citations; Table 20) reported on 

changes in self-breast examination as outcomes of CHW interventions.61,62,108,110-112,116,125 Of 

these five studies, three were of fair quality61,62,108,125 and two of poor quality.110-112,116 They 

included one high-intensity,61,62 three moderate-intensity,110-112,116,125 and one low-intensity 

study.108 

These studies provide conflicting evidence of the effectiveness of the CHW approach, either 

in comparison with an alternative or over time independent of a comparison. Two studies 

reported significant differences between the CHW arm and an alternative (low-intensity CHW, 

mailed intervention, delayed intervention, or no intervention).108,110-112 The same two studies also 

provided evidence of significant differences between baseline and followup for the CHW 

arm.108,110-112 A third study employed repeated cross-sectional measurements and reported higher 

rates in the followup assessment but these were not statistically significant.116 The fourth study 

63 
Table 20. CHW cancer screening: changing breast self-examination behavior 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Erwin et al., 

1997108

Prospective cohort 

Church or 

community 

groups, rural 

Mississippi River 

Delta region, 

Arkansas 

412 

Fair 

Low G1: Members of a Witness 

Project team, composed of 7 

local African-American women 

who had survived breast or 

cervical cancer, spoke in groups 

of 2 to 5 at local churches and 

community organization 

meetings 

G2: Delayed intervention 

(control) 

Regular practice of BSE (self-report): 

G1: 69.8% to 82% (P < 0.005 compared 

with baseline) 

G2: 82% to 82% (P = NS compared with 

baseline) 

BSE in the past month (self-report): 

G1: 49% to 65.4% (P < 0.001 compared 

with baseline) 

G2: 65% to 72% (P = NS compared with 

baseline) 

Hiatt et al., 

2008125

Prospective cohort 

Public health 

clinics and the 

low-income 

neighborhoods in 

San Francisco and 

Contra Costa 

County, California 

1,616 

Fair 

Moderate G1: One-on-one visits at various 

events and locations; 

presentations to communitybased organizations (agencies); 

and Women’s Health Days, 

offering free mammograms, Pap 

tests, and breast selfexamination instruction 

G2: No intervention (control) 

Ever completed breast self-examination 

(Total N [%] pretest/Total N [%] posttest):

G1: 800 (89)/810 (92) 

Χ2 = NR, P=0.031 

G2: 793 (83)/ 802(81) 

Χ2 = NR, not significant 

Completed breast self-examination 

monthly in the past year (Total N [%] 

pretest/Total N [%] posttest): 

G1: 800 (24)/808 (26) 

Χ2 = NR, not significant 

G2: 793 (18)/ 801(23) 

Χ2

 = NR, P=0.018 

AOR, adjusted odds ratio; BSE, breast self examination; CHW, community health worker; CI, confidence interval; G, group; NR, 

not reported; NS, not significant; OR, odds ratio; RCT, randomized controlled trial. 

64 
Table 20. CHW cancer screening: changing breast self-examination behavior (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Sung et al., 

199761; Sung et 

al., 199262

RCT 

Inner-city African 

Americans, state 

unspecified 

195 

Fair 

High G1: CHW home visits, education 

on breast and cervical cancer, 

BSE educational materials on 

screening, facilitation to address 

logistical barriers to screening 

G2: Mailed educational 

materials on cancer screening 

Pretest/posttest change in self-report of 

BSE for entire sample: 

G1: 52.1%/51.0% 

G2: 41.1%/41.0%, difference in change: 

-1.0 (95% CI, -6.1 to 4.1) 

Pretest/posttest change in self-report of 

BSE, postintervention respondents only:

G1: 57.0%/53.8% 

G2: 40.2%/40.2%, difference in change: 

-3.2 (95% CI, -17.5 to 11.1) 

Posttest report of BSE, women not 

previously on recommended screening 

schedules, whole sample: 

G1: 24.4% 

G2: 17.2%, difference in change: 7.2% 

(95% CI, -5.0-19.3) 

Posttest report of BSE, women not 

previously on recommended screening 

schedules, postintervention respondents 

only: 

G1: 47.5% 

G2: 26.2%, difference in change: 21.3% 

(95% CI, 2.3-40.3) 

Navarro et al., 

1998,111 Navarro 

et al., 1995,110

Navarro et al., 

2000112

RCT 

Low-income 

Latinas, Southeast 

San Diego 

County, California 

365 

Poor 

Moderate G1: CHW delivering community 

living skills sessions, details NR 

G2: CHW delivering cancer 

education sessions, 12 weekly 

group sessions conducted over 

3 months plus 2 additional 

sessions offered within a year of 

beginning of group meetings 

Pretest-posttest changes in percentage of 

women performing monthly BSEs: 

Participant unit of analysis (n = 361) 

G1: 18.5 

G2: 33.2 

P < 0.001 

t = 3.23 

CHW unit of analysis (n = 35) 

G1: 18.6 

G2: 31.8 

P = 0.021 

t = 2.43 

Odds of monthly BSE at 1-year and 2-

year followup for cancer screening group 

(P value): 

Year 1: 2.03 (0.016) 

Year 2: 0.96 (0.877) 

65 
Table 20. CHW cancer screening: changing breast self-examination behavior (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Wilson et al., 

2008116

Repeated crosssectional survey of 

women attending 

salons randomly 

assigned to 

experimental and 

control groups 

Neighborhood hair 

salons, Brooklyn, 

New York 

40 salons/1,210 

respondents 

Poor 

Moderate G1: Control, before intervention

G2: Stylist group, before 

intervention 

G3: Control, after intervention 

G4: Stylist group, after 

intervention 

Intervention: provide messages 

promoting breast health during 

salon visit 

Engaging in BSE in past 3 months: 

G1: 25% 

G2: 28%, P = 0.26 for differences 

between G1 and G2 

G3: 37% 

G4: 40% 

AOR for differences between G3 and G4 

1.3; adjusted 95% CI, 0.9-1.7 

failed to find any improvements over time.61,62 The fifth study found reported conflicting results 

for the two selected measures. 

Of the three fair-quality studies, the high-intensity study compared the CHW arm with a 

mailed intervention,61,62 the moderate-intensity study compared the CHW arm (outreach) to nointervention arm, and the low-intensity CHW arm compared the CHW arm to a delayed 

intervention.108 The high-intensity study found no significant improvements over time in either 

arm, or between arms, except when the sample was restricted to a much reduced subsample who 

were available at followup and were not on the recommended screening schedule.61,62 The 

moderate-intensity study found improvements in the intervention arm over time for ever use of 

breast self-examination, but no significant differences in the control arm, but also found opposite 

effects for another measure: monthly breast self-examinations, with significant differences in the 

control arm over time, but not the intervention arm The low-intensity study found that the CHW 

arm resulted in significant improvements over time compared with the delayed-intervention 

arm.108 However, baseline differences between the two arms were large; significant differences 

between the two arms could have resulted from ceiling effects. 

Of the two poor-quality studies, one moderate-intensity intervention compared a more 

intense CHW arm with a less intense CHW arm;110-112 the other moderate-intensity intervention 

compared the CHW arm with a no-intervention control.116 In the former study, the two arms 

differed significantly through 1-year followup but not at the 2-year followup.110-112 In the latter 

study, rates of breast self-examination were higher in followup interviews than in baseline 

interviews, but the differences between the arms was not statistically significant.116

Satisfaction. No study reported outcomes for satisfaction. 

Health outcomes: No study reported on health outcomes.

66 
Health care utilization: Pap smears. The evidence on the effectiveness of CHW 

interventions draws upon six studies (nine articles; Table 21).17,18,61-63,110-112 Most studies 

demonstrate that the CHW arm is as effective as the alternative in improving Pap smear rates. 

CHWs were not more effective than mailed interventions in high-intensity interventions. They 

were more effective than the alternative in limited circumstances involving low- or moderateintensity intervention in three of four studies. Because intensity may, thus, actually be an 

important policy variable for analyzing use of Pap smears, we present information on Pap smear 

use ordered first by intensity and then by the quality of the studies. 

Table 21. CHW cancer screening: Pap smears 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Taylor, et al., 

200263

RCT 

ChineseAmerican women, 

Seattle, 

Washington, and 

Vancouver, British 

Columbia 

402 (181 Seattle, 

221 Vancouver) 

Fair 

Low G1: Introductory mailing, CHW visit with 

multimedia and tailored counseling, 

telephone followup and tailored 

counseling, logistic assistance as 

needed 

G2: Direct mail multimedia materials 

G3: Usual care at local clinics and 

doctors' offices (control) 

Self-reported Pap testing completed 

since intervention: 

G1: 39%, G2: 25%, G3: 15% 

(G1 vs. G3, P < 0.001; G2 vs. G3, 

P = 0.03; G1 vs. G2, P = 0.02) 

Medical records for Pap screening 

received between randomization and 

followup, using intention-to-treat: 

Results not provided, significant 

differences between outreach worker 

versus control (P <.001), direct mail 

versus control (P =.07), and outreach 

worker versus direct mail (P =.04) 

Medical records for Pap screening 

received in the past 2 years, using 

intention-to-treat: 

Results not provided, significant 

differences between outreach worker 

versus control (P <.001) and direct mail 

versus control (P =.03) 

CHW, community health worker; CI, confidence interval; G, group; N, number; NCI, National Cancer Institute; NR, not 

reported; RCT, randomized controlled trial; TV, television. 

67 
Table 21. CHW cancer screening: Pap smears (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Hiatt et al., 

2008125

Prospective 

cohort 

Public health 

clinics and the 

low-income 

neighborhoods in 

San Francisco 

and Contra Costa 

County, California 

1,616 

Fair 

Moderate G1: One-on-one visits at various 

events and locations; presentations to 

community-based organizations 

(agencies); and Women’s Health Days, 

offering free mammograms, Pap tests, 

and breast self-examination instruction 

G2: No intervention (control) 

Ever completed Pap smear (logistic 

regression, 95% CI) 

Residence in outreach area over time: 1.5 

(0.6-4.2) 

Completed Pap smear in the past 3 years 

(logistic regression, 95% CI) 

Residence in outreach area over time: 0.9 

(0.6-1.3) 

Mock et al., 

2007109

RCT 

VietnameseAmerican women, 

Santa Clara 

County, California 

968 

Fair 

Moderate G1: CHW small group meetings, direct 

contact with subjects, Vietnamese 

language ads for TV/radio/newspaper, 

booklets and printed materials in 

various community locations 

G2: Vietnamese-language ads for 

TV/radio/newspaper, booklets and 

printed materials in various community 

locations, delayed educational session 

Self-report of having ever had Pap 

(baseline/followup): 

G1: 65.8%/81.8% (P < 0.001); 

G2: 70.1%/75.5% (P < 0.001); 

Z test P = 0.001 

Self-report of Pap in past year: 

G1: 45.7%/67.3% (P < 0.001); 

G2: 50.9%/55.7% (P = 0.035); 

Z test P < 0.001 

Ever had Pap test (among those who had 

not had Pap test pre-outreach): 

G1: 46.0 (N = 144); 

G2: 27.1 (N = 161) P < 0.001 

68 
Table 21. CHW cancer screening: Pap smears (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Navarro et al., 

1998;111 

Navarro et al., 

1995;110 

Navarro et al., 

2000112

RCT 

Low-income 

Latinas, southeast 

San Diego 

County, California 

365 

Poor 

Moderate G1: CHW delivering community living 

skills sessions, details NR 

G2: CHW delivering cancer education 

sessions, 12 weekly group sessions 

conducted over 3 months plus 2 

additional sessions offered within a 

year of beginning of group meetings 

Pretest-posttest changes in 

percentages of women who had a Pap 

test within past year: 

Participant unit of analysis (n = 360) 

G1: 16.2 

G2: 23.1 

P = 0.096 

t = 1.67 

CHW unit of analysis (n = 35) 

G1: 18.4 

G2: 23.4 

P = 0.369 

t = 0.91 

Odds of Pap smear 1-year and 2-year 

followup for cancer screening group (P

value): 

Year 1: 2.10 (0.017) 

Year 2: 1.70 (0.082) 

Paskett et al., 

2006;17

Katz et al., 200718

RCT 

Community health 

centers, Robeson 

County, North 

Carolina 

820 

Good 

High G1: Control sent letter and NCI 

brochure about the need for regular 

cervical cancer screening 6 months 

after random assignment, followed by 

letter and NCI brochure about the 

need for mammography 3 months 

after followup assessment 

G2: Individualized health education 

program that was culturally 

acceptable and tailored to meet the 

needs of each woman, intensive faceto-face interactive educational 

program administered over a 9- to 12-

month period, consisting of 3 inperson visits, with educational 

materials provided each visit and 

followup telephone calls and mailings 

after 

Cervical cancer screening rates within 

risk-appropriate guidelines: 

Significant differences between 

baseline and followup for both groups, 

no significant differences between 

intervention and control groups 

69 
Table 21. CHW cancer screening: Pap smears (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Sung et al., 

1997;61

Sung et al., 

199262

RCT 

Inner-city African 

Americans, state 

unspecified 

195 

Fair 

High G1: CHW home visits, education on 

breast and cervical cancer, breast selfexam, educational materials on screening, 

facilitation to address logistical barriers to 

screening 

G2: Mailed educational materials on 

cancer screening 

Pretest/posttest change in selfreport of receiving Pap smears for 

entire sample: 

G1: 50.3%/58.7% 

G2: 51.9%/62.1%, difference in 

change: -1.8 (95% CI, -8.0-4.4) 

Pretest/posttest change in selfreport of receiving Pap smears, 

postintervention respondents only:

G1: 52.7%/63.4% 

G2: 50.0%/62.7%, difference in 

change: -2.0 (95% CI, -11.0-7.0) 

Posttest rate of self-report of 

receiving Pap smears, women not 

previously on recommended 

screening schedules, whole 

sample: 

G1: 33.3% 

G2: 34.2%, difference in change: 

-0.9 (95% CI, -15.7-13.9) 

Posttest rate of self-report of 

receiving Pap smears, women not 

previously on recommended 

screening schedules, 

postintervention respondents only:

G1: 61.4% 

G2: 51.0%, difference in change: 

10.4 (95% CI, -9.5-30.0) 

One low-intensity trial, of fair quality, compared CHWs with direct mail and with usual care 

in cities in Washington and British Columbia.63 CHWs were more effective than either 

alternative in increasing Pap smear rates, using both self-report and medical records. 

Of the three moderate-intensity interventions, one in Santa Clara County, California, was of 

fair quality109, a second in San Francisco and Contra Costa was also fair quality,125 and the third 

in San Diego County, California, was rated poor quality.110-112 The fair-quality study in Santa 

Clara compared CHWs with a media intervention; CHWs were effective in increasing rates of 

Pap smears.109 The fair-quality study in San Francisco and Contra Costa found no statistically 

significant difference in changes in self-reported Pap smears between residents of intervention 

and control communities.125 The poor-quality study compared a higher-intensity CHW arm 

focusing on cancer control with a lower-intensity CHW arm.110-112 Although both arms 

demonstrated effectiveness compared with baseline values, participation in the more intense arm 

did not affect use of Pap smears compared with the less intense arm in the short term, but it did 

demonstrate effectiveness in the longer term (at 1- and 2-year followups). Followups were 

70 
marked by high dropout rates, however, so the effectiveness in the longer term could be 

explained by selection bias. 

Two high-intensity trials, one good-quality study in North Carolina,17,18 and one fair-quality 

study among inner-city African Americans (location unspecified),61,62 compared CHWs to 

mailed interventions. These two studies reported consistent results failing to demonstrate 

effectiveness of CHWs in improving Pap smear use compared with mailed interventions, but 

both studies showed that both arms demonstrated improvement compared with baseline values. 

Health care utilization: mammography. Eleven studies (21 articles; Table 22), provide 

evidence on the effectiveness of CHW intervention with respect to breast cancer screening by 

mammography.15,17-22,59-62,103,104,108,110-113,116 Eight of these studies demonstrated significantly 

greater improvements in the CHW arm compared with the alternative (no intervention, mail, 

print, or minimal CHW) in either the entire sample or in subsamples.17-22,59-62,103,104,108,110-113 Two 

of three studies reporting nonsignificant differences between the CHW arm and the alternative 

were moderate-intensity, poor-quality studies comparing CHWs with no intervention;15,116 one of 

these studies reported nonsignificant differences between the CHW arm and the control, favoring 

the CHW arm. The third was a moderate-intensity fair-quality study comparing the effect of 

CHW interventions with controls at the community level.125 As with use of Pap smears, intensity 

may be a relevant analytic variable, so we report findings below first by intensity, then by study 

quality. 

Four studies did not report changes over time;15,17-22,103,104 one study failed to show 

improvement in the intervention area,125 and the remaining six studies all demonstrated some 

improvement in the control arm (no intervention, delayed intervention, mail, print, or minimal 

CHW), although the improvement was not statistically significant. 

Studies conducting subgroup analyses demonstrated that CHW interventions can provide 

benefits for subpopulations. Four studies provide evidence that CHW interventions are likely to 

be more beneficial than alternative interventions in low-income, minority populations with some 

health care barriers.19-22,60,103,104,113

Low-intensity interventions generally compared CHW with minimal to no intervention, We 

identified five such studies, one good-quality,103 two fair,59,60,108 and two poor.19-22,104,113

Collectively CHWs were generally effective in raising mammography rates, but with potentially 

greater effects in subpopulations. 

The good study from Washington State, comparing a no-intervention control group with 

CHW groups receiving community activities, individual counseling, or a combination of 

community activities and individual counseling found that all the CHW intervention arms had 

higher rates of new users than the no-intervention control, but the study did not find significantly 

greater effectiveness of CHW arms in comparison with a no-intervention control.103 The 

community activities arm appeared to be more effective than a no-intervention control in 

preventing relapse (that is, in ensuring that regular users or women who were adherent to 

recommended screening guidelines at baseline continued to be adherent at followup) than in 

enrolling new users. 

71 
Table 22. CHW cancer screening: mammography 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Andersen, 

2000103

RCT of 

communities 

Rural 

communities, 

Washington 

6,685 

Good 

Low G1: Control—no intervention reported 

G2: Community activities—developing 

social norms 

G3: Individual counseling—telephone 

G4: Community activities and individual 

counseling 

Proportion of mammography 

rates among regular users 

(regular user is more than 1 

mammogram, last mammogram 

within 2 years, and the previous 

mammogram within 2 years of 

the last mammogram) (selfreported): 

G1: 0.922 

G2: 0.951, difference from G1 = 

0.029, P = 0.01 (95% CI, 0.008-

0.052) 

G3: 0.918, difference from G1 = 

0.004, P = 0.81 (95% CI, -0.043-

0.032) 

G4: 0.936, difference from G1 = 

0.014, P = 0.27 (95% CI, -0.013-

0.039) 

Proportion for G2+G3+G4: 

0.935, difference from G1 = 

0.013, P = 0.40 (95% CI, -0.012-

0.038) 

In subgroup analysis, the 

intervention was more effective 

than the control in preventing 

relapse among women who 

needed >2 hours to get a 

medical appointment 

G1: 88.1%, difference in 

proportions for G2: 7.1% 

(P ≤ 0.01) 

G2: 6.0% (P ≤ 0.01) 

G3: 5.6% (P ≤ 0.05) 

Proportion of mammography 

rates among new users (underusers at baseline) (selfreported): 

G1: 0.578 

G2: 0.599, difference from 

G1 = 0.021, P = 0.63 

(95% CI, -0.080-0.117) 

G3: 0.606, difference from G1 = 

0.028, P = 0.47 (95% CI, -0.064-

0.113) 

G4: 0.604, difference from 

G1 = 0.026, P = 0.55 

(95% CI, -0.062-0.122) 

CHW, community health worker; CI, confidence interval; G, group; GEE, generalized estimating equation; ICD, International 

Classification of Diseases; N, number; NCI, National Cancer Institute; NR, not reported; NS, not significant; OR, odds ratio; 

RCT, randomized controlled trial; RR, relative risk; t, t-test. 

72 
73 
Table 22. CHW cancer screening: mammography (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity 

R

of CHW 

Interventi

on Study Groups esults 

Andersen, 

2000103

(continued) 

P

d

P 5) 

In

users/intervention more effective 

th

m phy rates among women 

w e 

p .4%, G3: 10.5%, 

G ng 

w e 

(G2: 23.2%, G3: 9.9%, G4: 22.1%; 

roportion for G2+G3+G4: 0.603,

ifference from G1 = 0.025,

= 0.40 (95% CI, -0.035-0.08

 subgroup analysis, among underan control in increasing 

ammogra

ithin communities without a femal

hysician (G2: 12

4: 16.5%; P < 0.05) and amo

omen with no health insuranc

P ≤ 0.05) 

Erwin et al., 

1997108

Prospect

cohort 

ive 

hurch or 

unity 

roups, rural 

pi River 

Low G am, 

co

w

ca at local 

churches and community organization 

m

G

Ever had mammography (selfr

G

c baseline) 

G NS 

compared with baseline) 

C

comm

g

Mississip

Delta region, 

Arkansas 

412 

Fair 

1: Members of a Witness Project te

mposed of 7 local African-American 

omen who had survived breast or cervical 

ncer, spoke in groups of 2 to 5

eetings 

2: Delayed intervention (control) 

eport): 

1: 52.4% to 64.4% (P < 0.05 

ompared with

2: 60.4% to 63.3% (P = 

Sauaia et al.

2007;59 , 

elsh et al., 

etrospective 

ommunities, 

ado 

-only 

analysis: 4,73959; 

Latina vs. white 

analysis: 6,69660

air 

G

de

pe

bi

th ts, conducted 

health groups that met at the home of one of 

th

pr vention 

G2: Printed intervention incorporated into 

church display, bulletin, and/or pulpit 

announcements 

P

r

followup): 

L

G1: 59%/61% 

G2: 58%/58%, unadjusted rates not 

s

m

g ral vs. urban, 

a creased 

b grams in 

in

 

L

G 0% (unadjusted 

G 38% 

( ted GEE 

P = 0.4) 

G2: Latina 45%/43% (unadjusted 

GEE P = 0.27); non-Latina 

41%/44% (unadjusted GEE P = 

0.02)60

W

200560

R

cohort 

Church 

c

Color

Latina

F

Low 1: Trained peer counselors (Promotoras) 

livered health promotion message 

rsonally, through meetings held at least 

monthly immediately after mass and 

rough other church even

c

e participants, same newsletter used in the 

inted inter

retest/posttest mammography 

ates via ICD codes on Medicaid 

laims (baseline/

atina-only analysis: 

ignificant in either group, GEE 

odel adjusting for insurance 

roup, age, income, ru

nd disability found in

iennial mammo

tervention group (P = 0.03)59

atina vs. white analysis: 

1: Latina 25%/3

EE P = 0.3); non-Latina 32%/

unadjus

74 
Table 22. CHW cancer screening: mammography (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Sauaia et al., 

2007;59

Welsh et al., 0

y 

 and 

es on 

retest-posttest 

interaction term 

atina: G1 vs. G2 adjusted GEE 

20056

(continued) 

Comparison of mammograph

rates by intervention

ethnicity, via ICD cod

Medicaid claims (p

time-intervention 

by GEE) 

L

P = 0.07 

Non-Latina: G1 vs. G2 adjusted 

GEE P = 0.10 

Derose et al., 

2000;19 

Dean et al., 

2000;

Deros

20 

e et al., 

e et al., 

000;22

oor 

Low 

intervention: a library of resource materials 

on cancer and cancer prevention; 

assistance with starting a health committee 

or working with an existing health 

ng 

peer counselor; 

ounseling individualized to address 

uter 

upport offered to control churches 

1: 23.3% 

2: 15.8% (P = 0.029) 

24) 

2000;21 

Stockdal

2

Fox et al., 

1998104

RCT 

Church 

communities, 

Louisiana 

813 

P

G1: Control churches provided minimal 

committee; computer hardware, software, 

and a printer, as well as computer traini

for at least 1 church member 

G2: 1 session of telephone counseling 

annually, for 2 years, by 

c

barriers; churches also received comp

s

Nonadherence rate (among 

baseline adherent): 

G

G

Nonadherence rate (among 

baseline nonadherent): 

G1: 37.4% 

G2: 34.8% (P = 0.3

Earp et al., 113

rospective 

cohort 

Black women, 

eastern North 

Carolina 

801 

Poor 

Low G1: Counties receiving CHW and other 

targeted activity—presentations to 

community groups and events, one-on-one 

conversations, use of informational/ 

motivational materials 

G2: Comparison counties—no intervention 

reported 

ogram in 

ast 2 years (baseline/followup):

G1: 41%/58% 

G2: 56%/67% (adjusted P = 

0.05) 

Self-report of mammogram in 

past 2 years, stratified by income 

(baseline/followup): 

< $12k annually— 

G1: 37%/59% 

G2: 49%/60% (adjusted P = 

0.02) 

$12k or greater annually— 

G1: 56%/59% 

G2: 73%/82% (adjusted P = 

0.92) 

2002

S

p

elf-report of mamm

P

75 
Table 22. CHW cancer screening: mammography (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Dignan et al., 

200515

RCT 

Urban Americandian women, 

ado 

on 

oor 

hy Program 

data 

st cancer and value of 

early detection, review of brochure 

G3: Telephone intervention, as above 

50.0% 

2: 29%/41.8% 

e: 

+G3: 2.68, P = 0.10; 

. G3: 0.83; 

 pre-changes: 0.029; 

 for G3, pre-changes: 0.197 

In

Denver, Color

157 (for 

interventi

groups, N for 

control NR) 

P

Moderate G1: Control interventions NR data from 

Colorado Mammograp

G2: Tailored education brochure using 

from baseline interview. Face-to-face

planned for delivery at participant's home (1

session lasting 20-90 minutes), presenting 

information on brea

Mammograms over past 12 

months, self-report 

(baseline/followup): 

G1: 51.9%/

G

G3: 34.4%/45.2% 

Chi-squar

G1 vs. G2

P for G2 vs

P for G2,

P

Hiatt et al., 

Prospective 

cohort 

Public health 

clinics and the 

hoods in 

an Francisco 

Moderate G1: One-on-one visits at various events and 

locations; presentations to communitybased organizations (agencies); and 

Women’s Health Days, offering free 

mammograms, Pap tests, and breast selfexamination instruction 

G2: No intervention (control) 

eted mammography 

egression, 95% CI) 

n 

regression, 

0.5-1.0) 

s in 

past 5 years (logistic regression, 

95% CI) 

Residence in outreach area over 

time: 0.8 (0.5-1.1) 

2008125

low-income 

neighbor

S

and Contra Costa

County, 

California 

1,616 

Fair 

Ever compl

(logistic r

Residence in outreach area over 

time: 0.7 (0.5-1.0) 

Completed mammography i

past 2 years (logistic 

95% CI) 

Residence in outreach area over

time: 0.7 (

Completed 3 mammographie

76 
Table 22. CHW cancer screening: mammography (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Navarro et al., 

1998;111 

Navarro et al., 

1995;110 

avarro et al., 12

outheast San 

 County, 

alifornia 

365 

ate s 

onal 

essions offered within a year of beginning 

≥40 years 

mmogram within 

articipant unit of analysis (n = 

2: 21.4 

P = 0.029 

t = 2.22 

CHW unit of analysis (n = 33) 

G1: 6.8 

G2: 24.3 

P = 0.063 

N

20001

RCT 

Low-income 

Latinas, 

s

Diego

C

Poor 

Moder G1: CHW delivering community living skill

sessions, details NR 

G2: CHW delivering cancer education 

sessions, 12 weekly group sessions 

conducted over 3 months plus 2 additi

s

of group meetings 

Pretest-posttest changes in

percentage of women 

who had ma

past year: 

P

113) 

G1: 7 

G

t = 1.96 

Odds of mammogram 1-year and 

2-year followup for cancer 

screening group (P value): 

Year 1: 1.50 (0.484) 

Year 2: 3.88 (0.018)

Wilson et al., 

2008116

Repeated crossnal survey 

f women 

ing salons 

ndomly 

assigned to 

experimental and 

control groups 

Neighborhood 

hair salons, 

Brooklyn, New 

York 

40 salons/1,210 

respondents 

Poor 

Moderate consisted of education, 

counseling, and information on location of 

screening services during salon 

appointment 

G1: Control, before intervention 

G2: Stylist group, before intervention 

G3: Control, after intervention 

G4: Stylist group, after intervention 

0.8-1.7) 

sectio

o

attend

ra

Intervention Mammogram in past 3 months: 

G1: 13% 

G2: 14% 

AOR, 1.1 (95% CI, 

77 
Table 22. CHW cancer screening: mammography (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Paskett et al., 

2006;17

Katz et al., 

200718

RCT 

High G1: Sent control letter and NCI brochure 

about the need for regular cervical cancer 

screening 6 months after random 

assignment, followed by letter and NCI 

brochure about the need for mammography 

Mammogram receipt from 

medical record data: 

G1: 27.3% 

G2: 42.5%, RR, 1.56; 95% CI, 

1.29-1.87, P <.001 

Community 

health centers, 

Robeson County, 

Nort

G2: Individualized health education program 

that was culturally acceptable and tailored to 

Significant differences within 

racial groups as well 

h Carolina 

820 

Good 

face-to-face interactive educational program 

administered over a 9- to 12-month period, 

consisting of 3 in-person visits, with 

educational materials provided each visit 

and followup telephone calls and mailings 

after 

3 months after followup assessment 

meet the needs of each woman, intensive 

Sung et al., 

1997;61 

Sung et al., 

199262

RCT 

High G1: CHW home visits, education on breast 

and cervical cancer, breast self-exam, 

educational materials on screening, 

facilitation to address logistical barriers to 

screening 

Pretest/posttest change in selfreport of receiving 

mammography for entire sample:

G1: 35.5%/50.4% 

G2: 34.3%/39.4%, difference in 

change: 9.8% (95% CI, 2.9-16.7)

24.3) 

: 

Inner-city African 

Americans, state 

unspecified 

195 

Fair 

G2: Mailed educational materials on cancer 

screening Pretest/posttest change in selfreport of receiving 

mammography, postintervention 

respondents only: 

G1: 32.5%/58.7% 

G2: 34.0%/47.9%, difference in 

change: 12.4% (95% CI, 1.0-

Posttest rate of self-report of 

receiving mammography, 

women not previously on 

recommended screening 

schedules, whole sample: 

G1: 29.7% 

G2: 24.4%, difference in change

5.8% (95% CI, -7.0-18.6) 

Po st stte rate of self-report of 

receiving mammography, 

women not previously on 

recommended screening 

schedules, postintervention 

respondents only: 

G1: 50.0% 

G2: 35.5%, difference in change: 

14.5% (95% CI, 4.5-23.6) 

78 
One fair-quality study involved Latinas in Colorado enrolled in Medicare or Medicaid feefor-service, or three other health maintenance organizations (Kaiser Permanente of Colorado, 

Acc

e 

 suggested favorable results for the CHW 

arm

an 

stud

th 

e arm was more effective in the 3- to 6-month period 

foll

and 

ess, and Anthem Blue Cross and Blue Shield).59 It found nonsignificant and modest 

differences in mammography screening rates in unadjusted analyses that compared a CHW 

intervention with a printed intervention. In adjusted analysis, the difference between the two 

arms was statistically significant, favoring the CHW arm. The other fair-quality study, in 

Arkansas, also reported significantly greater improvements in self-reported use of 

mammography in the CHW arm compared with a delayed intervention arm. However, the two

groups differed significantly at baseline, with higher rates of ever-use of mammography reported

in the control group; thus a ceiling effect limiting improvements in the control group cannot b

ruled out.108 

The two poor-quality, low-intensity studies also

 compared with a minimal19-22,104 or no-intervention arm113 for the entire sample or for 

subpopulations. 

Four moderate-intensity interventions, one of fair quality125 and three of poor quality,15,110-

112,116 reported outcomes for self-reported mammography use. The fair-quality study in S

Francisco and Contra Costa found no statistically significant difference in changes in selfreported mammography between intervention communities and control communities.125 One 

y in New York, which compared CHW with no-intervention controls, found no significant 

differences between intervention and control arms after the intervention in use of mammography

during the prior 3 months.116 Both studies described measure effects at the community level 

rather than at the individual level. Low penetration of the intervention and potential 

contamination between experimental and control samples limit the interpretation of the results. 

Two other studies, both assessed as moderate intensity overall, compared higher-intensity 

CHW to lower-intensity CHW intervention;15,110-112 they both reported improvements in bo

arms. Only the study in San Diego County, California, found significant differences; it 

demonstrated that the relatively more intens

owing the intervention.110-112 These improvements were not consistently significantly 

different between the two arms over the long run (1- and 2-year followups) for a reduced 

potentially self-selected subsample. 

Two high-intensity trials, one good-quality17,18 and one fair-quality,61,62 both compared 

CHWs to mailed interventions and reported improvements in the CHW arms of their studies.

Only the good-quality study (using Medicaid records from North Carolina) found significant 

differences in mammography rates between the CHW arm and the mailed intervention arm.17,18

The fair-quality study, using self-reported mammography among inner-city African Americans 

(location unspecified), did not find any significant differences for the overall sample using 

intention-to-treat analysis, but it did report significant differences when analysis was limited to a 

potentially biased subsample of respondents available at followup.62,129

Four studies found evidence of effect modification in subgroup analysis. The 

evidence is derived from low-intensity studies of varying quality. The good-quality study from 

Washington found that CHW intervention arms were more effective than a control arm in 

subgroups: among regular users (women adherent at baseline), the CHW intervention arms 

showed significantly greater rates of mammography use among women who needed less than 2 

hours to schedule a medical appointment.103 In the same study, subgroup analysis for under-users 

(women who were not adherent at baseline) found that the CHW interventions were significantly 

more effective than the no-intervention control among women without female doctors or 

19-22,60,103,104,113

79 
insurance. These subgroup findings suggest that the CHW approach is effective in addressing 

some, but not all, access barriers to the use of mammography. 

The fair-quality study from Colorado59,60 reported weak but slightly more powerful effects of 

the CHW approach compared with a printed intervention approach in increasing mammography 

rates among Medicaid-enrolled Latinas compared with non-Latina whites (P = 0.07 for Latinas, 

and P = 0.10 for non-Latina whites).60 Similarly, the poor-quality studies also suggested 

subgroup effects. One study found CHWs to be more effective than a no-intervention control 

group in increasing rates of self-reported mammography for the overall sample and in groups 

with incomes below $12,000, but not in groups with incomes equal to or exceeding $12,000.113

Another found that the CHW approach was more effective than with a minimal intervention 

approach in ensuring conversion to adherence among under-users rather than in maintaining 

adherence among regular or adherent users.19-22,104

Health care utilization: clinical breast examination. Four studies reporting on clinical breast 

examination (seven articles; Table 23)61,62,110-112,116 included a high-intensity and three moderateintensity interventions. Two of these studies were of fair quality;61,62,125 the other two were rated 

poor.110-112,116 Together the studies suggest that CHW interventions are not effective in 

comparison with other alternatives, although two studies that provide information on changes 

between baseline and followup found that the CHW arm results in improvements over time. 

The fair-quality high-intensity trial found no differences between the CHW arm and a mailed 

intervention, with the exception of a reduced and possibly selective sample of respondents only 

at followup.61,62 The fair-quality moderate-intensity study found no difference over time in most 

measures of self-reported clinical breast examination in intervention communities or control 

communities.125 Of the two poor-quality moderate-intensity studies, one trial compared a more 

intense CHW arm with a less intense CHW arm110-112 and the cross-sectional study compared it 

with a no-intervention arm.116 Neither study reported significant differences, although the 

women in the more intense CHW arm of the trial did report higher rates of clinical breast 

examination after the intervention. 

Health care utilization: colorectal cancer screening. Two studies, one of moderate intensity 

and fair quality, and another of low intensity and poor quality compared three groups on 

outcomes for fecal occult blood tests (FOBT) and other colorectal cancer screening tests (Table 

24).

107 In the fair-quality moderate-intensity intervention, patients who received navigation 

services had higher rates of FOBT after three months of services than patients who received 

usual care, but these differences were not statistically significant. Patients receiving navigation 

services were significantly more likely than controls to have set an endoscopy appointment at 

three months and kept it by six months after the intervention.106 The low-intensity poor-quality 

study reported that rates of FOBT were higher in the CHW arm over time; however, the CHW 

arm and the comparison arms of a no-intervention control or of tailored print and videotapes did 

not differ significantly. The study reported no benefit of the intervention for other colorectal 

screening tests. 

80 
Table 23. CHW cancer screening: clinical breast examination 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Sung et al., 

199761; Sung et

al., 199262

RCT 

city African 

cans, state 

reast 

e: 4.9 

6.1-4.1) 

ttest change in self-report of 

 CBE, postintervention respondents 

/61.8%, difference in change: 

 CI, 1.1-16.7) 

rate of self-report of receiving CBE, 

ange: 8.4% (95% 

te of self-report of receiving CBE, 

hedules, postintervention 

nly: 

6% 

(95% CI, 3.9-45.3) 

InnerAmeri

unspecified 

195 

Fair 

High G1: CHW home visits, education on 

breast and cervical cancer, b

self-exam, educational materials on 

screening, facilitation to address 

logistical barriers to screening 

G2: Mailed educational materials on 

cancer screening 

Pretest/posttest change in self-report of 

receiving CBE for entire sample: 

G1: 55.2%/64.5% 

G2: 55.7%/59.5%, difference in chang

(95% CI, -

Pretest/pos

receiving

only: 

G1: 59.1%/72.0% 

G2: 57.8%

8.9% (95%

Posttest 

women not previously on recommended 

screening schedules, whole sample: 

G1: 37.0% 

G2: 28.6%, difference in ch

CI, -6.9-23.7) 

Posttest ra

women not previously on recommended 

screening sc

respondents o

G1: 71.1%

G2: 46.5%, difference in change: 24.

Hiatt et al., 

2008125

Prospective 

cohort 

Public health 

clinics and the 

ontra Costa 

y, California 

Fair 

Moderate 

to 

mmunity-based organizations 

gencies); and Women’s Health 

Days, offering free mammograms, 

Pap tests, and breast selfexamination instruction 

G2: No intervention (control) 

Ever completed clinical breast examination 

(Total N [%] pretest/Total N [%] posttest): 

G1: 801 (94)/812 (95) 

Χ2

 = NR, not significant 

G2: 798 (82)/ 803 (87) 

Χ2

 = NR, P=0.006 

Completed clinical breast examination in 

past year (Total N [%] pretest/Total N [%] 

posttest): 

G1: 800 (75)/809 (74) 

Χ2

 = NR, not significant 

G2: 796 (56)/ 803 (60) 

Χ2

 = NR, not significant 

Completed 3 or more clinical breast 

examinations in past 5 years (Total N [%] 

pretest/Total N [%] posttest): 

G1: 793 (73)/809 (73) 

Χ2

 = NR, not significant 

G2: 792 (54)/ 800 (54) 

Χ2

 = NR, not significant 

low-income 

neighborhoods in

San Francisco

and C

Count

G1: One-on-one visits at various 

events and locations; presentations 

co

(a

1,616 

Adj, adjusted; CBE, clinical breast examination; CHW, community health worker; CI, confidence interval; NR, not reported; OR, 

odds ratio; RCT, randomized controlled trial; t, t-test. 

81 
82 
Table 23. CHW cancer screening: clinical breast examination (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Navarro et al., 

1998;111 

Navarro et al., 

 al., 

t 

nia 

G1: CHW delivering community living 

skills sessi R 

G

s

c

a

y

Pretest-posttest changes in percentage of 

women within past year: 

ip

5

17

 0.5

0.54

W u

: 19

 of CBE 1-year and 2-year followup for 

ening group (P value): 

Year 1: 1.21 (0.556) 

Year 2: 1.93 (0.038) 

1995;110 

Navarro et

000112 2

RCT 

Low-income 

Latinas, southeas

San Diego 

County, Califor

365 

Poor 

Moderate 

ons, details N

2: CHW delivering cancer education 

essions, 12 weekly group sessions 

onducted over 3 months plus 2 

dditional sessions offered within a 

ear of beginning of group meetings 

Partic

G1: 1

G2: 

P =

t = 

CH

G1

G2: 19

P = 0.9

t = 0.04 

who had CBE 

ant unit of analysis (n = 359) 

.5 

.7 

89 

nit of analysis (n = 35) 

.3 

.5 

67 

Odds

cancer scre

Wilson et 

2008116 al., 

ted crossnal survey 

s 

nd 

ood 

lons, 

yn, New 

Poor 

 I

c

lo

s

G

G

G3: Control, after intervention 

G4: Stylist group, after intervention 

 in

 27

G2: 27 or differences between 

G1 and

G3: 27% 

29

, 1

Repea

sectio

of women 

attending salon

randomly 

assigned to 

experimental a

control groups 

Neighborh

hair sa

Brookl

York 

Moderate ntervention consisted of education, 

ounseling, and information on 

cation of screening services during 

alon appointment 

CBE

G1:

1: Control, before intervention 

2: Stylist group, before intervention

G4: 

AOR

 past 3 months: 

% 

%, P = 0.85 f

 G2 

% 

.2; adjusted 95% CI, 0.9-1.7 

40 salons/1,210 

respondents 

83 
Table 24. CHW cancer screening: colorectal cancer screening 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

ion ults 

CHW 

Intervent Study Groups Res

Jandorf et al., 20

New 

ork City 

oderate 

nd navigatio ths (%): 

: 42.1 

): 

G1: 18.4 

 0.005 

nths (%): 

: 23.7 

05 M

RCT 

East Harlem, 

Y

78 

Fair 

G1: Patient navigator (education and 

assistance with screening a

process) 

G2: Usual care 

n 

Completed FOBT after 3 

mon

G1

G2: 25.0 

P = 0.086 

Had endoscopy appointment 

at 3 months (%

G2: 0 

P =

Completed endoscopy at 3 

months (%): 

G1: 15.8 

G2: 5.0 

P = 0.115 

Completed endoscopy at 6 

mo

G1

G2: 5.0 

P = 0.019 

Campbell, 2004107

RCT 

African-American 

rural churches, 

North Carolina 

NR (12 churches; 

p

f individual 

pants from

ach church NR) 

Low ealt

peakers on top

of their choice not directly related to stud

objectives 

G2: Organized and conducted at least 3 

church-wide activities on spreading 

information and enhancing support for 

healthy lifestyle and CRC screening (LH

ed 

s 

ors m

ction; 4t

eotapes 

t year 

llowup): 

/31.0% 

test in past year 

1: 20.3%/27.5% 

s 

completers/dro outs 

o

partici

e

Poor 

G1: Control churches were offered h

education sessions and s

h 

cs 

FOBT test in pas

i (% baseline/% fo

y G1: 30.4%/21.7% 

G2: 23.5%/33.3% 

3: 19.7%/36.8% 

A) Other CRC 

G3: 4 personalized computer-tailor

newsletters and 4 targeted videotape

corresponding to the same behavi

to participants' homes bimonthly for first

months after baseline data colle

targeted videotape mailing was 9 months

after baseline 

G4: LHA and targeted vid

ailed G3: 23.7%/21.1% 

 6 

h 

G4: 26.4%/14.9% 

P = n

G

G4: 19.5%

P = 0.08 

(% baseline/% followup): 

G

G2: 19.6%/25.5% 

CRC, colorectal cancer; FOBT, fecal oc R t; RCT, 

mized controlled trial. 

Outcomes for Chronic Disease Management 

Chronic disease management: diabetes mellitus. Study characteristics. Four studies (eight 

articles; Table 25), three RCTs,27,88-92,124 and one prospective co outcomes 

of CHW interventions for diabetes care among underserved min

cult blood test; LHA, lay health advisor; N , not reported; ns, not significan

rando

hort study93 examined

ority populations with type 2 

84 
diabetes mellitus. All studies were rated fair quality. Three studies ity 27,88-93 used a high-intens

intervention; one study124 used a moderate-intensity intervention. 

Table 25. CHW chronic disease management: diabetes mellitus 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Beckham, 

200893 

Cohort 

High G1: Diabetes case management by CHW, 

including home visits, based on needs of 

patients; CHWs collaborate with 

multidisciplinary team to determine highpriority learning areas and develop an 

HgbA1c, mean change from 

baseline (SD): 

G1: -2.2 (1.8) 

G2: -0.2 (1.5) 

P < 0.0001* 

Health center s 

for underserved 

with type 2 

diabetes 

Hawaii 

N: 116 

Fair 

intervention plan to implement during 

subsequent visits, plan included a blood 

regimen and target levels, diet plan, 

exercise plan, medication schedule, insulin 

injection plan, and preventive health/health 

maintenance plan 

G2: Usual care with multidisciplinary team 

approach, minus CHW; glucose selfmonitoring 

*Note on P value: the investigator

did not report a value comparing the

groups; RTI researchers calculated 

the value using the data in the article

Corkery, 

1997124

RCT 

Moderate G1: Intervention—CHW acted as liaison, 

attended clinic sessions, interpreted, 

reinforced self-care instructions and 

ap

Diabetes education program 

completion: 

G1: 80% 

Hispanic and 

AfricanAmerican 

populations in 

East Harlem, 

New

pointment reminders 

G2: Encounters occurred between nurse 

and patient only (control) 

G2: 47% (P = 0.01) 

No difference in mean change in

HgbA1c between groups 

 York City, 

New York 

N: 64 

Fair 

Approx, approximately; CHW, Community Health Worker; DKQ, Diabetes Knowledge Questionnaire; HgbA1c, Hemoglobin

A1c; LDL, low-density lipoprotein; NCM, nurse case manager; RCT, randomized controlled trial; RN, Registered nurse; SBP, 

systolic blood pressure. 

85 
Table 25. CHW chronic disease management: diabetes mellitus (continued) 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of CHW 

Intervention Study Groups Results 

Gary 2000;91

Batts 2001;88 

Gar

High G1: Usual care—continued on-going HgbA1c, mean change from baseline at 

y 2003;89

92 professionals plus quarterly newsletter G1: ref 

Vett

care from their own health 

 60-

minute face-to-face home visits and/or 

telephone contacts, no direct 

implementation of therapeutic 

egies but facilitated preventive 

 offering to schedule 

vide education, 3 

G4: C

visits 

2 years: 

G2: +6 (approximate) (P < 0.05 for 

within-group change from baseline) 

G3: +6 (approximate) 

G4: +4 (approximate) (P < 0.05 for 

within-group change from baseline) 

SBP, mean change from baseline at 2 

years: 

G1: ref 

(appr

ro

G1: ref 

G2: -2.4 ± 1.9

G3: -3.45 ± 1

G4: -2.13 ± 1

er 2004;

Gary 200590

RCT 

Project Sugar 

AfricanAmerican 

containing information on diabetesrelated health topics 

G2: NCM intervention—RN + certified 

diabetes educator, 45-minute face-toface clinic visits and/or telephone 

contacts, direct patient care, 

management, education, counseling, 

followup, referral, physician feedback—

goal was 3 visits per year 

G2: -0.31 ± 0.49% 

G3: -0.30 ± 0.48% 

G4: 0.8 ± 0.52% (P < 0.05 for withingroup change from baseline for G4 

only) 

LDL, mean change from baseline at 2

years: 

G1: -16.7± 5.5 mg/dl 

population in 

East Baltimore, G3: CHW intervention—45 to

Maryland 

N: 186 

Fair 

strat

care by

appoi

visits

ntments and pro

 per year 

ombined NCM plus CHW—3 

per year with each 

G2: +6 

within-group

G3: -4 (app

G4: -2 (appro

oximate) (P < 0.05 for 

change from baseline) 

ximate) 

ximate) 

Dietary risk s

change from

cores—validated, mean 

baseline at 2 years: 

9 

.87 

.92 

Lujan, 200727

RCT 

Mexican 

Americans in a 

0 

air 

High G1: A team of 2 promotoras delivered 8 

weekly, 2-hour participative group 

classes and followup to intervention 

group, using multiple audiovisual 

teaching aids and handouts, contacted 

class participants by telephone 

weekl

uc

sent postcards biweekly 

G2: U

inform and 1 or 2 pamphlets on 

diabetes se

HgbA1c at bas

(SD): 

G1: 8.21 (2.2

G2: 7.71 (1.4

Mean change

P < 0.001 

ab

Questionnair

G2: 66.9 (15.

Mean change

Diabetes Hea

(validated): b

(SD): 

G1: 56.4 (12.

G2: 57.0 (10.6)/50.8 (13.6) 

n change between groups: P < 

major border 

city in Texas

N: 15

F

bi

ed

y to answer questions, reinforce 

ation, promoted behavior change, Bilingual Di

sual care by clinic staff—verbal 

ation 

(SD)/6 month

G1: 69.1 (13.6

lf-management 

eline (SD)/ 6 months 

)/7.76 (1.87) 

9)/8.01 (1.8) 

 between groups: 

etes Knowledge 

e (validated): baseline 

s (SD): 

)/77.2 (14.4) 

2)/65.1 (21.0) 

 between groups: P <.002 

lth Belief Measure– 

aseline (SD)/6 months 

2)/54.6 (8.4) 

Mea

0.01

86 
The 6-month RCT conducted in Texas used a high-intensity intervention for Mexican 

Americans that compared eight weekly, 2-hour group classes with promotoras to usual care plus 

educational pamphlets.27 The RCT in New York City used a moderate-intensity intervention for 

inner-city Hispanics and African Americans that evaluated the use of CHWs as clinic liaisons 

compared with nurse-patient encounters.124 The Project Sugar trial RCT in Baltimore, Maryland, 

compared several high-intensity interventions in inner-city African Americans with type 2 

diabetes: (1) CHW face-to-face home visits and telephone contact, (2) nurse care manager 

intervention, (3) a combined nurse care manager and CHW, and (4) standard clinical care with 

an additional quarterly diabetes newsletter.88-92 The prospective cohort study in Hawaii examined 

a high-intensity intervention comparing CHW diabetes case management, including home visits, 

in addition to a multidisciplinary team, with usual clinical care involving a multidisciplinary 

team approach.93 Heterogeneity of population, study designs, interventions, and outcomes 

preclude quantitative synthesis of results. 

Overview of results. Of these four studies on diabetes management, two studies found the 

CHW intervention to be beneficial in decreasing hemoglobin A1c (HgbA1c) as compared with 

usual care;27,93 conversely, two studies found no difference between groups in mean change from 

baseline in HgbA1c.88-92,124 The Texas study also evaluated outcomes of knowledge and found 

that the CHW intervention was effective compared with usual clinical care in increasing diabetes 

knowledge.27 The Hawaii study found that diabetes case management by a CHW in conjunction 

with a multidisciplinary team was more effective at decreasing HgbA1c than a multidisciplinary 

team alone.93 The New York study demonstrated that a CHW liaison was more effective than 

usual clinical care in behavioral changes leading to program completion rates.124 Project Sugar, a 

high-intensity study, found significant changes from baseline within, but not between, groups for 

various health outcomes.88-92 

Knowledge. The Texas study evaluated outcomes for improved knowledge at 6 months in 

diab 27

he 

 the four study 

etic patients following eight weekly CHW-led group classes in Mexican Americans. A 

validated tool, the bilingual Diabetes Knowledge Questionnaire (DKQ), showed a difference 

between arms, with an improved score in the CHW group compared with the group receiving 

usual care plus educational pamphlets (P < 0.002).27 

Behavior. Project Sugar evaluated dietary risk scores (which identifies positive as well as 

problematic dietary behaviors and measures potential barriers to dietary change). Scores 

improved across all CHW arms as compared with the usual clinical care group following a highintensity CHW intervention (all CHW arms versus usual clinical care [score ± standard 

deviation]: -2.4 ± 1.99 versus -3.45 ± 1.87 versus -2.13 ± 1.92; P not reported).88-92 The New 

York study demonstrated an increased proportion of completion of a diabetes education program

after a low-intensity CHW intervention compared with usual clinical care (80 percent versus 47

percent, P = 0.01).124 

Satisfaction. No study reported outcomes about satisfaction with diabetes care. 

Health outcomes. The Texas trial demonstrated better improvement in diabetes control 

(measured by mean change in HgbA1c) in the high-intensity CHW intervention group than in t

usual care group after 6 months (P < 0.001).27 The Hawaii study found that a high-intensity 

CHW intervention in conjunction with a multidisciplinary team was more effective in decreasing

mean HgbA1c when compared with usual care with a multidisciplinary team (-2.2 versus 0.2).93

The Hawaii study investigators did not report P value comparing the groups; we were able to 

calculate it using the data provided in the article and found the difference to be statistically 

significant (P < 0.0001).93 Project Sugar reported no significant change between

87 
gro m 

wered 

ect 

 diastolic 

; Table 26), two RCTs and two prospective cohorts, examined outcomes of 

mo anagement among adult patients 

wit d three as poor quality. All four studies 

eva on that involved a CHW in a lesser 

cap

ups for the primary outcome, HgbA1c. The only group with a significant improvement fro

baseline to2 years was the CHW plus nurse care manager arm (improvement of 0.8 percent ± 

0.52 percent, P < 0.05).88-92 Postintervention, a power calculation showed the study was po

to detect a difference of only 1.2 percent change in HgbA1c. Secondary outcomes from Proj

Sugar included low density lipoprotein (LDL) cholesterol, systolic blood pressure, and

blood pressure; none differed significantly between study groups in change from baseline 

measures. LDL cholesterol changed for the worse within the CHW plus nurse care manager arm 

(+4 mg/dl, P < 0.05).88-92 

Health care utilization. No study evaluated diabetes care utilization. 

Chronic disease management: hypertension. Study characteristics. Four studies (five 

articles 23,98,99 94,95,123

derate-intensity CHW interventions for blood pressure m

h hypertension. We rated one study as fair quality an

luated a CHW intervention compared with an interventi

acity.23,94,95,98,99,123 The two RCTs, one fair98 and one poor99 quality, evaluated CHW 

interventions in inner-city minority populations.23,98,99 

Table 26. CHW chronic disease management: hypertension 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Levine, 200398

RCT

High G1: G2 care plus 5 CHW visits with blood 

pressure measur

Pre/postintervention bloo

African Americans in 

inner-city Baltimore, 

Maryland 

N: 789 

Fair 

blood pressure management and access to 

medical care 

G2: CHW home visit for education, counseling, 

and referral 

G1: 147.7/89.2 (95%

149.9/87.8-90.6) → 145/86.2 

(95% CI, 142.3-147.7/84.2-8

G2: 148.6/89.3 (95% CI, 14

150.7/87.8-90.8) → 142.1/8

(95% CI, 138.8-145.4/8

P < 0.05 for differenc

group, P > 0.1 between gr

Percentage with

hypertension control (< 1

G1: 16% → 36% 

G2: 18% → 34% 

pre/post P <0.01 

group difference NS 

ement, addressing issues of 

d 

pressure (systolic/diastolic): 

 CI, 145.5-

8.2)

6.4-

4.7 

2.7-86.7)

es between 

baseline and followup for each 

oups 

 adequate 

40/90): 

Ward, 2000;99; 

Morisky, 200223 

RCT 

Moderate G1: CHW post-clinic appointment counseling 

session 

Percentage with blood pr

control (< 140/90)—baseline/ 

6 months/12 months: 

Inner-city African 

Americans and Hispanics 

in a large West Coast city 

calls 

G3: Home visits by CHW 

G1: 35.2%/46%/46% (P < 0

G2: 40.2%/42%/48% (P < 0

G3: 29.7%/NR but “

N: 1

Poo

G2: Appointment reminder cards and telephone 

essure 

.01) 

.01) 

improved” 

G4: 36.9%/NR but “improved” 

groups improved; differences 

between groups NR 

G4: Standard clinic care 

,367 All 

r 

CHW, community health worker; NS, not significant; RCT, randomized controlled trial. 

88 
Table 26. CHW chronic disease management: hypertension (continued) 

ity of 

n ups Results 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intens

CHW 

Interve tion Study Gro

Frate, 198395 

94 Frate,1985

rospective cohort 

Mississippi 

selor

pliance 

aco

G3: Church-based self-help 

controlled (< 160/95): 

6% 

P G2: 90.0% 

Rural central 

N: 667 

Poor 

High G1: Hypertension health coun

visits that encouraged com

pharmacological and nonpharm

therapy that had been prescribed

s—monthly 

to both 

Proportion of hypertensives

logical G1: 80.

G2: Family-based self-help 

G3: 79.9% 

(P < 0.0001) 

Bone, 1989123

ve cohort 

ncome African 

Mar

Moderate G1: Control (not able to be contacted by CHW) 

G2: Contacted by CHW; initially, all patients 

contacted by CHWs in emergency department; 

CHWs measured pulse and blood pressure, 

ucational counseling, identified 

ferrals, assisted with 

Returned to emergency 

department for followup 

appointment: 

G1: 41% 

G2: 60% (P < 0.001) 

Prospecti

Low-i

Americans in emergency 

department in Baltimore, 

provided ed

barriers related to re

yland 

N: 722 

Poor 

appointment-keeping and adherence to 

treatment plan; session lasted about 20 

minutes 

The fair-quality trial from Baltimore, Maryland, evaluated a CHW home visit for patient 

education, counseling, and referral compared with a CHW home visit plus five additional v

for blood pressure measurement and management, and access to medical care.98 The poor-quali

RCT from the West Coast, rated as such because of a high attrition rate, use of a complete

isits 

ty 

rs 

ana

hich we rated as poor quality 

bec ds, evaluated a 

mo lth counselors” in 

pro escribed pharmacological 

and re, 

riori, 

ment but 

y 

ive synthesis of results. 

lysis, and high potential for bias, evaluated CHW postclinic appointment counseling sessions, 

CHW home visits, appointment reminder cards and calls, and standard clinical care.23,99 

The prospective cohort study from rural central Mississippi, w

ause of a high potential for confounding and inappropriate statistical metho

derate-intensity CHW intervention using CHWs as “hypertension hea

viding monthly visits encouraging compliance with previously pr

 nonpharmacological therapies.94,95 The other prospective cohort study from Baltimo

Maryland, which we rated poor because of a lack of methods describing an analysis plan a p

a high potential for confounding, and lack of comparison of participant characteristics at 

baseline, evaluated a moderate-intensity CHW intervention..123 It examined the impact on 

appointment followup of a CHW followup telephone call after an emergency department visit 

during which patients had their blood pressure measured, were provided education counseling, 

and were assisted with appointment keeping and adherence to a treatment plan. The comparison 

group included patients who had received a single CHW visit in the emergency depart

who could not be reached later for assistance in appointment keeping.123 Heterogeneity of stud

designs, interventions, and outcomes preclude quantitat

89 
Overview of results. We did not find any fair- or good-quality studies that compared the 

impact of a CHW intervention with usual care on blood pressure control. Of the three studies that 

evaluated blood pressure control, only the Mississippi prospective cohort demonstrated a 

significant difference between study groups in terms of proportion of hypertensive subjects 

controlled (defined in this study as blood pressure less than 160/95).94,95 Neither RCT 

demonstrated between-group differences in blood pressure control.23,98,99 However, these studies 

did note improvement from baseline to study completion within all groups, some of which were 

statistically significant.23,98,99 The Baltimore prospective cohort did not evaluate blood pressure 

control but instead examined health care utilization.123 This study demonstrated that CHW 

worker followup was more effective than no followup in increasing return visit appointment 

rates. 

Knowledge. No study reported improved knowledge. 

Behavior. No study reported improved behaviors. 

Satisfaction. No study reported satisfaction outcomes. 

Health outcomes. We did not find any fair- or good-quality studies that compared the impact 

of a CHW intervention with usual care on blood pressure control. Three of the four studies did 

report on blood pressure control. Both RCTs found an improvement within most groups but no 

difference between groups in terms of blood pressure control.23,98,99 The fair-quality RCT 

demonstrated that the low-intensity CHW arm (1 home visit) and the high-intensity CHW arm (6 

home visits) both improved blood pressure control. However, the difference between the groups 

was not statistically significant.98 The poor-quality RCT also demonstrated an improvement in 

blood pressure within all groups, including the usual care arm, but no significant difference 

between groups.23,99 The Mississippi prospective cohort study did not report statistical tests for 

either between- or within-group comparisons.94 

Health care utilization. The poor-quality prospective cohort in a Baltimore emergency 

dep ere more likely to 

retu s 

y the CHW, thus biasing the results for this outcome in favor of the intervention 

arm

T of fair 

. 

on to 

nt and bus tokens and with a control group who were given clinic appointments and 

bus

n 

 This RCT did not report outcomes of health. 

artment demonstrated that patients in the low-intensity CHW intervention w

rn for a followup appointment than were patients in the comparison group (60 percent versu

40 percent, P < 0.001).123 However, the comparison patients were not able to be contacted for 

followup b

.

123

Chronic disease management: infectious diseases. Study characteristics. One RC

quality examined outcomes of a CHW intervention to facilitate access to health care for 

tuberculosis (TB) in a homeless population with positive purified protein derivative (PPD) test 

results in San Francisco, California (Table 27).122 This study used a moderate-intensity model

CHWs who were familiar with homelessness were assigned to TB-infected individuals and 

responsible for accompanying them to their clinic appointments.122 Outcomes were compared 

with outcomes for a group receiving a monetary incentive to attend the TB clinic in additi

an appointme

 tokens. 

Overview of results. This RCT demonstrated that a CHW intervention was less effective tha

the monetary incentive but more effective than usual care in leading to adherence to a first 

followup appointment.122 

Knowledge. This RCT did not report outcomes for improved knowledge. 

Behavior. This RCT did not report outcomes for improved behaviors. 

Satisfaction. This RCT did not report outcomes of satisfaction. 

Health outcomes.

90 
Table 27. CHW chronic disease management: infectious diseases 

Res

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups ults 

Pilote, 1996122

RCT 

omeless people 

rancisco, 

4 

Fair 

rate 

 tokens 

Adh

(95%

:

G3: )

H

with positive 

purified protein 

deriviative for 

tuberculosis in San 

F

California

N = 24

Mode G1: Peer health advisor—met with 

patient and took them to clinic 

appointment, facilitated paperwork, 

reviewed physician recommendations 

G2: Monetary incentive—$5 at clinic, 

appointment, and bus

P ca

G1:

G2

G3: Usual care—appointment and bus 

tokens 

erence to first followup appointment 

 CI): 

lculated vs. G3

 75% (70-80); (P = 0.004) 

 84% (76-92); (P < 0.001) 

 53% (47-59

CI, confidence interval; RCT, randomized controlled trial. 

Health care utilization. A moderate-intensity CHW intervention was less effective than a 

monetary incentive ($5) in increasing adherence to a first followup 

percent [95% CI, 70-80] versus 84 percent [95% CI, 76-92], P = not reported). However, the 

CHW intervention was more effective than a control group who received an appointment and bus 

tokens (75 percent [95% CI, 70-80] versus 53 percent [95% CI, 47-

One RCT of fair quality 

evaluated a moderate-intensity s 

com The classes 

foc ement and included 

fer significantly at 12 months.114 

er 

4

diff

clinic appointment (75 

59], P = 0.004).122

Chronic disease management: back pain. Study characteristics. 

intervention of four 2-hour weekly group classes led by CHW

pared with usual care supplemented by a book on back pain (Table 28).114

used on applying problem-solving techniques for back pain self-manag

educational materials (book and videos) supporting active management of back pain.114 

Overview of results. This fair-quality RCT found that a moderate-intensity CHW intervention

was significantly effective in reducing back pain when compared with a control group at 6 

months; the groups did not dif

Knowledge. This RCT did not report outcomes for improved knowledge. 

Behavior. This RCT did not report changes in participant behavior. 

Satisfaction. This RCT did not report outcomes of satisfaction. 

Health outcomes. The moderate-intensity CHW intervention was more effective in 

decreasing participant back pain than usual care supplemented by a book on back pain at 6 

months.114 More participants in the intervention arm achieved a 50 percent or greater reduction

in Roland Disability Score from baseline than in the control group at 6 months (47.9 percent

versus 33 percent, P = 0.02).114 However, Roland Disability Scores at 12 months did not diff

between arms (5.75 ± 6.31 versus 6.75 ±6.39, P = 0.092).11 The authors attributed this lack of 

erence to the fact that the intervention was intended not to reduce pain intensity but rather to 

lower patient worries about back pain.114 Additionally, participants receiving a CHW 

intervention had a lower worry rating (unvalidated tool) than those in the control group at 12 

months (2.63 ± 2.58 versus 3.83 ± 3.08, P = 0.013).114

91 
Table 28. CHW chronic disease management: back pain 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention 

Study Groups Results 

Von Korff, 1998114

RCT 

People with chronic 

back pain in 

Washington state 

N = 255 

Fair 

Moderate G1: 4, 2-hour classes held once a 

week, with 10 to 15 participants, led 

by 2 CHWs 

G2: Usual care includes back pain 

book 

"The next time I have back or leg pa

will try to manage the problem without 

seeing a health professional" (not 

validated): 

G1: 77% agreed 

G2: 60% agreed (P = 0.008) 

50% or greater reduction in Roland 

Disability Questionnaire Score fro

baseline at 6 months (validated): 

G1: 47.9% 

G2: 33% (P = 0.02) 

in, I 

m 

Roland Disability at 12 months 

(validated): 

G1: 5.75 (6.31) 

G2: 6.75 (6.39) (P = 0.092) 

Worry rating (0-10) at 12 months (not 

validated): 

G1: 2.63 (2.58) 

G2: 3.83 (3.08) (P = 0.013) 

CHW, community health worker; RCT, randomized controlled trial.

Health care utilization. This RCT did not report on health care utilization. 

Other. Participants in the CHW arm reported being more likely to self-manage back or leg

pain than those in the control arm, a measure of self-efficacy (77 percent versus 60 perc

0.008).114

Chronic disease management: mental health. Study characteristics. One RCT of poor 

quality with three trial arms evaluated an assertive community treatment with a CHW 

intervention compared with an assertive community treatment alone and with a brokered case 

management intervention (Table 29).120,121 The study population included people in St. Louis, 

Missouri, who were homeless or at risk for being homeless and were diagnosed with serious 

psychiatric diagnoses.120,121 The CHWs’ role was to assist with daily living and be available for 

leisure activities. This intervention was rated as high-intensity as defined in KQ 1. A high rate of 

attrition (only 85 of 165 provided followup) contributed to the poor-quality rating of this 

study.120,121

Overview of results. Clients in the assertive community treatment arm plus a CHW did not 

differ in results when compared with the assertive community treatment group alone, although 

for many outcomes both of these arms were superior to the brokered case management arm.120,121

The assertive community treatment arms (both with and without a CHW) had more contact with 

their case managers and were more satisfied than those in the brokered case management 

arm.120,121 Clients in the assertive community treatment also had fewer psychiatric symptoms at 

18 months than clients in the brokered condition.120,121 Days in stable housing did not differ 

among groups.120,121

ent, P = 

92 
Table 29. CHW chronic disease management: mental health 

Author, Year 

Study Design 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Wolff, 1997121

Morse, 1997

CT 

120

ess with 

c 

t,

oor

rsist

unseling 

e

agement 

n 

76) 

.45) 

12.25) 

G2: 57.97 (20.29)/38.77 (12.23) 

G3: 50.6 (14/31)/51.6 (16.7) 

P = 0.001 

Program contact (days/month): 

1) 

G3: 0.3 (0.49) P < 0.001 

R

Homel

serious psychiatri

conditions in 

St. Louis, Missouri 

N = 165 

Poor 

High G1: Assertive community treatmen

intensive individualized treatmen

responsibility for providing or c

services needed by client, pe

and in-person service delivery, per

staff with backgrounds in psycholo

ork, and co

t— Number of days in stable housing i

dinating all 

t followup 

past month—baseline (SD)/18 

months (SD): 

en G1: 6.36 (11.71)/21.75 (12.

formed by 

gy, social 

s to assist 

 available 

G2: 4.94 (11.08)/17.54 (14

G3: 7.18 (12.38)/16.00 (14.86) 

(P < 0.31) 

Client satisfaction (validated): 

G1: 3.27 (0.42) 

G2: 3.12 (0.57) 

G3: 2.74 (0.68) P < 0.01 

Brief Psychiatric Rating Scale Total 

Symptom Score (validated): 

G1: 53.54 (15.54)/39.96 (

w

G2: G1 plus CHW, whose role wa

with activities of daily living and b

for leisure activities 

G3: Brokered case man

G1: 8.29 (7.5

G2: 6.95 (4.91) 

CHW: community health worker; RCT ta

Knowledge. This RCT did not report outcomes for improved knowledge. 

Behavior. This RCT did not report outcomes for improved behaviors. 

Satisfaction. Clients in the assertive community treatment arms (both with and without a 

CHW) were more satisfied with their treatment program than clients in the brokered case 

management arm (satisfaction score ± standard deviation: 3.12 ± 0.57 versus 3.27 ± 0.42 versus 

2.74 ± 0.68, P < 0.05).120,121 

Health outcomes. Clients in the assertive community treatment arm plus a CHW did not 

differ in health outcome results as compared with the assertive community treatment group 

alone. Clients in the assertive community treatment arms (both with and without a CHW ) had 

fewer psychiatric symptoms as rated by the Brief Psychiatric Rating Scale (BPRS) at 18 months 

compared to baseline than did those in the brokered case management arm (baseline (SD)/18-

month followup (SD): 57.97 (20.29)/38.77 (12.23) versus 53.54 (15.54)/39.96 (12.25) versus 

50.60 (14.31)/51.60 (16.70), P = 0.001 for any difference among the three groups; P for 

comparison of either assertive community treatment arm not reported).120,121 Days in stable 

housing between groups did not differ across the groups. 

Health care utilization. Use of health services did not differ between the assertive community 

treatment plus a CHW arm and the assertive community treatment group alone. Clients in the 

assertive community treatment arms (both with and without a CHW) had more days in contact 

with the program than did clients in the brokered case management arm (6.95 (4.91) versus 8.29 

(7.51) versus 0.3 (0.49), P < 0.05). 

, randomized controlled trial; SD: s ndard deviation. 

93 
Chronic disease management: asthma. Study characteristics. Two RCTs (three articles), 

one good-quality,96,97 and one fair-quality,100 examined outcomes of CHW interventions for 

asthma care among pediatric patients with persistent asthma. Both studies used a highly 

resource-intensive CHW model. Both studies provided comprehensive multifaceted interventions 

that included an environmental assessment, asthma action plan, education, referrals, allergy 

control mattress covers and pillows, vacuums, and cleaning supplies, pest management, and 

smoking cessation assistance to the high-intensity intervention arm, delivered over a year in 

several home visits. The Seattle King County Healthy Homes (SKCHH) project (Washington 

State) compared outcomes for children receiving a high-intensity multivisit home intervention 

with those for children receiving a low-intensity single home visit that included an 

environmental assessment, some education, and bedding encasements, followed by the full 

intervention after a year.96,97 The Community Action Against Asthma (CAAA) project adapted 

the SKCHH project to Detroit, Michigan, comparing a group receiving the high-intensity 

multivisit home intervention with a control group receiving an asthma information booklet and 

the full intervention after a year.100 Variations in measures of health behavior, outcomes, and 

health care utilization preclude quantitative synthesis of the results. 

Overview of results. Two trials demonstrated that high-intensity CHW interventions are more 

effective than either low-intensity interventions or a control group in reducing unscheduled use 

of health care services and improving psychological outcomes for caregivers. Both studies 

demonstrated changes in behavior, such as increased use of bed encasements and vacuuming, 

associated with the materials distributed by the CHW, but not for other behaviors that may have 

required external or additional resources or change, such as removal of mold or reduced 

exposure to environmental tobacco smoke. Both studies demonstrated significant improvements 

within but not across trial arms for some measures of symptoms,96,97,100 reduced days with 

activity limitations, and reduced use of beta-agonists.96,97 Authors postulated that these results 

could be explained either because a minimal intervention may be effective for some outcomes or 

because of regression to the mean, temporal trends, or the Hawthorne effect (improvement in 

performance attributable to being observed) among the less intensive or control group 

participants.96,97 Nevertheless, for health outcomes demonstrating a difference between trial arms 

such as symptom days, the more intense arm was more effective than the less intense or control 

arm. 

Knowledge. Neither study reported outcomes for improved knowledge of asthma triggers. 

Behavior. Both studies examined a variety of behavioral changes (Table 30). Both studies 

reported increased use of materials provided—that is, mattress covers, pillows, and vacuums, 

suggesting reduced exposure to dust mites— in the more intense arm. Both studies failed to find 

differences between the two arms for behavioral changes associated with smoking cessation. 

Other behaviors that did not differ between arms included removal of pets and use of exhaust 

fans in the bathroom96,97 and removal of mold.100 

94 
Table 30. CHW asthma interventions and behavior 

Author, Yea

ion 

r 

Populat

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Krieger et al., 

005;96 2

Kriege

0029 r et al., 

7

e 

n 

unty, 

ington 

N: 274 

Good 

r 

ed 

-0.13-0.95); P = 0.141) 

 of actions to reduce dust 

ments 

p; 

sheets or dusting, nor 

ry 

oss2

RCT 

Children ages 4-

12 years with 

persistent asthma

Low-incom

households i

King Co

Wash

High G1: Environmental assessment; 

asthma action plan; education

and social support; mattress 

covers, pillows, vacuum, 

cleaning supplies; smoking

cessation referral; 4-8 visits ove

12 months 

G2: Environmental home 

assessment action plan, limit

education, bedding 

encasements; full intervention 

after 12 months 

Behavior, summary score of trigger reduction 

behaviors 

Across groups comparison: GEE coefficient

(95% CI, 0.41 (

Frequencies

exposure and the use of bedding encase

increased more in the high-intensity grou

kitchen ventilation improved more in the lowintensity group. Neither group increased the 

frequency of washing 

reduced exposure to pets (although pet 

ownership was uncommon among participants) 

and smoking in the home; behavior summa

score improved in both groups, and the acr

group difference was not significant 

Parker et al., 

2008100

RCT 

Children ages 7-

11 years with 

persistent asthma 

Southwest and 

eastside Detroit, 

Michigan 

N: 298 

Fair 

High G1: Environmental assessment; 

asthma action plan based on 

allergy tests; education and 

social support; mattress covers, 

pillows, vacuum, cleaning 

supplies; counseling on 

environmental tobacco smoke; 

integrated pest management 

services; minimum 9 planned 

home visits over 12 months 

G2: Asthma information booklet, 

full intervention after 12 months 

ontrol) 

r used: 

126); P < 0.0001 

n child's mattress: 

); P < 0.0001 

isible mold growth removed: 

ot for 

concentration 

Intervention effect (or-intervention/or-c

Vacuum cleane

29.5 (6.90, 

Allergen cover on child's pillow: 

19.7 (4.12, 94.2); P = 0.0006 

Allergen cover o

9.70 (4.33, 21.7

V

0.74 (0.33, 1.66); P = 0.47 

Child is around people who smoke: 

0.60 (0.28, 1.32); P = 0.20 

Statistically significant intervention effect in the 

reduction of concentration of dog allergen per 

gram of bedroom dust (P < 0.001) but n

cockroach, dust mite, or cat allergen 

CI, confidence interval; GEE, generalized estimating equation; RCT, randomized controlled trial. 

r 

Satisfaction. Neither study reported outcomes for satisfaction. 

Health outcomes. The SKCHH project reported on the number of symptom days in the past 2

weeks. The CAAA project looked at the occurrence of more than 2 symptom days per week fo

children not on any controller medication or corticosteroids (Table 31). 

95 
Table 31. CHW asthma interventions and health outcomes 

Author, Year 

Study Design 

Population 

Setting Intensity of 

Sample Size 

Quality 

CHW 

Intervention Study Groups Results 

Krieger et al., 

2005;96

Krieger et al., 

200297

RCT 

Children ages 4-

12 years with 

persistent asthma 

Low-income 

hous

High G1: Environmental assessment; 

asthma action plan; education 

and social support; mattress 

covers, pillows, vacuum, 

cleaning supplies; smoking 

cessation referral; 4-8 visits over 

12 months 

G2: Environmental home 

assessment action plan; limited 

education; bedding 

Pediatric Asthma Caregiver QoL Scale (score 

range 1-7 with higher scores indicating bette

QoL) 

Score at exit (G1 vs. G2): 5.6 vs. 5.4 

GEE coefficient 0.58 (95% CI, 0.18-0.99),

P = 0.005; NNT = 4.8 

ITT analysis yielded similar results: 

improvements in QoL were greater in G1 (data 

NR, P = 0.009) 

eholds in 

King County, 

Washington 

N: 274 

Good 

after 12 months of 24-hour periods during 2 weeks befo

interview with asthma symptoms: whee

tightness in chest, cough, shortness

slowing down activities due to asthma, 

nighttime awakenings): 

G1 vs. G2 at e t: 3.2 vs. 3.9 

encasements; full intervention 

r 

Asthma symptom days (self-reported number 

re 

zing, 

 of breath, 

xi

GEE coefficient -1.24 (95% CI, -2.9 to 0.4),

P = 0.138 

Days with activity limitation over 2-week period 

Score at exit (G1 vs. G2): 1.5 vs. 1.7 

GEE coefficient -1.5 (95% CI, -2.84 to -0.15), 

OR, 0.22 (0.06, 0.86), P = 0.29 

Mis l in past 2 weeks: 

E 7 (95% CI, -1.70 to 0.16), 

OR , P = 0.105 

Da

d: 

G1

GE

P =

Days used beta2-agonist over 2-week period: 

xit: 4.0 vs. 4.0 

GEE coefficient -0.23 (95% CI, -1.88 to 1.42),

P = 0.781 

G1 vs. G2 at exit: 11.2% vs. 13.0% 

GEE coefficient 0.07 (95% CI, -0.91 to 1.0.5), 

OR, 1.07 (0.40, 2.85), P = 0.890 

sed schoo

G1

G

peri

 vs. G2 at exit: 12.2% vs. 20.3% 

E coefficient -0.7

, 0.46 (0.18, 1.18)

ys used controller medication over 2–week 

o

 vs. G2 at exit: 3.5 vs. 3.6 

E coefficient -1.03 (95% CI, -2.79 to 0.73),

 0.250 

G1 vs. G2 at e

Caregiver missed work in past 2 weeks: 

CI, confidence interval; GEE, generalized estimating equation; ITT, intention to treat; NNT, number needed to treated; NR, not 

reported; OR, odds ratio; QoL, quality of life; vs., versus. 

96 
Table 31. CHW asthma interventions and health outcomes (continued) 

Author, Year 

Population 

Setting 

Sample Size 

Quality 

Int

CH

Int u Re

ensity of 

W 

ervention St dy Groups sults 

Parker et al., 100 H

2008

1 years with 

a 

astside Detroit, 

n 

8 

Fair 

ig G1

ast

alle

soc

pill

sup

env

inte

ser

hom

G2

full

 by 

Ce Studies Depression 

Scale (CES-D) mean at baseline/endpoint: 

G2

P =

Imp nstrumental and 

em

ins pport alone were not statistically 

significant (data NR) 

ptom 

fre

G1: symptoms occurred less frequently at 

 of 

gh at baseline, postintervention 

(on a 6-point scale, higher is worse): 

G1: 3.81, 3.36 

G2: 3.48, 3.44 

eek 

eek 

. G2 

RCT 

Children ages 7-

1

persistent asthm

Southwest and

e

Michiga

N: 29

h : Environmental assessment; 

hma action plan based on 

rgy tests; education and 

ial support; mattress covers, 

ows, vacuum, cleaning 

plies; counseling on 

ironmental tobacco smoke; 

grated pest management 

vices; minimum 9 planned 

e visits over 12 months 

Ca

G1

: Asthma information booklet, 

 intervention after 12 months Ch

regiver depressive symptoms measured

nter for Epidemiologic 

: 1.62/1.54 

: 1.58/1.64 

 0.0218 

rovements in both i

otional social support combined and 

trumental su

ild's self-reported average asthma sym

quency: 

baseline for all 8 symptoms assessed 

G2: symptoms occurred less frequently for 6

8 symptoms 

Persistent cou

P = 0.034 

Cough with exercise at baseline, 

postintervention (on a 6-point scale, higher is 

worse): 

G1: 4.27, 3.69 

G2: 3.80, 3.66 

P = 0.017 

Has any symptom more than 2 days per w

and not on a corticosteroid G1 (pre/post) vs. 

G2 (pre/post) intervention effect (95% CI): 

60/42 vs. 51/46; 0.56 (0.29 to 1.06); P = 0.073

Has any symptom more than 2 days per w

and not on any controller G1 (pre/post) vs

(pre/post) intervention effect (95% CI): 

53/32 vs. 38/37; 0.39 (0.20 to 0.73); P = 0.004 

Results from these two trials were mixed. The Seattle (SKCHH) project reported 

nonsignificant differences between the arms in the reduction in symptoms days, whereas the 

Detroit (CAAA) project found significant differences between the trial arms for children n

any controller medication (OR, 0.39 [95 percent CI, 0.20-0.73]).96,97 The differe

ot on 

nces between 

tria

activity 

l arms in reduction of symptom days was not statistically significant in the subset of children 

not on corticosteroids.100 

The Seattle (SKCHH) project also examined differences in trial arms in days with 

limitation, use of beta-agonists, use of controller medications, missed school days for the child, 

97 
and missed caregiver workdays. With the exception of days with activity limitations, the stu

found no differences between the intervention arms.96,97 It also found a significantly high

dy 

er 

incr

cha

nd 

uns : 

ease in caregiver quality of life (measured by the Center for Epidemiologic Studies 

Depression Scale in the more intense arm (coefficient for difference between groups in mean 

nge from exit to baseline: 0.58 [95 percent CI, 0.18-0.99]).96,97

The Detroit (CAAA) project found significant improvements in symptoms for both 

intervention and control arms, but differences were statistically significant only for coughing 

with exercise and persistent cough. It also found significant differences between trial arms in 

some but not all measures of lung function; these results could potentially be explained by 

seasonal influences, changes in instrumentation, and inadequate power.100 Finally, it reported a 

statistically significant reduction (P = 0.0218) in caregiver depressive symptoms (measured by 

the Center for Epidemiologic Studies Depression Scale) in the intervention arm (mean value at 

baseline and followup: 1.62 and 1.54) compared to a rise in depressive symptoms in the control 

arm (mean value at baseline and followup: 1.58 to 1.64). The study found no statistically 

significant differences between the two groups in changes in social support between baseline a

the endpoint.100 

Health care utilization. Both studies (Table 32). found a significant difference in the 

reduction in unscheduled medical care—emergency room visits, hospitalizations, and 

cheduled doctor visits—favoring the more intense intervention at three points: 2 months (OR

0.38; 95% CI, 0.16-0.89),96,97 3onths (OR: 0.43; 95% CI, 0.23-0.80),100 and 12 months (OR: 

0.40; 95% CI, 0.22-0.74).100 

Table 32. CHW asthma interventions and health care utilization 

Author, Year 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Krieger et al., 2 96

Krie

005; High G1: Environmental assessment; 

G2: Environmental home 

Urgent health services used over 2 months G1 

.12), 

 = 12.9 

es were 

greater in G1 (data NR, P = 0.062) 

ger et al., 200297

Children ages 4-12 

years with persistent 

asthma 

Low-income 

households in King 

Cou

asthma action plan; education 

and social support; mattress 

covers, pillows, vacuum, 

cleaning supplies; smoking 

cessation referral; 4 to 8 visits 

over 12 months 

vs. G2 at exit: 

8.4% vs. 16.4% 

GEE coefficient -0.97 (95% CI, -1.8 to -0

OR 0.38 (0.16, 0.89), P = 0.026; NNT

ITT analysis yielded similar results: 

improvements in urgent health servic

nty, Washington 

N: 274 

Good 

assessment action plan, limited 

education, bedding 

encasements; full intervention 

after 12 months 

CI; confidence interval; GEE, generalized estimating equation; ITT, intention to treat; NNT, number not treated; NR, not 

reported; OR, odds ratio; RCT, randomized controlled trial. 

98 
Table 32. CHW asthma interventions and health care utilization (continued) 

Author, Year 

Population 

Setting 

Sample Size 

Quality 

Intensity of 

CHW 

Intervention Study Groups Results 

Parker et al., 2008 

100

Children ages 7-11 

years with 

persistent asthma 

Southwest and 

eastside Detroit, 

Michigan 

N: 298 

Fair 

High G1: Environmental assessment; 

asthma action plan based on 

allergy tests; education and 

social support; mattress covers, 

pillows, vacuum, cleaning 

supplies; counseling on 

environmental tobacco smoke; 

integrated pest management 

services; minimum 9 planned 

home visits over 12 months 

G2: Asthma information booklet, 

full intervention after 12 months 

Reduction in unscheduled health care 

utilization for asthma 

Percentage needed unscheduled me

care–G1 (pre/post) vs. G2 (pre/post); 

intervention effect (95% CI): 

In past 3 months: 

50/45 vs. 42/56; 0.43 (0.23 to 0.80); 

P = 0.007 

In past 12 months: 

65/59 vs. 58/73; 0.40 (0.22 to 0.74); 

P = 0.004 

dical 

KQ 3: Cost-Effectiveness of Community Health Worker 

Interventions 

Overview of Economic Analyses 

out 

 that were analyzed or as compared with baseline, or usual, care. The 

stud

or 

CHWs as a study arm included early childhood and 

chil

vels for the CHW 

 and 

es 

ent, 

e 

The three studies with economic information that we eventually excluded involved (1) a diet 

change intervention that targeted Hispanic women,64 (2) an environmental tobacco smoke 

intervention that targeted young Latino children,67 and (3) a children’s immunization 

intervention that compared CHW interventions with mail or telephone interventions for raising 

A total of nine studies that met inclusion criteria for this review contained information ab

intervention costs, cost-effectiveness, or cost-benefits. We focused here on the six studies that 

also demonstrated effectiveness of the CHW intervention, either as compared with the 

alternatives 17-22,75,80,96,104,121

ies on CHWs that included economic information varied a great deal in terms of the 

populations targeted for intervention, the types of interventions implemented and the settings f

those interventions, the alternatives that were analyzed, and the outcomes the interventions 

sought to impact. 

Targeted populations, for example, ranged from Latina women to low-income infants and

children. The types of interventions using 

d health interventions, cancer screening interventions, and chronic disease management 

interventions. Some studies evaluated alternatives that varied intensity le

intervention; others compared the CHW intervention without nurse-delivered interventions;

others compared the CHW intervention with lower intensity alternatives that did not involve 

direct interaction with targeted patients (e.g., providing written materials only). Study outcom

also varied a great deal across studies, reflecting the diversity of types of interventions and 

targeted populations (e.g., outcomes related to use of health care, child health and developm

and impacts on usual activities such as work or school). Intervention settings also varied; som

CHW interventions focused on working with participants in their homes, one focused on 

working with homeless individuals, and another took place in urban churches. 

99 
children’s immunization rates.69,70 These three studies produced no statistically significant 

impact on CHW intervention groups as compared with outcomes in the control groups. 

In the discussion below, we cite only the articles with data specific to the cost-analysis; 

stud w.

ervention, which involved three home visits 

wit

tained 

 and within the 2-year window before that 

(“ad

r 

ould be incurred by a prevention 

pro

me that both 

 review of a woman’s medical 

comes were based on participants’ self-reports via a telephone 

ars saved based on a model of screening, diagnosis, and 

ost of the ROSE intervention was estimated to be $329,054,17

04 per participant, based on the 815 participants who fully 

ata collection. The year of costs was not reported for the 

he LAMP intervention were estimated to be $11 per participant 

ity cost of CHW volunteers’ time was excluded from the cost 

 at $28 per person when CHW volunteers’ time was valued at 

sts 

ies spanned several other citations specific to outcomes not relevant to the discussion belo

Economics: cancer screening. Study characteristics. Two studies (one trial and one 

prospective cohort) evaluated program costs or cost-effectiveness for CHW interventions that 

sought to improve women’s mammography rates.17,22 The ROSE study targeted low-income, 

rural white, African-American, and Native-American women in North Carolina ages 40 years 

and older, all of whom had not had a mammogram in the previous 12 months.17,18 These women 

were randomly assigned to a high-intensity CHW int

h followup telephone calls and mailings, or to a comparison group. The CHW intervention 

was delivered for a period of 12 to 14 months. The LAMP CHW study collected data on program 

costs and cost-effectiveness for a low-intensity cancer screening CHW intervention.19-22,104 The 

intervention was a church-based telephone counseling program that targeted female church

members ages 50 to 80 years to promote mammography. Some of these women had ob

mammograms 1 to 2 years before the initial survey

herent” group), whereas others had not (“nonadherent” group). Church volunteers made one 

telephone call per 12-month period to encourage and address barriers to mammography. 

Overview of economic analysis results. Both studies report program costs and the costs pe

additional mammography screening.17,22 Both studies estimated program costs using a program

or funder perspective (i.e., including only those costs that w

gram to deliver the intervention); that is, they did not employ a societal perspective. Because

the LAMP study used volunteer labor, the costs of the intervention from the program perspective 

are necessarily low compared with the costs of the ROSE intervention, which paid their CHWs. 

To better understand what costs would be if CHWs had to be hired to deliver the LAMP 

intervention, Stockdale et al.22 also report two alternative program cost estimates—one that 

values volunteer time at the minimum wage and another that values volunteer time at the average 

wage rate. 

Measures of effectiveness for economic analysis. The main effectiveness outco

studies used for their economic analyses was mammogram receipt in the 12 months before a

followup survey. The ROSE study outcomes were based on

record.17,22 The LAMP study out

interview; it also estimated life-ye

treatment for breast cancer.22 

Economic outcomes. The total c

which translates to approximately $4

participated in the intervention and d

ROSE study. Program costs for t

in 1997 dollars when the opportun

calculation. Costs were estimated

the minimum wage and $52 per person when an average wage rate for each type of volunteer 

was used (1997 dollars).22 To compare ROSE and LAMP costs, we assumed that the ROSE co

are in 2000 dollars (the midpoint of the study time period, 1998 through 2002). Using the 

consumer price index for all urban consumers (CPI-U) to adjust the LAMP intervention cost of

$52 per participant in 1997 dollars to 2000 dollars yields an estimate of $56 per LAMP 

100 
participant, as contrasted with the high-intensity ROSE intervention cost of about $404 per 

participant. 

Both studies also reported costs per additional screening.17,22 Paskett et al. estimated the 

impact of the ROSE intervention to be 66 additional mammograms in the CHW intervention 

group, resulting in a cost-effectiveness ratio of $4,986 per additional mammogram (assumed 

200

dy, 

o 

rent and nonadherent with screening guidelines, whereas the ROSE intervention 

targ ants 

urch per year 

e 

d 

ued 

 mental 

H) 

d a 1-year high-intensity CHW intervention approach, involving five to nine 

CH wn 

t 

t 

0 dollars).17 Stockdale et al. estimated the impact of the LAMP intervention to be 3.24

additional mammography screenings for each of the 45 churches that participated in the stu

resulting in an estimated cost per additional screening of $903 (1997 dollars) when CHW 

volunteers’ time was valued at the average wage rate.22 Although these findings appear to 

suggest that the LAMP intervention had a much lower cost per additional mammogram received

than did the ROSE intervention, the effectiveness and cost-effectiveness results are not 

comparable between these two studies because the LAMP intervention targeted women wh

were both adhe

eted only nonadherent women. Focusing on results for the nonadherent LAMP particip

only, the estimated intervention effectiveness is 1.46 additional screenings per ch

(not statistically significant), which we estimate to produce a cost-effectiveness ratio of $2,005 

per additional mammography screening in 1997 dollars, or $2,151 in 2000 dollars, when the tim

of CHWs is valued using expected wage rates. 

Stockdale et al. also estimated the cost per life-year saved by the LAMP intervention an

subsequent mammography screening as $46,308 (1997 dollars),22 when CHW time was val

using expected wage rates ($33,632 plus the estimated cost per life-year saved for 

mammography screening of $12,676). 

Economics: chronic disease management. Study characteristics. Two studies provided 

economic information on the management of chronic diseases; both studies are described in 

more detail in the last section of KQ 2. One study evaluated an asthma control intervention for 

children;96the other evaluated an intervention to prevent homelessness in patients with

illness.121 

The asthma intervention, known as the Seattle King County Healthy Homes (SKCH

project, evaluate

W home visits.96 The investigators compared this high-intensity intervention with a lo

intensity version that involved only one CHW home visit and evaluated health care utilizatio

and costs for participants, intervention program costs, and other measures related to asthma 

control, quality of life, and productivity. 

The homelessness prevention intervention compared three alternative case managemen

approaches for people with mental illness at high risk of homelessness: 

• brokered case management—a low-intensity intervention that can be viewed as the 

baseline, or usual care, approach; 

• assertive community treatment—a high-intensity intervention that involves frequent 

interaction with the client and assistance with a host of activities and social service 

acquisition; and 

• assertive community treatment with CHWs—a high-intensity CHW intervention tha

consists of assertive community treatment, adding a CHW to interact with and assist 

clients.121

101 
Eac

osts 

tion 

ion 

t 

r 

costs in 

s cost 

h intervention was provided over 18 months. Key outcomes were health care and social 

services utilization, program costs, and pre- and postintervention measures of 6 months of c

for health care and social services among study participants. 

Overview of economic analysis results. Both studies report program costs per participant 

from the program perspective. For the Seattle study, Krieger et al.96 estimated the cost of the 12-

month intervention by summing payments for salary and fringe benefits, supplies, rent, travel, 

and office expenses and adding indirect costs of 13 percent. For the homelessness preven

study, Wolff et al.121 estimated the additional intervention program costs of assertive community

treatment, with and without CHWs, as the costs above those for brokered case management; their 

estimates values CHW time at the minimum wage. 

Both studies estimated the impact of the intervention on health care and/or social services 

costs for program participants. For example, Krieger et al. assessed the pre- and postintervent

costs of urgent care services for both CHW intervention arms (high and low intensity).96 Wolff e

al. also assessed the pre- and postintervention costs of the following services for program 

participants in all three intervention arms: mental and physical health, vocational and 

educational, residential, and supportive social.121 

Measures of effectiveness for economic analysis. Neither study created a measure of the costs 

per unit of program effectiveness (e.g., cost per additional day in stable housing or cost pe

additional day of school attendance). Instead, both studies estimated program cost savings or 

potential cost savings by comparing health care or social services costs in the preintervention 

time period with costs in the postintervention time period. 

For example, the Seattle study estimated urgent care costs for the targeted children in the 2

months before the start of the intervention and compared these values without analogous 

the 2-month period before the exit interview.96 For this work, Krieger et al. defined urgent care 

costs as the costs of hospital admissions, emergency department visits, and unscheduled clinic

visits.96 Because this intervention sought to reduce use of urgent health care services among 

participants with asthma, a reduction in urgent care costs for participants may be viewed a

savings attributable to the intervention. 

The homelessness prevention intervention also compared preintervention and 

postintervention costs for participants in each of the study arms. For this work, Wolff et al. 

calculated costs for the following services, by study arm: 

• mental health inpatient, 

• mental health outpatient, 

• physical health inpatient, 

• physical health outpatient, 

• vocational and educational, 

• residential, 

• cash social support, and 

• in-kind social support.121

Wolff et al. also provided a total cost amount that summed the per-patient costs for all of the 

above services and included the intervention cost for assertive community treatment (with or 

without CHWs).121 However, reductions in these total or specific services costs should not be 

viewed as cost savings attributable to the intervention because utilization and costs of some 

services might be expected to rise, rather than fall, as the result of a successful intervention. For 

example, successful assertive community treatment interventions might lead to larger 

102 
pre/postintervention increases in vocational and educational service costs than a brokered case 

management approach. 

Economic outcomes. In the Seattle program, costs for the high-intensity CHW intervention 

were $1,124 per child higher in 2001 dollars than costs for the low-intensity CHW intervention 96

Estimated costs for the 96

.

 low-intensity asthma intervention were not provided. 

For the homelessness prevention intervention, annual program costs were $6,200 per 

participant for the assertive community treatment intervention with CHWs and $6,440 per 

participant for assertive community treatment only.121 These cost estimates are in 1992 dollars

and are in addition to costs for brokered case management—costs that were not reported in the 

article. Adjusting these cost estimates to 2001 dollars using the CPI-U, we estimate the costs of 

assertive community treatment with CHWs to be $7,826 per patient and the costs of assertive 

community treatment only to be $8,129 per patient, in addition to costs for brokered case 

management. 

For the Seattle study of children with asthma, Krieger et al. also provided estimates of 

pre/postintervention health care cost reductions attributable to the CHW asthma 

intervention.96Comparing urgent care costs in the 2 months before the intervention with costs in 

the 2 months at the end of the intervention, they estimated cost reductions of $201 to $334 per 

child in 2001 dollars.96 For the low-intensity CHW group, analogous cost reductions were $185 

to $315 per child. Assuming these cost reductions persist for 1 year, estimated annual cost 

reductions are $1,200 to $2,000 per child for the high-intensity CHW intervention in 2001 

dollars. Krieger et al. also discussed the cost-effectiveness of the high-intensity intervention 

relative to the low-intensity approach.96 They found savings in urgent care costs for the high 

intervention group relative to the low intervention group of $57 to $80 per child over a 2-month 

period.96 The authors reported that if these cost reductions were to last for 3 to 4 years, the highintensity intervention would be cost saving relative to the low-intensity intervention. Whether 

assuming the same level of reduced urgent care utilization and costs for several years 

postintervention is reasonable, however, remains unclear. The authors did find that urgent care 

utilization remained low in the high-intensity group for at least 6 months following the 

intervention.96 

For the study of homeless mentally ill participants, Wolff et al. conducted regression 

analyses to explore whether study arms differed in their measures of total costs over the 18-

month study period.121 They found no difference in total costs across study arms after controlling 

for patients’ costs in the preintervention period.121 They also compared 6-month costs in the 

preintervention period to 6-month costs for three separate postintervention periods (1 to 6 

months, 7 to 12 months, and 13 to 18 months). At least in part because the number of 

participants in each intervention arm was relatively small (N = 35, 28, and 22, respectively), 

postintervention costs varied a great deal across time periods. The authors point out that, when 

comparing the preintervention period with the first 6 months’ postintervention period, inpatient 

mental health services costs fell $1,315 for assertive community treatment with CHWs, rose 

almost $4,500 for assertive community treatment only, and rose more than $8,000 for brokered 

case management.121 Considering the second 6-month period of the intervention, inpatient 

mental health services costs fell by more ($4,400 per participant) in the assertive community 

treatment only group than in the assertive community treatment with CHWs group ($2,651 per 

participant). Inpatient mental health services costs also declined in that time period for the 

brokered case management group ($1,252 per participant). All of these cost estimates are in 1992 

dollars. 

103 
The cost cult to 

interpret usin ostctiveness 

 for use in 

cos nt 

is 

was to 

erspective, their measure of total costs excludes criminal justice 

and

 in 

ates, because 

cos

 for 

 a 

sts for 

e 

to t

 to 

pact 

tudies reported intervention program costs. 

 did not 

ness for economic analysis. Because both of these studies reported only 

us 

were 

 not explicitly state this, we assumed 

that this cost estimate reflects the additional costs of the CHW intervention relative to the clinical 

intervention (usual care). When adjusted to 2002 dollars using the CPI-U, the CHW intervention 

for these children has an estimated annual cost of $3,520 per child. For the Home Visitation 2000 

 estimates for health and social services that Wolff et al.121 report are diffi

g the currently recommended framework for performing and evaluating c

effectiveness analyses.130,131 The recommended approach for performing cost-effe

analysis is to specify the perspective of the study a priori and to calculate net costs

t-effectiveness evaluation as intervention costs less any costs for health care or other releva

variables (including productivity losses) averted by the intervention. The societal perspective 

recommended for economic evaluation, which implies that all costs should be included, 

regardless of who bears them. Although the Wolff et al.121 article implies that the intent 

estimate costs from the societal p

 family burden costs (mentioned as a limitation), it excludes productivity costs, and it 

includes societal transfers (cash and in-kind support) that are not recommended for inclusion

economic analyses from the societal perspective. The presentation of costs in three different 

intervention time periods also makes it difficult to interpret the Wolff et al. estim

ts differed a great deal over time for each intervention arm.121 Finally, the total cost measures 

they presented cannot readily be used in economic evaluations without some adjustments. Their 

total cost estimates represent the sum of intervention costs and specific health care and social 

services costs. These total cost estimates vary a great deal across intervention arms (including

the preintervention period) and across time within each intervention arm. In contrast, the 

recommended estimates for use in economic evaluations are measures of net costs that provide

single measure of costs for each intervention arm that subtract from intervention costs the health

care, productivity, and other related cost reductions attributable to the intervention.131

Economics: child health. Study characteristics. Two studies evaluated program co

CHW interventions that sought to improve child health.75,80 One study, set in Maryland, 

evaluated the impact of a high-intensity CHW intervention for children with nonorganic failur

hrive in a low-income urban setting. As reported by Black et al., children diagnosed with 

failure to thrive were randomized to receive either the CHW intervention, which involved the 

delivery of clinical services plus weekly home visits from a trained CHW, or the clinical 

intervention only.75 The Home Visitation 2000 RCT targeted low-income, pregnant women for a 

home visiting intervention that involved prenatal home visits, followed by home visits every 1

2 months until the target child was 2 years of age.80 In this study, Olds et al. compared the im

of using CHWs to deliver the home visiting intervention with the impact of using nurses.80 In 

addition to program costs, it evaluated several child health and developmental outcomes (e.g., 

mother-child interaction, quality of the home environment, child developmental outcomes). 

Overview of economic analysis results. Both s

Cost components for the failure-to-thrive trial included salaries for the CHW or nurse, materials

costs, transportation costs, costs of police service, and a 10 percent overhead fee.75 Olds et al. 

provided a per-family total cost of the 2.5 year Home Visitation 2000 trial,80 but they

specify details on what was included in the cost estimate. 

Measures of effective

the intervention costs, they did not examine intervention costs in relationship to outcomes. Th

we had no measures of intervention effectiveness for these economic analyses. 

Economic outcomes. Annual program costs for the failure-to-thrive CHW intervention 

$2,828 per child in 1993 dollars.75 Although the article did

104 
RCT, program costs were $9,140 per family in 2002 dollars for the nurse home visitation arm 

and $6,162 per family for the CHW intervention arm.80 These costs are for the full 2.5 years of 

. Dividing these estimates by 2.5, we estimate annual costs of $3,656 per family for 

me visitation intervention and $2,465 for the CHW home visitation intervention—

2 dollars. 

s: ings mariz

t infor ram 

th b al con

ac e st estim

PI-U. Although adjusting some of the cost estimates usin

ve been more appropriate, because that compo

alth care sector than in other parts of the US econom

l studies relied on nonmedical labor to provide the CHW intervention. 

mmary of economic analyses of CHW interventions 

, Year 

Intervention 

Description 

Annual Intervention 

Program Costs Per 

Participant, Year of 

Dollars Specified or 

Assumed 

Annual 

Intervention 

Program 

Costs, 2008 

Dollars 

Results of Other Economic 

Analyses 

the program

the nurse ho

both in 200

Economic

intervention ar

 summary of find

icles that provided

. Table 33 sum

mation on prog

es findings from the six CHW 

costs and other economic outcomes 

(presented in 

presented in e

e order of discussion a

h article, but we also r

ove, by clinic

port each co

text). Cost estimates are shown as 

ate adjusted to 2008 dollars using the 

g the medical care component of the 

nent accounts for faster growth in 

y, we used the CPI-U 

C

CPI might ha

prices in the he

because al

Table 33. Su

Author

Stockdale et 

al., 200022 Mammography 

s

in

$52 (1997) $70 $903 per additional 

ing, 

$46,308 per life-year saved 

for intervention plus 

creening 

tervention 

mammography screen

1997$ 

mammogram, 1997$ 

Paskett et al., 17 Mammography 

screening 

intervention 

$404 (2000 assumed) $505 

2006 mammography screening, 

$4,986 per additional 

(2000$ assumed) 

Krieger et a 96 l., 

005

Asthma management 

intervention 

$1,124 (2001) $1,366 

care costs per child, highntion, 2

$201-$334 reduced urgent 

intensity CHW interve

2001$ 

Wolff et al., 

1997121 Homelessness prevention 

intervention 

$6,200 (1992) (CHW 

intervention) 

$9,514 Reductions in inpatient 

intervention time periods 

mental health services costs 

for CHW intervention relative 

to usual care in all 

Olds et al., C

200280 d

in

n

hild health and 

evelopment 

tervention 

$2,565 

interve

(2002) (CHW 

tion) 

$3,070 None 

Black et al., 

199575 C

in

hild health 8 (1993) $4,214 

tervention 

$2,82 None 

CHW, community health worker. 

105 
KQ 4: Training of Community Health Workers 

Characteristics of Training for Community Health Workers 

Overview. Study characteristics. As noted in Chapter 2, an inclusion criterion specific to 

KQ 4 was that all studies reported on changes in knowledge or skills among CHWs after 

training. Although we identified 46 citations that were potential includes,111,132-176 only 9 studies 

(10 citations) provided evidence of changes in knowledge or skills among CHWs after 

training.137,141,143,147-150,155,169,176 

All included studies were set in minority or underserved communities. Three focused on 

cancer prevention,137,141,143,176 two on cardiovascular disease,147,149 and one each on health 

promotion,169 tobacco cessation,150 salmonella prevention in the manufacture of queso fresco,155

and on health insurance enrollment, immunizations, and asthma prevention.148 

The studies included in this section spanned a variety of models of CHW interventions. Five 

studies relied on volunteers;137,141,149,155,169,176 other studies either paid CHWs or did not report on 

payment status. The size of the intervention effort also varied: the number of CHWs trained 

through these programs ranged from 4147 to 1,504.148 The educational background and prior 

training of the CHWs undergoing training were rarely reported: one study reported that 98 

percent (of 79 CHWs) had either a college bachelor’s or graduate degree,137 whereas another 

study reported that all trainees (4 CHWs) had 10 years of prior experience as CHWs.147 Studies 

also varied in their degree of specificity in reporting eligibility criteria for CHWs. The 

contribution of CHWs to developing training materials varied, ranging from intensive 

involvement in pretesting to no involvement. Studies also varied in their reporting on training 

components; in the following sections, we describe reported data on components of training. 

Training on cultural competence. Two studies reported training for cultural competence, but 

they provided no details on the content, method, and number of sessions.148,149

Training on recruitment and retention process skills. Two studies reported training on 

recruitment and retention.141,150,176 One study noted that client recruitment was addressed, but the 

content, method, and number of sessions was not reported.150 The other recorded five 2-hour 

sessions covering recruitment strategies and role-playing practice.141,176

Training on intake and assessment. One study reported training for intake and assessment, 

specifically on community mobilization, communication skills, and outreach strategies, but it 

provided no details on the content, method, and number of sessions.148 A second study noted two 

training sessions for assessment and role-play.147

Training on protocol delivery. Two studies reported on training on protocol delivery.147,148

One provided no further details,148 and the second listed health education counseling as part of 

the curriculum, and included role play for cancer screening counseling sessions and 

cardiovascular disease counseling sessions that was followed by external feedback from a 

clinical psychologist.147

Training on health topic. The purpose of training CHWs on health topics was to prepare 

them to educate participants. Seven studies described the health content of their training in some 

detail;137,141,143,147,150,155,169,176 all provided evidence of change in knowledge of skills after 

training (Table 34). Only two reported significance tests. 

106 
Table 34. CHW training and evaluation results 

Author, Year 

Study Name 

Setting: 

Geography 

Setting: 

Organizational, 

Social, Cultural 

Objective or Aim of 

Training 

Training on 

Content/Health 

Topic 

Evaluation and Testing Results of the Curriculum 

(Improvements in CHW Knowledge) 

Balcazar et al

2006149 ., 

a Su 

ncil 

za 

scondido, 

liente, 

u ties 

althy

 Latinos or the pretest and 100% for the 

tatistically 

gnificant (P < 0.05) but data reported in bar graph 

Salud Par

CorazonNational Cou

of La Ra

E

California;

Chicago, Illinois; 

Ojo Ca

New Mexico 

Latino 

comm ni

To promote heart-he

behaviors among

Not described The closed-format pre/posttest scores reported a 

score of 74% correct f

posttest (n = 11). Differences in pre-post promotora 

knowledge score changes (N = 29) were s

si

only 

Beck et al., 143 2007

ommunities' 

on 

erican 

General: 89/93; breast: 79/86; colon: 15/57; prostate: 

80/75 

Ability to identify signs and symptoms of cancer: 

General: NA; breast: 71/88; colon: 81/93; prostate: 

; colon: NA; prostate: 80/75

Ability to identify strategies to reduce cancer risk: 

General: 70/78; breast: 8/33; colon: 92/96; prostate: 

20/75 

Center for Health

C

cancer educati

program 

Milwaukee 

County, 

Wisconsin 

African- Am

churches 

To train the trainer in 

cancer education 

2 90-minute train-thetrainer workshops Pre/post percentage correct— 

Ability to define cancer: 

40/75 

Ability to identify screening recommendations: 

General: NA; breast 67/67

Ability to identify risk factors: 

General: 59/85; breast: 54/92; colon: 19/89; prostate: 

40/75 

Bell et al.,1999155

Abuela Project 

ounty, 

ashington 

Hisp

To train Hispanic women

make queso fresco that 

was authentic in taste an

texture but did not use ra

milk in an effort to reduce 

the incidence of 

Salmonella serotype 

 raw milk) 

Pretraining/posttraining: 

Recognized health risks associated with eating 

unpasteurized milk and cheese (N): 10/14; 14/15 

Make queso fresco with fresh unpasteurized milk: 

6/12; 1/15. 

 to 

d 

w 

Workshops on how to 

make new queso 

fresco recipe (i.e., 

without

Yakima C

W

anic 

communities 

Typhimurium infections 

resulting from eating queso 

fresco made from raw milk 

BSE, breast self examination; CHW, community health workers; CVD, cardiovascular disease; NA, not applicable; SD

deviation. 

, standard 

107 
108 

Author, Ye

Stud

Setting: 

Org tional, 

Social, Cultural 

Objective or Aim of 

Training 

Training on 

Content/Health Topic 

Evaluation and Testing Results of the Curriculum 

(Improvements in CHW Knowledge) 

Table 34. CHW training and evaluation results (continued) 

ar 

y Name 

Setting: 

Geography 

aniza

Kuhajda et al., 

2006147

Pine Apple Heart 

Disease and 

Stroke Project 

Pine Apple, 

Alabama 

African-American 

women in rural 

southern 

community 

To train CHWs for heart 

disease and stroke and 

in skills for counseling 

and assessing high-risk 

women in the Pine 

Apple clinic 

Topics addressed in 

training included 

cardiovascular disease; 

developing action plans 

(heart attack, congestive 

heart failure, stroke); high 

blood pressure; tobacco 

control; cancer (lung, 

colorectal, breast, 

cervical) 

Counseling CHWs' responses on pre/post training 

questionnaires showed increases in knowledge and 

self-reported behaviors in each of the following areas: 

heart disease and stroke prevention strategies, cancer 

prevention strategies, heart attack or stroke signs and 

symptoms, cancer signs and symptoms, current heart 

disease and stroke prevention activities, current 

cancer prevention activities. Data reported in bar 

graph only 

Martinez-Bristow 

et al., 2006150

Tobacco Free El 

Paso 

El Paso, Texas 

Neighborhood 

clinics 

To train Spanishspeaking counselors to 

deliver tobacco 

cessation interventions 

5 days of training for each 

level of certification for 

nicotine addiction 

Results from pre/posttest measuring self-confidence 

suggest that participants understood training material; 

data NR 

Mean satisfaction scores (1 = definitely not confident 

to 5 = definitely confident) high for recipients of each 

certification: 

Beginner: 4.8, intermediate: 4.7, advanced: 4.6 

Navarro et al., 

2007141,176

Por La Vida 

Cuidandome 

San Diego, 

California 

Latino 

communities 

To train community 

health advisors to 

conduct interactive 

educational group 

sessions and train-thetrainer and their 

"learning partners" 

Manual had sessions for 

understanding female 

body, breast cancer, Pap 

test, breast health, risks 

Changes in knowledge and behavior, pre/post test for 

primary participants; and learning partners 

(percentage naming the following test for 

breast/cervical cancer early detection): 

BSE 58.6/74.7; 46.4/56.3 

Clinical breast exam: 29.1/28.8; 28.8/20.7 

Mammography: 49.8/71.2; 45.0/63.1 

Pap test: 84.6/91.9; 79.3/85.1 

Knows BSE: 90.5/99.3; 82.4/93.2 

Knows mammography recommendations: 32.3/55.8; 

27.4/38.1 

Names ≥1 breast cancer symptom: 75.1/96.8; 

70.3/94.1 

Names ≥1 treatment for breast cancer: 40.0/65.6; 

27.9/45.0 

Names ≥1 risk factor: 8.1/16.5; 6.8/7.2 

Names ≥1 factor for cervical cancer: 30.9/59.6; 

24.3/35.1 

BSE in past month: 62.3/87.4; 55.9/71.5 

Mammography ever: 63.3/70.0; 66.7/68.3 

Pap test ever: 92.3/97.9; 88.3/92.8 
Table 34. CHW training and evaluation results (continued) 

Auth

Stud

urriculum 

or, Year 

y Name 

Setting: 

Geography 

Setting: 

Organizational, 

Social, Cultural 

Objective or Aim of 

Training 

Training on 

Content/Health Topic 

Evaluation and Testing Results of the C

(Improvements in CHW Knowledge) 

Perez et al., 

2006148

Northern 

To train community 

health workers, 

focusing on facilitating 

insurance enrollment, 

Yes, but not described Pre/post scores in competency and knowledge (ga

percentage change): 

Insurance enrollment: 24%/72% (gain = 48%; 

percentage change =

Man

neighbor

ins, 

 200; n tested = 61) 

%; 

hattan 

Community 

Voices 

Collaborative 

Northern 

Manhattan, New 

York, 

child immunization, and 

asthma management Immunization promotion: 83%/96% (gain = 48

percentage change = 16; n tested = 472) 

Asthma management: 63%/83% (gain = 20%; 

percentage change = 32; n tested = 499) 

hoods 

Williams et al., 

1996169

No study name 

Atlanta and Fort 

Valley, Georgia 

To raise awareness of 

and increase 

participation of older 

African Americans in 

health promotion 

Training divided into 3 

categories: 

G1: chronic disease 

education and self-care 

G2: lifestyle education 

Obtained score ≥80 on pre/posttest for h

and diabetes training sessions: 

Urban, low to middle income: 32%/60% 

Inner-city, low income: 11%/72% 

Rural, mixed income: 28%/93% 

Older African 

Americans 

categories developed into 

12 training modules 

activities G3: consumer education 

Topics for these 

ypertension 

Yu et al., 2007137

No s

Chin

To increase the self- Training Change in trainees' knowledge and self-efficacy 

ers pre 

): 

61.0 (11.5)/65.0 (9.2), P = 0.016 

tudy name 

Southeast 

Michigan 

efficacy of CHWs in 

conducting breast 

cancer screening 

promotion 

chapters and 5 

appendices (1 was a 

bilingual glossary of 

medical terms); content 

includes 

socieodemographic 

Knowledge—mean number of correct answ

(SD)/post (SD): 

6 (1.4)/8 (1.1), P < 0.001 

Self-efficacy—mean score pre (SD)/post (SD

 manual had 9

ese 

communities 

characteristics and 

special health concerns, 

outreach strategies, 

effective communication 

skills for promoting 

screening. Also a web 

site, PowerPoint slides, 

and audio recordings 

available 

Training on evaluation. A single study reported evaluation as one of the seven core module

in their curriculum but provided no further details.148 

s 

Other training. Four studies reported training on communication skills,137,148,149,176 and a 

single study reported on making referrals.176 Training curricula may well have included 

additional elements that were not reported. 

109 
Patient Outcomes of Community Health Worker Training 

We did not identify any studies that reported on patient health outcomes of CHW

interventions that were linked to characteristics of training. 

110 
Chapter 4. Discussion 

This chapter discusses our findings for four key questions (KQs) relating to the interaction 

between community health workers (CHWs) and clients (KQ 1), outcomes of CHW 

interventions (KQ 2), costs of CHW interventions (KQ 3), and training of CHWs (KQ 4). As 

noted in earlier chapters, KQs 1 and 4 are largely descriptive. KQs 2 and 3 are more analytic; 

they focus on health and cost-effectiveness outcomes. We specify in this discussion the strength 

of the evidence for the KQs related to outcomes (KQ 2) and cost-effectiveness (KQ 3); we also 

evaluate the applicability of studies included for outcomes (KQ 2). We refer readers to Chapter 2 

for methods for evaluating the strength of evidence and quality of studies. 

The strength of evidence for each outcome incorporates grades for risk of bias, consistency, 

directness, precision, and the presence of other modifying factors. Our approach is based on one 

developed by the Evidence-based Practice Center program for its comparative effectiveness 

review activities.57 In the outcome-specific tables that follow, our overall grade of the strength of 

evidence appears in the far right column; grades for key domains are in the intermediate 

columns. 

In this review, we ultimately had grades of only moderate or low. To recapitulate, 

moderate means that we have moderate confidence that the evidence reflects the true effect; 

further research may change our confidence in the estimate of effect and in fact may change the 

estimate. Low means that we have only low confidence that the evidence reflects the true effect; 

further research is likely to change the confidence in the estimate of effect and is likely to change 

the estimate.57

Interactions between Community Health Workers and Clients 

(KQ 1) 

KQ 1 asks for descriptions of the interaction between CHWs and participants; specifically, 

we examined place of service, type of service, type of educational materials used, duration of 

interaction with participants, and length of followup. We identified 53 studies with 79 citations 

in all, addressing KQ 1.15-23,27,59-105,107-114,116-124,126-128

CHWs interacted with participants in a broad array of locations, using a spectrum of 

materials at varying levels of intensity. Studies usually described the place of service and type of 

intervention in some detail. Across the studies, one-on-one interventions generally occurred in 

the home, on the telephone, or in a medical setting; by contrast, group interventions tended to 

take place in a community setting. Studies described types of educational materials poorly or not 

at all. Studies inconsistently reported duration of interaction with participants and length of 

followup (the number and length of sessions), and they did not always clarify whether their 

reporting was based on protocol or on actual experience. The frequent failure to distinguish 

between protocol and actual experience represents a missed opportunity to explore the balance 

between planned and actual resource allocation and to identify strategies to translate effective 

CHW interventions into a variety of community settings. 

We synthesized the variety of ways that CHWs can interact with participants into a single 

measure of intensity that serves as a proxy of resource allocation. Interactions that reported at 

least four of six elements suggesting a higher intensity (one-on-one, face-to-face, 1 hour per 

session or more, 3 or more months’ duration, three or more interactions, and tailored materials) 

were classified as high intensity. Interventions with two or three elements were classified as 

111 
mo

ntensity, and 8 

as l

 child 

olve low-intensity 

Table 35. Number of studies, by clinical focus and intensity of inte entions 

Conte

Low Intensity Moderate Intensity High Intensity 

Total Number 

of Studies 

derate intensity. Interventions with only one or none of the elements of high intensity were

classified as low intensity. 

Of the total of 53 studies, we classified 27 as high intensity,16-18,27,61,62,64,65,67,68,71-

98,100,120,121,127,128 18 as moderate i 15,23,63,66,69,70,99,101,102,105,106,109-112,114,116,118,119,122-125

ow intensity.19-22,59,60,103,104,107,108,113,117,126

The intensity of CHW interventions varied by clinical context (Table 35). Maternal and

health and chronic disease management interventions were all moderate or high intensity, 

whereas prevention and screening studies were more likely to inv

interventions. 

rv

Primary Clinical 

xt (percentage) (percentage) (percentage) (percentage) 

Health promotion and 

disease prevention 

2107,117 (18.2) 466,69,70,105,118,119 (36.4) 516,64,65,67,68,71,127 (45.5) 11 (100) 

Injury prevention 1126 (33.3) 2101,102 (66.7) None 3 (100) 

Mate 71-87 rnal and child 

th 

None None 15 (100) 15 (100) 

heal

Cancer screening 619-

22,59,60,103,104,107,108,113

(40.0) 

715,63,106,109-112,116,125

(46.7) 

217,18,61,62 (13.3) 15 (100) 

Chronic disease 

management 

None 523,99,114,122-124 (38.5) 827,88-98,100,120 (61.5) 13 (100) 

Total (may be less 

than sum of rows 

because of 

overlapping studies) 

8 18 27 53 

Outcomes of Community Health Worker Interventions (KQ 2)

KQ 2 asks about the impact of CHWs on outcomes, with specific attention to the following 

five domains: knowledge, behavior and behavior change, satisfaction, health outcomes, and 

health care utilization. A key source of heterogeneity is the clinical context of the CHW 

intervention. The applicability of our findings is related to the clinical context of intervention. 

Stu cific 

gories. 

As Table 36 demonstrates, we found numerous research gaps in the key clinical areas and 

domains. Satisfaction and knowledge are virtually ignored by studies in this evidence base. By 

contrast, health outcomes and health care utilization are better represented by studies we 

included; more than one-half of the studies included one or both of these outcomes. 

dies targeted one or more of five primary contextual categories and a wide array of spe

topic areas (number of subdomains in parentheses): health promotion and disease prevention (3), 

injury prevention (2), maternal and child health (3), cancer screening (6), and chronic disease 

management (6); collectively the focus of the studies in this review covered 20 distinct clinical 

or public health activities. Four studies overlapped primary clinical cate 67,68,71,107

112 
Table 36. Summary of studies reporting on outcomes by primary clinical context and subtopic 

Number of Studies by Outcomes 

Primary Clinic

Subdomain 

al Context and lth 

e

Health 

care 

Knowledge Behavior Satisfaction tion Tota

Hea

Outcom s utiliza l* 

Health promo disease p tion and revention 

Health promotion and 

ase prev diatr

e 3 

dise

immunizatio

ention: pe ic 

ns 

None None None 3 Non

Health prom

disease prev

promotion – h 

otion and None 1 None None 

ention: health

 Latina healt

1 2 

Health promotion and 

disease prevention: disease 

prevention 

2 5 None 1 1 6 

Injury prevention 

Injury prevention: home 

safety 

None 2 None None None 2 

Injury prevention: workplace None 1 None None 1 

safety 

None

Maternal and child health 

Maternal an

prenatal car al 

outcomes 

d child health: None None None 5 1 6 

e and perinat

Maternal and child health: 

velo

N None 4 

child de pment 

one None None 4 

Maternal an health: 

environmen o 

child well-being 

d child 3 7 10 

t conducive t

None None None 

Cancer screening 

Cancer screening (overall) 2 2 None None None 2 

Cancer screening: breast 

self-examination 

None 5 None None None 5 

Cancer screen

smears 

ing: Pap None None None None 6 6 

Cancer screening: 

m

None None None None 11 11 

ammography 

Cancer screening: clinical 

breast examination 

None None None None 4 4 

Cancer screening: colorectal 

cancer screening 

None None None None 2 2 

Chronic disease management 

Chronic disease 

management: diabetes 

mellitus 

1 2 None 4 None 4 

Chronic disease 

management: hypertension 

None None None 3 1 4 

Chronic disease 

management: infectious 

diseases 

None None None None 1 1 

Chronic disease 

management: back pain 

None None None 1 None 1 

Chronic disease 

management: mental health 

None None 1 1 1 1 

Chronic disease 

management: asthma 

None 2 None 2 2 2 

Total* 5 22 1 27 30 53 

*Total may be less than sum of cells because of overlapping studies. 

113 
In the section below, we discuss the strength of evidence for these five primary outcome 

domains and specific subdomains, reflecting the clinical context of the intervention. We follow 

the examination of outcomes with a summary of results for each clinical context and subdomain 

and then consider applicability. 

We identified 53 studies comprising 79 citations addressing KQ 2. Thirty-eight were 

randomized controlled trials (RCTs)16-18,27,61,62,64,65,67,68,71-98,100,106,120,121,127,128 and 15 were 

observational studies.59,60,71,72,83,86,87,93-95,102,108,113,116,117,123,125,126 Of the 53 studies, we rated 4 as 

good quality,17,18,69,70,96,97,103 29 as fair,16,27,59-63,66-68,72,75,76,79-85,88-

93,98,100,101,105,106,108,109,114,117,122,124,125,127 and 20 as poor.15,19-

23,64,65,71,73,74,77,78,86,87,94,95,99,102,104,107,110-113,116,118-121,123,126,128

Knowledge 

As noted in Chapter 1, studies examining the effectiveness of CHW interventions are based 

in part on theories of individual behavior change. Studies relying on social cognitive theory as a 

model of individual behavior change anticipate that participants in CHW interventions will 

change their behavior based on knowledge they gain by observing and learning from CHWs. 

Very few studies presented evidence on the effect of CHW interventions on the knowledge of 

participants (Table 37). The five studies reporting information on knowledge together provide 

(a) moderate strength of evidence that CHW interventions improve the knowledge of participants 

on disease prevention16,117,127 and cancer screening17,18,109 compared with other alternatives, 

(b) low strength of evidence that CHW interventions improve knowledge of label reading 

compared with usual care, but (c) insufficient evidence for knowledge of other issues related to 

the clinical or self-management of diabetes, such as dietary knowledge, appropriate diet, 

frequency of checking blood sugar, understanding the need for eye doctor visits, knowledge of 

how diabetes affects the body (eye, kidney, nerve, cardiovascular problems), or understanding 

insulin or other medication.27

This literature did not compare CHWs with a comprehensive range of usual care providers. 

Therefore, we cannot conclude that CHWs outperform all alternatives in improving participant 

knowledge. Nevertheless, for the much smaller subset of comparators and outcomes included in 

this literature, the studies together suggest that CHW interventions can improve participant 

knowledge when compared with alternative approaches such as no intervention, media, mail, or 

usual care plus pamphlets. 

We found no evidence on knowledge for all other clinical topics and subdomains, as 

documented above in Table 36. The absence of data on the vast majority of clinical concerns that 

investigators in this field sought to study (as listed in Table 36) suggests that researchers may 

have elected to give priority to collecting and publishing data on health outcomes and health care 

utilization data rather than intermediate outcomes such as knowledge. 

114 
Table 37. Effect of CHW interventions on knowledge: strength of evidence 

Number of 

Studies; # of 

Subjects 

Risk of Bias 

Design/ 

Quality Consistency Directness Precision fo

(Int

Con

Other 

Factor

ens

lts

Ove

Stre

Evid

Modifying 

s 

ity, 

unding) Resu

rall 

ngth of 

ence 

Health promotion ease p dis ven and dis revention: ease pre tion 

2; 

6,84116,117,127 edium 

cohort/fair 

Consistent Indirect Precise Absent Favors 

interven

or no in

(for imp

knowled

reading

of fat in

knowled

to obtai

condom

M Moderate 

1 RCT, 1 

prospective 

CHW 

tion vs. print 

tervention 

roved 

ge of label 

, knowledge 

 diet, and 

ge of where 

n free 

s) 

Cancer sc reening

2; 

1,78817,18,109

ow 

2 RCTs/1 

good, 1 fair 

Consistent Indirect Imprecise Absent Favors 

media o

L CHW vs. derate 

r mail 

Mo

Chronic di nage sease ma ment: diabete s s mellitu

1; 15027

1 RCT/fair 

Consistency 

unknown 

(single study) 

Direct Not 

reported 

Absent Favors 

interven

usual c 

knowled

reading

Medium CHW Low 

tion vs. 

are plus

pamphlets (for 

ge of label 

) 

CHW, communi er; RCT, randomized controlled trial. 

Behavior 

Twenty-two studies reported on the effect of CHW interventions on participant behavior. The 

evidence for workplace safety, diabetes mellitus, and the use of bedding encasements for asthma, 

from five studies, suggests that CHW interventions can change participant behavior in the 

desired direction when compared with alternatives such as a community intervention, a lowerintensity CHW intervention, and usual care combined with a pamphlet (Table 38).17,18,88-

92,96,97,100,109,124,126 The strength of evidence is moderate for the use of bedding encasements for 

asthma and low for workplace safety and diabetes mellitus. 

The evidence for disease prevention, improving the environment for child well-being, 

planned use of cancer screening tests, and breast self-examination, from 14 studies, is mixed. 

Some studies demonstrate a statistically significant benefit from the CHW arm, but others show 

no significant differences.16,61-63,67,75,76,78,84,105,107,108,110-112,116,118,119,125,127,128 The strength of 

evidence for these outcomes is low. 

The evidence for health promotion among Latinas, injury prevention at home, and smoking 

cessation to reduce asthma, from five studies, failed to demonstrate that CHW interventions 

resulted in statistically significant different outcomes than alternatives; the strength of evidence 

for these outcomes is low.64,65,96,97,100-102 We found no evidence to evaluate the effectiveness of 

CHW interventions for all other clinical concerns described in Table 36. 

ty health work

115 
Table 38. Effect of CHW interventions on behavior: strength of evidence 

Number of 

Studies; # of 

Subjects 

Risk of Bias 

Design/ 

Quality Consistency Directness Precision 

Other Modifying 

Factors 

(Intensity, 

Confounding) Results 

Over

Stre

Evid

all 

ngth of 

ence 

Health promotion and disease prevention: health promotion – Latina health 

1; 35764,65 High 

/poor 

Consistency 

unknown (single 

study) 

Indirect Not reported Present No difference 

between CHW 

intervention and 

Low 

1 RCT

tailored or offthe-shelf 

interventions 

Health promotion and disease prevention: disease prevention 

5; 1,125+12 

churches16,67,

105,107,118,119,12

7

Medium 

5 RCTs/3 

fair, 2 poor 

Inconsistent Indirect Imprecise Present Mixed results: 

3of 5 studies 

favor CHW 

intervention vs. 

Lo

control (no 

intervention, 

combination of 

intervention

media/print) 

w 

s, 

Injury prevention: home safety 

2; 2,909101,102

s/1 

renc

tween CH

nal or 

vention 

Medium 

2 RCT

fair, 1 poor 

Inconsistent Indirect Precise Present No diffe e Low 

be

and health 

professio

no inter

W 

Injury prevention: workplace safety 

1;786126 High 

cohort/poor 

Consistency 

unknown (single 

Direct Imprecise Present W 

unity 

intervention 

Favors CH Low 

over comm

1 prospective study) 

Maternal and child health: environment conducive to child well-being 

3; 

1,05275,76,78,84

,128

Medium 

3 RCTs/2 

fair, 1 poor 

Inconsistent Direct Imprecise Present Mixed results: 

Most with no 

difference 

between CHW & 

Lo

control; some 

benefit to CHW 

over no 

intervention 

w 

Cancer screening: planned use of screening tests 

2; 1,61263,116 Medium Inconsistent Indirect Imprecise Present Mixed results: 1 

1 RCT, 1 

cohort/1 fair, 

1 poor 

benefit in CHW 

arm vs. usual, 

other shows no 

difference vs. n

study shows 

o 

intervention 

Low 

CHW, community health worker; RCT, randomized controlled trial. 

116 
Table 38. Effect of CHW interventions on behavior: strength of evidence (continued) 

 o

bjects 

 Bias 

Design/ 

Consistency Directness Precision

her Modifying 

s 

sity, 

unding) Results 

ll 

th of 

Evidence 

Number of

Studies; #

Su

f 

Risk of

Quality 

Ot

Factor

(Inten

Confo

Overa

Streng

Cancer screening: breast self-examination

5; 

108,1

125

Medium 

2 RCTs, 3 

fair, 

ults: 2 

enefit of 

s. 

(mail 

 of 5 

e vs. 

layed or no 

tion 

Low 

3,79861,62,

10-112,116,

cohorts/3 

2 poor 

Inconsistent Direct Imprecise Present Mixed res

of 5 studies

show b

CHW v

alternative 

or minimal 

CHW), 3

show no 

differenc

de

interven

Chronic disease management: diabetes mellitus 

2; 21388-92,124

r

 ect recise ent HW 

n vs. 

lus 

 Medium w 

2 RCTs/fai

Consistent Indir P Abs Favors C

interventio

usual care p

newsletter 

Lo

Chronic disease management: asthma, use of bedding encasements 

2; 57296,97,100 Low 

2 RCTs/1 

Consistent Indirect Precise Absent CHW vs. 

ss intense 

CHW arm or 

HW

Moderate 

good, 1 fair 

Favors

le

delayed C

arm 

Chronic disease managemen ma, other behaviors (smoking cessa val of mold) t: asth tion, remo

2; 57296,97,100

2 RCTs/1 

good, 1 fair 

Inconsistent Indirect Imprecise Absent e 

s intense 

CHW arm or 

W

 Low No differenc Low 

between CHW

vs. les

delayed CH

arm 

Together these studies suggest that CHW interventions can, in some instances, yield greater 

positive changes in participant behavior than a range of alternatives (including no intervention, 

community intervention, usual care plus a newsletter, media/print, a less intense or delayed 

CHW arm, or a combination of interventions). In other instances, CHWs interventions provided 

no statistically different benefit when compared with a range of alternative

improvements in a with the 

e of heal sio sen stati g differe rt 

Ws. 

The absence of consistent evidence showing that CHW interventions p enefit 

when compared with alternatives may be explained in part by either the inadequacy of the CHW 

approach in changing some behaviors or other factors such as limitations of study design and the 

Hawthorne effect. Regarding the effectiveness of the CHW approach, CHW ore 

effective at changing behaviors that are relatively easy to adopt (such as the use of bedding 

may require additional support (such as smoking cessation) or more resources (such as the 

removal of mold or changing home environments). Study design considerations such as the 

choice of lower-intensity CHW interventions or the use of other fairly intensive alternatives (or 

s, in the context of

ll arms. When the alternative requires greater resource allocation, as

us

use of CH

th profes

101

nals, the ab ce of a stically si nificant nce may suppo

rovide greater b

s may be m

the 

encasements provided through the intervention) and less effective in changing behaviors that 

117 
both situations) may not produce statistically significant differences between the CHW arm and 

the alternative; the absence of differences may be further compounded by inadequate power in 

many of th udies. As for the Hawthorne effect, when C ct or report on outcom

 ar as often the case in these studies), this l ding of outcomes asse

e rva m a

isfac 

CHW interventions are often expected to prompt individual and social change and thereby 

reduce health disparities in either access to care or outcomes of care (or both). An indirect 

measure of improved access to the health care system is the participant’s sa are. 

A single study, focusing on mental health among the homeless, found no differences between 

study arms in participant satis outcome is low (Table 39). 

ff t of CHW interventions on participant satisfaction: s ngth of eviden

Number of 

; # 

bjects cy ctness ion

Other 

Modifying 

s 

, 

ounding)

Overall 

S

E

ese st HWs colle

ack of blin

nce. 

es in 

all study ssors 

can induc

ms (as w

 an obse tion-related i provement in perform

Sat tion

tisfaction with c

faction; the strength of evidence for this 

Table 39. E ec tre ce 

Studies

of Su

Risk of 

Bias 

Design/

Quality Consisten Dire Precis

(Inte

Conf

Factor

nsity

 Results 

trength of 

vidence 

Chronic disease ma t: mental health nagemen

1;165120,121

1 RCT/poor 

unknown 

(single study) 

Direct Not 

reported 

Present 

l 

High Consistency No w 

difference 

between 

CHW 

intervention 

and contro

Lo

CHW, community health worker; RCT, randomized controlled trial. 

u evide enti ther 

r cli ic ncerns in T 36. W at o

comparison arms may ed program evaluations that examined p action 

in greater d

Health Outcomes 

The literature examined CHW effectiveness on a range of outcomes. O s, 27 

reported specifically on health outcomes (Table 40). 

The evidence for back pain and for improving psychosocial outcomes a ers of 

children with asthma, from three studies, provides moderate strength of evidence that CHW 

interventions improve health outcomes when compared with either a lower-intensity CHW 

inte on or a

The evidence for seven clinical areas and subdomains—pediatric immu at

care and perinatal outcomes, child development, environment conducive to child well-being, 

diabetes, m alth, and asthma symptoms—from 22 studies, is mixed. tudies 

suggested that CHW interventions are more effective than alternatives (inc

tervention, usual care, and nurses), but others produced no differences between CHW 

inte 27,67-93,96,97,100,124,128

We fo

othe n

nd no

l co

nce to eval

 described 

 have exclud

uat effectiv ss of C e the terv

able 

ene

e note th

HW in

ur exclusion of studies without 

ons for the o

articipant satisf

19 

a

etail. 

f the 53 studie

mong caregiv

rventi delayed-intervention control group.96,97,100,114 

nizations, pren

 Some s

luding no 

al 

ental he

in

rventions and alternatives. 

118 
Table 40. Effect of CHW interventions on health outcomes: strength of evidence 

umber of 

Risk of 

Bias 

Other 

N Modifying 

Stud

o

S

Overall 

Strength 

of 

ence 

ies; # 

f 

ubjects 

Design/ 

Quality Consistency Directness Precision 

Factors 

(Intensity, 

Confounding) Results Evid

Health promotion and disease prevention: pediatric immunizations 

3

7

intervention 

; 5,40668-

2 Medium 

2 RCTs, 1 

cohort/1 

good, 1 

fair, 1 poor 

Inconsistent Direct Imprecise Present Mixed results: 2 

of 3 studies 

favor CHW 

intervention vs. 

control; 1 shows 

no difference 

between CHW 

interventions 

and no 

 Low 

Health promotion and disease prevention: disease prevention 

1 Direct Not Absent No difference 

print intervention 

(for change in 

y mass 

index) 

; 294 Low 16,127 Medium Consistency 

1 RCT/fair 

unknown 

(single study) 

reported between CHW 

intervention and 

bod

Maternal and child health: prenatal care and perinatal outcomes 

5; 

3,38971,77,7

83,86,87

9,

Inconsistent Some 

direct, 

Imprecise Mixed results, 

between CHW 

nals or 

 or 

High

2 RCTs, 3 

cohorts/2 

fair, 3 poor no interv

some 

indirect 

Present 

and 

professio

ention

usual care 

Low 

Maternal and child health: child development 

4; 

1,66475,76,78,

80-83,128

/3 

Direct Imprecise Present lts: 2 

s show 

r 

 2 

ssional 

Medium Low 

3 RCTs, 1 

cohorts

fair, 1 poor 

Inconsistent Mixed resu

studie

some benefit for 

CHW vs. no 

intervention o

health 

professional,

show no 

difference 

between CHW

and health 

profe

Maternal and child h viron ealth: en ment condu hild wel cive to c l-being 

7; 

2,29967,68,73,

74,78,84,85,128 7 RCTs/4 

fair, 3 poor 

y 

indirect 

Imprecise Present ults: 5 

 no 

W 

ves, 

it of 

CHW arm vs. 

usual care or 

health 

professional 

Medium Inconsistent Mostl Mixed res Low 

studies show

benefit for CH

over alternati

2 show benef

CHW, community health worker; RCT, randomized controlled trial. 

119 
Table 40. Effect of CHW interventions on health outcomes: strength of evidence (continued) 

Number of

Studies; #

of Subjects

f 

/ 

y s

r 

, 

) s 

ll 

f 

e 

Risk o

Bias

Design

Quality Consistenc Directnes Precision

Othe

Modifying

Factors 

(Intensity

Confounding Result

Overa

Strength

o

Evidenc

Chronic disease management: diabetes mellitus 

4;

93,124

 47927,88-

re 

n 

ean 

nd 

e 

Low

4 

RCTs/fair

Inconsistent Direct Imprecise Absent Mixed results: 2

of 4 studies 

found CHW mo

effective than

usual care i

decreasing m

HgbA1c, 2 fou

no differenc

Low

Chronic disease management: hypertension 

3; 

2,82323,94,95,9

8,99

Medium 

2 RCTs, 1 

cohort/1 

fair, 2 poor 

Consistent Direct Precise Present nce 

nd 

esser 

capacity 

No differe Low 

between CHW

intervention a

CHW in a l

Chr ease m ent in onic dis anagem : back pa

1; 255114 Medium Consistency 

unknown 

(single study) 

Direct Not Absent Favors 

. 

lus a 

t 6 

ore at 12 

nce in 

Roland score at 

Moderate 

1 RCT/fair 

reported 

CHW 

intervention vs

usual care p

book for Roland

score a

months and 

worry sc

months; no

differe

12 months 

Chronic disease management: mental health 

1; 165120,121 Consistency 

unknown 

(single study) 

Direct Not 

reported 

Present 

W 

d 

professionals) 

High Low 

1 

RCT/poor 

No difference 

between CH

intervention an

usual care 

(health 

Chronic e mana ent: ast ptoms diseas gem hma sym

2; 57296,97,100 w 

Ts/1 

d, 1 

fair 

Inconsistent Direct Imprecise Absent lts: 1 

 vs. 

o 

e 

e 

 Lo Low 

2 RC

goo

Mixed resu

favors CHW

delayed 

intervention; n

differenc

between CHW

and less intens

intervention

Chronic disease management: asthma, caregiver psychosocial outcomes

2; 57296,97,100 Low 

2 RCTs/1 

d, 1 

fair 

Consistent Direct Precise Absent s. 

CHW arm or 

Moderate 

goo

Favors CHW v

less intense 

delayed 

intervention 

For disease prevention, hypertension, and mental health, the evidence from five studies 

suggests no difference between CHW interventions and alternative approaches, including the use 

120 
of CHWs in a lesser capacity, nurses, and print materials; the strength of evidence for these 

outcomes is 23,94,95,98,99,120,121,127 We found no evidence to te the effectiveness of 

CHW interventions for other clinical concerns described in Ta

ove ssment for the effect of CHWs on health o s similar to our 

nt eff io ogether these studies show that CHW 

interventions can have a alternative options such 

o inte , usu nu ut the ngs t consis ll 

several st no significant benefit to the CHW arm whe d with 

alternative approaches. The strength of evidence for the reported absence of differences is 

therefore low. As with our summary assessment of the effect of CHW interventions on change in 

participant behavior, we believe that in the context of comparable gains in nd the 

absence of statistically significant differences among study arms, the choic

interventions may be reasonable when the comparator is a high-resource al

Health Care Utilizati

More than half of the 53 identified studies (30 studies) reported on health care utilization 

(Table 41

Table 41. Effect of CHW intervention on health care utilization: strength of evidence 

of Subjects 

Risk of 

Bias 

Consistency Directness Precision 

ing 

(Intensity, 

Confounding) 

Overall 

of 

Evidence 

 low.16, evalua

ble 36. 

Our utcomes i

assessme

rall asse

 of their ect on behav r change. T

greater effect on health outcomes than certain 

as n rvention al care, and

 statistically

rses, b se findi are no tent across a

n compare

study arms a

e of CHW 

ternative. 

studies; 

udies find

on 

). 

Number of

Studies; # Design/ 

Quality 

Other 

Modify

Factors

Results 

Strength 

Health promotion and disease prevention: health promotion – Latina health 

1; 10366 Medium Consistency 

unknown 

Direct Imprecise Present Low 

1 RCT/fair (single study) CHW and 

mail 

No difference 

between 

Health promotion and disease prevention: disease prevention 

1; 421105 Medium 

1 RCT/fair 

Consistency 

unknown 

(single study) 

Direct Precise Absent Favors CHW 

intervention 

vs. no 

intervention 

Moderate

Maternal and child health: prenatal care and perinatal outcomes 

1; 145 w 79 Medium 

1 RCT/fair 

Consistency 

unknown 

(single study) 

Indirect Imprecise Absent Favors CHW 

vs. health 

professional 

Lo

Maternal and child health: Environment conducive to child well-being 

1; 73078,128 High 

1 RCT/poor 

Consistency 

unknown 

(single study) 

Indirect Imprecise Present No difference 

between 

CHW 

intervention 

and routine 

clinical care 

Low 

CHW, community health worker; RCT, randomized controlled trial. 

121 
Table 41. Effect of CHW intervention on health care utilization: strength of evidence (continued) 

Risk of 

Bias 

Other 

Number of 

Stu

of 

Modifying 

Factors 

tensity, 

onfounding) Results 

Overall 

Strength 

of 

Evidence 

dies; # 

Subjects 

Design/ 

Quality Consistency Directness Precision 

(In

C

Cancer screening: Pap smears 

6; 

4,3

63,1

between CHW 

6617,18,61-

10-112,125

Low 

5 RCTs, 1 

observatio

Inconsistent Direct Imprecise 

(when 

reported) 

Present Mixed results: 3 

of 6 studies show 

some difference 

Low

nal/1 

good, 4 

fair, 1 

poor 

and minimal 

CHW, media, 

direct mail, and 

usual care, 3 

show no 

difference 

between CHW 

and mail or no 

intervention 

Cancer screening: mammography 

11

17,401

22,5

62,1

10-

113,

; ate 1 Medium Consistent Di

5,17-

9-

03,104,108,1

116,125,177

6 RCTs, 5 

observational 

studies/2 

good, 4 

fair, 5 

poor 

rect Precise 

(when 

reported) 

Present 8 of 11 studies 

favor CHW vs. 

no intervention, 

mail, print, or 

minimal CHW; 3 

show no 

difference CHW 

and nointervention 

control 

Moder

Cancer screening: clinical breast examination 

4; 

3,3

0-11 d 

mail, CHW in 

8661,62,11

2,116,125

High 

2 RCTs, 2 

observaConsistent Direct Imprecise Present No difference 

between CHW 

intervention an

Low 

tional/2 

fair, 2 

poor 

lesser capacity 

and no 

intervention 

Cancer screening: colorectal cancer screening 

2; 

78

NR107, 106 High 

2 RCT/1 

fair, 1 

poor 

Inconsistent Direct NR Present Mixed results, 1 

study favors 

CHW versus 

usual care, the 

other shows no 

difference 

between CHW 

intervention and 

Low 

controls (nointervention 

control, tailored 

print and video) 

Chronic disease management: hypertension 

1; 

intervention vs. 

722123 High Consistency 

unknown 

Direct Not 

reported 

Present Favors CHW Low 

1 cohort/ 

poor 

(single study) no intervention 

122 
Table 41. Effect of CHW intervention on health care utilization: strength of evidence (continued) 

Ris

Nu

St

of Subjects 

k of 

Bias 

Other 

Modifying 

Factors 

(Intensity, 

Overall 

Strength 

of 

mber of 

udies; # Design/ 

Quality Consistency Directness Precision Confounding) Results Evidence

Chronic disease management: infectious diseases 

1; 

ens, 

244 derate 122 Medium 

1 RCT/fair 

Consistency 

unknown 

(single study) 

Direct Precise Absent Favors CHW 

intervention 

vs. control 

group given 

bus tok

but monetary 

incentive was 

more effective 

than CHW or 

control given 

bus tokens 

Mo

Chronic disease management: mental health 

1; 165

intervention 

120,121 High 

1 RCT/poor 

Consistency 

unknown 

(single study) 

Indirect Not 

reported 

Present No difference 

between 

CHW 

Low 

and usual 

care (health 

professionals) 

Chronic disease management: asthma 

2; 

57296,97,100

Low 

2 RCTs/1 

good, 1 fair 

Consistent Direct Precise Absent Favors CHW 

vs. less 

intense CHW 

arm or 

delayed 

intervention 

Moderate 

Fifteen studies provide moderate strength of evidence that CHW interventions increase 

appropriate health care utilization for disease prevention, mammography, infectious diseases, 

and asthma when compared with a range of alternatives such as no intervention, mail, print, or a 

less intense CHW arm. 15,17-22,59-62,96,97,100,103-105,108,110-113,116,122,177 Two studies provide low 

strength of evidence that CHW interventions provide benefits in health care utilization when 

compared with nurses for prenatal and perinatal care and usual care for hypertension.79,123 

For Pap smears, six studies provide mixed evidence. Some studies report statistically 

significant benefit for the CHW arm but others find no significant differences; the strength of 

evidence for this outcome is lo 17,18,61-63,110-112,125 For health promotion among Latina

well-being, clin ca

w. s, child 

i l breast examination, colorectal cancer screening, and mental health, evidence 

from nine studies suggests that the CHW intervention and alternatives do not differ; the strength 

of evidence for these outcomes is low.61,62,66,78,106,107,110-112,116,120,121,125,128 We found no evidence 

to evaluate the effectiveness of CHW interventions for all other clinical concerns described in 

Table 36. 

Together, these studies provide either low or moderate evidence that CHW interventions 

increase some appropriate health care utilization (e.g., more use of cancer screening tests, less 

use of emergency services) when compared with a range of alternatives for disease prevention, 

mammography, infectious diseases, and asthma. For other reported outcomes, however, the 

evidence is mixed or does not show a statistically significant benefit of the CHW arm. As with 

our discussion of results for participant behavior and health outcomes, we note that for some 

123 
outcomes that had no statistically significant benefit of the CHW arm, the strength of evidence

low; the reasons are similar to those discussed above and include study design, choice of 

comparators, and the Hawthorne effect. 

Applicability of Findings about Outcomes 

 is 

 and 

ntion 

ntensity interventions. We found no clear evidence of variation in the 

effe

ted 

tors across all included 

stud

ch as a 

e 

The choice of 

out

r 

utcomes 

igh 

Our analysis of applicability reviewed studies by clinical context along five dimensions: 

population, intensity of treatment, choice of comparator, outcomes, and timing of followup. We 

summarize these findings across all studies below. 

Population. CHW interventions were generally conducted in underserved populations

were not overly restrictive in their inclusion criteria. We note, however, that individual studies 

tended to focus on a specific subset, such as low-income Latinas or inner-city AfricanAmericans, of the larger and diverse group of the underserved. As a result, the interve

effects are likely to be applicable to the population studied, but the findings cannot be 

extrapolated as being relevant to all underserved populations. In particular, the applicability of

these studies to low-income populations that would not qualify for Medicaid, but could not 

afford health insurance, is unclear. 

Intensity of the treatment. As noted in earlier chapters, the studies in this review were

predominantly high intensity (51 percent) or moderate intensity (34 percent) rather than low 

intensity (15 percent). We found CHW interventions for Pap smears to be more effective than 

comparison efforts (such as no intervention, media, print, community interventions, and usual 

care) only in the relatively limited circumstances of low- and moderate-intensity interventions 

rather than high-i

ctiveness of CHW interventions by intensity of the intervention for any other outcomes. The 

absence of consistent evidence supporting the use of high-intensity interventions and the limi

applicability of these more costly approaches to a larger population suggests that future 

interventions may be well served if they re-examine assumptions that high-intensity 

interventions work better than moderate- or low-intensity interventions. 

Choice of comparator. The wide variation in the choice of compara

ies reflects the immense array of options for health care in the United States. Although 

investigators often did justify or explain their choices of comparator, the selections often 

reflected a reasonable range of usual care options for the appropriate subpopulations, su

health professional alternative for children with chronic diseases or no intervention for home 

safety. The diversity of these comparators does, however, limit the generalizability of our 

findings significantly. Our assessment of effectiveness of the CHW arm (or lack thereof) can b

interpreted only in the context of the specific comparators in the literature; these findings cannot 

be said to be meaningful for a comprehensive range of comparators or even for usual care. 

Outcomes. Forty-two percent of the 53 studies reported on behaviors, 51 percent on health

outcomes, and 57 percent on health care utilization. The focus on these outcomes was 

appropriate and applicable to settings other than those selected for the study. 

come measures was rarely comparable across studies. The variations in outcome measures 

and choice of comparators precluded quantitative syntheses. 

Timing of followup. Included studies by and large had an appropriate length of followup fo

examining the effect of the CHW intervention. Some outcomes, such as developmental o

for children in the relatively short term (12 months to 4 years), may not always have a h

124 
correlation with long-term health outcomes, but we regard them as appropriate for the 

intervention. 

Summary Findings by Clinical Context 

Health promotion and disease prevention. Eleven studies addressed health promotion an

disease prevention, including pediatric im 68-72 105,118,119

d 

munizations, cardiovascular disease,

diab cer 

t 

lf 

me

 four 

proving 

rved, 

n home 

sidered workplace injury prevention. The workplace study 

fou a 

h 

ury prevention study showed no significant difference in 

beh

e 

clusion criteria involved primarily 

maternal and/or child health. Of these, 12 focused exclusively on potentially vulnerable 

population er-city 

residents).

maltreatment.73,74,78,128 Pregnant pulation for eight 

stud 71,72,77,79-83,86,87 ),83

y in 

 in 

etes prevention,16,127 HIV prevention,117 second-hand smoke exposure,67 colorectal can

prevention,107 and general preventive care.64-66 Two studies on disease prevention found tha

CHW interventions were more effective in changing knowledge than print or no 

intervention.16,117,127 Results for CHW interventions on behavior outcomes were mixed, with ha

of the studies favoring CHW intervention versus control groups consisting of no intervention, 

dia/print, or a combination of interventions.16,105,118,119,127 None of the studies evaluated 

satisfaction outcomes. Results for CHW interventions on health outcomes, available from

studies,16,68-72,127 were also mixed. 

The results suggest that CHW interventions can serve as an effective means of im

knowledge outcomes and possibly other outcomes related to preventing disease in underse

minority populations. 

Injury prevention. Three studies assessed injury prevention measures: two focused o

injury prevention101,102 and one con 126

nd improvements in behavior associated with CHW interventions when compared with 

minimal community intervention.126 One home injury prevention study found mixed results wit

CHW interventions showing statistically significant benefit in some measures but controls (with 

no intervention) showing statistically significant benefit over CHW interventions for other 

measures.102 The other home inj

avior between CHW interventions and health care professional. 101 None of the studies 

assessed direct health outcomes. The mixed results preclude any firm conclusions regarding th

benefit of CHW interventions for injury prevention. 

Maternal and child health. Fifteen studies meeting our in

67,71-87,128

s (e.g., racial or ethnic minorities, recent immigrants, low-income families, inn

67,68,71,72,75-77,79-82,84-87 Another three targeted families identified as high risk for child 

women were part of the target po

ies. One study each addressed pregnant women with phenylketonuria (PKU

children with failure to thrive,75,76 and children with “chronic disease” (not otherwise 

characterized).85 

Statistically significant benefit of CHWs over standard care was shown most prominentl

the rapidity of metabolic control for mothers with PKU and in the mental development of infants 

of mothers with PKU.83 CHW interventions were associated with a greater likelihood of 

initiating breastfeeding among African Americans, more frequent use of nonviolent discipline 

methods by parents, and higher parenting efficacy scores than either video intervention or no 

intervention. The study of infants with failure to thrive found a decline in cognitive and motor 

development among infants and an increase in depressive symptoms among mothers over time in

both arms of the study; however, CHWs were significantly associated with attenuation in the 

decline in cognitive and motor development of infants with failure to thrive and in the increase

depressive symptoms among mothers when compared with no intervention.75,76 No significant 

advantage to CHW intervention was seen for improvements in incidence of low birth weight, 

125 
presence of neonatal or infant health problems, language development, maternal stress or s

esteem, continuation of breastfeeding beyond 1 week, tobacco exposure for children of smok

continued drug

elfers, 

 use among mothers with known prior drug use, growth of children with failure to 

thri

15 

e 

t 

that domain 

tion of two studies on colorectal cancer screening that included both 

cer screening 

among women. 

Together, the 15 studies suggest limited evidence of improvement in knowledge in the CHW 

arm compared with groups receiving alternative approaches such as media or mail. Findings 

were conflicting about the effect of CHWs on planned or actual behavior changes, specifically 

breast self-examination, when compared with no intervention, delayed intervention, mail, 

minimal CHW, or usual care. The volume of evidence on health outcomes is limited; the quality 

and design of the studies limits the interpretation of available evidence. 

Regarding health care utilization, our findings from limited evidence suggest that CHW 

interventions are not effective in comparison with other alternatives (such as no intervention, 

mail, tailored print and video, and minimal CHW) in raising the rates of clinical breast 

examination or colorectal cancer screening. More substantial evidence exists on Pap smears and 

mammography. It suggests that CHWs are at least as effective as alternative steps (such as mail 

or lower-intensity CHW interventions) in improving Pap smear rates; they are more effective 

than alternatives (such as no intervention, media, print, community interventions, and usual care) 

only in limited circumstances of low- and moderate-intensity interventions rather than highintensity interventions. Studies demonstrated significantly greater improvements in the CHW 

groups than in comparison groups (no intervention, mail, print, or minimal CHW) in either the 

entire sample or in low-income, minority, or other underserved subsamples. 

CHW interventions were more effective than alternatives (ranging from usual care to a less 

intense CHW arm) for increasing the appropriate use of Pap smears and mammograms, for 

specific subpopulations and subtypes of interventions. They were not, however, more effective 

than alternatives for increasing the utilization of breast self-examination, clinical breast 

examination, or colorectal cancer screening. CHWs can serve as a means of improving 

ve, or incidence of child maltreatment when compared with nurse interventions, 

multidisciplinary specialty clinical care, video or print intervention, routine health care, or no 

intervention. 

Most studies involving CHWs for maternal and child health were concerned with high-risk 

populations. For maternal and child health, CHWs appear to be most beneficial when addressing

existing health conditions instead of potential conditions, i.e., primary prevention. Eight of the 

studies evaluated reported statistically significant benefit to CHWs compared with nurs

interventions, multidisciplinary specialty clinical care, video or print intervention, routine health 

care, or no intervention. CHWs have not yet been shown to improve key health outcomes 

relating to maternal and child health such as prematurity, low birth weight, sustained 

breastfeeding, or child maltreatment relative to other alternatives such as video or prin

intervention, routine health care, or no intervention. The lack of such findings suggests either 

 further research is needed to demonstrate benefits or that the use of CHWs in this

actually does not produce greater benefits than the use of existing approaches. 

Cancer screening. Fifteen studies that examined outcomes of CHW interventions for 

improving breast, cervical, or colorectal cancer screening met inclusion criteria for this 

systematic review.15,17-22,59-63,103,104,106-113,116,125 All studies focused on minority or underserved 

communities. With the excep

men and women, all studies focus on increasing the rates of breast and cervical can

126 
utilization of Pap smear tests and mammograms for underserved populations; the effectiveness of 

CHWs for other outcomes requires further research.

Chronic disease management. Thirteen studies addressed disease management for several 

diagnoses: diabetes mellitus,27,88-93,124 hypertension,23,94,98,99,123 asthma,96,97,100 back pain,114

mental health,120,121 and tuberculosis.122 Only one of these studies addressed knowledge of 

diabetes and found an improved score in the CHW group compared with the group receiving 

usual care plus educational pamphlets.27 

Two CHW interventions on diabetes88-92,124 and both asthma studies96,97,100 addressed 

behavior changes; for diabetes, they favored CHW interventions over usual care and a less 

intense CHW arm, and for asthma, they favored CHWs with respect to improving use of bedding 

encasements but not smoking cessation. Only the study in mental health addressed satisfaction 

outcomes; it did not demonstrate a difference between the CHW and the control groups.120,121

Several studies investigated various health outcomes. In diabetes management, two of four 

studies found that a CHW intervention was more effective than usual care in decreasing 

HgbA1c.27,93 None of the four studies addressing hypertension management showed a significant 

difference in blood pressure control between groups.23,94,98,99,123 Both asthma studies 

demonstrated that CHW interventions were effective in reducing unscheduled health care 

services, psychological outcomes, and behavior changes between groups;96,97,100 however, 

symptom measures improved within the CHW and comparison groups but did not differ 

significantly between the groups. 

In four of five studies on chronic disease management, a CHW intervention was more 

effective than either usual care or a less intense CHW arm in improving health care utilization 

for hypertension, mental health, and asthma.96,97,100,122,123 The fifth study found that CHWs were 

less effective than a monetary incentive in increasing adherence to clinic appointments among 

tuberculosis-infected patients. 

For chronic disease management, the majority of CHW interventions failed to show greater 

improvement in health outcomes than were observed for usual care. The exception is asthma 

care, for which CHWs were effective for many outcomes. Further research is necessary to 

determine the role of CHWs in chronic disease management. 

Cost-Effectiveness of Community Health Worker 

Interventions (KQ 3) 

Only six studies that we identified in the literature provided economic analyses of CHW 

interventions.17,22,75,80,96,121 Our analysis does not include three other studies of CHW 

interventions that reported information on intervention program costs but found that CHW 

interventions were ineffective or less effective than the baseline care approach.64,67,69,70

All six studies included for this KQ estimated intervention program costs, but not all reported 

the specific components of those costs or the year for which costs were estimated. Four of the 

studies performed economic analyses beyond program cost estimation to examine program costs 

in relationship to effectiveness. The two cancer screening studies both reported estimates of the 

cost per additional mammography screening. Although the common measures reported across 

these two studies suggest that comparisons might be straightforward, differences in the targeted 

populations nonetheless hinder comparisons of cost-effectiveness ratios across the studies. In 

particular, the low-intensity intervention targeted women regardless of their adherence to 

screening guidelines; however, the high-intensity intervention targeted only nonadherent women. 

127 
The

a 

s 

l for comparing the intervention costs with those 

for o 

fectiveness according to standardized and commonly accepted 

mea udies; 

ature. 

nd 

ns 

of Subjects Quality Consistency Directness Precision 

(Intensity, 

Confounding) Results 

ngth 

of 

Evidence 

 other two studies that performed additional economic analyses focused on estimating 

potential reductions in costs of both health care and social services attributable to the CHW 

intervention. 

None of the CHW intervention evaluations that included an economic analysis reported 

standard measure of costs per quality-adjusted life year saved as recommended in recent guide

for performing economic evaluations.130,131 2003 One study did report on the costs per life-year 

saved of the CHW intervention, which is usefu

other life-saving interventions, but that study provided the intervention both to women wh

had previously obtained mammography in line with mammogram screening guidelines and to 

women who had not; this approach biases the cost-effectiveness results in favor of the 

intervention, even when CHW time was valued using average wage rates.22 The lack of reporting 

on intervention costs and cost-ef

sures makes it challenging to compare economic outcomes across CHW intervention st

it also makes it even more complicated to compare cost-effectiveness between CHW 

interventions and non-CHW health care interventions currently being reported in the liter

In sum, limited evidence is currently available on the cost-effectiveness of CHW 

interventions for 7 of the 20 clinical contexts and subdomains we have examined in this 

systematic review (Table 42). For all the other clinical concerns described in Table 36, we fou

no evidence. Until better information is made available, assessing whether CHW interventio

are a cost-effective alternative to clinical interventions to promote health and prevent disease is 

difficult, if not impossible. 

Table 42. Cost and cost-effectiveness of CHW interventions: strength of evidence 

Number of 

Studies; # 

Risk of 

Bias 

Design/ 

Other 

Modifying 

Factors 

Overall 

Stre

Health promotion and disease prevention: pediatric immunizations 

1; NA69,70 --- --- --- evaluated 

because of lack of 

evidence of 

intervention 

--- --- Not --- 

effectiveness 

Health promotion and disease prevention: health promotion – Latina health

1; NA64 --- --- --- --- --- Not evaluated 

because of lack of 

evidence of 

intervention 

effectiveness 

--- 

Maternal and child health: child development 

2;13075

63080 Low 

2 RCTs 

Consistent Direct Imprecise Absent Cost for CHW home 

visitation program was 

Low

home visitation 

program; no 

comparison of costs to 

program effectiveness

lower than for nurse 

CHW, community health worker; RCT, randomized controlled trial. 

128 
Table 42. Cost and cost-effectiveness of CHW interventions: strength of evidence (continued) 

Number of 

Stud

Risk of 

Bias 

Other 

Modifying 

Factors 

O

ies; # 

of Subjects 

Design/ 

Quality Consistency Directness Precision 

(Intensity, 

Confounding) Results 

of 

Evid

verall 

Strength 

ence 

Maternal and child health: environment conducive to child well-being 

1; NA67 --- --- --- --- --- Not evaluated 

because of lack of 

evidence of 

intervention 

effectiveness 

--- 

Cancer screening: mammography promotion 

2; 85117

1,44 22 Moderate Consistent Direct Imprecise 

3 

2 RCTs 

mammogram is not a 

standardized measure 

that can be compared 

to the costeffectiveness of other 

interventions 

Absent Cost per additional Low 

Chronic disease management: mental health 

1; 1 121 65 High 

1 RCT 

Consistency 

unknown 

(single study) 

Direct Imprecise Absent Intervention costs 

slightly lower for CHW 

arm than for traditional 

assertive commu

treatment; 

Low 

nity 

inconclusive results 

on impact of CHW on 

net program costs 

Chronic disease management: asthma 

1;17096 Low 

1 RCT 

Consistency 

unknown 

(single study) 

Direct Imprecise Absent Larger urgent care 

cost reductions for 

high-intensity CHW 

group as compared to 

low-intensity CHW 

group. 

Moderate 

Training of Community Health Workers (KQ 4) 

We found only nine studies meeting our inclusion criteria that described the training of 

CHWs.137,141,143,147,150,155,169 148,149,176 Our inclusion criterion required the evaluation of skills 

before and after training; all included studies reported evidence of improvement in knowledge

skil

 or 

on 

ls. Few studies reported on training for cultural competence, recruitment and retention 

process skills, intake and assessment, and protocol delivery; studies generally focused on aspects

of training relevant to the health concern. 

Such data are useful for future studies on the same clinical topic, but the failure to report 

common elements such as cultural competence, recruitment and retention process skills, intake 

and assessment, and protocol delivery presents a roadblock to identifying critical elements of a 

standardized curriculum applicable to all CHWs. Whether studies routinely conduct such training 

and do not report on them is unclear from the studies that we identified. 

129 
No study reported on the effects of CHW training on health outcomes. Practitioners an

policy makers seeking to institutionalize CHWs may seek to understand 

d 

what measures of CHW 

activities best assess the effectiveness of their contributions to improved health outcomes and 

further, how to incorporate n from the limited 

evidence available to answer ation to 

ans

aining, 

fe manufacture of queso fresco, tobacco cessation, breast cancer 

edu

raction of 

ge or 

raining period only, without a pretest. A 

sub

lative paucity of detail on specific elements of the interventions. Studies 

inco 9

 making 

r, 

opportunity to translate effective interventions into a variety of community settings; the absence 

l 

 those elements into training curricula. As see

KQ 4b, studies do not presently report sufficient inform

wer this question. The question of how to tailor CHW training to improve health outcomes is 

a significant gap for future studies to address. 

Two studies reported certification associated with their curricula. One study, focusing on 

tobacco cessation, offered three levels of certification: introductory (“Basic Skills to Stop Using 

Tobacco”), intermediate (“Treatment Specialist”), and advanced (“Leave the Addiction”).150 A 

second study, on cancer education, provided a certificate of completion at the end of the tr

but it gave no further details.143

Several studies reported on the availability of their curricula for future projects. These 

included topics related to sa 155 150

cation,137 heart disease and stroke,147 and heart healthy behaviors among Latinos.149 

We note that the nine studies identified as eligible for this KQ represent a small f

all studies reporting on training. Other ineligible studies did not evaluate pre- and posttraining 

skills or knowledge: many were purely descriptive of training programs.134,153,154,161,170,171,175

Among the ineligible studies that provided a critical appraisal or evaluation of the training 

program without pre- and posttraining results, several limited the assessment of the knowled

skills of the CHW to the postt 139,142,145,156,160,167,173,176

stantial number of other ineligible studies evaluated the training or curriculum based on 

feedback from designers, trainers, or other stakeholders.132,135,137,138,140,141,151,152,157-160,162-169,172-

174,176 These studies could not inform our key question on training; thus, we excluded them from 

the systematic review proper, but we note them here to be helpful to readers who may wish to 

pursue these topics further. 

Limitations of this Review 

Limitations of the Evidence Base 

Reporting. Our ability to draw conclusions on the effectiveness of CHW interventions is 

limited by the re

nsistently adhered to reporting standards such as STROBE178 and CONSORT,17

critical appraisal of internal validity and assessment of applicability challenging. In particula

many studies did not report on the intensity of the intervention (the number and length of 

sessions and the time period of interaction with clients), the existence of protocols governing the 

intensity of intervention, or fidelity to such protocols. CHW interventions represent an 

of information on fidelity limits their translation. The limited available information on protoco

also results in little usable data on training of CHWs. 

Choice of appropriate comparators. The evidence base is marked by great heterogeneity in 

comparators in addition to appreciable diversity in the CHW model itself. Although appropriate 

comparators can and should differ by the specific outcomes being addressed, studies often did 

not justify the choice of comparator(s), either on its own merits or in relation to usual care. For

that reason, our conclusions regarding the effectiveness of CHWs are necessarily limited. We 

130 
also note that a potential Hawthorne effect may exist for studies comparing variants of CHW 

interventions rather than CHW interventions with usual care: the effect of the more intense arm 

may

es 

“co

omes 

eir 

e 

riate adjustment for confounding. The evidence base is also limited by variations 

in t

tions 

s. 

s 

Lim

s of 

c 

this review, 

con ed our 

n of whether CHW interventions 

imp

eview 

 have been diluted by a Hawthorne effect in the less intense arm, whereby observation by 

CHWs could improve outcomes (at least in the short term) in the latter case. 

Study design. Many studies did not report a priori hypotheses about their primary outcom

or give details about their power calculations (if any were done). Limited sample sizes may have 

resulted in studies that were not powered to find a difference between “experimental” and 

ntrol” or “comparison” groups where one may in fact exist. 

A further design limitation is the frequent reliance on CHWs for data collection of outc

in all study arms. This practice can lead to potential bias on the part of the outcome assessor; 

when subjects are providing responses directly to the CHWs gathering data about outcomes, th

information may be colored by social desirability on their part. Moreover, a potential Hawthorn

effect in this situation cannot be ruled out, as noted above. 

Approp

he specific confounders and effect modifiers that investigators included or controlled for in 

their analyses. Omitting important confounders and effect modifiers, especially co-interven

in comparison arms, limits the interpretability and utility of the evidence from such 

investigations. Furthermore, using the studies that did account for confounders and effect 

modifiers is hampered by the lack of consistent definition and inclusion of key variable

These deficiencies together appreciably limit the consistency and validity of the evidence. A

a result, we found very few outcomes for which we were able to attribute at least a moderate 

strength of association, despite the relatively large body of evidence that we examined. 

itations of the Review 

We limited our search to articles published in English, primarily for reasons of time and 

resources. We excluded studies with samples sizes less than 40. We also limited our review to 

the United States, so our review does not address the nature, outcomes, or cost-effectivenes

CHW interventions, or the training of CHWs, elsewhere, particularly in developing countries. 

However, whether CHWs in the United States have the same professional and sociodemographi

characteristics as CHWs elsewhere is not well understood, so for purposes of 

straining the included studies to those done in the United States may not have influenc

findings much. 

Our decision to include studies with comparison arms for KQs 1 and 2 likely reduced our 

yield of studies for knowledge, behavior, and satisfaction. We note, however, that studies

reporting on knowledge, behavior, and satisfaction alone, without additional data on health 

outcomes, do not add to the evidence on the critical questio

rove health outcomes. 

For similar time and resource reasons, we did not conduct dual independent, blinded r

of articles for abstraction of information into evidence tables. Instead, one reviewer performed 

the initial review, and a second reviewer examined that input and recommended changes or 

corrections when needed. These two reviewers reconciled any differences by consensus 

discussion. These procedures are generally in accord with the usual procedures for the RTI-UNC 

Evidence-based Practice Center. To enable us to address any systematic bias in our work that the 

above approach may have introduced, however, we did apply dual independent review for 

assessing the quality of individual articles and grading the strength of evidence. 

131 
The paucity of “similar” articles, for populations, patient characteristics, settings, and 

outcomes measured, precluded any efforts to pool findings statistically.

Future Research Directions 

The evidence on CHW interventions, although extensive, could benefit from future research. 

We discuss methodological improvements, design considerations, and substantive gaps below. 

Methodological improvements. Future studies should consistently adopt four important 

steps: (1) give clear conceptual models that explain the expected mechanism of change initiated 

by the CHW intervention, (2) justify the choices of alternative or comparison steps; (3) specify

priori the primary outcomes to be measured; and (4) state hypotheses that build upon the 

conceptual framework and the choice of comparator. In addition, studies of CHW interven

should calculate required sample size to ensure that they are adequately powered and report on 

those power calculations. 

Studies will also benefit from external evaluation of outcomes by investigators or data

collection personnel blinded to the experimental and comparison groups rather than 

measurement of outcomes by CHWs. Such results would be less likely to be influenced by soc

a 

tions 

ial 

des

res, 

es to protocol 

deli

l for 

levant to decision makers, which include 

cost, quality of life, reach, and adoption) can enhance the utility of CHW studies for translational 

research.183-185 

The RE-AIM framework††–reach, effectiveness, adoption, implementation, and 

mai

 rarely 

irability bias or other problems of internal validity of results. These benefits must be weighed 

against the practical difficulties of obtaining outcome data through external observers who

(unlike CHWs) may not have a relationship with the community and may be viewed with a 

greater degree of suspicion. 

A significant gap that future studies can address is adequate reporting of design, exposu

and outcomes. Adherence to standards such as STROBE178 and CONSORT179 will help to 

improve the strength of evidence provided by this literature. More generally, studies infrequently

reported the gap between planned and actual protocol delivery; reporting the chang

very is critical to a better understanding of how to scale up effective interventions. 

Design considerations. CHW interventions will also benefit from the use of practical 

clinical trials. CHW interventions are examples of community-based research, which is vita

successful Type 2 translation – the adaption of evidence-based interventions to real-world 

settings.180-182 Representative participants, multiple and diverse settings, clinically relevant 

alternative interventions, and a focus on measures re

ntenance–provides practical guidance for the development of measures of public health 

impact for CHW interventions.186 Studies in our review focused on effectiveness, but they

provided quantitative assessments of these elements as measures of public health impact, despite 

their underlying reliance on models of community change in addition to individual change. 

 

††††

pact of 

ption is 

ram) who 

t 

framework, maintenance also applies at the individual level. At the individual level, maintenance has been defined as the longterm effects of a program on outcomes after 6 or more months after the most recent intervention contact.

According to the RE-AIM framework186 (reach is defined as the absolute number, proportion, and representativeness of 

individuals who are willing to participate in a given initiative, intervention, or program. Efficacy or effectiveness is the im

an intervention on important outcomes, including potential negative effects, quality of life, and economic outcomes. Ado

the absolute number, proportion, and representativeness of settings and intervention agents (people who deliver the prog

are willing to initiate a program. At the setting level, implementation refers to the intervention agents' fidelity to the various 

elements of an intervention's protocol, including consistency of delivery as intended and the time and cost of the intervention. A

the individual level, implementation refers to clients’ use of the intervention strategies. Maintenance is the extent to which a 

program or policy becomes institutionalized or part of the routine organizational practices and policies. Within the RE-AIM 

132 
133 

edge. Although the focus on 

hea n 

tion 

e as 

 are 

sful 

 of the intervention and eventual reduction in disparities. As with the literature on 

kno

h care utilization, can help illuminate the effects 

of CHW interventions on health disparities. 

Despite evidence of effectiveness and recommendations from a number of organizations 

including the US Preventive Services Task Force and the American Cancer Society, colorectal 

cancer screening uptake has been suboptimal. Roughly 60 percent of adults older than 50 report 

having been screened for colorectal cancer.187,188 In addition, even lower rates of screening have 

been reported in populations with high poverty rates189 and in racial and ethnic minorities, 

including Hispanic and nonwhite populations.190 We uncovered a single study focusing on CHW 

interventions for colorectal cancer;107 future research in this area may be fruitful in identifying 

successful strategies for increasing screening rates for this deadly condition. 

Existing CHW interventions often focus on underserved populations defined by race, 

ethnicity, or geographic location. Underserved groups such as low-income populations who are 

ineligible for Medicaid (such as low-income undocumented immigrants) and therefore at higher 

risk of being uninsured or the elderly may also potentially benefit from studies of CHW 

interventions. Important conditions for such investigators include mental health problems, 

dementia including Alzheimer's disease, and disabilities. 

Future research on CHW interventions should focus on designing studies that prospectively 

collect data on program costs and effectiveness. Such work should aim to ensure that all 

necessary data are collected to perform and report on the cost-effectiveness or net costs of the 

CHW intervention as compared with baseline and alternative approaches. Program managers and 

local evaluators may benefit from checklists130,131 and step-by-step instructions for designing and 

performing economic evaluations of health care and community prevention interventions.191 The 

first step in collecting program cost data is to list the key program activities. The next steps are to 

determine the perspective of the cost analysis (e.g., program, patient, or societal perspective) and 

to list all the resources required to support each activity (e.g., labor, contracted services, 

Investigators may find the RE-AIM formulation helpful in providing an analytic or logic model 

by which to design and conduct their studies. 

Substantive gaps. We identified several substantive gaps in the field that warrant further 

attention. They fall into several groups: (1) outcomes themselves, specifically knowledge and 

satisfaction; (2) clinical areas, including obesity prevention and colorectal cancer screening; 

(3) populations addressed, and specifically interventions for certain underserved populations; and 

(4) costs and cost-effectiveness analysis. We discuss these points in greater detail below. 

Theoretical models underpinning CHW interventions postulate changes in knowledge as 

precursors to changes in behavior, health outcomes, or health care utilization. Our review 

uncovered surprisingly few studies that examined changes in knowl

lth outcomes and health care utilization is appropriate, additional evaluation of changes i

knowledge would help to clarify the processes of change initiated by CHWs; such informa

would then aid investigators in refining aspects of their interventions that are not as effectiv

expected. 

CHW interventions serve as a bridge to the health care system for the underserved and

expected to serve as a tool to reduce disparities in access to and quality of care. Improved 

satisfaction of participants with CHW interventions is a necessary first step to succes

implementation

wledge and evaluation of public health impact, single-arm studies may well report 

satisfaction in greater depth; more rigorous comparative studies almost uniformly do not report 

on satisfaction. Further investigation of satisfaction, in addition to the existing and appropriate

focus on behaviors, health outcomes, and healt
materials and supplies, building space, donated resources). The final steps are to create a system 

and forms for the ongoing collection of program cost data. Many resources are available to guide 

program managers through each step of the cost data collection process, including checklists 

published in Gold et al., 1996130 and Haddix et al., 2003131 and forms available online in 

Honeycutt et al., 2006.191 These lists and forms can readily be adapted to capture all of the 

resources used or lost in providing CHW program activities. For example, to collect and analyze 

the costs of multiple arms of a CHW intervention program, a list of activities and resources to 

support the activities should be created for each arm. Based on these lists, worksheets should be 

developed specific to each intervention arm for use in prospective program data collection. After 

all data have been collected, costs for each intervention arm should be estimated and reported 

alongside other study outcomes. Economic evaluations of CHW interventions should also 

include sensitivity analyses to examine how uncertainty or variability in assumed costs or 

effectiveness affects program cost-effectiveness. For example, time spent by CHWs in delivering 

the intervention should be given a positive value in all economic evaluations of CHW 

interventions, but it may also be useful to explore the extent to which valuing time at the 

minimum wage makes the intervention look favorable as compared with valuing time at average 

wage rates for paid health care workers (e.g., licensed practical nurses or medical assistants). 

In summary, future economic evaluations of CHW interventions should (1) evaluate the costeffectiveness of the interventions as compared with baseline or alternative interventions, 

(2) model program outcomes to estimate the program’s full impact on life years or qualityadjusted life years saved to improve comparability of results, and (3) include sensitivity analyses 

to examine the impact of variability in economic inputs on the cost-effectiveness of CHW 

interventions. Using such standard approaches to evaluate CHW interventions will improve the 

utility and comparability of study results; thus, such approaches will also aid decision makers in 

determining which health promotion and disease prevention activities to support. 

In the absence of consistent data on intervention costs, we created a pragmatic measure in 

this report to approximate the intensity of resources used for CHW interventions. Consistent data 

on costs in future studies will ideally provide the best information to evaluate intervention 

intensity. In the interim, further development and validation of pragmatic measures of resource 

intensity can help policy makers shape the specifics of CHW interventions to provide the most 

meaningful benefit for improved health outcomes. 

Conclusion 

CHW interventions have the potential to address two fundamental imperatives in improving 

health care in the United States: the need to address substantial and persistent health care 

disparities and the need to translate more research into practice. CHWs, by virtue of their role as 

a bridge to the health care system, can help to disseminate widely efficacious interventions to 

populations that rarely benefit from health care advances. 

Evidence about the effectiveness of CHWs relative to other choices for providing these types 

of health care and public health services is at best mixed. Some studies that we assessed 

demonstrated statistically significant benefits of the CHW approach compared with other 

choices; other studies showed conflicting results or no statistically significant differences 

between study arms. For the latter studies, one explanation is a lack of true benefit of the CHW 

arm relative to other choices. In addition, the choice of controls, including health professionals 

134 
135 

and CHWs in a lesser capacity, inadequate study power, and the Hawthorne effect may explain 

the lack of significant differences between CHWs and alternatives. 

We found limited evidence that suggests that CHW interventions can improve participant 

knowledge when compared with alternative approaches such as no intervention, media, mail, or 

usual care plus pamphlets. We found mixed evidence for CHW effectiveness on participant 

behavior change and health outcomes: some studies suggested that CHW interventions can result 

in greater improvements in participant behavior and health outcomes when compared with 

various alternatives, but other studies suggested that CHW interventions provide no statistically 

different benefits. Low or moderate strength of evidence suggests that CHWs can increase 

appropriate utilization for some conditions or preventive services. 

The literature showed mixed results of effectiveness when analyzed by clinical context. 

CHW interventions had the greatest effectiveness relative to alternatives for some disease 

prevention, asthma management, cervical cancer screening, and mammography screening 

outcomes. CHW interventions were not significantly different from alternatives for clinical 

breast examination, self-breast examination, colorectal cancer screening, chronic disease 

management, or most maternal and child health interventions. We found insufficient evidence to 

evaluate the cost-effectiveness of CHW interventions relative to other public health 

interventions. 

Our review suggests that CHWs may serve as a means of improving outcomes for 

underserved populations for some health conditions, as described above. Other health concerns 

require further research that addresses methodological limitations of prior studies to evaluate 

fully the effectiveness of CHW interventions. 

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Appendix A: Exact Search Strings 
Appendix A: Exact Search Strings 

Medline Focused Search: April 2008 

#2 Search "Community Health Aides"[Mesh] OR "health advisor" OR "health 

worker" OR "health advocate" OR "health paraprofessional" OR 

"community health representative" OR "outreach worker" OR dumas OR 

promotoras OR embajadores OR consejeras 

6051

#3 Search "Community Health Aides"[Mesh] OR "health advisor" OR "health 

worker" OR "health advocate" OR "health paraprofessional" OR 

"community health representative" OR "outreach worker" OR dumas OR 

promotoras OR embajadores OR consejeras Limits: Humans, English 

3031

#6 Search (("Outcome Assessment (Health Care)"[Mesh] OR "Pregnancy 

Outcome"[Mesh])) OR ("Treatment Outcome"[Mesh] OR "Outcome and 

Process Assessment (Health Care)"[Mesh] OR "Fatal Outcome"[Mesh]) 

Limits: Humans, English 

369350

#7 Search #3 AND #6 Limits: Humans, English 175

#17 Search ((("Patient Education as Topic"[Mesh] OR "Patient Education 

Handout "[Publication Type])) OR "Professional-Patient Relations"[Mesh]) 

OR "Office Visits"[Mesh] Limits: Humans, English 

109582

#18 Search #3 AND #17 Limits: Humans, English 90

#26 Search ("Costs and Cost Analysis"[Mesh] OR "Economics"[Mesh] OR 

"economics "[Subheading] OR "Cost-Benefit Analysis"[Mesh] OR "Cost 

Allocation"[Mesh] OR "Cost of Illness"[Mesh] OR "Cost Control"[Mesh] 

OR "Cost Sharing"[Mesh] OR "Cost Savings"[Mesh] OR "Health Care 

Costs"[Mesh] OR "Direct Service Costs"[Mesh] OR "Hospital 

Costs"[Mesh] OR "Employer Health Costs"[Mesh] OR "Drug 

Costs"[Mesh]) Limits: Humans, English 

257114

#27 Search #3 AND #26 Limits: Humans, English 254

#28 Search United States Limits: Humans, English 606881

#29 Search #27 AND #28 Limits: Humans, English 71

#33 Search (("Education"[Mesh] OR "education "[Subheading])) OR 

"Education, Professional"[Mesh] OR training Limits: Humans, English 

370579

#34 Search #3 AND #33 Limits: Humans, English 1013

#35 Search #34 AND #28 Limits: Humans, English 241

#41 Search (((("Randomized Controlled Trials as Topic"[Mesh] OR 

"Randomized Controlled Trial "[Publication Type])) OR "Single-Blind 

Method"[Mesh]) OR "Double-Blind Method"[Mesh]) OR "Random 

Allocation"[Mesh] Limits: Humans, English 

303728

#42 Search #3 AND #41 Limits: Humans, English 165

#44 Search control OR controlled Limits: Humans, English 1368901

#45 Search #3 AND #44 Limits: Humans, English 908

A-1 
A-2 

#46 Search #45 AND #28 Limits: Humans, English 154

Medline unduplicated records = 640 

Cochrane April 2008 

Analogous terms 

= 11* 

*Unduplicated in Medline search 

Cochrane Clinical Trials Registry April 2008 

Analogous terms 

= 41* 

Unduplicated in Medline search 

CINAHL April 2008 

Analogous terms 

 KQ1 = 61* 

 KQ2 = 45* 

 KQ3 = 21* 

 KQ4 = 21* 

*Unduplicated in Medline search 

Total unduplicated across all searches = 815 

Update search November 2008 

Medline = 38* 

Cochrane = 0 

Cochrane Clinical Trials Registry = 9* 

CINAHL = 13* 

*Unduplicated in previous searches 

Supplemental search: “Patient Navigator” 

Medline = 21 

CINAHL = 26 

Cochrane – 8 

Total new (unduplicated across all new and prior searches) = 25 
Appendix B: Abstract Forms 
Appendix B.Abstraction Forms

Abstract Review Form (Originally in Excel)

Column Question 

A Refid 

B Author, Year 

C Original research (Exclude editorials, 

commentaries, letters to the editor, reviews 

etc)

D Includes community health worker 

component 

E Study published in English? 

F Is this study located in the US? 

G If not in US, where? 

H RCT and 

n > 40 

I Cohorts with comparison and 

 n > 40 

J Cost or cost-benefit analysis 

K Exclude 

("No" on one or more questions in Columns C 

- I)?

L Name of intervention (if provided) 

M Retain for - Background or 

discussion or review of references 

other.... 

N Comments 

O Reviewer initials 

B-1 
Full‐text review form (Originally in EXCEL)

Column Question

A Refid

B Author, year

C Reviewer Initials

D Abstract only

E Wrong population (non‐US)

F Wrong Outcomes (no patient related health

or economic outcomes)

G Study not about CHW

H Wrong publication type (review or letter to

the editor)

I Sample size too small (<40)

J No comparison arm/data

K Comparison arm/data not about CHW or

CHW alone

L CHW component insufficiently described to

distinguish between CHW and other peer

led models

M Other?   

N Exclude but save for background, cost,

training or setting, pick one! (only if yes for

at least one column D‐M)

O Should be included for KQ 4a   

(What are characteristics of training for

community health workers in the outpatient

setting?)

P Should be included!

Q Need more information

R Related citations

S Left blank  

T How do community health workers interact

with clients? Specifically, what is the place

of service, type of service, type of

educational materials used, duration of

interaction with clients, and length of

followup?

U What is the impact of community health

workers on outcomes, particularly

knowledge, behavior, satisfaction, health

outcomes, and health care utilization?

V What is known about the cost‐effectiveness

of community health workers for improving

B-2 
health outcomes?

W Are particular training characteristics

associated with improved outcomes for

patients?

X Study design  

Y Comparisons (identify arms)  i

Z Health condition of interest  

AA Name of intervention

AB Notes‐ including additional citations

B-3 
Abstraction Form for Evidence Tables(Originally in EXCEL)

Column Category Question 

A Reviewer Initials 

B Author 

Year 

{#RefID} 

C Trial Name 

D

Identifying information 

Objective or aim 

E Setting: Geography 

F Setting: Organizational, Social, Cultural 

G What is the community? (neighborhood, disease etc.) 

H Study design: RCT/Prospective cohort/Retropective 

cohort/Prospective cohort with historic control/casecontrol/case series/other 

I Start date- year 

J

Setting 

Duration - length 

K Eligible 

L Enrolled 

M Randomized 

N Completers 

O

N 

Withdrawals or dropouts 

P Health condition of interest

Q Inclusion criteria 

(include run-in details) 

R

Inclusion/Exclusion 

 Exclusion criteria 

S Groups (please useG1: G2: G3: etc.) 

T Describe interventions (if necessary) 

U

Groups 

n of each group 

V CHW definition: 

W CHW training: 

X Place of service 

Y Title of CHW (specify: lay health advisor, community health 

worker, etc) 

Z Paid or volunteer 

AA

Community Health 

Worker 

Relationship with the community (rshared race, ethnicity, 

disease condition, etc) 

AB N of CHW 

AC Supervision of CHW (who supervises [clinician vs non 

clinician] and frequency of supervision) 

ad Prior training of CHW 

AE Type of service 

AF Type of educational materials utilized 

AG Duration of interaction with clients 

AH

Community Health 

Worker (continued) 

Length of followup 

B-4 
Column Category Question 

AI Age (mean) 

AJ Sex (% female) 

AK Race (%) 

AL

Baseline 

characteristics of 

patients 

Other? 

AM Role of CHW in recruiting and retention 

AN Recruitment: Need rates for each group 

AO

Recruiting and 

retention 

Retention: Need rates for each group 

AP Measure (Is it valdidated?) 

AQ Results 

AR Measure (Is it valdidated?) 

AS Results 

AT Measure (Is it valdidated?) 

AU

Knowledge and 

attitude 

Results 

AV Measure (Is it valdidated?) 

AW Results 

AX Measure (Is it valdidated?) 

AY Results 

AZ Measure (Is it valdidated?) 

BA

Quality of Life 

Results 

BB Measure (Is it valdidated?) 

BC Results 

BD Measure (Is it valdidated?) 

BE Results 

BF Measure (Is it valdidated?) 

BG

Health Outcomes 

Results 

BH Measure (Is it valdidated?) 

BI Results 

BJ Measure (Is it valdidated?) 

BK Results 

BL Measure (Is it valdidated?) 

BM

Healthcare utilization 

Results 

BN Measure (Is it valdidated?) 

BO Results 

BP Measure (Is it valdidated?) 

BQ

Costs (Economics) 

Results 

BR Explanation of overall outcomes. 

BS Quality rating: Good / fair / poor 

BT KQ 1 - How do community health workers interact with 

clients? Specifically, what is the place of service, type 

of service, type of educational materials used, 

duration of interaction with clients, and length of 

followup? 

BU

Applicable key 

questions 

KQ 2 - What is the impact of community health 

workers on outcomes, particularly knowledge, 

B-5 
Column Category Question 

behavior, satisfaction, health outcomes, and health 

care utilization? 

BV KQ 3 - What is known about the cost-effectiveness of 

community health workers for improving health 

outcomes? 

BW KQ 4a - What are characteristics of training for 

community health workers in the outpatient setting? 

BX KQ 4b - Are particular training characteristics 

associated with improved outcomes for patients? 

BY Measure (Is it validated?) 

BZ Results 

CA Measure (Is it validated?) 

CB Results 

CC Measure (Is it validated?) 

CD Results 

CE Measure (Is it validated?) 

CF

Additional outcomes 

(please add more 

here at the end if 

you must!) 

Results 

CG The gulf between the rest and KQ4a 

CH (Blank) 

CI Eligibility for CHW training (inclusion criteria for CHW) 

CJ Input of CHW in curriculum development 

CK

Training 

Characteristics 

Training on cultural competency (describe content; 

instructional method; number of sessions; testing) 

CL Training on recruitment and retention process skills, 

e.g., motivational interviewing (describe content; 

instructional method; number of sessions; testing) 

CM Training on intake/assessment, (describe content; 

instructional method; number of sessions; testing) 

CN Training on protocol delivery, i.e., recruitment, 

followup, fidelity to the intervention, referrals (describe 

content; instructional method; number of sessions; 

testing) 

CO Training on health topic (describe content; 

instructional method; number of sessions; testing) 

CP Training on evaluation (describe content; instructional 

method; number of sessions; testing) 

CQ Other training (describe type) 

CR Other training content; instructional method; number 

of sessions; testing 

CS Other training (describe type) 

CT Other training content; instructional method; number 

of sessions; testing 

CU Name of curriculum 

CV Availability 

CW Evaluation and testing results of the curriculum 

(improvements in CHW knowledge) 

CX

Training 

Characteristics 

(continued) 

Certification (any certication [yes/no/nr]; if yes, name 

of certifying body 

B-6 
Quality Review for randomized controlled trials(Originally in EXCEL)

Column Category Question 

A REFID

B Reviewer initial

C Background/context Is the hypothesis/aim/objective of the study described? 

Yes 

No 

D Are the inclusion/exclusion criteria clearly stated (does not require 

the reader to infer)? [Abstractor: use “Partially” if only some 

criteria are stated clearly.] 

Yes 

Partially 

No 

E

Sample Definition 

and Selection 

Did the authors report conducting a power analysis or some other 

basis for determining the adequacy of study group sizes for the 

primary outcome(s) being abstracted? 

Yes 

No 

F Was the assignment to the treatment groups adequately 

randomized? 

Yes (Adequate approaches to sequence generation, i.e., 

computer-generated random numbers, random numbers tables) 

No (Inadequate approaches to sequence generation, i.e., use of 

alternation, case record numbers, birth dates or week days) 

NR 

G

Randomization 

Was allocation of randomization adequately concealed? 

Yes (Adequate approaches to concealment of randomisation, i.e., 

centralised or pharmacy-controlled randomisation, seriallynumbered identical containers, on-site computer based system 

with a randomisation sequence that is not readable until 

allocation, other approaches with robust methods to prevent 

foreknowledge of the allocation sequence to clinicians and 

patients) 

No (Inadequate approaches to concealment of randomisation, 

i.e., use of alternation, case record numbers, birth dates or week 

days, open random numbers lists, serially numbered envelopes 

(even sealed opaque envelopes can be subject to manipulation) 

NA (study not adequately randomized) 

NR 

H Interventions/Expos

ure 

What is the level of detail in describing the intervention or 

exposure? 

Low (unclear, many details missing) 

Medium (pretty clear, most details provided) 

High (very clear, all required details provided) 

B-7 
Column Category Question 

I Is usual clinical care (sometimes called standard care) 

described? 

Yes 

No 

NA (not an intervention study) 

J Did researchers rule out any impact from an unintended 

intervention/exposure that might bias results, e.g., through 

multivariate analysis, stratification, or subgroup analysis? 

Yes 

No 

NA (no unintended interventions reported) 

K

Contamination 

Could variation from the protocol have compromised the findings 

of study? 

Yes (variation from protocol exists and could have compromised 

findings) 

No (variation from protocol exists, but unlikely to have 

compromised findings) 

Cannot determine (no variation from protocol reported) 

NA (study does not require protocol, or no variation from protocol 

exists) 

L Outcome assessors masked? 

Yes 

No 

Yes, but method not described 

Not reported 

M Care provider masked? 

Yes 

No 

Yes, but method not described 

Not reported 

 NA 

N

Blinding 

Patient masked? 

Yes 

No 

Yes, but method not described 

Not reported 

O Are interventions/exposures measured in a valid and reliable 

manner? 

Objective (clinical reports, lab findings, previously validated 

measures) 

Objective measure, not validated 

Prospective documentation (including self-report in daily diaries) 

Retrospective self-report (patient/participant response) 

Not reported 

P

Soundness of 

information 

Are outcomes measured in a valid and reliable manner? 

B-8 
Column Category Question 

Objective (clinical reports, lab findings, previously validated 

measures) 

Objective measure, not validated 

Prospective documentation (including self-report in daily diaries) 

Retrospective self-report (patient/participant response) 

Not reported 

Q Is the length of time following the intervention/exposure sufficient 

to support the conclusions of the study regarding outcomes? 

Yes 

No 

R Did attrition from any group exceed 20 percent (after 

randomization)? 

Yes - how much? 

No 

Cannot determine 

S

Follow-up 

Did attrition differ between groups by more than 15 percentage 

points (after randomization)? 

Yes - how much? 

No 

Cannot determine 

T Are baseline characteristics similar in exposed and comparison 

cohorts? 

Yes 

No 

Cannot determine 

U

Analysis 

Comparability 

Does the analysis control for baseline differences? 

Yes 

No 

Cannot determine 

NA (no baseline differences reported) 

V Is the analysis conducted on an intention-to-treat (ITT) basis, that 

is, the intervention allocation status rather than the actual 

intervention received? 

Yes 

No 

W

Analysis Outcome 

Were there any post-randomization exclusions? 

Yes (how many?) 

No 

Cannot tell 

X Interpretation Are conclusions supported by results with possible bias and 

limitations taken into consideration? 

 

Yes 

Partially 

B-9 
Column Category Question 

No 

Y Quality Good 

Fair 

Poor 

B-10 
Quality Review for observational trials(Originally in EXCEL)

Column Category Question

A REFID

B Reviewer initial

C Background/

Context

Is the hypothesis/aim/objective of the study described? 

Yes 

No 

D Are the inclusion/exclusion criteria clearly stated (does not require 

the reader to infer)? [Abstractor: use “Partially” if only some criteria 

are stated clearly.] 

Yes 

Partially 

No 

E

Sample

Definition and

Selection

Did the authors report conducting a power analysis or some other 

basis for determining the adequacy of study group sizes for the 

primary outcome(s) being abstracted? 

Yes 

No 

F What is the level of detail in describing the intervention or 

exposure? 

Intensity, duration, frequency, setting and timing 

Low (unclear, many details missing) 

Medium (pretty clear, most details provided) 

High (very clear, all required details provided) 

G

Interventions/

Exposure

Is usual clinical care (sometimes called standard care) described? 

Yes 

No 

NA (not an intervention study) 

H Did researchers rule out any impact from an unintended 

intervention/exposure that might bias results, e.g., through 

multivariate analysis, stratification, or subgroup analysis? 

Yes 

No 

NA (no unintended interventions reported) 

I

Contamination

Could variation from the protocol have compromised the findings of 

study? 

Yes (variation from protocol exists and could have compromised 

findings) 

No (variation from protocol exists, but unlikely to have 

compromised findings) 

Cannot determine (no variation from protocol reported) 

NA (study does not require protocol, or no variation from protocol 

exists) 

J Blinding Were the outcome assessors blinded to the intervention or 

B-11 
Column Category Question

exposure status of participants? 

 

Yes 

No 

NA (not an intervention study) 

K Are interventions/exposures measured in a valid and reliable 

manner? 

Objective (clinical reports, lab findings, previously validated 

measures) 

Objective measure, not validated 

Prospective documentation (including self-report in daily diaries) 

Retrospective self-report (patient/participant response) 

Not reported 

L

Soundness of

information

Are outcomes measured in a valid and reliable manner? 

Objective (clinical reports, lab findings, previously validated 

measures) 

Objective measure, not validated 

Prospective documentation (including self-report in daily diaries) 

Retrospective self-report (patient/participant response) 

Not reported 

M In cohort studies, do the analyses adjust for different lengths of 

follow-up of patients, or in case-control studies, is the time period 

between the intervention/exposure and outcome the same for 

cases and controls? [Abstractor: Where follow-up was the same for 

all study patients the answer is yes. If different lengths of follow-up 

were adjusted by, for example, survival analysis, the answer is yes. 

Studies where differences in follow-up are ignored should be 

answered NA.] 

Yes 

No 

Cannot determine 

NA (cross-sectional) 

N Is the length of time following the intervention/exposure sufficient to 

support the conclusions of the study regarding outcomes? 

Yes 

No 

NA (cross-sectional) 

O Did attrition from any group exceed 20 percent (after allocation of 

treatment)? 

Yes - how much? 

No 

Cannot determine 

NA (cross sectional) 

P

Follow‐up

Did attrition differ between groups by more than 15 percentage 

points (after allocation of treatment)? 

B-12 
B-13 

Column Category Question

Yes - how much? 

No 

Cannot determine 

NA (cross sectional) 

Q Are baseline characteristics similar in exposed and comparison 

cohorts? 

Yes 

No 

Cannot determine 

NA (case series) 

R Does the analysis control for baseline differences? 

Yes 

No 

Cannot determine 

NA (no baseline differences reported) 

S

Analysis

comparability

Were the important confounding and modifying variables taken into 

account in the design and analysis (e.g., through matching, 

stratification, or statistical adjustment)? 

Yes 

Partially 

No 

Cannot determine 

T Is the analysis conducted on an intention-to-treat (ITT) basis, that 

is, the intervention allocation status rather than the actual 

intervention received? 

Yes 

No 

U Is the impact of loss to follow-up (or differential loss to followup) 

assessed (e.g. through sensitivity analysis or other intention-totreat adjustment methods? 

Yes 

No 

Cannot determine 

NA (cross-sectional or case-control selected on outcome) 

V

Analysis

Outcome

Are the statistical methods used to assess the primary outcomes 

appropriate to the data? [Abstractor: The statistical techniques 

used must be appropriate to the data. For example, non-parametric 

methods should be used for small sample sizes (N<30). If studies 

have not accounted for differences between the unit of allocation 

and the unit of analysis, (e.g., through mixed models or generalized 

estimating equations for analysis of individual covariates or through 

t-tests or weighted t-tests for cluster-level analysis) then the 

answer is no. If outcomes are rare and little or no statistical 

analysis has been conducted, answer yes if studies have 

accounted for alternative causes other than the 
B-14 

Column Category Question

intervention/exposure. For details on whether specific statistical 

tests are appropriate, go to 

http://bama.ua.edu/~jleeper/627/choosestat.html.4] 

Yes 

Partially 

No 

NA (not reported) 

W For cohort studies only, if the outcome has a greater than 10 

percent prevalence, is the risk ratio and relative risk calculated 

directly (not using logistic regression)? 

Yes 

No 

NA (not a cohort study) 

X Does the study report appropriate estimates of the random 

variability in the data for the main outcomes?4 [Abstractors: In nonnormally distributed data the inter-quartile range of results should 

be reported. In normally distributed data the standard error, 

standard deviation or confidence intervals should be reported.] 

Yes 

No 

Y Interpretation Are conclusions supported by results with possible bias and 

limitations taken into consideration? 

 

Yes 

Partially 

No 

Z Quality Good 

Fair 

Poor 
Appendix C: Evidence Tables 
List of Abbreviations 

AA African American 

AIDS Acquired immune deficiency syndrome 

b/c because 

BF breastfeeding 

BMI body mass index 

BP blood pressure 

BSN bachelor of science - Nursing 

BW body weight 

CAD Coronary artery disease 

CBC community based care 

CD cannot determine 

CES Community environmental specialists 

CES-D Center for Epidemiologic Studies Depression Scale 

CG control group 

CHD coronary heart disease 

CHO Carbohydrates 

CHW(s) community health worker(s) 

CPEP Child Parent Enrichment Program 

DR Doctor 

DSM-III-R Diagnostic and Statistical Manual of Mental Disorders, 3rd edition, revised 

EAG Enhanced Anticipatory Guidance 

EG experimental group 

EPC evidence-based practice center 

EPC “enhanced” primary care 

ER emergency room 

ETS Environmental tobacco smoke 

FPL federal poverty level 

FTT Failure to thrive 

g gram 

GED general education degree 

GHC Group Health Cooperative of Puget Sound 

gm gram 

h hour 

HbA1c Glycosylated (or glycated) hemoglobin 

HBP high blood pressure 

HIV Human immunodeficiency virus 

HMO Health Maintenance Organization 

HS high school 

HSP Hawaii’s Health Start Program 

ht height 

HTN hypertension 

hx history 

ICD International Classification of Diseases 

IHDP Infant Health and Development Program 

IL Illinois 

ITT intent to treat 

JNC-VI Sixth Report of Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High 

Blood Pressure 

kcal kilocalorie 

LBW low birth weight 

LDL Low-density lipoprotein 

LHA Lay Health Advisor 

MD medical doctor; Maryland 

mg/dl milligrams/deciliter 

MI Michigan 

min minute 

mmol/L millimoles/liter 

mo month 

N number 

C-1 
NA not applicable 

NCM nurse case manager 

NDS Nutrition Data System 

NNT number needed to treat 

NP nurse practitioner 

NR not reported 

NS not significant 

NW northwest 

NY New York 

NYC New York City 

PCP primary care physician 

PI principal investigator 

PKU phenylketonuria 

PSI Psychiatric Symptom Index 

RCT randomized controlled trials 

REACH Resources, Education and Care in Home 

RIA radioimmunoassay 

RN registered nurse 

SBP systolic blood pressure 

SD standard deviation 

SE standard error 

SLE stressful life events 

TPV tailored print and video 

UC usual care 

VLBW very low birth weight 

WATCH Wellness for African Americans Through Churches Project 

WIC Women, Infants, and Children 

wk week 

y year 

y/o years old 

YMCA Young Men’s Christian Association 

yr year 

C-2 
Evidence Table C-1. Key Questions 1, 2, and 3 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Andersen et al., 

2000 

Trial Name 

Community Trial of 

Mammography 

Promotion 

Objective or Aim 

To learn how best 

to increase use of 

screening among 

women aged 50 to 

80 

Geography 

40 communities in 

predominantly rural 

Washington state, 

selected by 

zipcodes 

corresponding to 

towns or clusters of 

towns 

Organization 

Community or 

telephone 

Type of 

Community 

Rural 

neighborhoods 

Study Design 

RCT of 

communities 

Start Date 

NR 

Duration 

2 years 

Eligible (N) 

10,967 at baseline 

8,907 at followup 

Enrolled (N) 

10,967 

Randomized (N) 

14,080 

Completers (N) 

6,685 

Withdrawals or Dropouts (N) 

2,222 of N eligible at followup 

Health Condition of Interest 

Mammography 

Inclusion Criteria 

Women age 50 to 80 living in one of 

40 communities 

Exclusion Criteria 

History of breast cancer 

Groups 

G1: Control 

G2: Community activities 

G3: Individual counseling 

G4: Both 

Interventions 

G1: Control, no intervention reported

G2: Community activities - 

developing social norms 

G3: Individual counseling - 

telephone 

G4: Community activities and 

individual couseling 

Group (N) 

G1: 1,688 

G2: 1,630 

G3: 1,650 

G4: 1,717 

Title of CHW 

Volunteer 

Paid or Volunteer 

Volunteer 

Relationship with 

Community 

Shared community 

CHW (N) 

NR 

Supervision of CHW 

Non-clinician- field research 

coordinators 

Prior Training 

NR 

Type of Service 

Barrier-specific telephone 

counseling to promote 

screening 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

One interaction (time of 

interaction NR) 

Length of Follow-up 

2 years 

Age (mean) 

NR 

Sex (% female) 

100 

Race (%) 

97% white 

Other 

NR 

Role of CHW in Recruiting 

and Retention 

None 

Recruitment Rates 

NA 

Retention Rates 

NA 

C-3 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

Measure 1 

Increase in mammography rates (self-reported) 

Results 

No significant differences between intervention groups 

and control; no significant differences for individual 

counseling or combined individual couseling and 

communitities activities, but increased mammography 

use by regular users between baseline and followup for 

community activities arm by 2.9% (P = 0.01). 

Measure 2 

Increase in mammography rates (self-reported) 

Results 

Among under-users at baseline, intervention more 

effective than control in increasing mammography rates 

amon women with in communities without a female 

physician (10% to 16%; P < 0.05), and among women 

with no health insurance (10% to 23%; P ≤ 0.05); NS 

effect for community attitudes on mammography, age, 

time taken to get a medical appointment, financial 

comfort, mammography facility in community, income, 

education, proportion of Hispanic population, 

urban/rural, size of community, and employment status 

among regular users, intervention was more effective 

than control in preventing relapse among women who 

needed > 2 hours to get a medical appointment. NS 

effect for community attitudes on mammography, age, 

use of mammography in community, female MD, 

financial comfort, mammography facility in community, 

income, education, proportion of Hispanic population, 

urban/rural, size of community, and employment status 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Good 

C-4 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Auslander et al., 

2002; 

Williams et al., 

2001 

Trial Name 

Eat Well Live Well 

Nutrition Program 

Objective or Aim 

A culturally 

specific, peer-led 

dietary change 

program designed 

to reduce risk of 

type 2 diabetes in 

low-income 

African-American 

women. 

Geography 

Large Midwestern 

city in Missouri 

Organization 

Targeted 

neighborhoods 

Type of 

Community 

Race, 

Neighborhood 

Study Design 

RCT 

Start Date 

NR 

Duration 

3 months 

Eligible (N) 

NR 

Enrolled (N) 

NR 

Randomized (N) 

NR 

Completers (N) 

294 

Withdrawals or Dropouts (N) 

104 

Health Condition of Interest 

Diabetes Prevention 

Inclusion Criteria 

African-American women ages 25–

55 years and living in neighborhoods

Exclusion Criteria 

Pregnancy, diabetes, BMI < 27 

Groups 

G1: Treatment 

G2: Control 

Interventions 

G1: Six group sessions 

(approximately six to eight 

participants per group) and six 

individual sessions targeting 

stages of change to tailor dietary 

pattern with a peer educator, 

meeting weekly over a 3-month 

period; duration of each session 

45-90 minutes 

G2: Control - a book 

Group (N) 

G1: Treatment 138 

G2: Control 156 

Title of CHW 

Peer educators 

Paid or Volunteer 

NR 

Relationship with 

Community 

African-American women 

from target community with 

no background in nutrition 

or education, were 

recruited by lead agency to 

deliver intervention. 

CHW (N) 

3 

Supervision of CHW 

Weekly supervision during 

implementation phases, 

including meeting with 

educators, research 

dietitian, project coordinator 

and research assistants 

Prior Training 

No background in nutrition 

or education 

Type of Service 

Counseling 

Type of Educational 

Materials Used 

Program Manual 

Duration of Interaction 

with Clients 

3 months 

Length of Follow-up 

3 months 

Age (mean) 

G1: 41.2 

G2: 40.2 

Sex (% female) 

1 

Race (%) 

African-American 

Other 

NR 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-5 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

Measure 1 

Knowledge of Label Reading 

Questionnaire (Unvalidated) 

–baseline/6 months 

Results 

G2: 5.4/5.7, 

G1: 5.5/6.3 (P > 0.0001)

Measure 2 

Readiness to change dietary 

patterns - no 

Results 

Overall, participants in 

treatment group reported a 

greater readiness to change 

their dietary patterns than 

those in control group at 

posttest assessment. 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Weight, BMI 

Results 

No significant group differences 

Measure 2 

FFQ - Validated 

Results 

Intervention was effective in reducing fat intake, as 

measured by percent of calories from total fat 

(baseline/6 months): 

G2: 36.0/34.5, 

G1: 35.9/32.3, 

P < 0.05

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Fair 

C-6 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Barnes et al., 1999 

Trial Name 

NR 

Objective or Aim 

To assess 

effectiveness of a 

volunteer driven 

outreach program 

on immunization 

rates in children 

younger than 2 

years. 

Geography 

NW Manhatten, NY 

Organization 

Organizational: 

Patients of 1 of 2 

ambulatory 

pediatric clinics of 

a major medical 

center 

Type of 

Community 

Low-income 

children who are 

part of a large, 

highly mobile 

immigrant 

community 

originating from DR 

Study Design 

RCT 

Start Date 

1993 

Duration 

6 months 

Eligible (N) 

434 

Enrolled (N) 

163 

Randomized (N) 

434 

Completers (N) 

140 

Withdrawals or Dropouts (N) 

23 

Health Condition of Interest 

Immunizations 

Inclusion Criteria 

• Younger than 2 years residing in 

NW Manhattan 

• No-shows for a scheduled 

appointment in pediatric clinic, 

and 

• Overdue for a vaccine. 

Exclusion Criteria 

NR 

Groups 

G1: Intervention 

G2: Control 

Interventions 

G1: Basic immunization education 

and referral. During subsequent 

contacts (home visits or telephone 

calls) throughout remainder of 

follow-up , families were reminded 

of upcoming vaccinations and 

were recontacted to ensure that 

requisite vaccines were received. 

If a family required support or 

assistance to obtain immunization 

services 

G2: Informed of their child’s 

immunization status at enrollment 

visit by control group interviewer 

and were instructed to reschedule 

missed appointment. 

Group (N) 

G1: 71 

G2: 84 

Title of CHW 

Community volunteers 

Paid or Volunteer 

Volunteer 

Relationship with 

Community 

NR- community volunteers 

CHW (N) 

NR 

Supervision of CHW 

Organized by coordinator 

from local branch of larger 

international charitable 

organization 

Prior Training 

NR 

Type of Service 

Unspecified # of home 

visits and phone calls 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

Unspecified # of calls and 

visits over 6 months (time 

per session NR) 

Length of Follow-up 

Maximum of 6 months 

Age (mean) 

G1: 9.5 months 

G2: 9.4 months 

Sex (% female) 

G1: 50 

G2: 40 

Race (%) 

G1: 87% Hispanic 

G2: 85% Hispanic 

Other 

Primary language of 

caregiver -spanish 

G1: 66 

G2: 75% 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-7 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

Measure 1 

Late for immunization 

Results 

G1: 18% 

G2: 38% 

P < 0.05 

Measure 2 

Up to date on immunizations 

Results 

G1: 75% 

G2: 54% 

P = 0.03 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Fair 

C-8 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Barnes-Boyd et al., 

2001 

Trial Name 

REACH-Futures 

Objective or Aim 

NR 

Geography 

Chicago 

Organization 

Inner city 

community clinic 

Type of 

Community 

Mostly AfricanAmerican; 

impoverished; low 

employment and 

literacy, high infant 

and child morbidity 

and mortality, poor 

maternal 

outcomes, high 

incidence early 

unplanned 

pregnancies and 

childhood injuries 

Study Design 

Cohort with historic 

control 

Start Date 

1986 

Duration 

8 years 

Eligible (N) 

1,922 

Enrolled (N) 

1,922 

Randomized (N) 

NA 

Completers (N) 

NA 

Withdrawals or Dropouts (N) 

0 

Health Condition of Interest 

Infant health 

Inclusion Criteria 

All recipients: 

• below 150% of poverty line 

• lived in inner-city communities 

Exclusion Criteria 

NA 

Groups 

G1: REACH-Futures CHW+nurse 

G2: REACH nurse-only historic 

control 

Interventions 

• Home visits-family focused care 

plan 

• Support model problem-solving 

skills 

• Promote self-development of 

mother 

• Provide instruction in infant care 

• Transportation 

• Find community resources for 

childhood immunizations 

Group (N) 

G1: 666 

G2: 1256 

Title of CHW 

Maternal-Child Health 

Advocate 

Paid or Volunteer 

Paid 

Relationship with 

Community 

Within community 

CHW (N) 

10 

Supervision of CHW 

Teamed with nurses (at 

least BSN) 

Prior Training 

• Minimum HS or GED 

• Experience in community 

service 

Type of Service 

home visits 

Type of Educational 

Materials Used 

Direct instruction 

Duration of Interaction 

with Clients 

12 monthly visits by CHW 

alone, teamed with nurses 

for one prenatal visit and at 

1, 6 and 12 months; 

duration per visit NR 

Length of Follow-up 

12 months 

Age (mean) 

G1: 51% < 20 y/o 

G2: 36% < 20 y/o 

Sex (% female) 

100 

Race (%) 

G1: 85% African-American 

G2: 80% African-American 

Other 

G1: 56% primiparous 

G2: 41% 

G1: 53% < HS education 

G2: 36% 

G1: 94% BW > 2500gm 

G2: 93% 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

G1: 2 mo 86%, 11 mo 56% 

G2: 2 mo 75%, 11 mo 58% 

C-9 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Extrapolated infant mortality rate (n too small) 

Results 

G1: 3.0 

G2: 4.7 (not significant) 

Measure 2 

Presence of health problems 

Results 

Neonatal 

G1: 27% 

G2: 25% 

Postneonatal 

G1: 27% 

G2: 25% (neither significant) 

Measure 3 

% fully immunized at 12 months 

Results 

G1: 77% 

G2: 63% (P < 0.001) 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

CHW+nurse home 

visits resulted in higher 

immunization status 

than nurse-only visits; 

no difference in health 

problems or mortality 

Quality Rating 

Poor 

C-10 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Barth et al., 1988 

Trial Name 

CPEP 

Objective or Aim 

Preventing child 

abuse 

Geography 

California / Contra 

Costa County 

Organization 

Social 

Type of 

Community 

At risk 

Study Design 

RCT 

Start Date 

NR 

Duration 

6 months 

Eligible (N) 

95 referred 

Enrolled (N) 

65 enrolled 

Randomized (N) 

65 

Completers (N) 

50 

G1: 24 

G2: 26 

Withdrawals or Dropouts (N) 

G1: 5 

G2: 10 

Health Condition of Interest 

Child abuse 

Inclusion Criteria 

Referred to CPEP, by public health, 

education, or social service 

professionals 

Exclusion Criteria 

NA 

Groups 

G1: Intervention 

G2: Control 

Interventions 

G1: CPEP 

services involved six months of 

home visiting by paraprofessional 

women and linkage to other formal 

and informal community resources. 

Group (N) 

G1: 24 

G2: 26 

Title of CHW 

Parenting Consultants 

Paid or Volunteer 

NR 

Relationship with 

Community 

Members of community 

CHW (N) 

8 

Supervision of CHW 

Group Supervision 

Prior Training 

100 hours 

Type of Service 

Task centered approach 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

≈2 visits per month, ≈ 4 

hours per session, over 6 

months 

Length of Follow-up 

6 months 

Age (mean) 

G1: 21.75 

G2: 23.04 

Sex (% female) 

100 

Race (%) 

• 43% white 

• 27% were Latino 

(primarily Chicano) 

• 20% black 

• 6% were Asian (primarily 

South East Asian 

refugees) 

• 4% Native American 

Other 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-11 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

Measure 1 

Child Abuse Potential 

Inventory 

Results 

G1: pre/post means 

116.33/88.54 

G2: pre/post means 

103.50/92.44 

No significant difference 

between posttests 

Health Outcomes: 

NR 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

Overall no differences 

in outcomes, though 

clients appreciated 

services 

Quality Rating 

Poor 

C-12 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Barth, 1991 

Trial Name 

CPEP 

Objective or Aim 

Prevent child 

abuse 

Geography 

Contra Costa 

County, California 

Organization 

Organizational/ 

Community 

Type of 

Community 

At risk for chid 

abuse 

Study Design 

RCT 

Start Date 

NR 

Duration 

6 months 

Eligible (N) 

313 referred 

Enrolled (N) 

240 

Randomized (N) 

240 

Completers (N) 

61% (191) 

Withdrawals or Dropouts (N) 

39% (49) 

Health Condition of Interest 

Child abuse 

Inclusion Criteria 

Referred to CPEP by public health, 

education, or social service 

professionals 

Exclusion Criteria 

NA 

Groups 

G1: Intervention 

G2: Control 

Interventions 

G1: Intervention 

G2: Control 

Group (N) 

G1: 97 

G2: 94 

(Completers - article indicates 240 

were initially randomized but only 

191 completed posttest) 

Title of CHW 

Parenting Consultants 

Paid or Volunteer 

NR 

Relationship with 

Community 

Members of community 

CHW (N) 

8 

Supervision of CHW 

Group supervision 

Prior Training 

NR 

Type of Service 

• Task centered approach 

• Home visits 

• Links to community 

resources 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

On average 11 visits (range 

5-20) over 6 months (time 

per session not reported 

but ≈ 4 hours implied) 

Length of Follow-up 

Mean 3 years (range 2-5) 

Age (mean) 

G1: 23.25 

G2: 23.75 

Sex (% female) 

100 

Race (%) 

• White: 45% 

• Latin (primarily Chicano): 

31% 

• Black: 17% 

• Other: 7% 

Other 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-13 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Reported child abuse 

Results 

No differences in increase between groups 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

Overall no differences 

in outcomes, though 

clients appreciated 

services 

Quality Rating 

Poor 

C-14 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Batts et al., 2001; 

Garyet al., 2003; 

Vetter, et al., 2004; 

Gary et al., 2005; 

Gary et al., 2000 

Trial Name 

Project Sugar 

Objective or Aim 

To determine 

diabetes care 

priorities and needs 

in a group of urban 

African-American 

adults with type 2 

diabetes; To 

determine 

prevalence of 

depressive 

symptoms and re l a 

t i o n s h i p 

between depressive 

symptoms and 

metabolic control . 

Geography 

East Baltimore, MD 

Organization 

2 primary care 

clinics 

Type of 

Community 

African-American 

adults with type 2 

diabetes 

Study Design 

RCT 

Start Date 

1994 

Duration 

2 years 

Eligible (N) 

822 

Enrolled (N) 

332 

Randomized (N) 

186 

Completers (N) 

183 

Withdrawals or Dropouts (N) 

3 

Health Condition of Interest 

• Diabetes Mellitus, type 2 

• Depression 

Inclusion Criteria 

Eligibility criteria included following: 

• Age 35–75 years 

• African-American ancestry 

• Residence in East Baltimore 

• Presence of type 2 diabetes 

• Absence of comorbid conditions 

limiting probable life span to 4 years 

(e.g., cancer, AIDS) 

• Attendance at either of 2 Johns 

Hopkins–affiliated primary care clinics 

• No indication of end-stage 

complications of diabetes (e.g., kidney 

dialysis or transplant, blindness, or 

lower- extremity amputation) 

Exclusion Criteria 

• Comorbid conditions limiting probable 

life span < 4 years 

• Indication of end-stage complications 

of diabetes (dialysis or t+R2ransplant, 

blindness or lower extremity 

amputation) 

Groups 

G1: usual care 

G2: nurse care manager 

G3: CHW 

G4: NCM + CHW 

Title of CHW 

Members of community of 

interest trained to perform 

non-medical case 

management tasks 

Paid or Volunteer 

NR 

Relationship with 

Community 

• Local hs graduate 

enrolled in college parttime 

• No formal training in 

health care prior to study 

CHW (N) 

1 

Supervision of CHW 

NR 

Prior Training 

None 

Type of Service 

• Home visits to provide 

education 

• Mobilize social support 

for adults with diabetes 

mellitus 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

3 visits (45-60 minutes 

each) per year over 2 years 

(+ additional contacts as 

needed) 

Length of Follow-up 

2 years 

Age (mean) 

59 

Sex (% female) 

75 

Race (%) 

100% AA 

Other 

• 50% had an income 

of $7,500 

• Participants had 

diabetes an average 

of 9 years 

• 91% on medication 

(46% used insulin, 

45% used an oral 

agent) 

Role of CHW in 

Recruiting and 

Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-15 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

LDL 

Results 

G1: -16.7± 5.5 mg/dl 

G2: +6 (approx) (P<0.05 for within-group change from 

baseline) 

G3: +6 (approx.) 

G4: + 4 (approx.) (P<0.05 for within-group change from 

baseline) 

Measure 2 

SBP 

Results 

G1: ref 

G2: +6 (approx.) (P<0.05 for within-group change from 

baseline) 

G3: -4 (approx) 

G4: -2 (approx). 

Measure 3 

hga1c 

Results 

G1: ref 

G2: -0.31 ± 0.49% 

G3: -0.30 ± 0.48% 

G4: 0.8 ± 0.52% 

Measure 4 

Dietary risk scores 

Results 

G1: ref 

G2: -2.4± 1.99 

G3: -3.45 ± 1.87 

G4: -2.13 ± 1.92 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Good 

C-16 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Batts et al., 2001; 

Garyet al., 2003; 

Vetter, et al., 2004; 

Gary et al., 2005; 

Gary et al., 2000 

(continued) 

Interventions 

G1: continued on-going care from their 

own health professionals + quarterly 

newsletter containing info on diabetesrelated health topics and trial 

communication 

G2: NCM intervention: NCM was RN + 

certified diabetes educator, 

interventions were 45 min face-to-face 

clinic visits and/or phone contacts, 

direct patient care, management, 

education, counseling, follow-up, 

referral and physician feedback - goal 

was 3 visits/yr 

G3: CHW interventions were 45-60 min 

face-to-face home visits and/or phone 

contacts, no direct implementation of 

therapeutic strategieis but facilitated 

preventibe care by offering to schedule 

appointments + provide education, 3 

visits/yr 

G4: combined NCM + CHW - three 

visits/year with each 

Group (N) 

G1: 34 

G2: 38 

G3: 41 

G4: 36 

C-17 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

This page intentionally left blank. 

C-18 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Becker et al., 2005; 

Cene et al., 2008 

Trial Name 

NR 

Objective or Aim 

Determine relative 

effectiveness of 

alternative model of 

community-based 

care provided in 

black community 

compared with 

"enhanced" primary 

care 

Geography 

Baltimore, MD 

Organization 

Identified from 

Baltimore Hospitals 

Type of Community 

Blacks 

Study Design 

RCT 

Start Date 

NR 

Duration 

1 year 

Eligible (N) 

NR 

Enrolled (N) 

NR 

Randomized (N) 

364 siblings (194 families) 

Completers (N) 

267 

Withdrawals or Dropouts (N) 

97 

Health Condition of Interest 

Cardiovascular disease prevention

Inclusion Criteria 

• Sibling of black < 60 years 

hospitalized for a CHD event at 

one of 10 Baltimore hospitals 

• Aged 30-59 

• No known history of CAD 

• No chronic glucocorticosteroid 

therapy 

• No autoimmune disease 

• No cancer 

• No immediate life-threatening 

comorbidity 

Exclusion Criteria 

See prior 

Groups 

G1: EPC 

G2: CBC 

Interventions 

G1: EPC- received risk-specific 

materials (same as intervention 

group), PCP received results 

and recommendations, sent info 

on YMCA program, etc. 

G2: CBC - received care in 1 

nonclinical site in community 

from a NP and CHW. CHW 

provided dietary counseling, 

smoking cessation, and 

exercise counseling lasting 30 

minutes. 

Group (N) 

G1: 168 

G2: 196 

Title of CHW 

CHW 

Paid or Volunteer 

NR 

Relationship with 

Community 

"Culturally sensitive 

navigator" 

CHW (N) 

1? 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Counseling for adults with 

risk factors for 

cardiovascular disease, 

face-to-face, phone calls 

Type of Educational 

Materials Used 

Written, culturally sensitive 

Duration of Interaction 

with Clients 

Multiple (# unspecified) 30 

minute sessions over 1 

year 

Length of Follow-up 

1 year 

Age (mean) 

G1: 47.9 

G2: 47.6 

Sex (% female) 

G1: 66 

G2: 61 

Race (%) 

African American:100% 

Other 

Role of CHW in Recruiting 

and Retention 

NA 

Recruitment Rates 

NA 

Retention Rates 

NA 

C-19 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Smoking Cessation (self-report) 

Results 

G1: 7% reduction 

G2: 16.2% reduction (P < 0.001) 

Measure 2 

BP 

Results 

Measure 3 

LDL (mmol/L) 

Results 

G1: 3.38+-1 

G2: 3.06+-1 (P < 0.0001) 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Fair 

C-20 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Beckham et al., 

2008 

Trial Name 

NR 

Objective or Aim 

Effectiveness of 

CHWs on diabetes 

management 

among a 

population with 

primarily Native 

Hawaiian and 

Samoan ethnic 

minority 

participants with 

HbA1c greater than 

10% 

Geography 

Hawaii 

Organization 

Organizational 

Type of 

Community 

Underserved 

diabetics 

Study Design 

Prospective cohort 

Start Date 

2002 

Duration 

Up to a year 

Eligible (N) 

175 

Enrolled (N) 

116 

Randomized (N) 

NA 

Completers (N) 

80 

Withdrawals or Dropouts (N) 

NA 

Health Condition of Interest 

Diabetes 

Inclusion Criteria 

Patients with HBa1C > 10 

Exclusion Criteria 

Refusal to participate (these became 

control group) 

Groups 

G1: Intervention 

G2: UC 

Interventions 

G1: diabetes case management by 

CHW, including home visits; 

based on needs of patients, 

CHWs collaborate with rest of 

multidisciplinary team to 

determine high-priority learning 

areas and to develop an 

intervention plan to implement 

during subsequent visits, plan 

included a blood regimen and 

target levels, diet plan, exercise 

plan, medication schedule, insulin 

injetion plan, and preventive 

health/health mainteance plan 

G2: UC 

Group (N) 

G1: 80 

G2: 36 

Title of CHW 

Community health worker 

Paid or Volunteer 

Paid 

Relationship with 

Community 

Ethnicity and language 

CHW (N) 

3 

Supervision of CHW 

CHWs met with Medical 

Director and Preventive 

Health Department Director 

once every 2 weeks for inservice training and case 

conferences for duration of 

project. 

Prior Training 

6 months of study at 

community college 

Type of Service 

Based on needs of patient - 

CHWs would collaborate with 

rest of multidisciplinary team 

to determine high-priority 

learning areas and to develop 

an intervention plan to 

implement during subsequent 

visits. Each plan included a 

blood glucose self-monitoring 

regimen and target levels, 

diet plan, exercise plan, 

medication schedule, insulin 

injection plan, and preventive 

health/health maintenance 

plan. 

Type of Educational 

Materials Used 

NR 

Duration of Interaction with 

Clients 

Up to a year - number of 

CHW visits per participant 

averaged 4.24 (range 5 1–15 

visits), with each visit 

averaging 1 to 1.5 hours. 

Length of Follow-up 

1 year 

Age (mean) 

G1: 51.8 

G2: 46.6 

Sex (% female) 

G1: 55 

G2: 50 

Race (%) 

G1: Hawaiian 51.3% 

Samoan 12.5% 

Filipino10% 

Caucasian 16.2% 

Tongan 2.5% 

Other 7.5% 

G2: Hawaiian 55.6% 

Samoan 11.1% 

Filipino 8.3% 

Caucasian 11.1% 

Tongan 2.8% 

Other 11.1% 

Other 

Baseline HbA1c (%) 

G1: 11.0 (6 .8) 

G2: 10.8 (6 (%) 

Role of CHW in 

Recruiting and 

Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-21 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Post intervention 

period HbA1c 

Results 

G1: 8.8 6 (1.7) 

G2: 10.4 (6 1.3) 

P < 0.0001 (Note on P value: investigators did not 

report one comparing groups, RTI researchers 

calculated it using data in article 

Measure 2 

Decrease in HbA1C 

Results 

G1: 2.2 (SD 1.8) 

G2: 0.2 (SD 1.5); P < 0.01 compared to baseline 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Fair 

C-22 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline Characteristics 

Recruiting and Retention

Author Year 

Blacket al., 1995; 

Hutcheson, et al., 

1997 

Trial Name 

NR 

Objective or Aim 

Evaluate efficacy of 

family-focused, 

home-based 

intervention on 

growth and 

development of 

children with 

nonorganic FTT 

Geography 

Baltimore, MD 

Organization 

Recruited from 

urban pediatric 

clinics serving low 

income families 

Type of 

Community 

Low-income, urban 

Study Design 

RCT 

Start Date 

NR 

Duration 

1 year 

Eligible (N) 

approx 163 

Enrolled (N) 

130 

Randomized (N) 

130 

Completers (N) 

706: 116 ( to end of intervention) 

1445: 74 (to 4 y/o) 

Withdrawals or Dropouts (N) 

706: 14 

1445: 56 

Health Condition of Interest 

Nonorganic failure to thrive 

Inclusion Criteria 

• < 25 mo 

• Wt for age < 5th percentile 

• EGA 36+ wk 

• Birth weight appropriate for 

gestational age 

• Wt for ht < 10th percentile 

Exclusion Criteria 

• No congenital disorders 

• No chronic illness 

• No developmental disabilities 

Groups 

G1: home intervention 

G2: clinic-only 

Interventions 

G1: CHW home visit weekly x 1 

year w/ community health nurse 

supervision 

G2: clinic-based multidisciplinary 

services 

Group (N) 

G1: 64 

G2: 66 

Title of CHW 

Lay home visitor 

Paid or Volunteer 

Paid 

Relationship with 

Community 

Knowledge of community 

Familiarity with culture 

CHW (N) 

3 part-time 

Supervision of CHW 

Community health nurse, 

frequency NR 

Prior Training 

Experience with children 

and families 

Type of Service 

• Home visits to develop 

individualized family 

service plan with specific 

goals 

• Support mother’s needs 

• Promote maternal-child 

relationship 

Type of Educational 

Materials Used 

Hawaii Early Learning 

Program was used as 

curriculum guide; handouts, 

developmental assessment 

toys, personalized 

notebooks 

Duration of Interaction 

with Clients 

Weekly visits (≈ 1 hour per 

visit) for 1 year 

Length of Follow-up 

18 months 

Age (mean) 

G1: younger 7.8 mo (SD 2.8); 

older 17.1 mo (3.7) 

G2: younger 6.6 (3.6); 

older 17.9 (4.3) 

Sex (% female) 

G1: younger 50%, older 44% 

G2: younger 45%, older 38% 

Race (%) 

African American – 

G1: younger 84%, older 91% 

G2: younger 85%, older 97% 

Other 

Mean BW 

G1: younger 2881 gm (400), 

older 2868 (385) 

G2: younger 3010 (524), 

older 2881 (432) 

Prior FTT hospitalization 

G1: younger 6%, older 0 

G2: younger 10%, older 3% 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

80% overall 

Retention Rates 

706: 

G1: 89% 

G2: 89% 

1,445: 

G1: 65% 

G2: 68% 

C-23 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

Measure 1 

Home environment 

(validated: Home 

Observation for 

Measurement of 

Environment Scales) 

Results 

G1 higher post-intervention 

scores than G2 (no 

significance testing reported) 

Measure 2 

Competence pre vs. post 

intervention 

Results 

Negative affect (below 

median on Brief Symptom 

Inventory) 

G1: 3.1 (SD 0.9) → 3.4 (0.6) 

G2: 2.9 (0.9) → 3.6 (0.7) 

Non-negative 

G1: 3.1 (0.6) → 3.6 (0.6) 

G2: 3.1 (0.9) → 3.5 (0.6) 

Measure 3 

Growth (wt for age, wt for ht, 

ht for age) (validated with 

Natl Center for Health 

Statistics charts) 

Results 

Significant improvement in 

each, no difference in 

improvement btw groups 

Measure 4 

Parent-child behavior during 

feeding (validated: modified 

Parent Child Early Relational 

Assessment) 

Results 

No significant differences 

between groups 

Health Outcomes: 

Measure 1 

Cognitive and motor development (validated: 

Bayley Scales of Infant Development @ postintervention; Battelle Developmental Inventory 

@ 4 y/o) 

Results 

Younger (1-12 mo at recruitment): 

G1: less decline pre/post vs. G2 (P = 0.02) 

Older (12.1-24.9 mo at recruitment): no 

significant difference in decline between groups 

Negative affect - cognitive 

G1: 96.6 (SD 17.0) → 86.2 (15.8) → 77.4 (18.3) 

G2: 91.8 (13.0) 

Measure 2 

Language development (validated: Bayley 

Scales and Receptive/Expressive Emergent 

Language Scale) 

Results 

Receptive-younger 

G1: 92.7→88.5 

G2: 98.7→88.0 

Older 

G1: 92.3→83.2 

G2: 98.3→82.7 (overall P = 0.05) 

Expressive - no differences in declines reported 

between groups 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Measure 1 

Annual per-child cost of home visits 

(ingredients method) 

Results 

$2,828/child/year

Explanation of Overall Outcomes 

CHW home visit + multidisciplinary clinic 

management were significantly better 

than MDC alone in attenuating cognitive 

and motor decline among infants (but not 

older children) and attenuating receptive 

language decline; no significant 

difference observed in growth, 

expressive language, or parent-child 

interaction 

Quality Rating 

Fair 

Health Outcomes: 

Measure 1 

Negative affect @ baseline, postintervention, 4 y/o 

Results 

Negative affect group 

G1: 4.2 (SD 1.0) → 4.4 (0.7) → 3.5 (0.5) 

G2: 4.3 (0.7) → 4.4 (0.6) → 3.6 (0.3) 

Non-negative group 

G1: 4.2 (0.7) → 4.3 (0.6) → 3.7 (0.2) 

G2: 4.5 (0.5) → 4.4 (0.7) → 3.4 (0.6) 

Measure 2 

Warmth @ 4 y/o 

Results 

Negative affect group 

G1: 2.8 (SD 0.5) 

G2: 2.9 (0.5) 

Non-negative group 

G1: 2.9 (0.5) 

G2: 2.5 (0.5) 

C-24 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Bone et al., 1989 

Trial Name 

NA 

Objective or Aim 

Determine 

(1) feasibility and 

impact of 

introducing 

indigenious CHWs 

into ED to 

supplement 

detection, referral, 

and follow-up 

efforts performed 

by ED clinical staff 

(2) degree to which 

CHWs efforts 

improve HBP 

follow-up in highrisk groups 

Geography 

Baltimore, MD 

Organization 

Johns Hopkins 

Hospital Adult ER 

Type of 

Community 

Predominately 

black, low-income 

Study Design 

Prospective cohort 

Start Date 

1982 

Duration 

2 years 

Eligible (N) 

722 

Enrolled (N) 

722 

Randomized (N) 

NA 

Completers (N) 

NA 

Withdrawals or Dropouts (N) 

NA 

Health Condition of Interest 

HTN 

Inclusion Criteria 

ER patients scheduled for BP followup 

Exclusion Criteria 

Patients without a telephone number

Groups 

G1: control (not able to be contacted 

by CHW) 

G2: contacted by CHW 

Initially, all patients were contacted 

initially by CHWs in ER. CHWs took 

pulse and BP measurements, 

provided educational counseling, 

identiifed barriers related to referrals, 

assisted 

Interventions 

G1: none 

G2: telephone preappointment 

reminder for scheduled BP followup, including education 

counseling. Multple attempts (at 

least 3) were made to contact 

patients 1-2 days before 

scheduled follow-up. Telephone 

encounters lasted 5-10 minutes, 

conducted at night. 

Group (N) 

G1: 278 

G2: 444 

Title of CHW 

CHW 

Paid or Volunteer 

NR 

Relationship with 

Community 

Individuals residing in 

community where ED is 

located and interested in 

HBP (usually b/c of family 

or personal history). All 

women, age 30-45 years. 

CHW (N) 

6 

Supervision of CHW 

Initially by community 

health nurse/health 

educator on adaily basis, 

later reduced to weekly as 

HCWs were judged 

competent by nurse 

educator and ED staff 

Prior Training 

No prior work in health 

related area but some had 

previous community 

service; all had HS 

education 

Type of Service 

Face-to-face session; 

Telephone 

Type of Educational 

Materials Used 

Verbal 

Duration of Interaction 

with Clients 

1 face-to-face session (≈20 

minutes) and at least 1 prefollowup appointment 

reminder telephone call (5-

10 minutes) 

(time period over which this 

occurred NR) 

Length of Follow-up 

NR 

Age (mean) 

NR 

Sex (% female) 

NR 

Race (%) 

NR 

Other 

Role of CHW in Recruiting 

and Retention 

CHW was to contact patients 

for pre-appointment 

reminders 

Recruitment Rates 

NA 

Retention Rates 

NA 

C-25 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

Measure 1 

Returned to ED for follow-up appt 

Results 

G1: 41% 

G2: 60% (P < 0.001) 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Poor 

C-26 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Campbell, 2004 

Trial Name 

WATCH 

Objective or Aim 

Compare 

effectiveness of 2 

strategies to 

promote colorectal 

cancer preventive 

behaviors among 

African American 

members of 12 

rural North 

Carolina churches. 

Geography 

Rural NC 

Organization 

Churches in rural 

counties 

Type of 

Community 

African American 

rural churches 

Study Design 

RCT 

Start Date 

1999 

Duration 

1 yr 

Eligible (N) 

26 churches 

Enrolled (N) 

12 churches 

Randomized (N) 

12 churches 

Completers (N) 

NR (presumably 12 churches; 

completers/dropouts of individual 

participants from each church not 

reported) 

Withdrawals or Dropouts (N) 

NR (presumably 12 churches; 

completers/dropouts of individual 

participants from each church not 

reported) 

Health Condition of Interest 

Colorectal cancer 

Inclusion Criteria 

• Church in one of five rural eastern 

NC counties with at least 80 active 

members and expressed interest 

in participation 

• All active members (i.e., attending 

study church at least once/month) 

aged 18 or older were eligible to 

participate 

Exclusion Criteria 

NR 

Groups 

G1: Control 

G2: LHA only 

G3: TPV only 

G4: Combined LHA and TPV 

Title of CHW 

Lay health advisor 

Paid or Volunteer 

Volunteer 

Relationship with 

Community 

Church membership 

CHW (N) 

62 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Provide information through 

existing networks; organize 

and conduct at least three 

church-wide activities 

focused on spreading 

information for colorectal 

cancer prevention 

Type of Educational 

Materials Used 

TPV and combined groups 

(G2 and G4): videos, 

computer-tailored 

newsletters 

Duration of Interaction 

with Clients 

Three church- based 

activities during 12 months 

(time per session NR) 

Length of Follow-up 

12 months 

Age (mean) 

52 

Sex (% female) 

74 

Race (%) 

African American: 99% 

Other 

BMI ≥30: 40% 

Role of CHW in Recruiting 

and Retention 

Organize church activities, 

but recruitment is really NA 

in this case 

Recruitment Rates 

NR 

Retention Rates 

Participated in WATCH 

church activities (%): 

G1: 22.5 

G2: 32.5 

G3: 23.3 

G4: 16.5 

C-27 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Dietary change--daily fruit and vegetable servings 

(Baseline/Followup) 

Results 

G1: 3.3/3.4 

G2: 3.5/3.5 

G3: 3.3/3.9 

G4: 3.4/3.7 

P = 0.02 for G3 vs. G1 

P = ns for G2 vs. G1 

Measure 2 

Physical Activity: 

recreational (moderate-vigorous) activity MET 

hours/week, 

M (SE) (baseline/followup) 

Results 

G1: 9.3 (0.88)/8.4 (0.69) 

G2: 10.5 (0.90)/10.6 (0.70) 

G3: 9.5 (0.80)/10.9 (0.61) 

G4: 9.7 (0.76)/9.7 (0.60) 

P = 0.07 for G2 

Healthcare Utilization: 

Measure 1 

Other CRC test in past year (% Baseline/% Followup) 

Results 

G1: 20.3/27.5 

G2: 19.6/25.5 

G3: 23.7/21.1 

G4: 26.4/14.9 

P = ns 

Measure 2 

FOBT test in past year (% Baseline/% Followup) 

Results 

G1: 30.4/21.7 

G2: 23.5/33.3 

G3: 19.7/36.8 

G4: 19.5/31.0 

P = 0.08 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Poor 

Health Outcomes: 

NR

C-28 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Campbell, 2004 

(continued) 

Interventions 

G1: Control churches offered health 

education sessions and speakers 

on topics of their choice not 

directly related to study objectives 

G2: Organize and conduct at least 3 

church-wide activities on 

spreading info and enhancing 

support for healthy lifestyle and 

CRC screening (LHA) 

G3: 4 personalized computertailored newsletters and 4 

targeted videotapes (TPV) 

corresponding to same behaviors 

mailed to participants' homes 

bimonthly for first 6 months after 

baseline data collection; 4th 

mailing was 9 months post 

baseline 

G4: LHA + TPV 

Group (N) 

G1: 129 

G2: 123 

G3: 159 

G4: 176 

C-29 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

This page intentionally left blank. 

C-30 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Caulfield et al., 

1998 

Trial Name 

NR 

Objective or Aim 

To promote breast 

feeding among 

African-American 

women 

Geography 

Baltimore, MD 

Organization 

Organizational - 

WIC 

Type of 

Community 

Neighborhoodsocioeconomic 

Study Design 

RCT 

Start Date 

1992 

Duration 

Various - from 

minimal to 20 

weeks 

Eligible (N) 

4 clinics, 674 women 

Enrolled (N) 

548 

Randomized (N) 

4 clinics 

Completers (N) 

242 

Withdrawals or Dropouts (N) 

306 

Health Condition of Interest 

Breast feeding 

Inclusion Criteria 

African-american woman attending 

prenatal care at participating clinic 

before 24 weeks gestation, 

singleton, planning to keep baby and 

remain in catchment area 

Exclusion Criteria 

Contraindications to BF; HIV, certain 

meds, pregnancy termination, twins, 

miscarriage, still birth, maternal or 

neonatal hospitalizatiion for 2 or 

more weeks 

Groups 

G1: Control 

G2: Video 

G3: Peer counselor 

G4: Video and Peer Counselor 

Interventions 

G1: All on-going WIC services as 

required by state and federal 

regulation 

G2: WIC services plus motivational 

video additional literature 

G3: WIC services plus peer 

counselling before and after birth 

G4: WIC services plus video plus 

peer counselling 

Group (N) 

G1: 57 

G2: 64 

G3: 55 

G4: 66 

Title of CHW 

Peer counselor 

Paid or Volunteer 

NR 

Relationship with 

Community 

Shared condition - WIC 

recipient that successfully 

breast fed in past 

CHW (N) 

NR 

Supervision of CHW 

Random quality assurance 

visit to one clinic each week

Prior Training 

5 weeks of training 

Type of Service 

One-on-one counselling 

Type of Educational 

Materials Used 

Various - NR 

Duration of Interaction 

with Clients 

3 or more meetings during 

pregnancy (from 24 weeks 

of gestation) and then 

weekly up to 16 weeks 

postpartum if they 

continued breast feeding 

Length of Follow-up 

Up to 16 weeks post 

partum 

Age (mean) 

G1: < 18 37%, 

18-25 40%, 

 > 25 23% 

G2: < 18 27%, 

18-25 53%, 

 > 25 20% 

G3: < 18 33%, 

18-25 40%, 

 > 25 27% 

G4: < 18 23%, 

18-25 53%, 

 > 25 24% 

Sex (% female) 

100 

Race (%) 

100% African- American 

Other 

Nulliparity 

G1: 23% 

G2: 48% 

G3: 20% 

G4: 32% 

 

< HS 

G1: 86% 

G2: 64% 

G3: 75% 

G4: 85% 

Employed 

G1: 13% 

G2: 33% 

G3: 17% 

G4: 28% 

Role of CHW in Recruiting 

and Retention: 

NR 

Recruitment Rates: 

NR 

Retention Rates: 

NR 

C-31 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, and 

Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Still breast feeding at 7-10 days 

Results 

G1: 14% OR 1.00 

G2: 30% OR 0.79 95% CI, (0.25, 2.52) 

G3: 38% OR 1.11 95% CI, (0.34, 3.61) 

G4: 38% OR 1.52 95% CI, (0.50, 4.59) 

P < 0.05 

Measure 2 

Odds of intitiating and continuing BF (@7-10 d) relative 

to control group 

Results 

G1: 1 (control) 

G2: 1.36 (0.52, 3.54) / 0.79 (0.25, 2.52) 

G3: 3.84 (1.44, 10.21) / 1.11 (0.34, 3.61) 

G4: 1.92 (0.78, 4.76) / 1.52 (0.50, 4.59) 

Measure 3 

Intiation of breast feeding 

Results 

G1: 26% (OR, 1.00) 

G2: 50% (OR, 1.36; 

95% CI, 0.52-3.54) 

G3: 62% (OR, 3.84; 

95% CI, 1.44-10.21)G4: 52% (OR, 1.92; 

95% CI, 0.78-4.76) 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

CHW were effective at 

increasing initiation of 

BF, but no difference in 

continuation at 7-10 

days 

Quality Rating 

Poor 

C-32 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Conway et al., 

2004 

Trial Name 

NR 

Objective or Aim 

Evaluate a 

culturally tailored 

behavioral problem 

solving intervention 

to reduce 

environmental 

tobacco smoke 

exposure amongst 

young Latino 

children 

Geography 

San Diego County 

Organization 

Areas with large 

Latino population 

Type of 

Community 

Community 

organizations and 

venues 

Study Design 

RCT 

Start Date 

NR 

Duration 

12 months 

Eligible (N) 

NR 

Enrolled (N) 

143 

Randomized (N) 

143 

Completers (N) 

127 

Withdrawals or Dropouts (N) 

16 

Health Condition of Interest 

Environmental tobacco smoke 

exposure 

Inclusion Criteria 

• Latino 

• Have child 1-9 y/o 

• Exposure of child to 6+ 

cigarettes/week 

Exclusion Criteria 

NR 

Groups 

G1: CHW 

G2: control 

Interventions 

G1: Home and telephone visits on 

problem-solving techniques to 

reduce environmental tobacco 

smoke exposure; 6 visits over 4 

months 

G2: Participated in surveys but 

received no other intervention 

Group (N) 

1 adult + 1 child dyad 

G1: 71 

G2: 72 

Title of CHW 

Promotora 

Paid or Volunteer 

NR (text implies volunteer) 

Relationship with 

Community 

Bicultural, bilingual, Latina 

CHW (N) 

NR 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Home and telephone visits 

on problem-solving 

techniques to reduce ETS 

exposure to children 

Type of Educational 

Materials Used 

Contracting, shaping, 

positive reinforcement, 

problem solving, social 

support 

Duration of Interaction 

with Clients 

6 home and telephone 

visits over 4 months (time 

per session NR) 

Length of Follow-up 

12 mo 

Age (mean) 

33 y (adults), 4 y (children) 

Sex (% female) 

• Adult: Nearly 100% 

• Children: 55% 

Race (%) 

100% Latino 

Other 

• Income: $700-1099/mo 

• Mexican-born: 85% 

• Acculturation: 2.0/5 

• Mexican-educated: 71% 

• Median education: 9-11 y 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

81% overall 

C-33 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

RIA of child's hair for nicotine and cotinine 

Results 

No significant differences between groups 

Measure 2 

Parent report of child's past month ETS exposure 

Results 

No significant differences between groups 

Healthcare Utilization: 

NR 

Costs (Economics): 

Measure 1 

CHW intervention cost 

(estimated) 

Results 

$29000

Explanation of Overall 

Outcomes 

No difference observed 

in subjective or 

objective measures of 

ETS exposure with 

CHW visits vs. control 

Quality Rating 

Fair 

C-34 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Corkery et al., 

1997 

Trial Name 

NR 

Objective or Aim 

Determine effect of 

bicultural CHW on 

completion of 

diabetes education 

in inner-city 

Hispanic patient 

population and 

evaluate impact of 

completion of 

education program 

on patient 

knowledge, selfcare behaviors, 

and glycemic 

control. 

Geography 

NYC - East Harlem 

Organization 

Cultural: HispanicAmericans, 

primarily PR origin, 

and AfricanAmericans 

Type of 

Community 

Disease: diabetes, 

neighborhood, 

socio-economic, 

cultural 

Study Design 

RCT 

Start Date 

NR 

Duration 

Mean 3.4 months 

(range 0.9 to 5.4) 

Eligible (N) 

64 

Enrolled (N) 

64 

Randomized (N) 

64 

Completers (N) 

40 (63%) 

Withdrawals or Dropouts (N) 

24 (37%) 

Health Condition of Interest 

Diabetes 

Inclusion Criteria 

• Newly referred to clinic for patient 

education 

• Hispanic 

• > 20 yrs old 

Exclusion Criteria 

None 

Groups 

G1: Intervention 

G2: Control 

Interventions 

G1: Intervention- CHW acted as 

liason, attended clinic sessions, 

interpreter, reinforced self are 

instructions and appointment 

reminders 

G2: Control - encounters occurred 

between nurse and patient only 

Group (N) 

G1: 30 

G2: 34 

Title of CHW 

CHW 

Paid or Volunteer 

NR 

Relationship with 

Community 

Bicultural, bilingual 

Hispanic-American of 

Puerto Rican heritage who 

lived in East Harlem 

CHW (N) 

1 

Supervision of CHW 

NR 

Prior Training 

Previously volunteered in a 

diabetes clinic 

Type of Service 

Attended clinic visits 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

Varied (mean = 3.4 

months, range: 0.9-5.4), 

time per session equal to 

clinic visit duration 

Length of Follow-up 

Mean - 7.7 months (range 

6-16.2) 

Age (mean) 

52.8 years 

Sex (% female) 

74 

Race (%) 

100% Hispanic 

Other 

46% literate 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR

C-35 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

HgbA1c 

Results 

No difference in mean change between groups 

Measure 2 

Diabetes Education Program Completion 

Results 

G1: 80% 

G2: 47% (P = 0.01) 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Fair 

C-36 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Derose et al., 

2000; 

Dean et al., 2000; 

Derose et al., 

2000; 

Stockdale et al., 

2000; 

Fox et al., 1998 

Trial Name 

Los Angeles 

Mammography 

Promotion 

Objective or Aim 

Assess 

effectiveness of 

telephone 

counseling in a 

church-based 

mammography 

promotion 

intervention trial 

Geography 

LA county 

Organization 

Telephone 

counseling 

Type of 

Community 

Church 

communities 

Study Design 

RCT 

Start Date 

1996 

Duration 

2 years 

Eligible (N) 

1,969 on first screening 

1,777 on second screening 

Enrolled (N) 

1443 

Randomized (N) 

1113 

Completers (N) 

813 

Withdrawals or Dropouts (N) 

300 

Health Condition of Interest 

Breast cancer screening 

Inclusion Criteria 

Women ages 50-80, living in private 

residencies, not being too ill or 

impaired to be interviewed, being 

able to be interveiwed in English or 

Spanish, living in a sample area, and 

being reachable by telephone 

Exclusion Criteria 

NR 

Groups 

G1: Control 

G2: CHW 

Interventions 

G1: Control churches provided 

minimal intervention: a library of 

resource materials on cancer and 

cancer prevention, assistance 

with starting a health committee or 

working with an existing health 

committee, computer hardware, 

software, and a printer, as well as 

computer training for at least one 

church member 

G2: One session of telephone 

counseling annually, for 2 years, 

by peer counselor; counseling 

individualized to address barriers, 

churches also received computer 

support offered to control 

churches 

Group (N) 

G1: 397 

G2: 416 

Title of CHW 

Peer counselor 

Paid or Volunteer 

Some full-time staff, 

telephone counselors paid 

$150 stipend per year 

Relationship with 

Community 

Hired from participating 

churches assigned to 

telephone counseling 

CHW (N) 

26 

Supervision of CHW 

NR 

Prior Training 

NA 

Type of Service 

Barrier-specific telephone 

counseling to promote 

screening, discussion of 

resources for free- and 

reduced-cost 

mammograms, translation 

services, transportation, 

and childcare assistance 

Type of Educational 

Materials Used 

Verbal 

Duration of Interaction 

with Clients 

2 telephone calls (one per 

year over 2 years), time per 

session 7-11 minutes on 

average 

Length of Follow-up 

2 years 

Age (mean) 

NR 

Sex (% female) 

100 

Race (%) 

NR 

Other 

Role of CHW in Recruiting 

and Retention 

NA 

Recruitment Rates 

NA 

Retention Rates 

NA 

C-37 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

Measure 1 

Nonadherence to mammogram, by self-report 

Results 

Nonadherence rates among adherent users at 

baseline: 

G1: 23.3% 

G2: 15.8% (P = 0 .029) 

Nonadherence rate among nonadherent users at 

baseline 

G1: 37.4% 

G2: 34.8 (P = 0.324) 

Costs (Economics): 

Measure 1 

Sensitivity Analysis 

Results 

Assuming that all labor 

is voluntary and that 

churches provide 

materials and 

resources: 

• Cost per additional 

screening for a 

LAMP study 

participant = $188; 

• Cost if all participants 

are adherent at 

baseline = $145; 

• Cost if all participants 

nonadherent at 

baseline = $419 

(using LAMP 

effectiveness rates 

for adherent (7.5%) 

and nonadherent 

(2.6%) participants

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Fair 

C-38 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Dignan et al., 2005 

Trial Name 

Objective or Aim 

Determine relative 

effectiveness of 

face-to-face and 

telephone delivery 

of culturally 

sensitive Navigator 

intervention to 

increase 

adherence to 

guidelines for 

mammography 

screening among 

American Indian 

women 

Geography 

Denver 

metropolitan area 

Organization 

Urban American 

Indian Women 

Type of 

Community 

NR 

Study Design 

RCT 

Start Date 

August 2001 

Duration 

One year 

Eligible (N) 

929 

Enrolled (N) 

157 (for intervention groups, N for 

control NR) 

Randomized (N) 

157 (for intervention groups, N for 

control NR) 

Completers (N) 

157 (for intervention groups, N for 

control NR) 

Withdrawals or Dropouts (N) 

157 (for intervention groups, N for 

control NR) 

Health Condition of Interest 

Breast cancer screening 

Inclusion Criteria 

Urban American Indian women 40 

years and older living in greater 

Denver Metropolitan area and had 

not had a mammogram within 

previous 18 months 

Exclusion Criteria 

Groups 

G1: control 

G2: face-to-face 

G3: telephone intervention 

Interventions 

G1: Control, interventions not 

reported, data from Colorado 

Mammography Program data 

G2: Tailored education brochure 

using data from baseline 

interview. face-to-face planned for 

delivery at participant's home (1 

session lasting 20-90 minutes), 

presenting information on breast 

cancer and value of early 

detection, review of brochure 

G3: Telephone intervention, as 

above 

Group (N) 

G1: 

G2: 77 

G3:133 

Title of CHW 

Native sister/Navigators 

Paid or Volunteer 

NR 

Relationship with 

Community 

Recruited from Denver 

metro area 

CHW (N) 

N 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Barrier-specific counseling 

to promote screening, faceto-face vs. telephone 

Type of Educational 

Materials Used 

Tailored educational 

brochure 

Duration of Interaction 

with Clients 

One time session 20-90 

minutes 

Length of Follow-up 

6 months 

Age (mean) 

54.2 years 

Sex (% female) 

100 

Race (%) 

Native Americans 

Other 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-39 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

Measure 1 

Mammograms over past 12 months (self-report) 

Results 

G1: 51.9 -- > 50.0 

G2: 29 -- > 41.8 

G3: 34.4 -- > 45.2 

Chi-square G1 vs G2+G3:2.68, P = 0.10; 

P for G2 vs G3: 0.83; 

P for G2, pre-post changes: 0.029; P for G3, pre-post 

changes: 0.197 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Poor 

C-40 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline Characteristics 

Recruiting and Retention 

Author Year 

Duggan et al., 

1999; Duggan et 

al., 2000 

Trial Name 

Hawaii's Healthy 

Start Program 

(HSP) 

Objective or Aim 

Prevent child 

abuse and neglect 

and promote child 

health and 

development in 

newborns of 

families at risk for 

poor child 

outcomes 

Geography 

Hawaii Oahu 

Organization 

Organizational 

Type of 

Community 

At risk for chid 

abuse 

Study Design 

RCT 

Start Date 

1994 

Duration 

2 years 

Eligible (N) 

901 families 

Enrolled (N) 

730 families 

Randomized (N) 

730 families 

Completers (N) 

566 at 2 years 

Withdrawals or Dropouts (N) 

164 families 

Health Condition of Interest 

Child abuse 

Inclusion Criteria 

Lived in target community, and not 

known to child protective services 

Exclusion Criteria 

Non-English speaking 

Groups 

G1: Healthy Start Program 

G2: Control 

G3: Test Control 

Interventions 

G1: Home visiting with individualized 

service plans, child developmental 

screenings, and mother-child 

interaction assessments; family 

support plan within 45 days of 

initial visit, reviewed q 6 mo, 

revised annually; periodic 

screening for DD, observational 

assessment of parent-child 

interaction and home 

environment; ensure existence of 

medical home, links to other 

needed resources 

G2: Control 

G3: Test Control was only 

interviewed at end 

Group (N) 

G1: HSP: 373 

G2: Control: 270 

G3: Test Control: 41 

Title of CHW 

Home visitors 

Paid or Volunteer 

NR 

Relationship with 

Community 

from community 

CHW (N) 

NR 

Supervision of CHW 

Non-clinician- met weekly 

w/home visitors 

Prior Training 

NR 

Type of Service 

Counselling--building 

relationship with families; 

active assistance to 

address existing crises; 

model problem-solving 

skills and effective 

parent-child interaction; 

link families with needed 

resources; provide 

parenting education; 

ensuring presence of 

medical home for 

children 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

≈22 visits (1 hour each) 

over 2 years [Protocol 

called for weekly visits] 

Length of Follow-up 

2 years 

Age (mean) 

Mother's average age 

G1: 24 years 

G2: 24 years 

Sex (% female) 

100 

Race (%) 

G1: Hawaiian: 21% 

Pacific Islander: 13% 

Asian: 10% 

Filipino: 18% 

Caucasian: 11% 

Multiracial or unknown: 28% 

G2: Hawaiian: 19% 

Pacific Islander: 14% 

Asian: 7% 

Filipino: 20 

Caucasian: 13% 

Multiracial or unknown: 26% 

Other 

Role of CHW in Recruiting 

and Retention 

NA 

Recruitment Rates 

NA 

Retention Rates 

NA 

C-41 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Bayley Scales of Infant Development, Mental 

Development Index at 2 years post-intervention 

Results 

G1: 90.0 

G2: 89.2 

P = 0.60 

Measure 2 

Bayley Scales of Infant Development, Psychomotor 

Development Index at 2 years post-interventino 

Results 

G1: 92.1 

G2: 90.4 

P = 0.12 

Measure 3 

Has primary care provider? 

Results 

G1: 91% 

G2: 86% 

P = 0.09 

Healthcare Utilization: 

Measure 1 

Adequate # of well-child visits 

Results 

G1: 89% 

G2: 84% 

P = 0.09 

Measure 2 

Immunizations up to date 

Results 

G1: 87% 

G2: 85% 

P = 0.45 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Poor 

C-42 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Earp et al., 2002 

Trial Name 

North Carolina 

Breast Cancer 

Screening Program 

Objective or Aim 

Determine 

effectiveness of lay 

health advisor 

intervention, 

supplemented by 

limited number of 

other activities, 

aimed at increasing 

self-reported 

mammography use 

among African 

American women 

50 years and older 

in eastern North 

Carolina; correcting 

beliefs about 

causes of breast 

cancer; increasing 

acceptance of 

need for regular 

mammography 

Geography 

Eastern NC 

Organization 

Black women 

Type of 

Community 

Mostly rural, 37% 

minority, 12% 

below FPL; low 

likelihood of having 

had mammogram 

Study Design 

Prospective cohort 

for main analysis 

Start Date 

1993 

Duration 

4 years 

Eligible (N) 

10 counties, 2441 women 

Enrolled (N) 

2296 

Randomized (N) 

993 (African American) 

Completers (N) 

801 

Withdrawals or Dropouts (N) 

192 

Health Condition of Interest 

Breast cancer screening 

Inclusion Criteria 

• Living in study county 

• African-American 

• At least 50 y/o 

• no h/o breast cancer 

Exclusion Criteria 

• Death 

• Departure from study area 

• Admission to nursing home 

• Development of breast cancer 

• Prior participation in CHW training 

Groups 

G1: Counties receiving CHW and 

other targeted activity 

G2: Comparison 

Interventions 

G1: Counties receiving CHW and 

other targeted activity: 

presentations to community 

groups and events, one-on-one 

conversations, use of 

informational/ motivational 

materials 

G2: Comparison counties, no 

intervention reported 

Group (N) 

G1: 390 

G2: 411 

Title of CHW 

Lay health advisor 

Paid or Volunteer 

Volunteer 

Relationship with 

Community 

Members of community; 

same county 

CHW (N) 

170 

Supervision of CHW 

Main analysis: - described 

in Earp JA, Viadro CI, 

Vincus AA, et al. Lay health 

advisors: a strategy for 

getting word out about 

breast cancer. Health Educ 

Behav. 1997;24:432–451. 

412 - by "community 

outreach specialists" 

monthly (meetings and 

assistance 

Prior Training 

NR 

Type of Service 

Presentations to community 

groups and events, one-onone conversations, use of 

informational/motivational 

materials 

Type of Educational 

Materials Used 

Brochures, posters, church 

fans, holiday cards 

Duration of Interaction 

with Clients 

2 community activities per 

month; one-on-one 

conversations once a week 

over a 24- month period, 

time per session NR 

Length of Follow-up 

32 months 

Age (mean) 

G1: 46% < 65, 23% > 74 

G2: 44% < 65, 24% > 74 

Sex (% female) 

100 

Race (%) 

African American 100% 

Other 

Income < $12k 

G1: 81% 

G2: 63%; 

No medical visits in past 

year 

G1: 9% 

G2: 7%; 

Low breast cancer 

knowledge 

G1: 43% 

G2: 31%; 

Low perceived support for 

breast cancer screening 

G1: 43% 

G2: 35% 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

Main analyis: 87% all races 

(no recruitment rate given for 

African Americans or for 

G1/G2 

412 - NR 

Retention Rates 

G1: 89% 

G2: 88% 

C-43 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Pre/post percentage point difference in reported 

mammogram, adjusted for change in mammography 

attitude 

Results 

• No recent mammogram at baseline: 

CHW advice: +9 

diffused discussion: +10 

project awareness: +15 

• Recent mammogram at baseline: 

CHW advice: +8 

diffused discussion: 0 

project awareness: +5 

Healthcare Utilization: 

Measure 1 

Self-report of mammogram in past 2 years, stratified by 

income 

Results 

 < $12k annually 

G1: pre 37%, post 59% 

G2: pre 49%, post 60% (adjusted P = 0.02); 

$12k or greater annually 

G1: pre 56%, post 59% 

G2: pre 73%, post 82% (adjusted P = 0.92) 

Measure 2 

Self-report of mammogram in past 2 years 

Results 

G1: pre 41%, post 58% 

G2: pre 56%, post 67% (adjusted P = 0.05) 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

CHW community 

intervention is associated 

with significantly higher 

proportions of AfricanAmerican women reporting 

having received 

mammograms, especially 

among lower income strata 

Quality Rating 

Poor 

Health Outcomes: 

NR

C-44 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Elder et al., 2006; 

Elder et al., 2005 

Trial Name 

Secretos de la 

Buena Vida 

Objective or Aim 

Determine whether 

CHW + tailored 

print materials vs. 

tailored print 

materials vs. offthe-shelf print 

materials was more 

effective to 

maintain diet 

change at 1 y f/u 

Geography 

San Diego County 

Organization 

Spanish-dominant 

Latina 

Type of 

Community 

Central and 

southern regions 

Study Design 

RCT 

Start Date 

2001 

Duration 

2 years 

Eligible (N) 

510 

Enrolled (N) 

357 

Randomized (N) 

357 

Completers (N) 

281 

Withdrawals or Dropouts (N) 

76 

Health Condition of Interest 

Dietary behavior 

Inclusion Criteria 

• Female 

• 18-65 y/o 

• Hispanic surname 

• Spanish-dominant 

• Valid telephone number 

Exclusion Criteria 

• Pregnant 

• Medically prescribed diet 

• Not remaining in San Diego 

Groups 

G1: CHW + tailored print 

G2: tailored print 

G3: control 

Interventions 

G1: CHW home visits and/or phone 

calls + tailored print materials 

G2: 12 weekly tailored newsletters 

and homework 

G3: 12 weekly off-the-shelf dietary 

printed material 

Group (N) 

G1: 120 

G2: 118 

G3: 119 

Title of CHW 

Promotora 

Paid or Volunteer 

NR 

Relationship with 

Community 

Indigenous to community, 

Spanish language 

dominant, perceived as a 

community role model 

CHW (N) 

4 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

G1: weekly home visits or 

telephone calls + tailored 

health info newsletters 

G2: tailored health info 

newsletters 

G3: population-targeted 

print materials 

Type of Educational 

Materials Used 

G1: negotiated behavioral 

change goals 

G1 and G2: tailored 

newsletters and activity 

inserts based on 

baseline participant data; 

magnets w/ healthy 

lifestyle messages; 

recipes 

G3: language-appropriate 

materials w/ dietary 

information developed 

for Latino popul 

Duration of Interaction 

with Clients 

12 home visits or telephone 

calls over a 12-week 

period, 12 weekly tailored 

newsletters (duration per 

session NR) 

Length of Follow-up 

1 year 

Age (mean) 

G1: 38.6 (SD 10.1) 

G2: 40.4 (9.9) 

G3: 40.1 (9.8) 

Sex (% female) 

100 

Race (%) 

Hispanic 

Other 

Married 

G1: 94% 

G2: 93% 

G3: 93%; 

BMI 

G1: 28.9 (SD 5.7) 

G2: 30.4 (5.6) 

G3: > 29.6 (5.4) 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

G1: 93/120 = 78% 

G2: 90/118 = 76% 

G3: 98/119 = 82% 

C-45 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

% calories from fat (Nutrition Data System 24-h dietary 

recall interview) 

Results 

No significant difference between groups at 6 and 12 

months post-intervention 

Measure 2 

Total gm fiber (Nutrition Data System 24-h dietary recall 

interview) 

Results 

No significant difference between groups at 6 and 12 

months post-intervention 

Measure 3 

Total fat gm (Nutrition Data System 24-h dietary recall 

interview) 

Results 

No significant difference between groups at 6 and 12 

months post-intervention 

Measure 4 

Post-intervention calorie/fat intake (using Nutrition Data 

System) 

Results 

kcal (P < .01) 

G1: 1,286.9 

G2: 1,419.2 

G3: 1,436.2 (G1-G3 P < .05 

G1-G2 P < .1) 

Fat gm (P < .05) 

G1: 43.1 

G2: 49.8 

G3: 49.3 (G1-G3 p < .1 

G1-G2 P < .05) 

% fat cal 

G1: 29.3 

G2: 30.4 

G3: 30 (NS) 

Saturated fat gm (P < .05) 

G1: 14.4 

G2: 16.9 

G3: 16.6 (G1-G3 P < .1 

G1-G2 

Healthcare Utilization: 

NR 

Measure 1 

Cost per unit of change 

Results 

Per reduced fat gm 

G1: $8.28 

G2: $5.11 

G3: $1.30 

Per reduced saturated fat gm 

G1: $21.09 

G2: $17.31 

G3: $3.21 

Per reduced calorie 

G1: $0.36 

G2: $3.21 

G3: $0.07 

Measure 2 

Per-participant cost 

Results 

G1: $135 

G2: $45 

G3: 9 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Poor 

C-46 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Elder et al., 2006; 

Elder et al., 2005 

(continued) 

C-47 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional Outcomes 

Measure 2 

Dietary fiber intake (gm) 

(using Nutrition Data 

System) 

Results 

Total fiber gm 

G1: 16.1 

G2: 17.2 

G3: 15.6 (NS) 

Soluble fiber gm 

G1: 4.7 

G2: 5.1 

G3: 4.8 (NS) 

Insoluble fiber gm 

G1: 11.1 

G2: 11.8 

G3: 10.5 (NS) 

Measure 3 

Other dietary intake (via 

NDS) 

Results 

CHO gm (P < .05) 

G1: 171.2 

G2: 187.3 

G3: 187.1 (G1-G3 P < .05 

G1-G2 P < .1) 

Glucose gm ( P < .01) 

G1: 16 

G2: 21.1 

G3: 18.4 (G1-G3 NS) 

G1-G2 P < .05) 

Fructose gm ( P < .001) 

G1: 16.9 

G2: 22.7 

G3: 19.1 

G1-G3 NS 

G1-G2 P < .05 

G2-G3 P < .1) 

Sucrose gm 

G1: 30.5 

G2: 31.2 

G3 

C-48 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Erwin et al., 1997 

Trial Name 

Witness project 

Objective or Aim 

Examine 

effectiveness of 

Witness Project, a 

culturally 

competent cancer 

education program 

that trains cancer 

survivors to 

promote early 

detection and 

increased breast 

self-examination 

and mammography 

in population of 

rural, underserved, 

African American 

women 

Geography 

Rural Mississippi 

River Delta region 

of Arkansas 

Organization 

Church or 

community group 

Type of 

Community 

Neighborhood 

Study Design 

Prospective cohort 

Start Date 

1994 

Duration 

6 months 

Eligible (N) 

NA 

Enrolled (N) 

433 

Randomized (N) 

NA 

Completers (N) 

412 

Withdrawals or Dropouts (N) 

21 

Health Condition of Interest 

BSE and mammography 

Inclusion Criteria 

Inclusion criteria for women NR, 

churches selected from convenience 

sample 

Exclusion Criteria 

NA 

Groups 

G1: Intervention 

G2: Control 

Interventions 

G1: Members of a Witness Project 

team, composed of 7 local African 

American women who had 

survived breast or cervical cancer, 

speak in groups of 2 to 5 at local 

churches and community 

organization meetings 

G2: Control group offered delayed 

intervention 

Group (N) 

G1: 204 (152 aged ≥40) 

G2: 206 (140 aged ≥40) 

Title of CHW 

Witness role model 

Paid or Volunteer 

NR 

Relationship with 

Community 

Shared race, cancer 

survivors 

CHW (N) 

7 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Motivational speeches 

based on cancer survivor, 

experience of CHWs, 

breast self-exam lessons 

using a breast model, 

discussion of resources for 

free- and reduced-cost 

mammograms 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

One presentation, time NR 

Length of Follow-up 

6 months 

Age (mean) 

G1: 52.5 

G2: 49.3 

Sex (% female) 

100 

Race (%) 

100% African-American 

Other 

Role of CHW in Recruiting 

and Retention 

NA 

Recruitment Rates 

NA 

Retention Rates 

NA 

C-49 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Breast self exam in past month (self-report) 

Results 

G1: 49% to 65.4% (P < 0.001 compared to baseline) 

G2: 65% to 72% (P = NS compared to baseline) 

Measure 2 

Regular practice of breast self-exam (self-report) 

Results 

Baseline 

G1: 69.8% to 82% (P = NS compared to baseline) 

G2: 82% to 82% (P < 0.005 compared to baseline) 

Measure 3 

Ever had mammography (self-report) 

Results 

G1: 52.4% to 64.4% (P < 0.05 compared to baseline) 

G2: 60.4% to 63.3% (P = NS compared to baseline) 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

Through use of 

community churches 

and cancer survivors, 

breast cancer 

screening activities can 

be improved in this 

population 

Quality Rating 

Fair 

C-50 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Forst et al., 2004 

Trial Name 

NR 

Objective or Aim 

Evaluate CHW 

model to reduce 

eye injuries and 

illnesses in Latino 

migrant and 

seasonal 

farmworkers 

Geography 

SE Michigan, 

northern Illinois 

Organization 

Latino migrant and 

seasonal farm 

workers 

Type of 

Community 

Farm workers; high 

incidence of eye 

injury 

Study Design 

Prospective cohort 

Start Date 

2001 

Duration 

16 wk 

Eligible (N) 

36 farms, total workers NR 

Enrolled (N) 

34 farms, 1,000 workers 

Randomized (N) 

786 

Completers (N) 

703 

Withdrawals or Dropouts (N) 

83 

Health Condition of Interest 

Eye injury 

Inclusion Criteria 

Farm owners' consent 

Exclusion Criteria 

NR 

Groups 

G1: CHW + protective eyewear + 

training + information sheet 

G2: CHW + eyewear + information 

sheet 

G3: Eyewear + information sheet 

Interventions 

G1: CHW worked w/ subjects, 

trained subjects on eye health and 

safety (minimum of 2 training 

sessions = 1 individual + 1 group) 

G2: CHW distributed eyewear w/o 

additional training 

G3: Research team distributed 

eyewear w/o additional training 

Group (N) 

G1: 256 (141 IL, 115 MI) 

G2: 298 (179 IL, 119 MI) 

G3: 149 (78 IL, 71 MI) 

Title of CHW 

Promotor de salud 

Paid or Volunteer 

NR 

Relationship with 

Community 

Actively employed farm 

workers; Spanish fluency 

CHW (N) 

16 

Supervision of CHW 

Weekly with promotorcoordinators from study 

team 

Prior Training 

Demonstrated leadership 

and communication skills; 

demonstrated respect for 

farm workers and owners 

Type of Service 

G1: CHW worked w/ 

subjects, trained subjects 

on eye health and safety 

G2: CHW distributed 

eyewear w/o additional 

training 

Type of Educational 

Materials Used 

G1: Trainer training; 

reference manual on 

agricultural eye illness 

and injury; photos and 

fotonovelas; tool kit to 

demonstrate eye injuries 

and hazards 

Duration of Interaction 

with Clients 

G1: At least 1 individual 

and at least 1 group 

session during farming 

season (duration per 

session NR) 

Length of Follow-up 

16 wk 

Age (mean) 

G1: 33.5 

G2: 32.4 

G3: 32.8 

Sex (% female) 

G1: 24 

G2: 19 

G3: 15 

Race (%) 

90% Mexican 

10% Mexican-American 

Other 

• Read Spanish: 77% 

• < 8 y school: 75% 

• < 4 y school: 25% 

• Read English: 16% 

Role of CHW in Recruiting 

and Retention 

G1: Recruited and worked 

alongside subjects, 

collected data 

G2: Recruited, collected 

data 

Recruitment Rates 

786/1000 = 78.6% 

Retention Rates 

G1: 67/186 = 36% 

G2: 172/198 = 87% 

G3: 76/107 = 71% 

C-51 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

Measure 1 

Pre/post change in % 

wearing safety glasses 

Results 

Self-report: 

G1: 1.48 (P < .0001) 

G2: 0.71 (P < .0001) 

G3: 0.96 (P < .0001) 

G1-G2 P < .0001 

G1-G3 P = .03 

G1and 2-G3 P = .0004 

Observed: 

G1: 1.1→36% 

G2: 0→5.2% 

G3: 0→14%) 

Measure 2 

Pre/post subject risk 

perception of eye injury 

Results 

Results not interpretable 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Cumulative number of eye injuries for season 

Results 

IL 11 cases pterygium; MI 4 (both likely underreported) 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

CHW intervention 

increased reported and 

observed use of 

protective eyewear, 

more so with 

associated training 

Quality Rating 

Poor 

C-52 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Frate et al., 1985; 

Frate et al., 1983 

Trial Name 

NR 

Objective or Aim 

Evaluation of 

different 

interventions to 

contol hypertension 

in a rural setting 

Geography 

Central Mississippi 

Organization 

Cultural 

Type of 

Community 

Hypertension and 

rural community 

Study Design 

Observationalquasi-experimental 

Start Date 

Early 1980's 

Duration 

18 months 

Eligible (N) 

NR 

Enrolled (N) 

NR 

Randomized (N) 

NA 

Completers (N) 

667 

Withdrawals or Dropouts (N) 

NR 

Health Condition of Interest 

Hypertension 

Inclusion Criteria 

Patients with physician confirmed 

hpertension 

Exclusion Criteria 

NA 

Groups 

G1: Hypertension Health Counselors

G2: Family based self help 

G3: Church based self help 

Interventions 

Group (N) 

G1: 207 

G2: 131 

G3: 229 

Title of CHW 

Hypertension Health 

Counselors 

Paid or Volunteer 

Volunteer 

Relationship with 

Community 

Native 

CHW (N) 

5 

Supervision of CHW 

NR 

Prior Training 

Certified and equipped to 

measure blood pressure 

Type of Service 

Monitoring BP, education 

and support 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

Monthly visits over 18 

months (time per session 

NR) 

Length of Follow-up 

18 months 

Age (mean) 

NR 

Sex (% female) 

NR 

Race (%) 

NR 

Other 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-53 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Proportion controlled 

Results 

G1: 80.6% 

G2: 90.0% 

G3: 79.9% 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Extra Poor! 

C-54 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Gielen et al., 2002 

Trial Name 

NA 

Objective or Aim 

Present results of 

an intervention trial 

to enhance 

parents' homesafety practices 

through pediatric 

safety counseling, 

home visits and an 

on-site children's 

safety center 

where paretns 

receive 

personalized 

education and can 

purchase reducedcost products 

Geography 

NR (probably 

Baltimore, MD) 

Organization 

Pediatric resident 

continuity clinic in 

large, urban 

teaching hospital 

Type of 

Community 

Same 

Study Design 

RCT 

Start Date 

NR 

Duration 

18 months 

Eligible (N) 

43 first- and second-year residents; 

305 patients' parents 

Enrolled (N) 

39 residents; 187 families 

Randomized (N) 

39 residents; 187 families 

Completers (N) 

122 families 

Withdrawals or Dropouts (N) 

11 became ineligible, 

15 refused further contact, 

39 unable to contact 

Health Condition of Interest 

Pediatric safety 

Inclusion Criteria 

• Residents: all first- and secondyear resdients 

• Parent-patient dyads of 

participating residents were then 

approached in clinic waiting room 

- elgibiliy criteria included infants 6 

mos or younger, free of serious 

medical problems, caretakers 

were english-speaking and lived 

with child 

Exclusion Criteria 

See prior 

Groups 

G1: Standard intervention 

G2: Enhanced intervention 

Interventions 

Both groups of pediatric residents 

invited to attend 1-hour seminar on 

problme of injuries; both groups 

received 5-hr EAG training program 

G1: received safety counseling and 

referral to children's safety center 

from their pediatrician 

G2: received standard services plus 

"offer of" a home-safety visit from 

a CHW 

Group (N) 

G1: 20 residents, 93 parents 

G2: 19 residents, 94 parents 

Title of CHW 

CHW 

Paid or Volunteer 

NR 

Relationship with 

Community 

NR 

CHW (N) 

NR 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Home visits between 6 and 

9 mo well child checks: 

assessed injury hazards; 

made recommendations 

about appropriate safety 

products and practices; 

referred families to CSC 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

1 home-safety visit 

sometime between 

patient’s 6- and 9-month 

well-infant visits (duration of 

session NR) 

Length of Follow-up 

NA 

Age (mean) 

Mean age of mother = 24 

years 

Sex (% female) 

Parents 98% female 

Race (%) 

94% AA 

Other 

NR 

Role of CHW in Recruiting 

and Retention 

NA 

Recruitment Rates 

NA 

Retention Rates 

NA 

C-55 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

Measure 1 

Poisons kept latched or 

locked 

Results 

G1: 12% 

G2: 10% 

P-value not reported 

Measure 2 

Presence of ipecac 

Results 

G1: 27% 

G2: 31% 

P-value NR 

Quality of Life: 

Measure 1 

Hot water ≤ 48.9 C 

Results 

G1: 47% 

G2: 47% 

P-value NR 

Measure 2 

Working smoke alarm 

Results 

G1: 84% 

G2: 81% 

P-value NR 

Measure 3 

Stairs protected by gate or 

door, 

Results 

G1: 23% 

G2: 27% 

P-value NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Fair 

C-56 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Graham et al., 

1992 

Trial Name 

NR 

Objective or Aim 

Prevention of low 

birth weight using 

home intervention 

Geography 

Cleveland 

Organization 

Organizational 

clinic-derived 

sample 

Type of 

Community 

Inner city black 

Study Design 

RCT 

Start Date 

1987 

Duration 

NR 

Eligible (N) 

190 145 (190 total used to validate 

instrument, but some were ineligible 

at > 28 wk) 

Enrolled (N) 

145 

Randomized (N) 

87 in experimental group, 

145 overall 

Completers (N) 

52 in experimental group 110 total 

Withdrawals or Dropouts (N) 

35 out of 87 in experimental group 

Health Condition of Interest 

Low birth weight 

Inclusion Criteria 

• Black 

• Between 17th and 28th week of 

gestation 

• Low family functioning score 

• At least 1 stressful life event prior 

to registration 

• Registering at study clinic during 

specified period 

Exclusion Criteria 

• Living > 5 mi from clinic 

• Limited reading ability 

Groups 

G1: Experimental 

G2: Control 

Interventions 

G1: Experimental - 4 home visits 

G2: Control 

Group (N) 

G1: Experimental- 87 

G2: Control - 58 

Title of CHW 

Home visitors 

Paid or Volunteer 

NR 

Relationship with 

Community 

Shared race and gender 

having children of their own

CHW (N) 

2 

Supervision of CHW 

NR 

Prior Training 

motherhood 

Type of Service 

Home visits: psychosocial 

support to patient and 

encouragement to family to 

be supportive of pregnancy, 

accomplished through 

education about pregnancy 

and encouragement of 

significant others to attend 

home visits, clinic visits, 

clinic 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

4 visits (1 hour each) at 2-4 

week intervals for 2 to 5 

months (until birth of child) 

Length of Follow-up 

Birth of child 

Age (mean) 

24 y 

Sex (% female) 

100 

Race (%) 

Black 100% 

Other 

• 38% primiparous 

• 11% married 

• 84% receiving Medicaid 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

• 1326 screened 

• 190 high-risk 

• 145 randomized 

Retention Rates 

G1: 52/87 completed all 4 

visits (60%) 

G2: 100% (only birth 

information needed for 

this group) 

C-57 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

LBW rate 

Results 

G1: (All): 12.9% (P = 0.51) 

G1: (Completers): 7.7% (P = 0.98) 

G2: 7.5% 

Healthcare Utilization: 

Measure 1 

Ratio of actual:expected prenatal clinic visits 

Results 

G1 (All): 1.12 (SD 0.48, P = 0.029) 

G1 (Completers): 1.17 (SD 0.46, P = 0.007) 

G2: 0.93 (SD 0.44) 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

CHW home visits 

increased utilization of 

prenatal clinic care, but 

had no effect on LBW 

incidence 

Quality Rating 

Fair 

C-58 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Hiatt et al., 2008 

Trial Name 

Breast and 

Cervical cancer 

Intervention Study 

(BACCIS) 

Objective or Aim 

Effect of Breast 

and Cervical

Cancer 

Intervention Study 

(BACCIS), a multicomponent 

intervention

conducted in San 

Francisco Bay 

Area between 1992 

and 1997. 

Geography 

San Francisco, CA 

Organization 

Hospital 

Type of 

Community 

Income, 

Neighborhood 

Study Design 

Modified 2x2 

design in 8 

neighborhoods 

Start Date 

1993 

Duration 

4 years 

Eligible (N) 

25,000 

Enrolled (N) 

NA 

Randomized (N) 

NA 

Completers (N) 

1,616 

Withdrawals or Dropouts (N) 

NR 

Health Condition of Interest 

Cancer 

Inclusion Criteria 

Women living in area of interest 

Exclusion Criteria 

NR 

Groups 

G1: Intervention 

G2: Control 

Interventions 

G1: one-on-one visits at various 

events and locations; presentations 

to community-based organizations 

(agencies); and Women’s Health 

Days, offering free mammograms, 

Pap tests, and breast selfexamination instruction. 

G2: Control 

Group (N) 

G1: 801 

G2: 798 

Title of CHW 

Lay health workers 

Paid or Volunteer 

Paid 

Relationship with 

Community 

Locally recruited 

CHW (N) 

NR 

Supervision of CHW 

NR 

Prior Training 

Intensively trained in basic 

breast and cervical cancer 

biology, screening and 

treatment, and availability 

of health care and 

screening services 

Type of Service 

Support and information 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

Unspecified # of 

interactions (length per 

session NR) over 2 years 

Length of Follow-up 

4 years 

Age (mean) 

~60% > 50 yrs 

Sex (% female) 

100 

Race (%) 

White: 31 

Black: 30 

Latina: 14% Latina 

Chinese: 17% 

Other: 7% 

Other 

NR 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-59 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

Measure 1 

Ever completed breast selfexamination (Total N [%] 

pretest/Total N [%] posttest) 

Results 

G1: 800 (89)/810 (92) 

Χ2

 = NR, P=0.031 

G2: 793 (83)/ 802(81) 

Χ2 = NR, not significant 

Measure 2 

Completed breast selfexamination monthly in past 

year (Total N [%] 

pretest/Total N [%] posttest) 

Results 

G1: 800 (24)/808 (26) 

Χ2

 = NR, not significant 

G2: 793 (18)/ 801(23) 

Χ2 = NR, P=0.018 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

Measure 1 

Ever completed mammography (Total N [%] 

pretest/Total N [%] posttest) 

Results 

G1: 798 (83)/812 (86) 

Χ2

 = NR, not significant 

G2: 798 (68)/ 803 (77) 

Χ2 = NR, P=0.001 

Measure 2 

Ever completed mammography (logistic regression, 

95% CI) 

Results 

Residence in outreach area over time: 0.7 (0.5, 1.0) 

Measure 3 

Completed mammography in the past 2 years (Total N 

[%] pretest/Total N [%] posttest) 

Results 

G1: 798 (73)/812 (71) 

Χ2

 = NR, not significant 

G2: 798 (57)/ 803 (62) 

Χ2

 = NR, P=0.022 

Measure 4 

Completed mammography in past 2 years (logistic 

regression, 95% CI) 

Results 

Residence in outreach area over time: 0.7 (0.5, 1.0) 

Measure 5 

Completed 3 or more mammographies in past 5 years 

(Total N [%] pretest/Total N [%] posttest) 

Results 

G1: 794 (50)/812 (51) 

Χ2

 = NR, not significant 

G2: 794 (35)/ 803 (41) 

Χ2

 = NR, P=0.008 

Measure 6 

Completed 3 mammographies in past 5 years (logistic 

regression, 95% CI) 

Results 

Residence in outreach area over time: 0.8 (0.5, 1.1) 

Measure 7 

Ever completed clinical breast examination (Total N [%] 

pretest/Total N [%] posttest) 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Fair 

C-60 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Hiatt et al., 2008 

(continued) 

C-61 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Results 

G1: 801 (94)/812 (95) 

Χ2

 = NR, not significant 

G2: 798 (82)/ 803 (87) 

Χ2

 = NR, P=0.006 

Measure 8 

Completed clinical breast examination in past year 

(Total N [%] pretest/Total N [%] posttest) 

Results 

G1: 800 (75)/809 (74) 

Χ2

 = NR, not significant 

G2: 796 (56)/ 803 (60) 

Χ2 = NR, not significant 

Measure 9 

Completed 3 or more clinical breast examinations in 

past 5 years (Total N [%] pretest/Total N [%] posttest) 

Results 

G1: 793 (73)/809 (73) 

Χ2

 = NR, not significant 

G2: 792 (54)/ 800 (54) 

Χ2 = NR, not significant 

Measure 10 

Ever completed pap smear (Total N [%] pretest/Total N 

[%] posttest) 

Results 

G1: 801 (95)/812 (96) 

Χ2

 = NR, not significant 

G2: 798 (83)/ 801 (87) 

Χ2 = NR, P=0.021 

Measure 11 

Ever completed Pap smear (logistic regression, 95% 

CI) 

Results 

Residence in outreach area over time: 1.5 (0.6, 4.2) 

Measure 12 

Completed pap smear in past 3 years (Total N [%] 

pretest/Total N [%] posttest) 

Results 

G1: 799 (84)/811 (87) 

Χ2

 = NR, not significant 

G2: 798 (69)/ 801 (75) 

Χ2

 = NR, P=0.009 

Measure 13 

Completed Pap smear in the past 3 years (logistic 

regression, 95% CI) 

Results 

Residence in outreach area over time: 0.9 (0.6, 1.3) 

C-62 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline Characteristics 

Recruiting and Retention 

Author Year 

Hunter et al., 2004 

Trial Name 

NR 

Objective or Aim 

Test effectiveness 

of a CHW 

(promotora) 

program to 

increase 

compliance with 

annual preventive 

exams among 

uninsured Hispanic 

women, aged 40 

and older, living at 

US-Mexico border 

Geography 

US-Mexico border 

communities: 

Douglas, Arizona - 

16,500 residents 

Organization 

cultural/community 

Type of 

Community 

Latina women 

Study Design 

RCT 

Start Date 

1999 

Duration 

1 year 

Eligible (N) 

151 

Enrolled (N) 

103 

Randomized (N) 

101 

Completers (N) 

98 

Withdrawals or Dropouts (N) 

3 

Health Condition of Interest 

Preventive care - Women's health 

Inclusion Criteria 

• Aged 40 or older 

• Residents of household 

• Not pregnant 

• At least 2 months postpartum 

• US women who participated in an 

initial comprehensive clinical 

exam 

Exclusion Criteria 

Groups 

G1: Postcard 

G2: Promotora 

Interventions 

G1: received postcards in mail 2 

weeks before month their annual 

exams were due, printed in 

language used to complete 

original questionnaire 

G2: Received postcard reminders 

and were visited by promotora 2 

weeks after postcard had been 

mailed. Promotora facilitated 

appointment scheduling, 

contacted them to facilitate 

rescheduling if appt was missed. 

Group (N) 

G1: 50 

G2: 51 

Title of CHW 

Promotora 

Paid or Volunteer 

NR 

Relationship with 

Community 

NR 

CHW (N) 

NR 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Home visits; telephone 

calls to facilitate appt 

scheduling for annual 

preventive exams 

Type of Educational 

Materials Used 

None 

Duration of Interaction 

with Clients 

One initial home visit and 

one final follow-up visit 8 

weeks after postcard 

mailing to begin 

intervention(time per 

session NR) 

Length of Follow-up 

NA 

Age (mean) 

50.3 years 

Sex (% female) 

100 

Race (%) 

96% Hispanic 

Other 

• Born in Mexico: 86% 

• Blow federal poverty line: 76% 

• Less than hs education: 77% 

Role of CHW in Recruiting and 

Retention 

NA 

Recruitment Rates 

NA 

Retention Rates 

NA 

C-63 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Measure 3 

Healthcare Utilization: 

Measure 1 

Returned to clinic for a second comprehensive annual 

exam 

Results 

G1: 48% (n = 24) 

G2: 65% (n = 33) 

RR, 1.35, 95% CI, 0.95-1.92 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Fair 

C-64 
Evidence Table C-1. Key Questions 1, 2, and 3 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Jandorf et al., 2005 

Trial Name 

NR 

Objective or Aim 

To determine 

whether a patient 

navigator (PN) 

would enhance 

CRC screening 

participation 

beyond physician 

recommendation 

alone in a 

neighborhood 

healthcare setting. 

Geography 

East Harlem, NYC 

Organization 

Inner city primary 

care practice 

Type of 

Community 

NR 

Study Design 

RCT 

Start Date 

2002 

Duration 

6 months 

Eligible (N) 

125 

Enrolled (N) 

NR 

Randomized (N) 

78 

Completers (N) 

78 

Withdrawals or Dropouts (N) 

0 

Health Condition of Interest 

Colorectal cancer 

Inclusion Criteria 

Men and women ≥ 50 yrs of age 

Exclusion Criteria 

FOBT within past yr; FS or barium 

enema within past 3-5 yrs; 

colonoscopy within past 10 yrs 

Groups 

G1: Patient navigator 

G2: Usual care 

Interventions 

G1: Navigated 

G2: Not navigated 

Group (N) 

G1: 38 

G2: 40 

Title of CHW 

Patient Navigator 

Paid or Volunteer 

Paid 

Relationship with 

Community 

Shared community & ethnic 

background 

CHW (N) 

1 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Assistance with completing 

screening process including 

written and telephone 

reminders, scheduling & 

assistance; education; 

support and advocacy 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

Telephone calls 

(unspecified #, unspecified 

length) over 6 month period

Length of Follow-up 

6 months 

Age (mean) 

G1: 61.1 

G2: 61.2 

Sex (% female) 

G1: 76.3 

G2: 72.5 

Race (% Hispanic) 

G1: 78.9 

G2: 85.0 

Other 

G1: 

Income ≤$10,000: 72.2%

≥ HS education: 13.2% 

Had family history of 

cancer: 36.8% 

G2: 

Income ≤$10,000: 64.1%

≥ HS education:10.0% 

Had family history of 

cancer: 38.5% 

Role of CHW in Recruiting 

and Retention 

PN approached prospective 

participants 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-65 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

Measure 1 

Completed FOBT after 3 months (% yes) 

Results 

G1: 42.1 

G2: 25.0 

P = 0.086 

Measure 2 

Had endoscopy appointment at 3 months (%) 

Results 

G1: 18.4 

G2: 0 

P = 0.005 

Measure 3 

Completed endoscopy at 3 months (%) 

Results 

G1: 15.8 

G2: 5.0 

P = 0.115 

Measure 4 

Completed endoscopy at 6 months (%) 

Results 

G1: 23.7 

G2: 5.0 

P = 0.019 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Fair 

C-66 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline Characteristics 

Recruiting and Retention 

Author Year 

Korfmacher et al., 

1999; 

Olds et al., 2002; 

Olds et al., 2004; 

Trial Name 

Home Visitation 

2000 

Objective or Aim 

Examine 

differences 

between CHWs 

and nurses in using 

home visitation to 

reduce incidence of 

child maltreatment; 

to examine distal 

effects of prenatal 

and infancy home 

visiting by CHWs 

or nurses, at 2-4 

y/o 

Geography 

Denver 

Organization 

Recruited from 

prenatal clinics 

Type of 

Community 

Low-income 

Study Design 

RCT 

Start Date 

1994 

Duration 

15 mo 

Eligible (N) 

1178 

Enrolled (N) 

735 

Randomized (N) 

735 

Completers (N) 

560 

Withdrawals or Dropouts (N) 

175 (n at 24 month assessment), 

130 (n at 4 year assessment) 

Health Condition of Interest 

Child maltreatment; maternal and 

child health 

Inclusion Criteria 

Pregnant; Medicaid-qualified or no 

private insurance 

Exclusion Criteria 

Previous live birth 

Groups 

G1: CHW visitation 

G2: nurse visitation 

G3: control 

Interventions 

G1: Incremental developmental 

screening and referral + CHW 

home visitations 

G2: Developmental screening and 

referral + nurse home visitations 

G3: Developmental screening and 

referral 

Group (N) 

G1: 244 

G2: 236 

G3: 255 

Title of CHW 

Paraprofessional 

Paid or Volunteer 

Paid 

Relationship with 

Community 

"Shared social 

characteristics" 

CHW (N) 

10 

Supervision of CHW 

2 LCSWs (2 supervisors to 

10 visitors) 

Prior Training 

HS education, no degree in 

"helping professions"; 

preferentially prior work 

experience in human 

services agencies 

Type of Service 

Intensive home visitation: 

promoting healthy 

behaviors, competent child 

care, pregnancy planning, 

education, employment; 

linking to social and health 

services; promoting healthy 

family/friend relationships 

Type of Educational 

Materials Used 

Visit-specific protocol, 

adapted to individual needs 

of mother 

Duration of Interaction 

with Clients 

Every other week (except 

for weekly visits during first 

4 weeks after enrollment 

and first 6 weeks after 

delivery) through child's 

21st month, followed by 

monthly visits during final 3 

months, ≈ 75 min per 

session 

Length of Follow-up 

until child 4 y/o 

Age (mean) 

G1: 19.44 

G2: 20.24 

G3: 19.70 

Sex (% female) 

100 

Race (%) 

G1: Hispanic: 45%, 

Caucasian non-Hispanic: 35%

African-American: 17% 

G2: Hispanic: 44% 

Caucasian non-Hispanic: 37% 

African-American: 16% 

G3: Hispanic: 46% 

Caucasian non-Hispanic: 35%

African-American: 16% 

Other 

G1 younger and living in denser 

households than G2 

Role of CHW in Recruiting and 

Retention 

Recruiting: NR 

Retention: emphasis on 

developing continuous 

relationship between home visitor 

and subject families 

Recruitment Rates 

62% overall 

Retention Rates 

G1: 77% 

G2: 71% 

G3: 80% 

C-67 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional Outcomes 

Knowledge, Attitude, and 

Behavior: 

Measure 1 

Content of home visit, 

pregnancy 

Results 

Personal health 

G1 27% 

G2: 38% (P < 0.001) 

Environmental health 

G1 15% 

G2: 7% (P < 0.001) 

Life course development 

G1: 15% 

G2: 14% (P < 0.05) 

Parental caregiving 

G1: 24% 

G2: 25% 

Friends/family 

G1: 19% 

G2: 15% (P < 0.001) 

Health Outcomes: 

Measure 1 

Language @ 21 mo (Preschool Lanaguge Scale) 

Results 

Least squares mean 

G1: 99.89 

G2: 101.22 

G3: 99.49 

Mean difference 

G1-G3: 0.4 (-1.94 - 2.74) 

G2-G3: 1.73 (-0.64 - 4.11) 

Least squares mean (low resource group) 

G1: 97.83 

G2: 101.52 

G3: 96.85 

Mean difference 

G1-G3: 0.98 (-2.65 - 4.62) 

G2-G3: 4.67 (0.85-8.49, 

Measure 2 

Mental development delay @ 24 mo (Mental 

Development Index) 

Results 

Least squares mean 

G1: 89.45 

G2: 90.13 

G3: 89.38 

Difference 

G1-G3: 0.07 (-2.39 - 2.53) 

G2-G3: 0.75 (-1.77 - 3.28) 

Low resource group: least squares mean 

G1: 88.54 

G2: 90.18 

G3: 86.2 

Difference 

G1-G3: 2.33 (-1.46 - 6.12) 

G2-G3: 3.98 (-0.07 - 8.02) 

G1-G2 1.26 

Measure 1 

Subsequent fertility @ 24 mo 

Results 

Pregnancy 

G1: 33% 

G2: 29% 

G3: 41% 

G1-G3: 0.7 (0.46-1.06, P < 0.1) 

G2-G3: 0.6 (0.39-0.93, P ≤ 0.05) 

G1-G2: 0.88 (0.57-1.36) 

G1-G2 (adjusted) = 0.82 (0.51-1.31) 

Costs (Economics): 

Measure 1 

Per-family cost over 2.5 years 

(inflation adjusted, 2002 dollars) 

Results 

G2: $6,162 

G3: $9,140 

Measure 3 

Average cost (including salary + 

benefits, supplies, travel, rent, 

equipment, training) over approx 

2.5 y 

Results 

G1: $5,178/family 

G2: $7,681/family 

Explanation of Overall 

Outcomes 

CHWs were more likely than 

nurses to discuss environmental 

health and friends/family, life 

course development (after 

pregnancy), and less likely to 

discuss personal health (during 

pregnancy) and parental 

caregiving (after pregnancy); 

CHWs home visits have little 

significant effect on maternal & 

infant health outcomes, except for 

improved mother-child 

interactions among low 

psychological resource 

subpopulation; CHW visits 

showed improvement over control 

in maternal health but not in child 

health; nurse visit outcomes 

generally favored child health but 

not maternal 

Quality Rating 

Fair 

Health Outcomes: 

NR

C-68 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Korfmacher et al., 

1999; 

Olds et al., 2002; 

Olds et al., 2004 

(continued) 

C-69 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional Outcomes 

Measure 3 

Mother-infant interaction 

Results 

Least squares mean 

G1: 100.15 

G2: 100.31 

G3: 98.99 

G1 vs. G3: 1.16 (-0.11 - 

2.42, P < 0.1) 

G2 vs. G3: 1.32 (0.03-2.60, 

P ≤ 0.05) 

Least squares mean 

difference G1 vs. G2 (low 

resource group) = 0.06 

(01.87 - 1.98), adjusted 0.08 

(-1.99 - 2.16) 

Quality of Life: 

Measure 1 

Home environment 

Results 

Least squares mean 

G1: 37.4 

G2: 37.79 

G3: 37.1; 

Mean difference 

G1-G3: 0.3 (-0.49 - 1.1) 

G2-G3: 0.69 (-0.12 - 1.5, P < 

0.1) 

Least squares mean 

difference (low resource 

group) 

G1-G2: 0.26 (-0.95 - 1.47), 

adjusted -0.05 (-1.35 - 1.24) 

Measure 3 

Post-intervention reductino 

in urine cotinine levels 

among smokers (ng/mL) 

Results 

G1: 89 

G2: 259 

G3: 12 (NS) 

Least squares mean 

difference G1 vs G2: 189.16 

(-51.38 - 429.69), adjusted 

266.75 (-3.34 - 536.84) 

Mean difference 

G1 vs. G3 -76.19 ng/dL 

(95% CI, -302.21,-149.82) 

G2 vs. G3 -246.68 ng/dL 

(95% CI, -466.19,-27.16) 

P ≤0.05 

Birth 

G1: 13% 

G2: 12% 

G3: 19% 

G1-G3: 0.63 (0.37-1.07, P < 0.1) 

G2-G3: 0.58 (0.33-1.01, P ≤ 0.05) 

G1-G2: 0.9 

Healthcare Utilization: 

NR 

Measure 2 

Maternal life course 

Results 

Married 

G1: 32% 

G3: 44% (P = 0.02) 

Living w/ bio father 

G1: 33% 

G3: 43% (P = 0.03) 

Working at child 2-4 y/o 

G1: 15 mo 

G3: 13 mo (P = 0.04) 

Sense of mastery 

G1: 101 

G3: 99 (P = 0.03) 

Mental health score 

G1: 101 

G2: 99 (P = 0.03) 

No G1-G3 difference on education, welfare 

Measure 3 

Mother-child interaction 

Results 

Sensitive responsive interactions during free 

play 

G1: 101 

G3: 99 (P = 0.03); no difference G2 vs G3 

Measure 4 

Home environment (Home Observation for 

Measurement of Environment inventory) 

Results 

For low psychologic resource group: 

environment supportive of early learning 

G1: 24.63 

G2: 24.61 

G3: 23.35 (G1-G3 P = 0.03 

G2-G3: P = 0.03) 

C-70 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Krieger et al., 1999 

Trial Name 

Seattle 

Hypertension 

Intervention Project 

Objective or Aim 

Determine whether 

tracking and 

outreach 

intervention 

delivered by 

community health 

workers improved 

medical follow-up 

of persons whose 

elevated blood 

pressure detected 

during blood 

pressure 

measurement at 

community sites 

Geography 

Seattle 

Organization 

Various community 

sites: social 

services agencies, 

food banks, 

shelters/missions, 

public libraries, 

grocery stores, 

community centers, 

etc. 

Type of 

Community 

Low-income 

neighborhoods 

Study Design 

RCT 

Start Date 

1994 

Duration 

28 months 

Eligible (N) 

759 

Enrolled (N) 

421 

Randomized (N) 

421 

Completers (N) 

397 

Withdrawals or Dropouts (N) 

110 

Health Condition of Interest 

Hypertension 

Inclusion Criteria 

• BP at least 140/90 

• 18+ y/o 

• Black or White race 

• Income no more than 200% FPL 

(1995) 

Exclusion Criteria 

See inclusion criteria 

Groups 

G1: Intervention 

G2: Usual care 

Interventions 

G1: CHW assistance with medical 

follow-up 

G2: advice to see medical provider, 

list of public and community 

clinics 

Group (N) 

G1: 209 

G2: 212 

Title of CHW 

Community health worker 

Paid or Volunteer 

NR 

Relationship with 

Community 

Similar income community, 

predominantly black (12/14)

CHW (N) 

14 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Medical referral, telephone 

appt scheduling, appt 

reminder letter, post-appt 

f/u, rescheduling missed 

appt, assistance with other 

barriers to care (e.g. 

transportation) 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

Various, brief interactions 

over 3 months (time per 

session NR) 

Length of Follow-up 

3 months 

Age (mean) 

24.9% < 40 y/o 

18.3% > 64 y/o 

Sex (% female) 

27.8 

Race (%) 

79.1% Black 

Other 

40% uninsured 

Role of CHW in Recruiting 

and Retention 

Providing initial BP 

measurement 

Recruitment Rates 

55.5% (421 enrolled of 759 

eligible) 

Retention Rates 

G1: 95% 

G2: 93% 

C-71 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization:

Self-report of completed f/u appt (validated by medical 

provider report) 

Results 

G1: 65.1% completed f/u within 90 days 

G2: 46.7% (P = 0.001) 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

CHW intervention was 

associated with 

significantly higher 

proportion of subjects 

completing HTN followup exam within 90 days 

Quality Rating 

Fair 

C-72 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Krieger et al., 

2002; Krieger et 

al., 200547,48

Trial Name 

Seattle-King 

County Health 

Homes Project 

(SKCHH) 

Objective or Aim 

Assess 

effectiveness of a 

CHW intervention 

focused on 

reducing 

exposure to 

indoor asthma 

triggers 

Geography 

King Co, 

Washington 

Organization 

Low income urban 

households 

Type of 

Community 

Low income urban 

households with 

child diagnosed 

with asthma 

Study Design 

RCT 

Start Date 

1999 

Duration 

1 year 

Eligible (N) 

447 

Enrolled (N) 

274 

Randomized (N) 

274 

Completers (N) 

214 

Withdrawals or Dropouts (N) 

60 

Health Condition of Interest 

pediatric asthma 

Inclusion Criteria 

A household was eligibile if: 

• home to a child 4-12 years with diagnosed 

persistent asthma 

• income < 200% of 1996 federal poverty 

threshold 

• child enrolled in Medicaid 

• caregiver verbally proficient in English, 

Spanish or Vietnamese 

• child spent ≥ 50% of nights in house 

• house was in King County. 

Exclusion Criteria 

A child with another chronic illness requiring daily 

medications; household participation in other 

asthma case management or care coordination 

programs in past 2 years; plans to leave King 

County during next 6 months 

Groups 

G1: high intensity 

G2: low intensity 

Interventions 

G1: Initial home environmental assessment and 

individualized action plans specifying 

participant and CHES actions to reduce 

household exposures. CHES made additional 

visits over 12-month period to provide 

education and social support, materials to 

reduce exposures (e.g., bedding covers, 

vacuums); free allergy testing; advocacy for 

improved housing conditions. 

G2: Single CHES visit which consisted of initial 

environmental assessment, home action plan, 

limited education, and bedding encasements 

Group (N) 

G1: 138 

G2: 136 

Title of CHW 

Community Home 

Environmental 

Specialists (CHES) 

Paid or Volunteer 

Paid 

Relationship with 

Community 

Connection to and 

understanding of 

community; shared 

ethnic, linguistic, and 

cultural background 

with project 

participants; 

recognition as a 

person who can be 

respected and trusted 

CHW (N) 

6 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

home visits 

Type of Educational 

Materials Used 

NR 

Duration of 

Interaction with 

Clients 

4 to 9 visits over 12 

months (time per 

session NR) 

Length of Follow-up 

1 year 

Age (mean) 

G1: 7.4 

G2: 7.3 

Sex (% female) 

G1: 44.2 

G2: 38.2 

Race (%) 

Non-Hispanic White 

G1: 12.3 

G2: 21.3 

Non-Hispanic AA 

G1: 31.9 

G2: 27.9 

Vietnamese 

G1: 25.4 

G2: 22.1 

Other Asian 

G1: 9.4 

G2: 5.2 

Hispanic 

G1: 17.4 

G2: 17.7 

Other 

G1: 3.6 

G2: 5.9 

Other 

Household had at 

least 1 asthma 

trigger: 75% 

Urgent health use in 

past 2 months (%) 

G1: 25.9 

G2: 21.3 

Smoker in home (%) 

G1: 39.9 

G2: 41.9 

Severe persist 

asthma 

G1: 32.6 

G2: 23.5 

Role of CHW in 

Recruiting and 

Retention 

Cannot determine 

Recruitment Rates 

NR 

Retention Rates 

G1: 80% 

G2: 76% 

C-73 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional Outcomes 

Knowledge, Attitude, and Behavior: 

Measure 1 

Behavior summary score of trigger reduction 

behaviors (vacuum and dust child's bedroom at 

least twice/2 weeks, vacuum cloth-covered 

furniture at least twice/2 weeks or remove it, use 

doormat or remove shoes, use allergy control 

covers on mattress and pillow 

Results 

Across groups comparison: GEE coefficient 

(95% CI): 0.41 (-0.13, 0.95); P = 0.141 

frequencies of actions to reduce dust exposure 

and use of bedding encasements increased 

more in high-intensity group. Kitchen ventilation 

improved more in low-intensity group. Neither 

group increased frequency of washing sheets or 

dusting nor reduced exposure to pets (although 

pet ownership was uncommon among 

participants) and smoking in home. behavior 

summary score improved in both groups, and 

across-group difference was not significant 

Quality of Life: 

Measure 1 

Pediatric Asthma Caregiver Quality of Life Scale 

(score range 1-7 with higher scores indicating 

better QoL) 

Results 

Score at exit (G1 vs. G2): 5.6 vs. 5.4 

GEE coefficient 0.58 (95% CI, 0.18, 0.99), P = 

0.005; NNT = 4.8 

ITT analysis yielded simalr results: 

improvements in QoL were greater in G1 (data 

NR, P = 0.009) 

Measure 2 

Asthma symptom days (self-reported # of 24-

hour periods during 2 weeks before interview 

with asthma symptoms: wheeze, tightness in 

chest, cough, shortness of breath, slowing down 

activities due to asthma, nighttime awakenings) 

Results 

G1 vs. G2 at exit: 3.2 vs. 3.9 

GEE coefficient -1.24 (95% CI, -2.9, 0.4), 

P = 0.138 

Health Outcomes: 

Measure 1 

Days with activity limitation/2 weeks 

Results 

Score at exit (G1 vs. G2): 1.5 vs. 1.7 

GEE coefficient -1.5 (95% CI, -2.84, -

0.15), OR 0.22 (0.06, 0.86), P = 0.29 

Measure 2 

Missed school in past 2 weeks (%) 

Results 

G1 vs. G2 at exit: 12.2 vs. 20.3 

GEE coefficient -0.77 (95% CI, -1.70, 

0.16), OR 0.46 (0.18, 1.18), P = 0.105 

Measure 3 

Urgent health services use/2 months 

(%) 

Results 

G1 vs. G2 at exit: 8.4 vs. 16.4 

GEE coefficient -0.97 (95% CI, -1.8, -

0.12), OR 0.38 (0.16, 0.89), P = 0.026; 

NNT = 12.9 

ITT analysis yielded simalr results: 

improvements in urgent health services 

were greater in G1 (data NR, P = 

0.062) 

Measure 4 

Days used controller medication/2 

weeks 

Results 

G1 vs. G2 at exit: 3.5 vs. 3.6 

GEE coefficient -1.03 (95% CI, -2.79, 

0.73), P = 0.250 

Measure 5 

Days used beta2-agonist/2 weeks 

Results 

G1 vs. G2 at exit: 4.0 vs. 4.0 

GEE coefficient -0.23 (95% CI, -1.88, 

1.42), P = 0.781 

Measure 6 

Missed work in past 2 weeks (%) 

Results 

G1 vs. G2 at exit: 11.2 vs. 13.0 

GEE coefficient 0.07 (95% CI, -0.91, 

1.0.5), OR 1.07 (0.40, 2.85), P = 0.890 

Healthcare Utilization: 

NR 

Costs (Economics): 

Measure 1 

Urgent care costs 

(hospital admissions, ER 

visits, unscheduled clinic 

visits) 

Results 

Two months before exit 

interview G1 $6301-

$8856 ($57-$80/child) 

less than G2. Estimated 

decrease in 2 month costs 

between baseline and 

exit: 

G1: $22084-$36700 

($201-$344/child) vs. 

G2: $19246-$32756 

($185-$315/child)

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Good 

Health Outcomes: 

C-74 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline Characteristics 

Recruiting and Retention 

Author Year 

Levine et al., 2003 

Trial Name 

NR 

Objective or Aim 

Compare program 

effectiveness and 

intervention 

efficacy of more 

and less intensive 

education/behavior 

interventions on 

control of SBP 

Geography 

SandtownWinchester 

Community, 

Baltimore 

Organization 

inner city 

Type of 

Community 

Urban AfricanAmerican 

Study Design 

RCT 

Start Date 

NR 

Duration 

30 months 

Eligible (N) 

817 

Enrolled (N) 

789 

Randomized (N) 

789 

Completers (N) 

471 

Withdrawals or Dropouts (N) 

318 

Health Condition of Interest 

Hypertensive heart disease 

Inclusion Criteria 

African-American adults w/ HTN 

(140+/90+) 

Exclusion Criteria 

• Terminal conditions 

• Mental impairment 

• Acute conditions precluding 

participation 

Groups 

G1: More intense intervention 

G2: Less intense intervention 

Interventions 

G1: G2 care + 5 CHW visits with BP 

measurement, addressing issues 

of BP management and access to 

medical care 

G2: CHW home visit for education, 

counseling, and referral 

Group (N) 

G1: 387 

G2: 402 

Title of CHW 

Community health worker 

Paid or Volunteer 

NR 

Relationship with 

Community 

Indigenous to community 

CHW (N) 

NR 

Supervision of CHW 

Nurse-supervised 

Prior Training 

NR 

Type of Service 

Home visits; BP 

measurement; education; 

assistance with access to 

care 

Type of Educational 

Materials Used 

Counseling; BP tracking 

card; educational pamphlet 

Duration of Interaction 

with Clients 

6 visits over 2.5 years 

(length per visit NR) 

Length of Follow-up 

40 mo 

Age (mean) 

G1: 53.8 

G2: 54.6 

Sex (% female) 

G1: 61.2 

G2: 62.5 

Race (%) 

100'% African-American 

Other 

• HS-level education: 42% 

• < HS: 45% 

• Unemployed: 32% 

• Income < $10k: 65% 

• With usual source of care: 79% 

• Uninsured: 20% 

Role of CHW in Recruiting and 

Retention 

• Initial neighborhood surveillance 

• Recruiting for individual RCT 

Recruitment Rates 

0.97 

Retention Rates 

G1: 240/387 = 62% 

G2: 231/402 = 57% 

C-75 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

BP change (unadjusted systolic/diastolic ± SE; adjusted 

systolic/diastolic ± SE) 

Results 

G1: -5.5±1.5/-4.1±0.9; 5.6±1.5/-3.8±1.0) 

G2: -3.2±1.5/-2.9±1.0; -3.3±1.5/-2.6±1.0 ) 

P < .005 for differences between baseline and followup 

for each group, no differences between groups 

Measure 2 

% with adequate HTN control ( < 140/90) 

Results 

G1: 16% → 36% 

G2: 18% → 34% 

pre/post P < .01 

group difference NS 

Measure 3 

Pre/post BP (systolic/diastolic) 

Results 

G1: 147.7/89.2 (95% CI, 145.5, 149.9 / 87.8, 90.6) →

145/86.2 (95% CI, 142.3, 147.7 / 84.2, 88.2) 

G2: 148.6/89.3 (95% CI, 146.4, 150.7 / 87.8, 90.8) →

142.1/84.7 (95% CI, 138.8, 145.4 / 82.7, 86.7) 

P < 0.05 for differences between baseline and followup 

for eachHealthcare 

Measure 4 

JNC-VI classification pre/post 

Results 

No significant differences 

Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

CHW intervention 

produced significant 

pre/post change in 

proportion of HTN 

under control in both 

arms, but no difference 

between arms; no 

significant pre vs post 

change in BP 

classification within or 

between arms; more 

intensive group had 

less favorable results 

than less intensive 

group 

Quality Rating 

Fair 

Health Outcomes: 

NR

C-76 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline Characteristics 

Recruiting and Retention 

Author Year 

Lujan; 2007 

Trial Name 

NA 

Objective or Aim 

Determine 

effectiveness of 

intervention led by 

promotoras on 

glycemic control, 

diabetes 

knowledge and 

diabetes health 

beliefs of MexicanAmericans with 

type 2 DM living on 

Texas-Mexico 

border 

Geography 

Texas-Mexico 

border city 

Organization 

Mexican 

Americans at a 

Catholic faithbased community 

clinic 

Type of 

Community 

Type 2 diabetes 

mellitus 

Study Design 

RCT 

Start Date 

NR 

Duration 

NR 

Eligible (N) 

160 

Enrolled (N) 

150 

Randomized (N) 

150 

Completers (N) 

141 

Withdrawals or Dropouts (N) 

9 

Health Condition of Interest 

Diabetes mellitus type 2 

Inclusion Criteria 

40+ years, self-reported Mexican 

American ethnicity, diagnosed with 

type 2 diabetes for at least 1 year, 

taking or having taken hypoglycemic 

agents within past 6 months, willing to 

participate, noncompletion of formal 

diabetes education program at clinic, 

ability to speak either English or 

Spanish, only 1 per household 

Exclusion Criteria 

Type 1 diabetes, younger than 40 

years, diagnosed with diabetes for 

less than 1 year, being treated for 

complciations that would interfere 

with ability to participate in classes 

Groups 

G1: Promotoras 

G2: Usual Care 

Interventions 

G1: A team of 2 promotoras delivered 

8 weekly, 2 hour participative group 

classes and follow-up to 

intervention group, using multiple 

visual audio teaching aides and 

handouts, contacted class 

participants by phone biweekly to 

answer questions, reinforce 

education, promote behavior 

change, sent postcards biweekly 

G2: Usual care by clinic staff - verbal 

information and 1 or 2 pamphlets 

on diabetes self-management 

Group (N) 

G1: 75 

G2: 75 

Title of CHW 

Community lay workers 

(promotoras) 

Paid or Volunteer 

paid 

Relationship with 

Community 

bilingual clinic employees 

CHW (N) 

NR 

Supervision of CHW 

PI attended every class 

Prior Training 

NR 

Type of Service 

Classroom: 8 weekly 2-

hour group classes; 

Biweekly Telephone calls 

Type of Educational 

Materials Used 

Developed by certified 

health educator with 

promotoras, based on 

ADA Guidelines 

Duration of Interaction 

with Clients 

8 weekly 2-hour classes + 

biweekly telephone calls 

for 8 weeks followed by 

biweekly postcards for 16 

weeks 

24 weeks total duration of 

interaction with 

participants 

Length of Follow-up 

6 months 

Age (mean) 

58 years 

Sex (% female) 

80 

Race (%) 

100% Mexican American 

Other 

• Without health insurance: 68% 

• Preferred to speak Spanish: 97%

• Catholic: 74% 

Role of CHW in Recruiting and 

Retention 

Unclear 

Recruitment Rates 

NA 

Retention Rates 

G1: 71 

G2: 70 (at 6 months) 

C-77 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

Measure 1 

Bilingual DKQ - validated: 24 

itms designed for Mexican 

Americans and elicits 

information about 

respondent's understanding 

of cause of diabetes, types 

of diabetes, selfmanagement skills, and 

complications of diabetes 

Results 

Baseline/ 6 months (SD): 

G1: 69.1 (13.6)/77.2 (14.4) 

G2: 66.9 (15.2)/65.1 (21.0) 

(P < .002 for mean change 

between groups) 

Measure 2 

Diabetes Health Belief 

Measure (DHBM) 

Results 

Baseline(SD)/6 

months(SD): 

G1: 56.4(12.2)/54.6(8.4) G2: 

57.0(10.6)/50.8(13.6) Mean 

change between groups: P < 

0.01 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

HgbA1c 

Results 

Baseline(SD)/6 months(SD): 

G1: 8.21(2.2)/7.76(1.87) 

G2: 7.71(1.47)/8.01(1.8) 

Mean change between groups: P < 0.001 

Measure 3 

HgbA1c - validated 

Results 

At 6 months: 

G1: 7.76 

G2: 8.01 (P < .001) 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Good 

C-78 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Mock et al., 2007 

Trial Name 

Vietnamese 

REACH for Health 

Initiative 

Objective or Aim 

Increase cervical 

cancer screening 

rates 

Geography 

Santa Clara 

County, CA 

Organization 

Commnity 

Type of 

Community 

Vietnamese 

American women 

Study Design 

RCT 

Start Date 

2001 

Duration 

3 years 

Eligible (N) 

NR 

Enrolled (N) 

1005 

Randomized (N) 

NR 

Completers (N) 

968 

Withdrawals or Dropouts (N) 

37 

Health Condition of Interest 

Pap screening 

Inclusion Criteria 

• Vietnamese American 

• Female 

• ≥18 years 

• Living in Santa Clara County 

Exclusion Criteria 

NR 

Groups 

G1: CHW + media 

G2: media only 

Interventions 

G1: CHW small group meetings, 

direct contact with subjects, 

Vietnamese language ads for 

TV/radio/newspaper, booklets and 

printed materials in various 

community locations 

G2: Vietnamese language ads for 

TV/radio/newspaper, booklets and 

printed materials in various 

community locations, delayed 

educational session 

Group (N) 

G1: 491 

G2: 477 

Title of CHW 

Lay health worker 

Paid or Volunteer 

Paid, $1500 

Relationship with 

Community 

Shared race/ethnicity, 

physical community 

CHW (N) 

50 

Supervision of CHW 

Non clinician 

Prior Training 

NR 

Type of Service 

Small group gatherings, 

direct contacts to help 

access medical services 

and schedule appts 

Type of Educational 

Materials Used 

Prepared presentation with 

flip chart, QandA 

Duration of Interaction 

with Clients 

2 sessions of 90 or 120 

minutes each plus 

individual contacts over 3 to 

4 months 

Length of Follow-up 

3-4 months 

Age (mean) 

G1: 45.7 

G2: 46.0 

Sex (% female) 

G1: 100 

G2: 100 

Race (%) 

Vietnamese 100 

Other 

Mean years in US 

G1: 8.92 

G2: 9.23 

Self-rated speaking English 

poorly/not at all 

G1: 56.3% 

G2: 57.7% 

 > HS education 

G1: 57.5% 

G2: 54.8% 

Married 

G1: 61.3% 

G2: 64.3% 

Employed 

G1: 26% 

G2: 27.1% 

Role of CHW in Recruiting 

and Retention 

CHW recruited subjects from 

within her own social 

network 

Recruitment Rates 

G1: 100% 

G2: 100% 

Retention Rates 

G1: 97.8% 

G2: 94.8% 

C-79 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

Measure 1 

Reported awareness of need 

for Pap by women 18+ y/o 

Results 

G1: 68.4→93.9% (P < 

0.001) 

G2: 68.5→70.2% (P = 0.55); 

Z-test P < 0.001) 

Measure 2 

Reported awareness of need 

for pap test by women 18+ 

years old 

Results 

G1: 81.8%/99.6% (P < 

0.001) 

G2: 87.2%/95.2% (P < 

0.001) 

Z-test P < 0.001 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

Measure 1 

Self-report of Pap in past year 

Results 

G1: 45.7→67.3% (P < 0.001) 

G2: 50.9→55.7% (P = 0.035); Z test P < 0.001 

Measure 2 

Ever had Pap test (among those who had not had Pap 

test preoutreach) 

Results 

G1: 46.0 (N = 144) 

G2: 27.1 P < .001 (N = 161) 

Measure 3 

Self-report of having ever had Pap 

Results 

G1: 65.8→81.8% (P < 0.001) 

G2: 70.1→75.5 (P < 0.001); Z test P = 0.001 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

CHW + media 

intervention 

significantly increases 

understanding of and 

utilization of Pap 

compared to media 

intervention alone 

Quality Rating 

Fair 

C-80 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Morisky et al., 

2002; 

Ward et al., 2000 

Trial Name 

Community 

Hypertension 

Intervention Project 

(CHIP) 

Objective or Aim 

Develop effective 

strategies for 

enhancing 

treatment 

adherence for 

hypertensive 

minority 

populations 

Geography 

Large West Coast 

city 

Organization 

County medical 

center 

Type of 

Community 

Low-income, innercity Blacks and 

Hispanics 

Study Design 

RCT 

Start Date 

NR 

Duration 

4 years 

Eligible (N) 

NR 

Enrolled (N) 

1367 

Randomized (N) 

1367 

Completers (N) 

NR 

Withdrawals or Dropouts (N) 

NR 

Health Condition of Interest 

Hypertension 

Inclusion Criteria 

Adult w/ diagnosis of HTN attending 

county hospital clinic or private 

health clinic 

Exclusion Criteria 

NR 

Groups 

G1: Individualized CHW pt 

counseling 

G2: Appt tracking 

G3: CHW home visits + voluntary 

discussion group attendance 

G4: Usual care 

Interventions 

G1: CHW post-clinic appt counseling 

session 

G2: Appt reminder cards and phone 

calls 

G3: Home visits by CHW 

G4: Standard clinic care 

Group (N) 

G1: 330 

G2: 328 

G3: 333 

G4: 328 

Title of CHW 

Community health worker 

Paid or Volunteer 

NR 

Relationship with 

Community 

Same ethnic group as 

patient, language 

concordant 

CHW (N) 

NR 

Supervision of CHW 

NR 

Prior Training 

1 month interview training 

program 

Type of Service 

Counselling after clinic 

visits, or home visits 

Type of Educational 

Materials Used 

Education on treatment, 

lifestyle modification info, 

info on community 

resources 

Duration of Interaction 

with Clients 

G1: 5-10 min after each 

clinic visit 

G3: variable 

Number of visits, 

duration per session, 

time period over which 

interactions occurred 

NR 

Length of Follow-up 

12 mo 

Age (mean) 

53.5 (SD 12.0) 

Sex (% female) 

59.2 

Race (%) 

Black: 77% 

Hispanic: 21% 

Other 

• < HS education: 49% 

• Married: 33% 

• Income < $14k/y: > 87% 

• Public insurance: 54% 

• Uninsured: 30% 

Role of CHW in Recruiting 

and Retention 

Interviews with new 

enrollees 

Recruitment Rates 

 > 98% overall 

Retention Rates 

NR 

C-81 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

BP Control 

Results 

G1: 35.2% @ baseline, 

46% @ 6 and 12 mo (P < 0.01) 

G2: 40.2% @ baseline 

42% @ 6 mo 

48% @ 12 mo (P < 0.01) 

G3: 29.7% @ baseline 

 %NR but “improved” @ 6 & 12 mo 

G4: 36.9% @ baseline 

 % NR but “improved” 

No significant differences vs. control - all groups 

improved 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Poor 

C-82 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Nacion et al., 2000 

Trial Name 

REACH-Futures 

Objective or Aim 

Can maternal-child 

health advocates, 

working with 

professional 

nurses, provdie 

health screening, 

problem 

identification, self 

and infant care 

information, and 

referrals in a safe 

manner? 

Geography 

Chicago 

Organization 

inner city 

Type of 

Community 

Predominantly 

African-American 

and Latino 

Study Design 

Retrospective 

cohort 

Start Date 

1992 

Duration 

32 mo 

Eligible (N) 

218 

Enrolled (N) 

213 

Randomized (N) 

213 

Completers (N) 

213 

Withdrawals or Dropouts (N) 

0 

Health Condition of Interest 

Maternal and child health 

Inclusion Criteria 

Home visit accomplished by CHW 

with validating follow-up by nurse 

Exclusion Criteria 

Visit conducted by CHW + nurse 

together 

Groups 

G1: CHW visit 

G2: nurse visit 

Interventions 

NR 

Group (N) 

G1: 213 

G2: 213 

Title of CHW 

Maternal-Child Health 

Advocate 

Paid or Volunteer 

Paid 

Relationship with 

Community 

Within community, minority 

CHW (N) 

11 

Supervision of CHW 

Validation by nurse after 

each visit 

Prior Training 

Minimum HS or GED; 

experience in community 

service 

Type of Service 

Intensive home visits for 

assessment, problem 

solving, emotional support, 

and information 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

NR 

Length of Follow-up 

NR 

Age (mean) 

58% 20+ y/o 

Sex (% female) 

100 

Race (%) 

• African-American: 90% 

• Latina: 9% 

Other 

• < HS education: 51% 

• Gravida-1: 53% 

Role of CHW in Recruiting 

and Retention 

NA - CHW visits were unit of 

analysis 

Recruitment Rates 

NA - CHW visits were unit of 

analysis 

Retention Rates 

NA - CHW visits were unit of 

analysis 

C-83 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

Measure 1 

Agreement in identifying problems 

Results 

CHW more likely to identify problems in woman's health 

(P =0.01), well child health care deficits (P = 0.02), 

parenting (P = 0.02), socioeconomic (P < 0.01); most 

visits identified no problems 

Measure 2 

Agreement in placing referrals 

Results 

Nurse more likely to make referrals for woman's health 

(P = 0.01), well woman (P = 0.02), 

emotional/interpersonal, parental support, and 

socioeconomic (P < 0.01); most visits involved no 

referrals 

Measure 3 

Services provided (per completed Maternal-Child 

Activity form) 

Results 

Problem solving 

G1: 16% 

G2: 7% (P < 0.01) 

Emotional support 

G1: 4% 

G2: 14% (P < 0.01) 

Assessment, information: 

No difference between groups 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

• CHW and nurse 

home visits were 

comparable in most 

regards 

• CHW more likely to 

identify problems and 

provide problem 

solving 

• Nurse more likely to 

provide referrals and 

emotional support 

Quality Rating 

Fair 

C-84 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Navarro et al., 

1998; 

Navarro et al., 

1995; 

Navarro et al., 

2000 

Trial Name 

Por La Vida Damos 

Cuenta Program 

Objective or Aim 

To describe impact 

of intervention 

known as Por La 

Vida (PLV) on 

cancer screening 

for Latinas in San 

Diego, California 

Geography 

Southeast area of 

San Diego County, 

CA 

Organization 

Low-income Latino 

communites 

Type of 

Community 

Low-income Latino 

women 

Study Design 

RCT 

Start Date 

NR 

Duration 

NR 

Eligible (N) 

NR 

Enrolled (N) 

512 

Randomized (N) 

512 

Completers (N) 

365 

Withdrawals or Dropouts (N) 

147 

Health Condition of Interest 

Breast and cervical cancer 

Inclusion Criteria 

Part of social network of consejeras 

recruiting participants. No other 

inclusion criteria reported. 

Exclusion Criteria 

NR 

Groups 

G1: Lower intensity CHW 

intervention 

G2: Higher intensity CHW 

intervention 

Interventions 

G1: CHW delivering Community 

Living Skills sessions, details NR 

G2: CHW delivering Cancer 

education sessions, 12 weekly 

group sessions conducted over 3-

months plus 2 additional sessions 

offered within a year of beginning 

of group meetings 

Group (N) 

G1: 18 consejeras, 238 women 

G2: 18 consejeras, 274 women 

Title of CHW 

Consejeras 

Paid or Volunteer 

NR 

Relationship with 

Community 

Member of Latino 

community perceived, as 

"natural helpers" by 

community 

CHW (N) 

36 

Supervision of CHW 

Yes--"unobtrusive 

observations" of ongoing 

sessions and debriefing 

sessions with consejeras 

each month by PLV "staff" 

but no reporting of who 

these staff members are 

Prior Training 

NR 

Type of Service 

Small group educational 

sessions 

Type of Educational 

Materials Used 

Pamphlets, work sheets, 

posters, plastic models of 

female body, pelvic models 

Duration of Interaction 

with Clients 

12 sessions of 90 minutes 

each over 3 months 

Length of Follow-up 

3 months 

1 and 2 year followup 

Age (mean) 

• Average: 34 

• Range: 18-72 

Sex (% female) 

100 

Race (%) 

Latina: 100 

Other 

• Median gross family 

income: $12,000 

• Median years of formal 

education: 7 

• Born in Mexico: 92% 

• Avg acculturation: 2 

Role of CHW in Recruiting 

and Retention 

CHW recruited all 

participants through social 

networks 

Recruitment Rates 

1 

Retention Rates 

G1: 68.1 

G2: 72.6 

C-85 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, 

and Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Pretest-posttest changes in % of women performing 

monthly BSEs 

Results 

Participant unit of analysis (n = 361) 

G1: 18.5 

G2: 33.2 

P < 0.001 

t = 3.23 

Consejera unit of analysis (n = 35) 

G1: 18.6 

G2: 31.8 

P = 0.021 t = 2.43 

Measure 3 

Pretest-posttest changes in % of women ≥40 yrs who had 

mammogram within past year 

Results 

Participant unit of analysis (n = 113) 

G1: 7 

G2: 21.4 

P = 0.029 

t = 2.22 

Consejera unit of analysis (n = 33) 

G1: 6.8 

G2: 24.3 

P = 0.063 

t = 1.96 

Healthcare Utilization: 

Measure 1 

Pretest-posttest changes in % of women who had physical 

breast exam within past year 

Results 

Participant unit of analysis (n = 359) 

G1: 15.5 

G2: 17.7 

P = 0.589 

t = 0.54 

Consejera unit of analysis (n = 35) 

G1: 19.3 

G2: 19.5 

P = 0.967 

t = 0.04 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

Increase in use of 

cancer screening tests 

higher in PLV cancer 

intervention group 

compared to 

community living skills 

(control) group 

Results from 1 and 2 yr 

followup suggest that 

cancer screening rates 

in Latinas of low socioeconomic level with 

limited a 

Quality Rating 

Poor 

Health Outcomes: 

Measure 1 

Odds of montly BSE 1 

yr and 2 yr followup for 

cancer screening group 

(P value) 

Results 

Year 1: 2.03 (.016) 

Year 2: 0.96 (.877) 

Measure 2 

Odds of CBE 1 yr and 2 

yr followup for cancer 

screening group (P 

value) 

Results 

Year 1: 1.21 (.556) 

Year 2: 1.93 (.038) 

Measure 3 

Odds of mammogram 1 

yr and 2 yr followup for 

cancer screening group 

(P value) 

Results 

Year 1: 1.50 (.484) 

Year 2: 3.88 (.018) 

C-86 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Navarro et al., 

1998; 

Navarro et al., 

1995; 

Navarro et al., 

2000 

(continued) 

C-87 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Measure 2 

Pretest-posttest changes in percentages of women who 

had a Pap test within past year 

Results 

Participant unit of analysis (n = 360) 

G1: 16.2 

G2: 23.1 

P = 0.096 

t = 1.67 

Consejera unit of analysis (n = 35) 

G1: 18.4 

G2: 23.4 

P = 0.369 

t = 0.91 

Measure 4 

Odds of pap smear 1 yr 

and 2 yr followup for 

cancer screening group 

(P value) 

Results 

Year 1: 2.10 (.017) 

Year 2: 1.70 (.082) 

C-88 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Parker et al., 2008 

Trial Name 

Community Action 

Against Asthma 

(CAAA) 

Objective or Aim 

Evaluate a CHW 

intervention to 

improve children's 

asthma-related 

health by reducing 

household 

environmental 

triggers for asthma 

Geography 

Eastside and 

southwest Detroit, 

MI 

Organization 

Urban households 

with children 

attending 

neighborhood 

elementary schools 

Type of 

Community 

Urban 

neighborhoods with 

child with asthma 

Study Design 

RCT 

Start Date 

2000 

Duration 

1 year 

Eligible (N) 

510 

Enrolled (N) 

328 

Randomized (N) 

328 

Completers (N) 

227 

Withdrawals or Dropouts (N) 

101 

Health Condition of Interest 

pediatric asthma 

Inclusion Criteria 

Child 7-11 years with persistent 

asthma (defined as any of following 

being true: one or more daytime 

symptoms reported as being present 

“more than two times per week,”; sleep 

disturbance reported “more than two 

times per week”; and daily use of 

doctor-prescribed medicine for 

respiratory symptoms) living in 

southwest or eastside Detroit 

Exclusion Criteria 

Children who lived outside of defined 

geographic area or were monolingual 

in a language other than Spanish or 

English were excluded from study. 

Groups 

G1: CHW 

G2: Control 

Interventions 

G1: Environmental assessment; 

asthma action plan based on allergy 

tests; education and social support; 

social support; mattress covers, 

pillows, vacuum, cleaning supplies; 

counseling on environmental 

tobacco smoke; integrated pest 

management services; minimum 9 

planned home visits over 12 months 

G2: Asthma information booklet, full 

intervention after 12 months 

Group (N) 

G1: 150 

G2: 148 

Title of CHW 

CES 

Paid or Volunteer 

NR 

Relationship with 

Community 

Detroit residents; 2 were 

bilingual (Spanish and 

English) 

CHW (N) 

4 

Supervision of CHW 

NR; however, there was 

a steering committee of 

community members, 

health agencies, etc. 

involved in project; also 

CHWs had continued 

training throughout 

intervention period 

Prior Training 

NR 

Type of Service 

home visits 

Type of Educational 

Materials Used 

Written materials on on 

dangers of ETS exposure 

for children with asthma 

Global Initiative for 

Asthma booklet 

Duration of Interaction 

with Clients 

At least 9 visits over 12 

months (time per session 

NR 

Length of Follow-up 

1 year 

Age (mean) 

G1: 9.01 

G2: 8.8 

Sex (% female) 

G1: 43 

G2: 41 

Race (%) 

African American 

G1: 83 

G2: 79 

Hispanic 

G1: 11 

G2: 10 

Caucasian 

G1: 4 

G2: 5 

Other 

G1: 3 

G2: 6 

Other 

Caregiver smokers (%) 

G1: 40 

G2: 35 

Moderate-severe persistent 

asthma 

G1: 51 

G2: 44 

Household income < $10000

G1: 37 

G2: 46 

Role of CHW in Recruiting 

and Retention 

No role; CES was assigned 

cases 

Recruitment Rates 

NA 

Retention Rates 

G1: 77% 

G2: 75% 

(Does not include 30 

postrandomization 

exclusions) 

C-89 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, 

and Behavior: 

Measure 1 

Behavior to reduce 

asthma triggers in house 

Results 

Intervention Effect (ORintervention/OR-control) 

Vacuum cleaner used: 

29.5 (6.90, 126); P < 

0.0001 

Allergen cover on child's 

pillow: 19.7 (4.12, 94.2); P

= 0.0006 

Allergen cover on child's 

mattress: 9.70 (4.33, 

21.7); P < 0.0001 

Visible mold growth remo 

Measure 3 

Caregiver depressive 

symptoms measured by 

CES-D 

Results 

Mean @ 

Baseline/Endpoint 

G1: 1.62/1.54 

G2: 1.58/1.64 

P = 0.0218 

Improvements in both 

instrumental and 

emotional social support 

combined and 

instrumental support alone 

were not statistically 

significant (data NR) 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Child's average asthma symptom frequency 

Results 

G1: Symptoms occurring less frequently at baseline for all 

eight symptoms assessed 

G2: Symptoms occurring less frequently for 6 of 8 

Persistent cough baseline, post-intervention: 

G1: 3.81, 3.36 

G2: 3.48, 3.44 

P = 0.034 

Cough w/ exercise baseline, post: 

G1: 4.27, 3.69 

G2: 3.80, 3.66 

P = 0.017

Healthcare Utilization: 

Measure 1 

Has any symptom more than 2 days/week and not on a 

corticosteroid 

Results 

G1 (pre/post) vs. G2 (pre/post) 

Intervention Effect (95% CI): 

60/42 vs. 51/46; 0.56 (0.29, 1.06); P = 0.073 

Measure 2 

Has any symptom more than 2 days/week and not on any 

controller 

Results 

G1 (pre/post) vs. G2 (pre/post) 

Intervention Effect (95% CI: 

53/32 vs. 38/37; 0.39 (0.20, 0.73); P = 0.004 

Measure 3 

Reduction in unscheduled health care utilization for 

asthma 

Results 

Needed unscheduled medical care G1 (pre/post) vs. G2 

(pre/post) 

Intervention Effect (95% CI): 

In last 12 months: 65/59 vs. 58/73; 0.40 (0.22, 0.74); P = 

0.004 

In last 3 months: 50/45 vs. 42/56; 0.43 (0.23, 0.80); P = 

0.007 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Fair 

C-90 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Paskett et al., 

2006; 

Katz et al., 2007 

Trial Name 

ROSE (Robeson 

County Outreach 

Screening and 

Education) 

Objective or Aim 

To use LHAs to 

deliver 

individualized 

health education to 

improve rates of 

mammography 

screening 

Geography 

Robeson County, 

NC 

Organization 

Community health 

centers - Robeson 

Health Care 

Corporation 

(federally funded, 

four centers) 

Type of 

Community 

County 

Study Design 

RCT 

Start Date 

February 1998 

Duration 

4 years 

Eligible (N) 

1,503 

Enrolled (N) 

901 

Randomized (N) 

897 

Completers (N) 

820 

Withdrawals or Dropouts (N) 

77 

Health Condition of Interest 

Breast cancer screening 

Inclusion Criteria 

Women without a mammogram in 

past 12 months 

Exclusion Criteria 

Mentally or physically unable to 

participate, unreachable, 

language/hearing barrier 

Groups 

G1: Control 

G2: Intervention 

Interventions 

G1: Control sent letter and NCI 

brochure about need for regular 

cervical cancer screening 6 

months after random assignment, 

followed by letter and NCI 

brochure about need for 

mammography 3 months after 

follow-up assssment 

G2: Individualized health education 

program that was culturally 

acceptable and tailored to meet 

needs of each woman, intensive 

face-to-face interactive 

educational program administered 

over a 9- to 12 month period, 

consisting of 3 in-person visits, 

with educational materials 

provided each visit and follow-up 

phone calls and mailings after 

Group (N) 

G1: 444 

G2: 453 

Title of CHW 

Lay health advisor 

Paid or Volunteer 

Paid 

Relationship with 

Community 

Ethnicity: 2 native American 

and 1 African-American 

CHW (N) 

3 

Supervision of CHW 

LHA supervisor checked in 

weekly by phone or inperson to discuss cases 

and problems; periodic 

attendance of LHA 

supervisor during patient 

visits 

Prior Training 

1 nurse, 1 social worker, 1 

research study interviewer 

Type of Service 

home visits, phone calls 

Type of Educational 

Materials Used 

written, culturally sensitive 

Duration of Interaction 

with Clients 

Two visits, 45-60 minutes, 

and 30-45 minutes, two 

intervening telephone calls, 

and a final visit (duration of 

final visit NR) over 9 to 12 

months 

Length of Follow-up 

14 months 

Age (mean) 

55.1 

Sex (% female) 

100 

Race (%) 

• African-American: 33% 

• Native American: 42% 

• White: 25% 

Other 

NR 

Role of CHW in Recruiting 

and Retention 

NA 

Recruitment Rates 

NA 

Retention Rates 

NA 

C-91 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

Measure 1 

Composite belief scores 

(higher is better) 

Results 

G1: 6.95 

G2: 7.55 (P = 0.004) 

Measure 2 

Composite knowledge 

scores 

Results 

Specific scores NR, P value 

for G1 = 0.002, G1 < 0.001, 

no statistically significant 

differences 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

Measure 1 

Cervical cancer screening rates within risk-appropriate 

guidelines 

Results 

Significant differences between baseline and followup 

for both groups, no significant differences between 

intervention and control groups 

Measure 2 

Mammogram receipt from medical record data 

Results 

G1: 27.3% 

G2: 42.5%, RR = 1.56, 95% CI, 1.29 to 1.87, P < .001; 

significant differences within racial groups as well 

Measure 3 

Intervention cost divided by additional mammograms in 

LHA group compared with usual care 

Results 

$4,986 per additional mammogram in LHA group 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Good 

C-92 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Pilote et al., 1996 

Trial Name 

NR 

Objective or Aim 

Peer health 

advisers familiar 

with homelessness 

and ways of street 

could facilitate 

access to health 

care for TB in a 

homeless 

population. 

Geography 

San Francisco, CA 

Organization 

Homeless 

population 

Type of 

Community 

Lack of 

neighborhood 

(homeless) 

Study Design 

RCT 

Start Date 

June 1992 

Duration 

23 months 

Eligible (N) 

297 

Enrolled (N) 

244 

Randomized (N) 

244 

Completers (N) 

173 

Withdrawals or Dropouts (N) 

71 

Health Condition of Interest 

TB 

Inclusion Criteria 

Homeless men and women, PPD 

positive 

Exclusion Criteria 

recent follow-up 

Groups 

G1: Peer health advisor 

G2: Monetary incentive 

G3: Usual care 

Interventions 

G1: Peer health advisor- met with 

patient and took them to clinic 

appointment, facilitated 

paperwork, reviewed physician 

recommendations 

G2: Monetary incentive - $5 at clinic, 

appointment and bus tokens 

G3: Usual care - appointment and 

bus tokens 

Group (N) 

G1: 83 

G2: 82 

G3: 79 

Title of CHW 

Peer health adviser 

Paid or Volunteer 

Paid 

Relationship with 

Community 

Also homeless 

CHW (N) 

7 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Took client to clinic and 

helped with proccess 

Type of Educational 

Materials Used 

None 

Duration of Interaction 

with Clients 

NR - met client and went to 

clinic within a 3 week 

period (duration of session 

NR) 

Length of Follow-up 

3 weeks 

Age (mean) 

Median 

G1: 40 

G2: 39 

G3: 40 

Sex (% female) 

G1: 13 

G2:19 

G3:16 

Race (%) 

G1: African American: 48 

White: 33 

Hispanic: 16 

G2: African American: 57 

White: 27 

Hispanic: 11 

G3: African American: 54 

White: 27 

Hispanic: 13 

Other 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-93 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

Measure 1 

Adherence to first follow-up appointment % (95% CI) P

versus usual care - unclear how obtained 

Results 

G1: Peer health advisor 75 (70-80) P = 0.004 

G2: Monetary incentive 84 (76-92) P < 0.001 

G3: Usual care 53 (47-59) 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

Quality Rating 

Fair 

C-94 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Rask et al., 2001; 

LeBaron et al., 

200463

Trial Name 

NA 

Objective or Aim 

(1) Prospectively 

measure costs of 3 

different registrybased interventions 

implemented in an 

urban indigent 

population and (2) 

evaluate how size of 

targeted population 

affects cost 

estimates 

Geography 

Fulton County, GA 

Organization 

MATCH (Metro 

Atlanta Team for 

Child Health) 

immunization 

registry: communitybased partnership 

between two county 

health agencies, 

local nonprofit, 

federally qualified 

community health 

centers 

Type of 

Community 

See prior 

Study Design 

RCT 

Start Date 

1996 

Duration 

22 months (35 mo 

for follow-up 

contact; 53 months 

for electronic 

acquisition of 

vaccine information) 

Eligible (N) 

3050 

Enrolled (N) 

3050 

Randomized (N) 

3050 

Completers (N) 

NR 

Withdrawals or Dropouts (N) 

304 not exposed to intervention 

(within intervention arms) 

Health Condition of Interest 

Pediatric immunizations 

Inclusion Criteria 

Children aged < 12 months seen in 

a county public health clinic 

Exclusion Criteria 

NR 

Groups 

G1: AUTODIAL 

G2: OUTREACH worker 

G3: combination of 1 and 2 

G4: CONTROL 

Interventions 

G1: Autodial -received an 

automated telephone call or 

postcard to remind families 7 

calendar days before child was 

due to be immunized. Patient 

received postcard if no number 

or nonworking. Delivered 

recorded message from head 

medical staff. 

G2: Outreach - contacted by 

outreach worker following a 

standardized protocol initated by 

a phone call wihtin 1 week. 

outreach worker made reminder 

call before appt if time known. if 

child remained behind next 

monht, a home visit was 

attempted monthly until contact 

was made. 

Group (N) 

G1: 763 

G2: 760 

G3: 764 

G4: 763 

Title of CHW 

Outreach worker 

Paid or Volunteer 

NR 

Relationship with 

Community 

• African American woman 

raised in inner-city 

Atlanta 

• Bilingual Hispanic worker

CHW (N) 

2 

Supervision of CHW 

Doctorate in community 

psychology and extensive 

experience in conducting 

inner-city studies 

Prior Training 

College-educated 

Type of Service 

Phone calls, home visit for 

appointment reminder, 

assistance in overcoming 

barriers to appointment for 

pediatric immunizations if 

needed Phone calls, home 

visits 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

At least one telephone call, 

followed by repeat calls and 

home visit if no telephone 

contact, over 15 months or 

less (time per interaction 

NR) 

Length of Follow-up 

15 months 

Age (mean) 

9 months 

Sex (% female) 

51 

Race (%) 

93% minority (black or 

Hispanic) 

Other 

NR 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-95 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Vaccine Series complete from immunization registry 

Results No statistical difference between CHW and 

control groups 

Healthcare Utilization: 

NR 

Costs (Economics): 

Measure 1 

Average monthly costs 

to dleiver immunization 

interventions per child 

Results 

G1: $1.34 

G2: $1.87 

G3: $2.76

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Good 

C-96 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Sauaia et al., 2007; 

Welsh et al., 2005 

Trial Name 

Tepeyac Project 

Objective or Aim 

To increase breast 

cancer screening 

rates among 

Latinas in 

Colorado;64 To 

compare effect of 

promotora vs 

printed statewide 

interventions on 

mammogram rates 

of Latinas and nonLatina whites 

(NLWs) enrolled in 

Medicaid fee-forservice program 65

Geography 

Colorado 

Organization 

Catholic Churches, 

Latina Women 

Type of 

Community 

Church 

communities 

Study Design 

Retrospective 

cohort 

Start Date 

2000 

Duration 

5 yrs 

Eligible (N) 

• Latina only analysis: 4,739;64

• Latina vs. white analysis: 6,69665

Enrolled (N) 

NA 

Randomized (N) 

NA 

Completers (N) 

Latina only analysis: 473964; Latina 

vs. white analysis: 669665

Withdrawals or Dropouts (N) 

NA 

Health Condition of Interest 

Breast cancer screening 

Inclusion Criteria 

Latina only analysis: 

• Latinas (identified through race 

and ethnicity data combined with 

surnames) 

• Aged 50 to 69 years 

• Continuously enrolled in insurance 

plan (Medicaid or Medicare) for 

longer than 23 months with no 

gap in coverage longer than 30 

days 

• Survived entire baseline or followup period64 

Latina vs. white comparison: 

• White or Latina women (identified 

through race and ethnicity data) 

• Aged 50-64 years 

• Enrolled in CO Medicaid at least 

18 mo during baseline and followup periods65

Exclusion Criteria 

NR 

Groups 

G1: Promotora Intervention - study 

subjects living in zip codes of 

churches visited by promotoras 

during 2000 and 2001 

G2: Printed intervention - Subjects 

living in remaining zip codes 

Title of CHW 

Promotora (peer 

counselors) 

Paid or Volunteer 

Paid 

Relationship with 

Community 

Shared community and 

ethnicity 

CHW (N) 

NR 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Peer "approach" after 

Sunday mass and during 

church-related activities; 

facilitation of home 

discussion groups 

Type of Educational 

Materials Used 

• Letter describing project 

• Bilingual printed 

materials from NCI that 

promote breast ca 

screening and reflect a 

sense of family 

• Display unit 

• Short bilingual messages 

suitable for delivery from 

pulpit and publication in 

church bulletins 

Duration of Interaction 

with Clients 

At least bimonthly 

meetings(length NR) over 5 

years 

Length of Follow-up 

NA 

Age (mean) 

Latina only analysis: 

Not specified;64 

Latina vs. white analysis 

G1: Latina 59 (SD 4.1); 

non-Latina 57.5 (4.3) 

G2: Latina 58.4 (4.4); 

non-Latina 57.9 (4.5)65

Sex (% female) 

100 

Race (%) 

Latina only analysis: 

100% Latina;64 

Latina vs. white analysis 

G1: 52% Latina, 

48% non-Latina white 

G2: 26% Latina, 

74% non-Latina white65

Other 

Role of CHW in Recruiting 

and Retention 

Unclear 

Recruitment Rates 

NA 

Retention Rates 

NA 

C-97 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

Measure 1 

comparison of mammography rates by intervention and 

ethnicity, via ICD codes on Medicaid claims (pre/post 

time-intervention interaction term by GEE) 

Results 

Latina, G1 vs. G2 adjusted GEE P = 0.07 

Non-Latina, G1 vs. G2 adjusted GEE P = 0.10 

Measure 2 

Pre/post mammography rates via ICD codes on 

Medicaid claims 

Results 

Latina only analysis 

G1: 59 to 61% 

G2: 58% at baseline and followup, unadjusted rates not 

significant in either group, GEE model adjusting for 

insurance group, age, income, rural vs. urban, and 

disability found increased biennial mammograms in 

Intervention group (P = 0.03);64 

Latina vs. white analysis 

G1: Latina 25→30% (unadjusted GEE P = 0.3); 

non-Latina 32→38% (unadjusted GEE P = 0.4) 

G2: Latina 45→43% (unadjusted GEE P = 0.27); 

non-Latina 41→44% (unadjusted GEE P = 0.02)65

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

CHW intervention in 

churches resulted in 

slight improvement in 

mammography rates 

among Medicaideligible Latinas, no 

statistically significant 

difference in ethnic 

disparities within 

promotora group, 

increased disparities in 

non promotora group 

(because non Latina 

had greater 

improvement than 

Latinas) 

Quality Rating 

Fair 

C-98 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Sauaia et al., 2007; 

Welsh et al., 2005 

(continued) 

Interventions 

G1: Trained peer counselors 

(Promotoras) delived health 

promotion message personally, 

through meetings held at least 

bimonthly immediately after mass 

and through other church events, 

conducted health groups that met 

at home of one of participants, 

same newsletter used in printed 

Intervention 

G2: Printed intervention incorporated 

into church display, bulletin and/or 

pulpit announcements 

Group (N) 

Latina only analysis 

G1: 4 churches, 

N at baseline: 536, 

N at followup: 590 

G2: 209 churches, 

N at baseline: 5130, 

N at followup: 5708;64 

Latina vs. white analysis 

G1: 4 churches, 

N at baseline: 197, 

N at followup: 211 

G2: 209 churches, 

N at baseline 

C-99 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

This page intentionally left blank. 

C-100 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups Community Health Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Schuler et al., 

2000 

Trial Name 

NR 

Objective or Aim 

Effects of homebased intervention 

on mother-infant 

interaction among 

drug using women 

and their infants 

to compare 

mother–infant 

interaction among 

drug-using 

mothers who did 

and did not 

receive homebased intervention 

Geography 

Maryland NR 

Organization 

Organizational 

recruited from 

large university 

hospital 

Type of 

Community 

Drug abuse Inner 

city, AfricanAmerican 

Study Design 

RCT 

Start Date 

NR 

Duration 

6 months 

Eligible (N) 

NR 

Enrolled (N) 

192 families 

Randomized (N) 

192 

Completers (N) 

171 

Withdrawals or Dropouts (N) 

21 families Not at all clear from article: 

"study included 171 families (87 control, 

84 intervention). 31 dyads were lost 

before 2-week baseline visit, and 32 

additional families lost after 2-week visit 

(see Table 1). Thus, 192 (97 control, 95 

intervention) families seen for 6-month 

evaluation visit. Observation data 

dropped from 13 families because 

interaction involved caretaker other than 

mother, and data from 8 families were 

lost because of mechanical difficulties" 

Health Condition of Interest 

Infant health Maternal drug use; motherchild interaction 

Inclusion Criteria 

Women were eligible if they or their 

infants had a positive urine toxicology 

screen at birth or history of recent drug 

use was noted in medical charts. 

Exclusion Criteria 

Infants who were not discharged into 

care of their mothers or had serious 

developmental or congenital problems 

that required special services (e.g., 

spina bifida) 

Groups 

G1: CHW 

G2: Control 

Interventions 

G1: Visits to enhance mothers’ ability to 

manage self-identified problems by 

using existing services and family 

and social supports; modeling infant 

development behavior/activities 

G2: Meetings for tracking purposes only

Group (N) 

G1: 84 

G2: 87 

Title of CHW 

Lay Visitors 

Paid or Volunteer 

NR 

Relationship with Community 

Shared ethnicity African 

American women who "knew 

community" 

CHW (N) 

3- 2 for intervention, one for 

control group 

Supervision of CHW 

Visitors met with a psychologist 

and a pediatrician weekly to 

track progress of families and to 

discuss concerns about families 

Prior Training 

Past experience making home 

visits, no additional details 

provided 

Type of Service 

G1: home intervention was 

developmentally oriented and 

was based on program used 

by IHDP- visitors went once a 

week enhancing mothers’ 

ability to manage selfidentified problems by using 

existing services and family 

and social supports; 

modelling infant development 

behavior/activities 

G2: brief monthly home tracking 

visits to reduce attrition 

Type of Educational Materials 

Used 

HELP at Home: Hawaii Early 

Learning Profile 

Duration of Interaction with 

Clients 

G1: 9 visits, about 30 minutes 

per visit 

G2: 3 visits, about 17 minutes 

each 

Length of Follow-up 

6 months 

Age (mean) 

27 years 

Sex (% female) 

100 

Race (%) 

African American: 96% 

Other 

NR 

Role of CHW in 

Recruiting and 

Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-101 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

Measure 1 

Infant warmth measured by 

assessment of videotaped 

mother-infant interaction 

using previously validated 

scale 

Results 

No difference between 

groups. In control group, 

mothers who continued to 

use drugs were less 

responsive to their babies 

than were mothers who were 

drug free. In intervention 

group, drug use was not 

associated with maternal 

responsiveness. 

Health Outcomes: 

Measure 3 

Self-reported maternal drug use 

Results 

At 6 months, there were no significant group 

differences in cocaine and/or heroin use, alcohol use, 

or marijuana use during last 6 months 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

No direct effects of 

intervention, in control 

group, mothers who 

continued to use drugs 

were less responsive to 

their babies than 

mothers who were drug 

free. In intervention 

group, drug use was 

not associated with 

maternal 

responsiveness. 

Quality Rating 

Fair 

C-102 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline Characteristics 

Recruiting and Retention 

Author Year 

Schwarz et al., 

1993 

Trial Name 

Safe Block Project 

Objective or Aim 

Improve injury 

prevention 

knowledge and 

reduce number of 

hazards in home 

and reduce rates of 

injury occurring to 

residents of an 

inner city 

community. 

Geography 

Philadelphia 

Organization 

Social 

Type of 

Community 

Neighborhood High 

injury rate 

Study Design 

Prospective casecontrol 

observational 

Quasiexperimental; nonrandom controlled 

trial 

Start Date 

1989 

Duration 

1 year 21 months 

Eligible (N) 

34 203 (17,058 intervention = 

approx 5,890 homes; 17,145 control)

Enrolled (N) 

2722 4476 (3004 received 

intervention, 1472 control homes 

randomly selected) 

Randomized (N) 

NA 2722 (1250 intervention + 1472 

control homes selected for 

assessment) 

Completers (N) 

1962 (902 intervention, 

1060 control) 

Withdrawals or Dropouts (N) 

28% not inspected in each group 

(348 intervention, 412 control) 

Health Condition of Interest 

Home Safety 

Inclusion Criteria 

Residents of 17 neighborhoods 9 

census tracks with highest injury 

rates in community 

Exclusion Criteria 

NA inability to contact household 

residents 

Groups 

G1: Intervention 

G2: Control 

Interventions 

• Home modification for simple 

prevention measures 

• Home inspection to inform 

residents about hazards and ways 

of alleviating them 

• Education about selected injury 

prevention practices. 

Group (N) 

G1: 17 085 

G2: 17 145 

For postintervention assessments, 

1250 of 3004 homes were randomly 

selected. assessments were 

conducted in 902 of1250 homes 

(72%). 

Title of CHW 

Intervention team 

Paid or Volunteer 

Paid and volunteer 

Relationship with 

Community 

Shared community 

CHW (N) 

3 community safety liaisons 

who recruited an 

undisclosed # of volunteer 

block supervisors and 10 

safety inspectors. 

Supervision of CHW 

Supervised by personnel 

from Injury Control Section 

of Philadelphia Department 

of Public Health. 

Prior Training 

NR 

Type of Service 

Safety inspections home 

modifications, inspections, 

and education; myriad 

safety devices (e.g. smoke 

detectors, ipecac, 

emergency phone 

numbers, light bulbs, 

batteries, bathwater 

thermometer) 

Type of Educational 

Materials Used 

NR direct teaching from 

safety inspectors 

Duration of Interaction 

with Clients 

1 home visit and monthly 

block meetings over 18 

month-period (duration per 

session NR) 

Length of Follow-up 

12 months 

Age (mean) 

G1: < 5 yrs: 9.3%, 

5-17 yrs: 17.6%, 

18-64 yrs: 53.7%, 

 > 64 yrs: 19.5% 

G2: < 5 yrs: 9.9%, 

5-17 yrs: 18.9%, 

18-64 yrs: 58.1%, 

 > 64 yrs: 13.1% 

Sex (% female) 

NR 

Race (%) 

G1: African-American: 96.8%, 

Other: 3.2% 

G2: African-American: 95.7%, 

Other: 4.3% 

Other 

Injuries in 1987- rate per 1000 

residents 

G1: 17.1 

G2: 15.7 

Role of CHW in Recruiting 

and Retention 

Block Representatives were 

asked to urge neighbors to 

participate in project. 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-103 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

Measure 1 

No syrup of ipecac for 

children < 5 yrs 

Results 

G1: 29% G2: 90.2% 

P < 0.001 

Adjusted OR, 0.04 

95% CI, 0.02-0.07 

Measure 2 

Inadequate light on stairs 

Results 

G1: 17.9% G2: 19.9% 

P = 0.41 

Adjusted OR, .41 

95% CI, 0.69-1.16 

Measure 3 

Hot water ≥125°F 

Results 

G1: 36.8% G2: 26.8% 

P < 0.001 

Adjusted OR, 1.73 

95% CI, 1.39, 2.15 

Measure 1 

No bedside light for > 64 yrs 

adults 

Results 

G1: 13.3% G2: 15.1% 

P = 0.90 

Adjusted OR, 1.03 

95% CI, 0.68- 1.57 

Measure 2 

No smoke detectors 

Results 

G1: 4% G2: 23% 

P < 0.001 

Adjusted OR, 0.14 

95% CI, 0.09- 0.20 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

Principal positive 

finding of this study is a 

distinct difference 

between control and 

intervention homes with 

respect to safety 

knowledge and home 

hazards that required 

minimal to moderate 

effort to correct. 

Intervention homes 

were found to be safer 

than control homes, 

particularly with respect 

to hazards related to 

fires and poisonings. 

Quality Rating 

Poor 

C-104 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Silver et al., 1997 

Trial Name 

Parent to Parent 

Network 

Objective or Aim 

Evaluate 

psychological 

outcomes of 

Parent-To-Parent 

Network (PTPN), a 

community-based 

support program 

for mothers of fiveto eight-year-old 

children with a 

variety of ongoing 

health conditions 

Geography 

NYC - Bronx; or 

Lower Westchester 

Organization 

Organizational 

Large urban 

medical centers; 

community-based 

delivery of 

intervention 

Type of 

Community 

Mothers that have 

children with 

chronic disease 

Inner-city, lowincome, minority 

Study Design 

RCT 

Start Date 

1990 

Duration 

1-2 years 

Eligible (N) 

512 

Enrolled (N) 

365 mothers 

Randomized (N) 

365 

Completers (N) 

94% completed 12 month interview 

(343) 

Withdrawals or Dropouts (N) 

6% LTF 

Health Condition of Interest 

Maternal health Mothers' psychiatric 

well-being 

Inclusion Criteria 

• Five-to-eight-year-old children 

who had ongoing health 

conditions (defined as one that 

had lasted or was expected to last 

for at least three months or had 

required hospitalization for 30 

days or more in previous year) 

• Mother could speak 

conversational english and live 

with her child in catchment area 

• Have easy access to a phone 

Exclusion Criteria 

A family was excluded if child was 

moderately or severely mentally 

retarded or had a life expectancy 

under 18 months. 

Groups 

G1: Experimental 

G2: Control 

Interventions 

G1: 6 one-hour meetings and 3 

group activities 6 face-to-face 

interventions at home or in 

hospital + telephone calls + group 

activities 

G2: Usual care 

Group (N) 

G1: 183 

G2: 182 

Title of CHW 

Lay Intervenor 

Paid or Volunteer 

NR (guessing paid) Paid 

("accepted jobs") 

Relationship with 

Community 

Shared experience Same 

neighborhoods (recruited 

via community 

newspapers); raised 

children with ongoing 

healht conditions 

CHW (N) 

3 

Supervision of CHW 

Supervised by a clinical 

psychologist and a social 

worker - frequency NR 

Prior Training 

40 hours plus intensive 

training 

Type of Service 

Counselling, face-to-face 

meetings; telephone calls; 

group activities with others 

in program 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

6 meetings (1 hour each) 

with at least biweekly 

telephone calls + 3 group 

social activities over 12 

months 

Length of Follow-up 

12 months 6, 12, and 18 

mo 

Age (mean) 

Mother's age 

G1: 34.7 

G2: 34.0 

Children's age 

G1: 7.2 

G2: 7.0 

Sex (% female) 

100% female (mothers) 

Children 

G1: (45%) 

G2: (47%) 

Race (%) 

Mother’s ethnicity % 

Hispanic 

G1:43 

G2: 46 

Black 

G1: 41 

G2:32 

White, not Hispanic 

G1:11 

G2: 17 

Mixed/Other 

G1: 5 

G2: 6 

Other 

Asthma 35%, sickle cell 

anemia, epilepsy, and 

congenital heart disease 

(8% each), and cleft lip or 

palate, cancer, and 

endocrine disorders (5% 

each). Spina bifida and other 

congenital anomalies each 

occurred in 2%; 15% had 

multiple health conditions, 

mostly asthma 

G1: 35% fair to poor health; 

G2: 31% 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

G1: 95% 

G2: 93% 

C-105 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

PSI 

Results 

Pre- intervention 

G1: 24.1 

G2: 20.3 (P < 0.05) 

Post intervention 

G1: 22.1 

G2: 20.1 (no significant difference between groups) 

Measure 2 

PSI subsets 

Results 

All adjusted posttest scores other than Depression 

were directionally lower in EG than CG 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

Posttest scores of EG 

and CG mothers did 

not differ significantly. 

Although intervention 

effects were not related 

to participation level or 

illness-related and 

sociodemographic 

factors, a significant 

interaction with 

stressful life events 

(SLE) was found. 

Quality Rating 

Fair 

C-106 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

St. James et al., 

1999 

Trial Name 

Resource Mothers 

Program for 

Maternal PKU 

Objective or Aim 

Increase number of 

well-treated 

pregnancies and 

thus reduce 

number of adverely 

affected offspring 

Geography 

New England 

Organization 

Maternal PKU 

Collaborative Study 

enrollees 

Type of 

Community 

PKU 

Study Design 

Retrospective 

cohort 

Start Date 

NR 

Duration 

NR 

Eligible (N) 

NR 

Enrolled (N) 

83 pregnancies from 69 mothers 

Randomized (N) 

NA 

Completers (N) 

NA 

Withdrawals or Dropouts (N) 

NA 

Health Condition of Interest 

PKU outcomes in children 

Inclusion Criteria 

Mothers with PKU 

Exclusion Criteria 

NA 

Groups 

G1: control (no resource mother) - 

women with PKU 

G2: PKU women with resource 

mother 

Interventions 

G1: NR 

G2: resource mothers met with 

pregnant women for approx 20 

sessions of 2 hours each, weekly 

in beginning and less frequently 

as pregnancy proceeded. 

Activities included cooking, 

shopping, meal planning, 

preparing for baby, discussing 

pregnancy, discussing medical 

recommendations. 

Group (N) 

G1: 64 offspring from 55 mothers 

G2: 19 offspring from 14 mothers 

Title of CHW 

Resource Mother 

Paid or Volunteer 

Paid 

Relationship with 

Community 

Resource mothers had 

children with PKU 

CHW (N) 

NR 

Supervision of CHW 

NR 

Prior Training 

Lived with disease 

Type of Service 

Face-to-face meetings 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

≈20 sessions of 2 hours 

each (weekly in beginning 

then less frequently) 

throughout pregnancy 

Length of Follow-up 

12 months after birth 

Age (mean) 

Maternal age 

G1: 26.5 

G2: 24.1 

Sex (% female) 

100 

Race (%) 

NR 

Other 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-107 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Birth head-circumference z score 

Results 

G1: -1.4 (95% CI, -1.56- -1.2) 

G2:-0.56 (95% CI, -0.88 - -0.24); P = 0.08 

Measure 2 

Baylely developmental quotient 

Results 

G1: 95 (95% CI, 92-98) 

G2: 108 (95% CI, 104-112); P < 0.05 

Measure 3 

maternal metabolic control 

Results 

G1: 16.1 weeks(95% CI, 14.4-17.8) 

G2: 8.5 weeks (95% CI, 6.3-10.7); P < 0.05 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Fair 

C-108 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline Characteristics 

Recruiting and Retention 

Author Year 

Sung et al., 1997; 

Sung et al., 1992 

Trial Name 

National Black 

Women's Health 

Project 

Objective or Aim 

Test effectiveness 

of in-home, 

culturally sensitive 

educational 

program conducted 

by lay health 

workers by 

measuring 

improvement in 

frequency of breast 

and cervical cancer 

screening 

Geography 

Unclear, possibly 

Atlanta 

Organization 

Inner city 

community health 

center 

Type of 

Community 

Inner city AfricanAmerican 

Study Design 

RCT 

Start Date 

NR 

Duration 

17 months 

Eligible (N) 

NR 

Enrolled (N) 

321 

Randomized (N) 

321 

Completers (N) 

195 

Withdrawals or Dropouts (N) 

126 

Health Condition of Interest 

breast cancer, cervical cancer 

Inclusion Criteria 

NR 

Exclusion Criteria 

NR 

Groups 

G1: intervention 

G2: control 

Interventions 

G1: CHW home visits, education on 

breast and cervical cancer, breast 

self-exam, educational materials 

on screening, facilitation to 

address logistical barriers to 

screening 

G2: mailed educational materials on 

cancer screening 

Group (N) 

G1: 163 

G2: 158 

Title of CHW 

Lay health worker 

Paid or Volunteer 

NR 

Relationship with 

Community 

Recruited from National 

Black Women's Health 

Project 

CHW (N) 

NR 

Supervision of CHW 

NR 

Prior Training 

Self-help support group 

leaders within NBWHP 

Type of Service 

Home visits 

Type of Educational 

Materials Used 

Home visits, video of Pap 

and breast exam, printed 

materials 

Duration of Interaction 

with Clients 

3 visits (months 1, 2, 4) 

over four month period, 

visits 1 and 2 1.5 hours 

each, time for visit 3 NR 

Length of Follow-up 

11 months 

Age (mean) 

G1: 18-34: 13.5% 

35-44: 46% 

45-59: 22.1% 

60-97: 18.4% 

G2: 18-34: 13.3% 

35-44: 44.3% 

45-59: 24.7% 

60-97: 17.7% 

Sex (% female) 

100 

Race (%) 

NR (presumed 100% African 

American) 

Other 

G1: 

Income ≤$15,000: 45.4% 

Married: 33.7% 

> HS education: 40.5% 

Employed: 55.2% 

G2: 

Income ≤$15,000: 48% 

Married: 30.4% 

> HS education: 38.4% 

Employed: 46.8% 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

1st attempt: 20% (55/275) 

2nd attempt: 44% (266/600) 

Retention Rates 

G1: 57% (93/163) 

G2: 65% (102/158) 

C-109 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

Measure 1 

Pretest-posttest change in 

self-report of BSE for entire 

sample 

Results 

G1: 52.1%/51.0%; 

G2: 41.1%/41.0%, 

diff in change: -1.0 (95% CI, 

-6.1-4.1) 

Measure 2 

Pretest-posttest change in 

self-report of BSE, postintervention respondents 

only 

Results 

G1: 57.0%/53.8%; G2: 

40.2%/40.2%, diff in change: 

-3.2 (95% CI, -17.5, 11.1) 

Measure 3 

Posttest report of BSE, 

women not previously on 

recommended screening 

schedules, whole sample 

Results 

G1: 24.4%; G2: 17.2%, diff 

in change: 7.2% 

(95% CI, -5.0-19.3) 

Measure 4 

Posttest report of BSE, 

women not previously on 

recommended screening 

schedules, post-intervention 

respondents only 

Results 

G1: 47.5%; G2: 26.2%, diff 

in change: 21.3% 

(95% CI, 2.3-40.3) 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Pre/post change in self-report of receiving screening 

exams, women not previously on recommended 

screening schedules, whole sample 

Results 

No significant difference between groups for any 

screening modality 

Healthcare Utilization: 

Measure 1 

Pretest-posttest change in self-report of receiving Pap 

smears for entire sample 

Results 

G1: 50.3%/58.7%; 

G2: 51.9%/62.1%, 

diff in change: -1.8 

(95% CI, -8.0-4.4) 

Measure 2 

Pretest-posttest change in self-report of receiving Pap 

smears, postintervention respondents only 

Results 

G1: 52.7%/63.4%; 

G2: 50.0%/62.7%, 

diff in change: -2.0 

(95% CI, -11.0-7.0) 

Measure 3 

Posttest rate of self-report of receiving Pap smears, 

women not previously on recommended screening 

schedules, whole sample 

Results 

G1: 33.3% 

G2: 34.2% 

diff in change: -0.9 (95% CI, -15.7-13.9) 

Measure 4 

Posttest rate of self-report of receiving Pap smears, 

women not previously on recommended screening 

schedules, postintervention respondents only 

Results 

G1: 61.4% 

G2: 51.0% 

diff in change: 10.4 (95% CI, -9.5-30.0) 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

CHW intervention 

effective in increasing 

receipt of clinical breast 

exam and 

mammogram, only 

when including women 

already on some 

recommended 

screening schedule, 

and only when 

nonrespondents are 

assumed to be similar 

to respondents. Using 

intention-to-treat, no 

differences in any 

screening modality 

Quality Rating 

Poor 

C-110 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline Characteristics 

Recruiting and Retention 

Author Year 

Sung et al., 1997; 

Sung et al., 1992 

C-111 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Measure 5 

Pretest-posttest change in self-report of receiving 

mammography for entire sample 

Results 

G1: 35.5%/50.4% 

G2: 34.3%/39.4% 

diff in change: 9.8% 

(95% CI, 2.9-16.7) 

Measure 6 

Pretest-posttest change in self-report of receiving 

mammography, postintervention respondents only 

Results 

G1: 32.5%/58.7%; 

G2: 34.0%/47.9%, 

diff in change: 12.4% difference (95% CI, 1.0-24.3) 

Measure 7 

Posttest rate of self-report of receiving mammography, 

women not previously on recommended screening 

schedules, whole sample 

Results 

G1: 29.7% 

G2: 24.4% 

diff in change: 5.8% (95% CI, -7.0-18.6) 

Measure 8 

Posttest rate of self-report of receiving mammography, 

women not previously on recommended screening 

schedules, postintervention respondents only 

Results 

G1: 50.0% 

G2: 35.5% 

diff in change: 14.5% (95% CI, 4.5-23.6) 

Measure 9 

Pretest-posttest change in self-report of receiving CBE 

for entire sample 

Results 

G1: 55.2%/64.5% 

G2: 55.7%/59.5% 

diff in change: 4.9 (95% CI, -6.1-4.1) 

Measure 10 

Pretest-posttest change in self-report of receiving CBE, 

postintervention respondents only 

Results 

G1: 59.1%/72.0% 

G2: 57.8%/61.8% 

diff in change: 8.9% (95% CI, 1.1-16.7) 

C-112 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline Characteristics 

Recruiting and Retention 

Author Year 

Sung et al., 1997; 

Sung et al., 199271

C-113 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Measure 11 

Posttest rate of self-report of receiving CBE, women not 

previously on recommended screening schedules, 

whole sample 

Results 

G1: 37.0% 

G2: 28.6% 

diff in change: 8.4% (95% CI, -6.9-23.7) 

Measure 12 

Posttest rate of self-report of receiving CBE, women not 

previously on recommended screening schedules, 

postintervention respondents only: 

Results 

G1: 71.1% 

G2: 46.5% 

diff in change: 24.6% (95% CI, 3.9-45.3) 

C-114 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Taylor et al., 2002 

Trial Name 

NR 

Objective or Aim 

Evaluate impact of 

2 culturally and 

linguistically 

appropriate 

cervical cancer 

control educational 

interventions: a 

“high intensity” 

outreach workerbased intervention 

and a “low 

intensity” direct 

mail intervention 

Geography 

Seattle and 

Vancouver BC 

Organization 

Recruited from 

respondents to 

community-based 

survey 

Type of 

Community 

Chinese-American 

women 

Study Design 

RCT 

Start Date 

1999 

Duration 

18 months 

Eligible (N) 

2312 (986 Seattle, 1326 Vancouver) 

(numbers deduced from text) 

Enrolled (N) 

1532 (710 Seattle, 822 Vancouver) 

Randomized (N) 

482 (199 Seattle, 283 Vancouver) 

Completers (N) 

402 (181 Seattle, 221 Vancouver) 

Withdrawals or Dropouts (N) 

80 (18 Seattle, 62 Vancouver) 

Health Condition of Interest 

Pap testing 

Inclusion Criteria 

• Chinese women 

• No history of Pap or intention of 

Pap within 2 years of survey 

• 20-69 years old 

• Speak Cantonese, English, or 

Mandarin 

Exclusion Criteria 

• Hysterectomy 

• Invasive cervical cancer 

Groups 

G1: CHW 

G2: direct mail 

G3: control 

Interventions 

G1: Introductory mailing, CHW visit 

with multimedia and tailored 

counseling, phone followup and 

tailored counseling, logistic 

assistance as needed 

G2: Direct mail multimedia materials 

G3: Control: usual care at local 

clinics and doctors' offices 

Group (N) 

G1: 161 

G2: 161 

G3: 160 

Title of CHW 

Outreach worker 

Paid or Volunteer 

NR 

Relationship with 

Community 

Shared culture, ethnicity 

CHW (N) 

NR 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Trained to act as role 

models, to provide social 

support, to serve as cultural 

mediators between women 

and health care facilities, to 

use visual aids and provide 

tailored responses to each 

woman’s individual barriers 

to cervical cancer 

screening 

Type of Educational 

Materials Used 

Video, motivational 

pamphlet, educational 

brochure, fact sheet, 

tailored counseling 

Duration of Interaction 

with Clients 

One time visit with follow up 

telephone call (time per 

interaction NR) 

Length of Follow-up 

6 months 

Age (mean) 

58% 45-69 y/o: 

G1: 53% 

G2: 63% 

G3: 58% 

Sex (% female) 

100 

Race (%) 

Chinese 100% 

Other 

• 12 or more years 

education: 44% 

• Married: 81% 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

66% (proportions not 

available for each group) 

Retention Rates 

402/432 = 83% 

G1: 129/161 = 80% 

G2: 139/161 = 86% 

G3: 134/160 = 84% 

C-115 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

Measure 1 

Report Pap testing planned 

within 2 years 

Results 

G1: 72% 

G2: 59% 

G3: 48% (G1 vs G3 P < 

0.001 

G2 vs G3: P = 0.05 

G1 vs G2 P = 0.03) 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

Measure 1 

Medical records for pap screening received between 

randomization and followup, using intent-to-treat 

Results 

Results not provided, significant differences between 

outreach worker versus control (P < .001), direct mail 

versus control (P = .07), and outreach worker versus 

direct mail (P = .04) 

Measure 2 

Medical records for pap screening received in past 2 

years, using intent-to-treat 

Results 

Results not provided, significant differences between 

outreach worker versus control (P < .001) and direct 

mail versus control (P = .03) 

Measure 3 

Self-reported Pap testing completed since intervention 

Results 

G1: 39% 

G2: 25% 

G3: 15% (G1 vs G3, P < 0.001 

G2 vs G3, P = 0.03 

G1 vs G2, P = 0.02) 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

Women who received 

CHW home visits were 

significantly more likely 

to report having Pap 

testing after 

intervention compared 

to women receiving 

direct mail or no 

intervention 

Quality Rating 

Fair 

C-116 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline Characteristics 

Recruiting and Retention

Author Year 

Tessaro et al., 

1997; NavaieWaliser et al., 2000 

Trial Name 

Maternal Outreach 

Worker (MOW) 

Program 

Objective or Aim 

Reduce infant 

morbidity and 

mortality via early 

prenatal care, 

consistence of 

care, health 

behavior and 

parenting skills, 

infant preventive 

care and social 

services, increased 

pregnancy spacing, 

decreasing 

unplanned 

pregnancies; to 

determine whether 

particip 

Geography 

North Carolina 

Organization 

Medicaid-eligible 

population, via 

social worker or 

nurse referral 

Type of 

Community 

High infant 

mortality with 

disproportionately 

higher in AfricanAmericans vs. 

Caucasians 

Study Design 

prospective cohort 

Start Date 

1992 

Duration 

3 years 

Eligible (N) 

14,977 

Enrolled (N) 

705 

Randomized (N) 

NA 

Completers (N) 

447 

Withdrawals or Dropouts (N) 

258 

Health Condition of Interest 

Infant health 

Inclusion Criteria 

Medicaid-eligible, < 28 wk EGA, 

singleton livebirth; Caucasian or 

African-American (this study) 

Exclusion Criteria 

Moved away, lost to follow-up, 

declined services, interview not 

completed 

Groups 

G1: CHW 

G2: matched controls 

Interventions 

G1: CHW home visits 

Group (N) 

G1: 373 (yr 2) -- > 221 (yr 3) 

G2: 332 (yr 2) -- > 198 (yr 3) 

Title of CHW 

Maternal Outreach Worker 

(MOW) 

Paid or Volunteer 

NR 

Relationship with 

Community 

NR 

CHW (N) 

NR 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Home visits, assistance in 

applying for govt benefits, 

housing, employment, 

education; general 

advocacy for families 

Type of Educational 

Materials Used 

Reinforcing positive health 

behavior; modeling parentinfant interactions; reinforce 

need for prenatal care, 

immunizations, family 

planning 

Duration of Interaction 

with Clients 

One visit/month (more if 

needed) for approximately 

14 months (duration per 

visit NR) 

Length of Follow-up 

1 year 

Age (mean) 

 < 18 y 

G1: 31% 

G2: 15.6% 

Sex (% female) 

100 

Race (%) 

G1: 

African-American: 61.8% 

Caucasian: 38.2% 

G2: 

African-American, 59.4% 

Caucasian (limited to 

African-American and 

Caucasian): 40.6% 

Other 

Often receive aid from 

friends/family 

G1: 41.4% 

G2: 58.1% (P < 0.001) 

Reported good health 

G1: 78.4% 

G2: 85.5% (P < 0.05) 

Social supportiveness of 

pregnancy 

G1: 52.6% 

G2: 62.9% (P < 0.05) 

Prior physical abuse by 

partner 

G1: 14.9% 

G2: 10% (P < 0.1) 

No difference in education, 

gravidity, smoking

Role of CHW in Recruiting 

and Retention 

Active recruitment of very 

high risk population 

Recruitment Rates 

NR 

Retention Rates 

G1: 249/373 = 67% 

G2: 198/332 = 60% 

C-117 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Low birth weight (observed minus expected) 

Results 

African-American: 

LBW -13 (P = 0.12); 

VLBW -6 (P = 0.1) 

Caucasian: 

LBW +1 (P = 0.58); 

VLBW 0 (P = 0.6) 

Measure 2 

Prenatal care adequate (Kessner index) 

Results 

African American 

G1: 

Adequate: 60.7% 

Intermediate: 32.6% 

Inadequate: 6.7% 

G2: 

Adequate: 63.8% 

Intermediate: 31.5% 

Inadequate: 4.7% 

Caucasian: 

G1: 

Adequate: 77.4% 

Intermediate: 19.7% 

Inadequate: 2.9% 

G2: 

Adequate: 75.1% 

Intermediate: 22.8% 

Inadequate: 2.1% 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

CHW visits resulted in 

higher proportion of 

adequate care for 

Caucasian but lower for 

African-Americans 

(significant difference 

for African-Americans); 

fewer than expected 

LBW and VLBW for 

African-Americans but 

not Caucasians 

Quality Rating 

Poor 

C-118 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Von Korff et al., 

1998 

Trial Name 

NR 

Objective or Aim 

Evaluate a4-

session selfmanagement group 

intervention for 

patients with pain 

in primary care, led 

by trained lay 

persons with back 

pain. intervention 

was designed to 

reduce patient 

worries, encourage 

self-care, and 

reduce activity 

limitations. 

Geography 

Western 

Washington State 

Organization 

HMO 

Type of 

Community 

Condition - back 

pain 

Study Design 

RCT 

Start Date 

1996 

Duration 

NR 

Eligible (N) 

364 

Enrolled (N) 

255 

Randomized (N) 

255 

Completers (N) 

0.85 

Withdrawals or Dropouts (N) 

0.145 

Health Condition of Interest 

Back pain 

Inclusion Criteria 

Patients diagnosed with back pain 

ages 25-70, at least one prior back 

pain visit, interested in learning more 

about caring for back pain,enrolled 

for at least a year Group Health 

Cooperative of Puget Sound 

Exclusion Criteria 

Surgery or disenrollment from GHC 

Groups 

G1: Self management group 

G2: Usual care 

Interventions 

G1: Four 2-hour classes held once a 

week, with 10 to 15 participants, 

led by two trained volunteers. 

G2: Usual care includes back pain 

book 

Group (N) 

G1: 129 

G2: 126 

Title of CHW 

Lay leaders 

Paid or Volunteer 

Volunteer 

Relationship with 

Community 

Shared disease 

CHW (N) 

8 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

classes 

Type of Educational 

Materials Used 

Book, pamphlets, 

videotapes 

Duration of Interaction 

with Clients 

Four 2-hour classes held 

once a week for 1 month 

Length of Follow-up 

12 months 

Age (mean) 

G1: 49.4 

G2: 50.3 

Sex (% female) 

G1: 68.2 

G2: 56.4 

Race (%) 

G1: 

White: 91.4% 

Non-white: 8.6% 

G2: 

White: 79.7% 

Non-white: 20.3% 

Other 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-119 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

Measure 1 

"Next time I have back or leg 

pain, I will try to manage 

problem without seeing a 

health professional" - Not 

validated 

Results 

G1: 77% agreed G2: 60% 

(P = 0.008) 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Roland Disability at 12 months - validated 

Results 

G1: 5.75 (6.31) 

G2: 6.75 (6.39) 

P = 0.092 

Measure 2 

Worry rating (0-10) at 12 months - not validated 

Results 

G1: 2.63 (2.58) 

G2: 3.83 (3.08) 

P = 0.013 

Measure 3 

50% or greater reduction in Roland Disability 

Questionnaire Score from baseline at 6 months - 

validated 

Results 

G1: 47.9% 

G2: 33% 

(X2 = 5.2; df = 1; P = 0.02) 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Fair 

C-120 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Wendell et al., 

2003 

Trial Name 

NA 

Objective or Aim 

To determine 

whether street 

outreach to prevent 

HIV infection as 

practised by 

state-funded 

community-based 

organizations 

(CBOs) is effective 

in promoting 

condom 

use 

Geography 

Louisiana 

Organization 

Neighborhoods 

through out state 

characterized by 

one or more of 

following: high 

rates of STD/HIV, 

high levels of drug 

use, exchange of 

sex for money or 

drugs, 'crack' 

houses, or injection 

drug users 

Type of 

Community 

At risk 

neighborhoods 

Study Design 

Observational - 

cross sectional 

Start Date 

1998 

Duration 

2 years 

Eligible (N) 

NA 

Enrolled (N) 

NA 

Randomized (N) 

NA 

Completers (N) 

NA 

Withdrawals or Dropouts (N) 

NA 

Health Condition of Interest 

HIV prevention 

Inclusion Criteria 

NA 

Exclusion Criteria 

NA 

Groups 

G1: Intervention 

G2: Comparison 

Interventions 

G1: Discussions with community 

members during which they 

assessed client’s needs, imparted 

a risk- or harm-reduction message 

on sexual disease, answered 

questions, made referrals, and 

negotiated and reinforced 

behaviour change. 

Group (N) 

G1: 4950 

G2: 1597 

Title of CHW 

Outreach workers 

Paid or Volunteer 

Paid 

Relationship with 

Community 

Members of community 

except in New Orleans 

CHW (N) 

at least 42 

Supervision of CHW 

OPH (Office of public 

health) 

Prior Training 

NR 

Type of Service 

Interview - survey 

interaction 

Type of Educational 

Materials Used 

Condoms, educational 

materials, bleach kits, 

coupons for new needles, 

services such as substance 

abuse treatment, STD care 

and social services 

Duration of Interaction 

with Clients 

Brief - Most interactions 

involved introducing 

themselves, handing out 

condoms and literature and 

perhaps delivering a brief 

prevention message 

Length of Follow-up 

NA 

Age (mean) 

G1: 

12-14 yrs: 2% 

15-19 yrs: 27% 

20-24 yrs: 24% 

25-34 yrs: 27% 

35+ yrs: 20% 

G2: 

12-14 yrs: 1% 

15-19 yrs: 24% 

20-24 yrs: 23% 

25-34 yrs: 28% 

35+ yrs: 24% 

Sex (% female) 

G1: 48 

G2: 40 

Race (%) 

G1: 

African American: 89% 

White: 7% 

Other: 4% 

G2: 

African American: 87% 

White: 8% 

Other :5% 

Other 

Two or more sexual partners 

G1: 72 69 

G2:1.14 

OR 95% CI (1.01, 1.29) 

P = 0.04 

Men who had sex with men 

(men only) 

G1: 16 11 

G2: 1.64 OR 

95% CI, (1.3, 2.06) 

P = 0.001 

Injected drugs 

G1: 7% 

G2: 4% OR 95% CI, 1.8 

(1.37, 2.37) P = 0.001 

Role of CHW in Recruiting 

and Retention 

NA 

Recruitment Rates 

NA 

Retention Rates 

NA 

C-121 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

Measure 1 

Survey - not validated 

Results 

Know where to get free 

condoms G1: 90 G2: 74 OR 

95% CI, 3.2 (2.75, 3.73) P = 

0.001 

Quality of Life: 

NR 

Health Outcomes: 

Measure 1 

Survey - not validated 

Results 

Condom use Intervention vs. comparison [odds ratio 

1.37 (95% confidence 

Interval 1.20, 1.56; P<0.001)]. 

Healthcare Utilization: 

NR 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Fair 

C-122 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Wilson et al., 2008 

Trial Name 

NR 

Objective or Aim 

Assess 

effectiveness of 

breast health 

promoting 

messages 

administered by 

salon stylists to 

clients in salon 

setting 

Geography 

Brooklyn, NY 

Organization 

Neighborhood hair 

salons 

Type of 

Community 

Neighborhoods 

Study Design 

Repeated crosssectional survey of 

women attending 

salons randomly 

assigned to 

experimental and 

control groups 

Start Date 

2002 

Duration 

3 months for each 

salon 

Eligible (N) 

257 salons 

Enrolled (N) 

NR 

Randomized (N) 

40 salons 

Completers (N) 

40 salons/1210 respondents 

Withdrawals or Dropouts (N) 

NA 

Health Condition of Interest 

breast cancer 

Inclusion Criteria 

Salons providing services in target 

NYC neighborhoods; clients 

receiving services at experimental 

and control salons were eligible to 

participate 

Exclusion Criteria 

Salons were excluded if owner was 

a member of Health and Beauty 

Council 

Groups 

G1: Control salon, at baseline 

G2: Experimental salon, at baseline 

G3: Control salon, at followup 

G4: Experimental salon, at followup 

Interventions 

G1: Control, before intervention 

G2: Stylists group, before 

intervention 

G3: Control, after intervention 

G4: Stylists group, after intervention 

Intervention consisted of education, 

counseling, and information on 

location of screening services during 

salon appointment 

Group (N) 

G1: 369 (12 salons) 

G2: 816 (28 salons) 

G3+G4: 1210 (N of salons NR, 

individual N NR) 

Title of CHW 

Lay health advisor 

Paid or Volunteer 

Volunteer (with $30 

compensation for training 

time) 

Relationship with 

Community 

Hair stylist working in 

neighborhood/community 

CHW (N) 

29 

Supervision of CHW 

Program staff made 

frequent visits to salons to 

support stylists in their 

promotion of message 

delivery throughout time 

during which program was 

administered. 

Prior Training 

NR 

Type of Service 

One-on-one counseling 

during salon visit to provide 

education, counseling, and 

information on location of 

cancer screening services 

Type of Educational 

Materials Used 

Written materials (not 

described) 

Duration of Interaction 

with Clients 

One visit - (time of session 

NR) 

Length of Follow-up 

3 months 

Age (mean) 

G1: 38 

G2: 39 

G3+G4: 38 

Sex (% female) 

100 

Race (%) 

African 

G1: 91 

G2: 93 

Hispanic 

G1: 7 

G2: 6 

Other 

G1: 2 

G2: 1 

Other 

Born in US (%) 

G1: 56 

G2: 52 

Family hx of breast cancer 

(%) 

G1: 10 

G2: 9 

Role of CHW in Recruiting 

and Retention 

NA 

Recruitment Rates 

NA 

Retention Rates 

NA 

C-123 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, 

and Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

Measure 1 

Engaging in BSE in past 3 

months 

Results 

G1: 25% 

G2: 28%, P = 0.26 for 

differences between G1 

and G2 

G3: 37% 

G4: 40% 

Adjusted OR, for differences 

between G3: and G4 1.3; 

Adj 95% CI, 0.9-1.7 

Measure 2 

Intention to receive 

mammogram in next year 

Results 

G3: 70% 

G4: 74% 

Adj OR 1.3; Adj 

95% CI, 0.9-1.2 

Quality of Life: 

NR 

Health Outcomes: 

NR 

Healthcare Utilization: 

Measure 1 

Clinical breast exam (CBE) in past 3 months 

Results 

G1: 27% 

G2: 27%, P = 0.85 for differences between G1 and G2 

G3: 27% 

G4: 29% 

AOR 1.2 (95% CI, 0.9-1.7) 

Measure 2 

Mammogram in past 3 months 

Results 

G1: 13% 

G2: 14% 

Adj OR 1.1; Adj 95% CI, 0.8-1.7 

Costs (Economics): 

NR 

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Poor 

C-124 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Study 

Characteristics 

Setting 

Number (N) 

Inclusion/Exclusion 

Groups 

Community Health 

Worker 

Baseline 

Characteristics 

Recruiting and 

Retention 

Author Year 

Wolff et al. 1997; 

Morse et al. 1997 

Trial Name 

NR 

Objective or Aim 

Three types of 

case management 

were compared to 

determine their 

relative 

effectiveness in 

helping people with 

severe mental 

illness who were 

homeless or at risk 

of homelessness. 

and costeffectiveness of 

three approaches 

to case 

management for 

individuals with 

severe mental 

illness who were at 

risk for 

homelessness 

Geography 

St. Louis, Missouri 

Organization 

Organizational 

Type of 

Community 

Mental Illness and 

homelessness 

Study Design 

RCT 

Start Date 

1990 

Duration 

18 months 

Eligible (N) 

204 

Enrolled (N) 

NR 

Randomized (N) 

165 

Completers (N) 

135 (Outcomes based on 85) 

Withdrawals or Dropouts (N) 

30 

Health Condition of Interest 

Mental illness 

Inclusion Criteria 

Current homelessness or risk for 

homelessness; serious DSM-III-R 

axis I diagnosis; no recent convictions 

for rape, homicide, or serious assault; 

and willingness to receive services and 

participate in a longitudinal study 

Exclusion Criteria 

See Inclusion criteria 

Groups 

G1: Assertive community treatment 

G2: Assertive community treatment 

with community workers, 

G3: Receiving brokered case 

management (purchase of services).

Interventions 

G1: Assertive community treatment - 

intensive individualized treatment, 

responsibility for providing or 

coordingating all services needed by 

client, persistent follow-up and in 

vivo service delivery, performed by 

staff with backgounds in psychology, 

social work, and counseling 

G2: G1 + Community Health Worker, 

whose role was to assist with 

activities of daily living and be 

available for leisure activities 

Group (N) 

NR for primary intervention study 

G1: 28 in assertive community 

treatment 

G2: 35 in assertive community 

treatment with community workers, 

G3: 22 receiving brokered case 

management (purchase of services).

Title of CHW 

Community worker 

Paid or Volunteer 

Some paid and some 

volunteer 

Relationship with 

Community 

NR 

CHW (N) 

NR 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Included participation in 

individual and community 

leisure activities. Some 

also supplemented work 

of assertive community 

treatment staff by 

assisting clients with 

activities of daily living, 

although this usually 

occurred only on a 

limited basis. 

Type of Educational 

Materials Used 

NR 

Duration of Interaction 

with Clients 

Face-to-face meetings 

(length of each and 

number NR) over 18 

months 

Length of Follow-up 

18 months 

Age (mean) 

33.6 years 

Sex (% female) 

41.2 

Race (%) 

• African-American: 55.3 % 

• Aglo-American: 44.7% 

Other 

Role of CHW in Recruiting 

and Retention 

NR 

Recruitment Rates 

NR 

Retention Rates 

NR 

C-125 
Evidence Table C-1. Key Questions 1, 2, and 3 (continued) 

Knowledge, Attitude, and 

Behavior 

Quality of Life 

Health Outcomes 

Healthcare Utilization 

Costs (Economics) 

Additional 

Outcomes 

Knowledge, Attitude, and 

Behavior: 

NR 

Quality of Life: 

Measure 1 

Client Satisfaction 

Results 

G1: 3.27(0.42) 

G2: 3.12(0.57) 

G3: 2.74(0.68) P < 0.01 

Measure 2 

N of days in stable housing in 

past month 

Results 

Basline(SD)/18 months(SD) 

G1: 6.36(11.71)/21.75(12.76) 

G2: 4.94(11.08)/17.54(14.45) 

G3: 7.18(12.38)/16.00(14.86) 

(P < 0.31) 

Health Outcomes: 

Measure 1 

BPRS (Brief Psychiatric Rating Scale score) Total 

Symptom Score 

Results 

G1:53.54(15.54)/39.96(12.25) 

G2: 57.97(20.29)/38.77(12.23) 

G3: 50.6(14/31)/51.6(16.7) P = 0.001 

Healthcare Utilization: 

Measure 1 

Program contact (days/mo) 

Results 

G1:8.29(7.51) 

G2: 6.95(4.91) 

G3: 0.3(0.49) P < 0.001 

Costs (Economics): 

Measure 1 

Total costs over 18-

month study period for 

average client in each 

treatment condition 

Results 

Assertive community 

treatment only, 

$49,510; No significant 

difference 

Assertive community 

treatment with 

community workers, 

$39,913; brokered case 

management, $45,076

Explanation of Overall 

Outcomes 

NR 

Quality Rating 

Poor 

C-126 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Andersen et al., 2000 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable 

Manner 

Retrospective self-report 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

Yes 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

Cannot tell 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Good 

C-127 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Auslander, et al., 2002; 

Williams et al., 2001 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

NR 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

No 

Outcome Assessors Masked? 

NR 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Retrospective self-report (patient/participant 

response) 

Outcomes Measured in Valid and Reliable 

Manner 

Retrospective self-report (patient/participant 

response) 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Cannot determine 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

Cannot determine 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

No 

Any Post-Randomization Exclusions? 

Cannot tell 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Fair 

C-128 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Barnes et al., 1999 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Partially 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

Not reported 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Prospective documentation 

Outcomes Measured in Valid and Reliable 

Manner 

Objective 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes: 24% in G1 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

No 

Does Analysis Control for Baseline 

Differences? 

No 

Analysis Conducted on ITT Basis? 

No 

Any Post-Randomization Exclusions? 

Yes many as they were randomized before 

enrollment 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Fair 

C-129 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Barth, 1991 

Hypothesis/Aim/ Objective of Study Described? 

YES- kind of 

Criteria Clearly Stated? 

Partially 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

No 

Allocation of Randomization Adequately Concealed? 

Can't tell so No 

Level of Detail in Describing Intervention/Exposure 

Low 

Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

NA 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Objective in some 

Outcomes Measured in Valid and Reliable 

Manner 

Objective in some 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

No 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

Yes 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

Yes 

Analysis Conducted on ITT Basis? 

No 

Any Post-Randomization Exclusions? 

Yes at least 3 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Poor 

C-130 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Barth et al., 1988 

Hypothesis/Aim/ Objective of Study Described? 

YES- kind of 

Criteria Clearly Stated? 

Partially 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

No 

Allocation of Randomization Adequately Concealed? 

Can't tell so No 

Level of Detail in Describing Intervention/Exposure 

Low 

Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

Not reported 

Care Provider Masked? 

NA 

Patient Masked? 

Not reported 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Objective in some 

Outcomes Measured in Valid and Reliable 

Manner 

Objective in some 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

No 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

Yes 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

Yes 

Analysis Conducted on ITT Basis? 

No 

Any Post-Randomization Exclusions? 

Yes at least 3 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Poor 

C-131 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Batts et al., 2001; 

Gary et al., 2005; 

Gary et al., 2003; 

Gary et al., 2000; 

Vetter et al., 2004 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No (and primary outcome not clearly identified) 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised Study 

Findings? 

Yes 

Outcome Assessors Masked? 

Yes 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Objective measure, not validated 

Outcomes Measured in Valid and Reliable 

Manner 

Objective 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

No (completers analysis) 

Any Post-Randomization Exclusions? 

No 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Good 

C-132 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Becker et al., 2005; 

Cene et al., 2008 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Low 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised Study 

Findings? 

Yes 

Outcome Assessors Masked? 

NR 

Care Provider Masked? 

NR 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable 

Manner 

Retrospective self-report (patient/participant 

response) 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes - G1:26% G2:27% 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

No 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

No 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-133 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Black et al., 1995; 

Hutcheson et al., 1997 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

Yes 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable 

Manner 

Objective, validated; and retrospective self-report

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes, for characteristics in table 1, but trend 

toward lower baseline receptive language in 

intervention group at baseline (table 2); no 

reporting of maternal baseline psychiatric 

measures 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

Cannot tell 

Conclusions Supported by Results? 

Partially (difficult to tell since there is no sample 

size calculation, no definition of primary outcome, 

numerous comparisons/outcomes evaluated, no 

clarity of what represents a clinically important 

difference for outcomes rather than just a 

statistically important difference, and there were 

baseline differences in receptive language 

socres...) 

Quality Rating 

Fair 

C-134 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Campbell et al., 2004 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

No 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

No 

Allocation of Randomization Adequately Concealed? 

No 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

NA 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

No 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable 

Manner 

NR 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Cannot determine 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

Cannot determine 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

No 

Does Analysis Control for Baseline 

Differences? 

Yes 

Analysis Conducted on ITT Basis? 

No 

Any Post-Randomization Exclusions? 

Cannot tell 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Poor 

C-135 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Caulfield et al., 1998 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

No 

Allocation of Randomization Adequately Concealed? 

NA 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised Study 

Findings? 

Yes 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Retrospective self-report (patient/participant 

response) 

Outcomes Measured in Valid and Reliable 

Manner 

Retrospective self-report (patient/participant 

response) 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

56% overall drop out 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

NR 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

No 

Does Analysis Control for Baseline 

Differences? 

Yes (via logistic regression) 

Analysis Conducted on ITT Basis? 

No 

Any Post-Randomization Exclusions? 

Yes 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Poor 

C-136 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Conway et al., 2004 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

Yes 

Assignment Randomized 

NR (randomization method NR) 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Low, broad concepts provided without detailed description of 

promotoras intervetion techniques 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

NA 

Could Variation from Protocol have Compromised Study 

Findings? 

NA 

Outcome Assessors Masked? 

Yes 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Objective, not validated 

Outcomes Measured in Valid and Reliable 

Manner 

Objective, validated 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

NR, no table 1, inadequate description of 

comparability of groups 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

No, completers analysis 

Any Post-Randomization Exclusions? 

Yes 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Good 

C-137 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Corkery et al., 1997 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

NR 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

Not reported 

Care Provider Masked? 

Not reported 

Patient Masked? 

Not reported 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Objective (some validated, some not) and 

retrospective self-report 

Outcomes Measured in Valid and Reliable 

Manner 

Objective (some validated, some not) and 

retrospective self-report 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes - 37% 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

Yes 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

No 

Analysis Conducted on ITT Basis? 

No 

Any Post-Randomization Exclusions? 

Cannot tell 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Fair 

C-138 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Dean et al., 2000; 

Derose et al., 2000; 

Derose et al., 2000; 

Fox et al., 1998; 

Stockdale et al., 2000 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

NR 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised Study 

Findings? 

No 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

NA 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Prospective documentation 

Outcomes Measured in Valid and Reliable 

Manner 

Retrospective self-report 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes - 73% 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

CD 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

Yes 

Analysis Conducted on ITT Basis? 

CD 

Any Post-Randomization Exclusions? 

No 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-139 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Dignan et al., 2005 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Partially 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

NR 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Low 

Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

Yes 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Prospective documentation 

Outcomes Measured in Valid and Reliable 

Manner 

Retrospective self-report 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

No (outcome asks about past 12 months, 

followup data obtained within 6 months) 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes - 29% 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

Cannot determine 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Greater number of patients age 65+ in telephone 

group 

Does Analysis Control for Baseline 

Differences? 

Cannot determine 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

Cannot tell 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Poor 

C-140 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Duggan et al., 1999; Duggan et al., 2000 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Partially 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

No 

Allocation of Randomization Adequately Concealed? 

NA 

Level of Detail in Describing Intervention/Exposure 

Low 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

Yes 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Retrospective self-report (patient/participant 

response) 

Outcomes Measured in Valid and Reliable 

Manner 

Retrospective self-report (patient/participant 

response) 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

No 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

No 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Poor 

C-141 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Elder et al., 2006; 

Elder et al., 2005 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

No 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Low, many details about tailored print materials not 

provided (just general topics covered are identified); 

minimal description of what promotoras acually did 

Usual Clinical Care Described? 

NA 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised 

Study Findings? 

Cannot determine, possible there could be contamination if 

subjects in various groups had interactions w/ each other 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable Manner 

Retrospective self-report (24-hour dietary recall) for 

primary outcomes; accuracy of measure is debatable 

given recall issues, social desirability/those working with 

promotoras may have greater desire to report lower 

intake of fat/etc. to please promotoras with which 

they've established a relationship. Of not, BMI changes 

from baseline were similar in all groups but decreased 

least in promotoras group—suggesting that 

intermediate measures used (dietary intake of fat, etc.) 

were not in line with BMI changes that would be 

expected. 

Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% After 

Randomization? 

No for 12 week outcomes; Yes for 1 year outcomes (G1 

22%, G2 24%) 

Did Attrition Differ by More Than 15 Percentage 

Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

No, important differences in perceived barriers to fat, 

stages of change for fat, ...More participants in tailored 

condition (than promotoras group) were in earlier stages 

of change. Also, tailored group had worse overall health 

(per self-report) 

Does Analysis Control for Baseline Differences? 

No 

Analysis Conducted on ITT Basis? 

No 

Any Post-Randomization Exclusions? 

No 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Poor 

C-142 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Gielen et al., 2002 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

Yes 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

Yes 

Level of Detail in Describing Intervention/Exposure 

Low 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised Study 

Findings? 

CD 

Outcome Assessors Masked? 

NR 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Objective measure, not validated 

Outcomes Measured in Valid and Reliable 

Manner 

Objective meansure, not validated 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes - 27% in standard; 15% in enhanced 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

Yes 

Analysis Conducted on ITT Basis? 

CD 

Any Post-Randomization Exclusions? 

No 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-143 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Graham et al., 1992 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

Yes 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

Yes 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

Yes 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable 

Manner 

Objective 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

G1: 60% completers; 72% overall received some 

visits 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

Yes (control group 100% of sample available) 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Cannot determine 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

Yes (24) 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-144 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Hiatt et al., 2008 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

No 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

2x2 

Allocation of Randomization Adequately Concealed? 

No 

Level of Detail in Describing Intervention/Exposure 

Low 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

Yes 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Retrospective self-report 

Outcomes Measured in Valid and Reliable 

Manner 

Objective, previously validated 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

No 

Does Analysis Control for Baseline 

Differences? 

Yes - some 

Analysis Conducted on ITT Basis? 

No 

Any Post-Randomization Exclusions? 

Cannot tell 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-145 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Hunter et al., 2004 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

NR 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised Study 

Findings? 

No 

Outcome Assessors Masked? 

NR 

Care Provider Masked? 

NR 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Objective measure, not validated 

Outcomes Measured in Valid and Reliable 

Manner 

Objective 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

No 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-146 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Jandorf et al., 2005 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

No 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

Yes 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Objective 

Outcomes Measured in Valid and Reliable 

Manner 

Objective 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

No 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-147 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Korfmacher et al., 1999; 

Olds et al., 2002; 

Olds et al., 2004 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

Yes 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

Yes 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

Yes 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Prospective documentation 

Outcomes Measured in Valid and Reliable 

Manner 

Objective, some validated; Prospective 

documentation 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes - G1 48%, G2 38% 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

Yes - G1 48%, G2 38%, G3 20% 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

Yes (G1 = 11, G2 = 12, G3 = 17 in one study); 

Yes (G1 = 34, G2 = 35, G3 = 34 in another 

study) 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-148 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Krieger et al., 1999 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

Yes 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

Yes 

Level of Detail in Describing Intervention/Exposure 

High 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

NR 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Prospective documentation 

Outcomes Measured in Valid and Reliable 

Manner 

For main outcome (completing follow-up visit): 

retrospective self-report of patient 

For blood pressure: Objective, previously 

validated 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes (30% vs. 22% attrition) 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes (by report) 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

No, completers analysis 

Any Post-Randomization Exclusions? 

Yes 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-149 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Krieger et al., 2002; Krieger et al., 2005 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

Yes 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

Yes 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

NA 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised Study 

Findings? 

No 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable 

Manner 

NR 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

Yes 

Analysis Conducted on ITT Basis? 

Yes and no 

Any Post-Randomization Exclusions? 

Yes 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Good 

C-150 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Levine et al., 2003 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

No 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

High 

Usual Clinical Care Described? 

NA 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

NA 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

NR 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Prospective documentation 

Outcomes Measured in Valid and Reliable 

Manner 

Objective, validated 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes - G1 38%, G2 43% 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

Yes (G1 = 145, G2 = 173) 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-151 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Lujanet al., 2007 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

Yes 

Assignment Randomized 

NR 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

NA 

Could Variation from Protocol have Compromised Study 

Findings? 

Yes (but only 1 subject crossed over from control to intervention, 

so minimal impact on results) 

Outcome Assessors Masked? 

Yes 

Care Provider Masked? 

NR 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Objective measure, not validated 

Outcomes Measured in Valid and Reliable 

Manner 

Objective 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Cannot determine (for most characteristics 

because no table 1; most characteristics reported 

for entire sample rather than for each group; of 

note, mean Hgb A1c levels were different at 

baseline---8.71 vs. 7.71) 

Does Analysis Control for Baseline 

Differences? 

CD 

Analysis Conducted on ITT Basis? 

No 

Any Post-Randomization Exclusions? 

Yes (1) 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Good 

C-152 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Mock et al., 2007 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Partially 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

NR (but subjects from same household were kept in same arm) 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

NA 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable 

Manner 

Retrospective self-report 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

Cannot tell 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-153 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Morisky et al., 2002; 

Ward et al., 2000 

Hypothesis/Aim/ Objective of Study Described? 

No 

Criteria Clearly Stated? 

No 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

NR 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

High 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

NR 

Care Provider Masked? 

NR 

Patient Masked? 

NR 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable 

Manner 

Blood pressure measurement technique not 

reported 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes (flow diagram/attrition not clearly reported, 

but Table 2 "BP in control" section indicates that 

was quite high) 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

Cannot determine 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Cannot determine (they suggest that they are, 

but there is no Table 1 and baseline 

characteristics are not adequately reported) 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

No, completers analysis 

Any Post-Randomization Exclusions? 

Yes 

Conclusions Supported by Results? 

Partially (no discussion of effect of CHWs) 

Quality Rating 

Poor 

C-154 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Navarro et al., 1998; 

Navarro et al., 1995; 

Navarro et al., 2000 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

No 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

NR 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

High 

Usual Clinical Care Described? 

NA 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

No 

Outcome Assessors Masked? 

NR 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Retrospective self-report 

Outcomes Measured in Valid and Reliable 

Manner 

Retrospective self-report 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

Yes 

Analysis Conducted on ITT Basis? 

No 

Any Post-Randomization Exclusions? 

Cannot tell 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Poor 

C-155 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Parker et al., 2008 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

High 

Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

No 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Objective (some validated, some not) and 

retrospective self-report 

Outcomes Measured in Valid and Reliable 

Manner 

Objective (some validated, some not) and 

retrospective self-report 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes (23% and 25%) 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

Yes 

Analysis Conducted on ITT Basis? 

No 

Any Post-Randomization Exclusions? 

Yes (30) 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-156 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Paskett et al., 2006; 

Katz et al., 2007 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

Yes 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

Yes 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised Study 

Findings? 

No 

Outcome Assessors Masked? 

Yes 

Care Provider Masked? 

Yes 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Prospective documentation 

Outcomes Measured in Valid and Reliable 

Manner 

Objective 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

Yes: 17 refused 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Good 

C-157 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Pilote et al., 1996 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

NA 

Could Variation from Protocol have Compromised Study 

Findings? 

CD 

Outcome Assessors Masked? 

NR 

Care Provider Masked? 

NR 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable 

Manner 

NR 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

CD 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

CD 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

Cannot tell 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Fair 

C-158 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Rask t al., 2001; 

LeBaron et al., 2004 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Partially 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

NR 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

High 

Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

CD 

Outcome Assessors Masked? 

NR 

Care Provider Masked? 

NR 

Patient Masked? 

NR 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Prospective documentation 

Outcomes Measured in Valid and Reliable 

Manner 

Objective 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

CD 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

CD 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

CD 

Does Analysis Control for Baseline 

Differences? 

CD 

Analysis Conducted on ITT Basis? 

CD 

Any Post-Randomization Exclusions? 

CD 

Conclusions Supported by Results? 

NR 

Quality Rating 

Good 

C-159 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Schuler et al., 2000 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

No Partially 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

No NR 

Allocation of Randomization Adequately Concealed? 

No NR 

Level of Detail in Describing Intervention/Exposure 

Low 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No Yes: exclusion of families with a different home visiting 

component; multivariate analyses 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

Yes, but method not described 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Retrospective self-report (patient/participant 

response) 

Outcomes Measured in Valid and Reliable 

Manner 

Some objective; others Retrospective self-report 

(patient/participant response) 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

Kind of Yes 

Any Post-Randomization Exclusions? 

Yes 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Fair 

C-160 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Silver et al., 1997 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

NR 

Allocation of Randomization Adequately Concealed? 

Yes (randomizer unaware of baseline responses & not involved 

with intervention) 

Level of Detail in Describing Intervention/Exposure 

Low 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

Yes, but method not described Not reported 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Retrospective self-report (patient/participant 

response) 

Outcomes Measured in Valid and Reliable 

Manner 

Objective 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

No: experimental group had significantly higher 

baseline PSI score 

Does Analysis Control for Baseline 

Differences? 

NA Yes 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

Cannot tell Yes (22) 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-161 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Sung et al., 1997; 

Sung et al., 1992 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

No 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

NR 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Low 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

na 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable 

Manner 

Retrospective self-report 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes (G1 43%, G2 35%) 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

No 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Poor 

C-162 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Taylor et al., 2002 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

Yes 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

High 

Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

NA 

Could Variation from Protocol have Compromised Study 

Findings? 

No 

Outcome Assessors Masked? 

No 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Retrospective self-report 

Outcomes Measured in Valid and Reliable 

Manner 

Objective, previously validated 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

NA 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

Cannot tell 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-163 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Von Korff et al., 1998 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

NR 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Medium 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

NA 

Could Variation from Protocol have Compromised Study 

Findings? 

Cannot determine 

Outcome Assessors Masked? 

Yes, but method not described 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable 

Manner 

Objective 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

No 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline 

Differences? 

Yes 

Analysis Conducted on ITT Basis? 

Yes 

Any Post-Randomization Exclusions? 

No 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Fair 

C-164 
Evidence Table C-2. Key Questions 1, 2, and 3: Quality RCTs (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Wolff et al., 1997 

Morse et al., 1997 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary Outcome(s)? 

No 

Assignment Randomized 

No 

Allocation of Randomization Adequately Concealed? 

NR 

Level of Detail in Describing Intervention/Exposure 

Low 

Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised Study 

Findings? 

Yes 

Outcome Assessors Masked? 

NR 

Care Provider Masked? 

No 

Patient Masked? 

No 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

Retrospective self-report (patient/participant 

response) 

Outcomes Measured in Valid and Reliable 

Manner 

Retrospective self-report (patient/participant 

response) 

Length of Time Following 

Intervention/Exposure Sufficient to Support 

Conclusions? 

Yes 

Did Attrition from Any Group Exceed 20% 

After Randomization? 

Yes 85/165 

Did Attrition Differ by More Than 15 

Percentage Points After Randomization? 

Yes - 30+% 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Cannot determine 

Does Analysis Control for Baseline 

Differences? 

Cannot determine 

Analysis Conducted on ITT Basis? 

No 

Any Post-Randomization Exclusions? 

Cannot tell 

Conclusions Supported by Results? 

No 

Quality Rating 

Poor 

C-165 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Barnes-Boyd et al., 2001 

Hypothesis/Aim/ Objective of Study Described? 

No 

Criteria Clearly Stated? 

No 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

No 

Level of Detail in Describing Intervention/Exposure? 

Medium 

Is Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised 

Study Findings? 

Cannot determine 

Outcome Assessors Blinded to Intervention/Exposure 

Status of Participants? 

No 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

Prospective documentation 

Outcomes Measured in Valid and Reliable Manner? 

NR 

Same Length of Follow-up or Adjustment for 

Different Length of Follow-up? 

Cannot determine 

Is Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

Yes 

Did Attrition for Any Group Exceed 20% After 

Allocation of Treatment? 

Yes (14% at 2 months and 44% at 11 months for 

REACH-Futures and 25% and 42% for REACH, 

respectively) 

Did Attrition Differ by More Than 15 Percentage 

Points After Allocation of Treatment? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

No 

Does Analysis Control for Baseline Differences? 

No 

Confounding and Modifying Variables Accounted 

for? 

No (no assessment of secular trend; this is a historical 

comparison) 

Analysis Conducted on ITT Basis? 

Yes 

Impact of Loss to Follow-up (or Differential Loss to 

Follow-up) Assessed? 

Cannot determine 

Statistical Methods Used to Assess Primary 

Outcomes Appropriate to Data? 

Yes 

For Cohort Studies Only, If Outcome has Greater 

than 10% Prevalence, is Risk Ratio and Relative 

Risk Calculated Directly? 

No (no RR reported) 

Does Study Report Appropriate Estimates of 

Random Variability in Data for Main Outcomes? 

No 

Conclusions Supported by Results? 

No 

Quality Rating 

Poor 

C-166 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Beckham et al., 2008 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

NA 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

No 

Level of Detail in Describing Intervention/Exposure? 

Medium 

Is Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised 

Study Findings? 

NA 

Outcome Assessors Blinded to Intervention/Exposure 

Status of Participants? 

No 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

Objective (clinical reports, lab findings, previously validated 

measures) 

Outcomes Measured in Valid and Reliable Manner? 

Objective (clinical reports, lab findings, previously validated 

measures) 

Same Length of Follow-up or Adjustment for 

Different Length of Follow-up? 

No 

Is Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

Yes 

Did Attrition for Any Group Exceed 20% After 

Allocation of Treatment? 

No 

Did Attrition Differ by More Than 15 Percentage 

Points After Allocation of Treatment? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline Differences? 

NA 

Confounding and Modifying Variables Accounted 

for? 

No 

Analysis Conducted on ITT Basis? 

No 

Impact of Loss to Follow-up (or Differential Loss to 

Follow-up) Assessed? 

NA 

Statistical Methods Used to Assess Primary 

Outcomes Appropriate to Data? 

Partially 

For Cohort Studies Only, If Outcome has Greater 

than 10% Prevalence, is Risk Ratio and Relative 

Risk Calculated Directly? 

NA 

Does Study Report Appropriate Estimates of 

Random Variability in Data for Main Outcomes? 

No 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Fair 

C-167 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Bone et al., 1989 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Partially 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

No 

Level of Detail in Describing Intervention/Exposure? 

Medium (odd that it is described in results rather than 

methods section) 

Is Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

NA 

Could Variation from Protocol have Compromised 

Study Findings? 

Yes 

Outcome Assessors Blinded to Intervention/Exposure 

Status of Participants? 

No 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

prospective documentation 

Outcomes Measured in Valid and Reliable Manner? 

Prospective documentation (return to ED for follow up visit)

Same Length of Follow-up or Adjustment for 

Different Length of Follow-up? 

CD 

Is Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

Yes 

Did Attrition for Any Group Exceed 20% After 

Allocation of Treatment? 

No 

Did Attrition Differ by More Than 15 Percentage 

Points After Allocation of Treatment? 

Cannot determine (this is really just one prospective 

cohort, they did not a priori define analysis plan and 

only in results define those that CHWs were unable to 

reach as comparison group) 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

No or cannot determine, not reported 

Does Analysis Control for Baseline Differences? 

Cannot determine, no description of analysis 

Confounding and Modifying Variables Accounted 

for? 

CD 

Analysis Conducted on ITT Basis? 

No 

Impact of Loss to Follow-up (or Differential Loss to 

Follow-up) Assessed? 

No 

Statistical Methods Used to Assess Primary 

Outcomes Appropriate to Data? 

NA, methods not reported 

For Cohort Studies Only, If Outcome has Greater 

than 10% Prevalence, is Risk Ratio and Relative 

Risk Calculated Directly? 

NA 

Does Study Report Appropriate Estimates of 

Random Variability in Data for Main Outcomes? 

No 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Poor 

C-168 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Caulfield et al., 1998 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

No 

Level of Detail in Describing Intervention/Exposure? 

Medium 

Is Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised 

Study Findings? 

Yes 

Outcome Assessors Blinded to Intervention/Exposure 

Status of Participants? 

No 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

Objective measure, not validated 

Outcomes Measured in Valid and Reliable Manner? 

Retrospective self-report (patient/participant response) 

Same Length of Follow-up or Adjustment for 

Different Length of Follow-up? 

No 

Is Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

Yes 

Did Attrition for Any Group Exceed 20% After 

Allocation of Treatment? 

Yes 

Did Attrition Differ by More Than 15 Percentage 

Points After Allocation of Treatment? 

Yes 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

No 

Does Analysis Control for Baseline Differences? 

Yes 

Confounding and Modifying Variables Accounted 

for? 

Yes 

Analysis Conducted on ITT Basis? 

No 

Impact of Loss to Follow-up (or Differential Loss to 

Follow-up) Assessed? 

Yes a bit 

Statistical Methods Used to Assess Primary 

Outcomes Appropriate to Data? 

Partially 

For Cohort Studies Only, If Outcome has Greater 

than 10% Prevalence, is Risk Ratio and Relative 

Risk Calculated Directly? 

NA 

Does Study Report Appropriate Estimates of 

Random Variability in Data for Main Outcomes? 

Yes 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Poor 

C-169 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Earp et al., 2002 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

Partially 

Level of Detail in Describing Intervention/Exposure? 

Low 

Is Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised 

Study Findings? 

NA 

Outcome Assessors Blinded to Intervention/Exposure 

Status of Participants? 

No 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable Manner? 

Retrospective self-report 

Same Length of Follow-up or Adjustment for 

Different Length of Follow-up? 

Yes 

Is Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

Yes 

Did Attrition for Any Group Exceed 20% After 

Allocation of Treatment? 

No 

Did Attrition Differ by More Than 15 Percentage 

Points After Allocation of Treatment? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

No (for income, lack of medical visits, perceived barriers 

to screening, knowledge about breast cancer) 

Does Analysis Control for Baseline Differences? 

Yes 

Confounding and Modifying Variables Accounted 

for? 

Yes 

Analysis Conducted on ITT Basis? 

Yes 

Impact of Loss to Follow-up (or Differential Loss to 

Follow-up) Assessed? 

No 

Statistical Methods Used to Assess Primary 

Outcomes Appropriate to Data? 

Partially 

For Cohort Studies Only, If Outcome has Greater 

than 10% Prevalence, is Risk Ratio and Relative 

Risk Calculated Directly? 

NA 

Does Study Report Appropriate Estimates of 

Random Variability in Data for Main Outcomes? 

Yes 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Poor 

C-170 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Erwin et al., 1997 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

No 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

No 

Level of Detail in Describing Intervention/Exposure? 

Medium 

Is Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised 

Study Findings? 

Cannot determine 

Outcome Assessors Blinded to Intervention/Exposure 

Status of Participants? 

No 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

Objective measure, not validated 

Outcomes Measured in Valid and Reliable Manner? 

Retrospective self-report (patient/participant response) 

Same Length of Follow-up or Adjustment for 

Different Length of Follow-up? 

No 

Is Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

Yes 

Did Attrition for Any Group Exceed 20% After 

Allocation of Treatment? 

No 

Did Attrition Differ by More Than 15 Percentage 

Points After Allocation of Treatment? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

No 

Does Analysis Control for Baseline Differences? 

Yes 

Confounding and Modifying Variables Accounted 

for? 

Partially 

Analysis Conducted on ITT Basis? 

NA 

Impact of Loss to Follow-up (or Differential Loss to 

Follow-up) Assessed? 

No 

Statistical Methods Used to Assess Primary 

Outcomes Appropriate to Data? 

Yes 

For Cohort Studies Only, If Outcome has Greater 

than 10% Prevalence, is Risk Ratio and Relative 

Risk Calculated Directly? 

NA 

Does Study Report Appropriate Estimates of 

Random Variability in Data for Main Outcomes? 

Yes 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-171 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Forst et al., 2004 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Partially 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

No 

Level of Detail in Describing Intervention/Exposure? 

Medium 

Is Usual Clinical Care Described? 

Yes 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised 

Study Findings? 

No (authors do not describe any variation, or lack of 

variation, from protocol; however, there is fair potential for 

contamination) 

Outcome Assessors Blinded to Intervention/Exposure 

Status of Participants? 

No 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

Objective, not validated 

Outcomes Measured in Valid and Reliable Manner? 

Retrospective self-report 

Same Length of Follow-up or Adjustment for 

Different Length of Follow-up? 

Yes 

Is Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

Yes 

Did Attrition for Any Group Exceed 20% After 

Allocation of Treatment? 

Yes - about 30% overall (note: 83 subjects were 

excluded at end b/c one CHW admitted to completing 

questionnaires herself) 

Did Attrition Differ by More Than 15 Percentage 

Points After Allocation of Treatment? 

Cannot determine 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Cannot determine 

Does Analysis Control for Baseline Differences? 

NA 

Confounding and Modifying Variables Accounted 

for? 

No 

Analysis Conducted on ITT Basis? 

Yes 

Impact of Loss to Follow-up (or Differential Loss to 

Follow-up) Assessed? 

No 

Statistical Methods Used to Assess Primary 

Outcomes Appropriate to Data? 

Yes 

For Cohort Studies Only, If Outcome has Greater 

than 10% Prevalence, is Risk Ratio and Relative 

Risk Calculated Directly? 

NA 

Does Study Report Appropriate Estimates of 

Random Variability in Data for Main Outcomes? 

No 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Poor 

C-172 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Frate et al., 1985 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

No 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

No 

Level of Detail in Describing Intervention/Exposure? 

Low 

Is Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised 

Study Findings? 

NA 

Outcome Assessors Blinded to Intervention/Exposure 

Status of Participants? 

No 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

Objective 

Outcomes Measured in Valid and Reliable Manner? 

Objective 

Same Length of Follow-up or Adjustment for 

Different Length of Follow-up? 

NA 

Is Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

Yes 

Did Attrition for Any Group Exceed 20% After 

Allocation of Treatment? 

Cannot determine 

Did Attrition Differ by More Than 15 Percentage 

Points After Allocation of Treatment? 

Cannot determine 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Cannot determine 

Does Analysis Control for Baseline Differences? 

NA 

Confounding and Modifying Variables Accounted 

for? 

No 

Analysis Conducted on ITT Basis? 

No 

Impact of Loss to Follow-up (or Differential Loss to 

Follow-up) Assessed? 

No 

Statistical Methods Used to Assess Primary 

Outcomes Appropriate to Data? 

No 

For Cohort Studies Only, If Outcome has Greater 

than 10% Prevalence, is Risk Ratio and Relative 

Risk Calculated Directly? 

NA 

Does Study Report Appropriate Estimates of 

Random Variability in Data for Main Outcomes? 

No 

Conclusions Supported by Results? 

No 

Quality Rating 

Extra Poor 

C-173 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Nacion et al., 2000 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

No 

Level of Detail in Describing Intervention/Exposure? 

Low 

Is Usual Clinical Care Described? 

NA 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

NA 

Could Variation from Protocol have Compromised 

Study Findings? 

NA 

Outcome Assessors Blinded to Intervention/Exposure 

Status of Participants? 

No 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

Prospective documentation 

Outcomes Measured in Valid and Reliable Manner? 

NR 

Same Length of Follow-up or Adjustment for 

Different Length of Follow-up? 

NA 

Is Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

Yes 

Did Attrition for Any Group Exceed 20% After 

Allocation of Treatment? 

No 

Did Attrition Differ by More Than 15 Percentage 

Points After Allocation of Treatment? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

No 

Does Analysis Control for Baseline Differences? 

No 

Confounding and Modifying Variables Accounted 

for? 

Cannot determine 

Analysis Conducted on ITT Basis? 

Yes 

Impact of Loss to Follow-up (or Differential Loss to 

Follow-up) Assessed? 

NA 

Statistical Methods Used to Assess Primary 

Outcomes Appropriate to Data? 

Yes 

For Cohort Studies Only, If Outcome has Greater 

than 10% Prevalence, is Risk Ratio and Relative 

Risk Calculated Directly? 

NA 

Does Study Report Appropriate Estimates of 

Random Variability in Data for Main Outcomes? 

No 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-174 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Sauaia et al., 2007; 

Welsh et al., 2005 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

No 

Level of Detail in Describing Intervention/Exposure? 

Medium 

Is Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised 

Study Findings? 

NA 

Outcome Assessors Blinded to Intervention/Exposure 

Status of Participants? 

No 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

Prospective documentation 

Outcomes Measured in Valid and Reliable Manner? 

objective measure 

Same Length of Follow-up or Adjustment for 

Different Length of Follow-up? 

NA 

Is Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

Yes 

Did Attrition for Any Group Exceed 20% After 

Allocation of Treatment? 

NA 

Did Attrition Differ by More Than 15 Percentage 

Points After Allocation of Treatment? 

NA 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

CD 

Does Analysis Control for Baseline Differences? 

NA 

Confounding and Modifying Variables Accounted 

for? 

Partially 

Analysis Conducted on ITT Basis? 

Yes 

Impact of Loss to Follow-up (or Differential Loss to 

Follow-up) Assessed? 

NA 

Statistical Methods Used to Assess Primary 

Outcomes Appropriate to Data? 

Yes 

For Cohort Studies Only, If Outcome has Greater 

than 10% Prevalence, is Risk Ratio and Relative 

Risk Calculated Directly? 

NA 

Does Study Report Appropriate Estimates of 

Random Variability in Data for Main Outcomes? 

No 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-175 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Schwarz et al., 1993 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

No 

Level of Detail in Describing Intervention/Exposure? 

Medium 

Is Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Not really 

Could Variation from Protocol have Compromised 

Study Findings? 

Yes 

Outcome Assessors Blinded to Intervention/Exposure 

Status of Participants? 

No: "health department personnel were not blinded to 

intervention or control status of each household" 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

Objective measure, not validated 

Outcomes Measured in Valid and Reliable Manner? 

Objective measure, not validated 

Same Length of Follow-up or Adjustment for 

Different Length of Follow-up? 

NA 

Is Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

Yes 

Did Attrition for Any Group Exceed 20% After 

Allocation of Treatment? 

No 

Did Attrition Differ by More Than 15 Percentage 

Points After Allocation of Treatment? 

No 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

No 

Does Analysis Control for Baseline Differences? 

No 

Confounding and Modifying Variables Accounted 

for? 

No 

Analysis Conducted on ITT Basis? 

No 

Impact of Loss to Follow-up (or Differential Loss to 

Follow-up) Assessed? 

No 

Statistical Methods Used to Assess Primary 

Outcomes Appropriate to Data? 

Partially 

For Cohort Studies Only, If Outcome has Greater 

than 10% Prevalence, is Risk Ratio and Relative 

Risk Calculated Directly? 

NA 

Does Study Report Appropriate Estimates of 

Random Variability in Data for Main Outcomes? 

Yes 

Conclusions Supported by Results? 

Partially 

Quality Rating 

Poor 

C-176 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

St. James et al., 1999 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

Partially 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

No 

Level of Detail in Describing Intervention/Exposure? 

Low 

Is Usual Clinical Care Described? 

No 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised 

Study Findings? 

Yes 

Outcome Assessors Blinded to Intervention/Exposure 

Status of Participants? 

Yes 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

Objective measure, not validated 

Outcomes Measured in Valid and Reliable Manner? 

Objective 

Same Length of Follow-up or Adjustment for 

Different Length of Follow-up? 

NA 

Is Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

Yes 

Did Attrition for Any Group Exceed 20% After 

Allocation of Treatment? 

NA 

Did Attrition Differ by More Than 15 Percentage 

Points After Allocation of Treatment? 

NA 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

CD 

Does Analysis Control for Baseline Differences? 

CD 

Confounding and Modifying Variables Accounted 

for? 

CD 

Analysis Conducted on ITT Basis? 

Yes 

Impact of Loss to Follow-up (or Differential Loss to 

Follow-up) Assessed? 

NA 

Statistical Methods Used to Assess Primary 

Outcomes Appropriate to Data? 

Yes 

For Cohort Studies Only, If Outcome has Greater 

than 10% Prevalence, is Risk Ratio and Relative 

Risk Calculated Directly? 

No 

Does Study Report Appropriate Estimates of 

Random Variability in Data for Main Outcomes? 

No 

Conclusions Supported by Results? 

No 

Quality Rating 

Fair 

C-177 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Tessaro et al., 1997; 

Navaie-Waliser, et al., 2000 

Hypothesis/Aim/ Objective of Study 

Described? 

Yes 

Criteria Clearly Stated? 

Yes 

Power Analysis or Some Other Basis for 

Determining Adequacy of Study Group Sizes 

for Primary Outcome(s)? 

No 

Level of Detail in Describing 

Intervention/Exposure? 

Low 

Is Usual Clinical Care Described? 

No 

Researchers Rule out Impact from 

Unintended Intervention/Exposure that Might 

Bias Results? 

Yes 

Could Variation from Protocol have 

Compromised Study Findings? 

Cannot determine 

Outcome Assessors Blinded to 

Intervention/Exposure Status of 

Participants? 

NR 

Interventions/Exposures Measured in Valid 

and Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable 

Manner? 

Combination of validated scales/questionnaires 

and responses to interview questions 

Same Length of Follow-up or Adjustment for Different Length 

of Follow-up? 

Yes 

Is Length of Time Following Intervention/Exposure Sufficient 

to Support Conclusions? 

Yes 

Did Attrition for Any Group Exceed 20% After Allocation of 

Treatment? 

Yes - G1 34%; G2 40% 

Did Attrition Differ by More Than 15 Percentage Points After 

Allocation of Treatment? 

No 

Baseline Characteristics Similar in Exposed/Comparison 

Cohorts? 

No, differences in age, race, marital status, education, annual 

family income. (Baseline data for a number of other important 

factors NR) 

Does Analysis Control for Baseline Differences? 

Yes 

Confounding and Modifying Variables Accounted for? 

Partially 

Analysis Conducted on ITT Basis? 

Yes 

Impact of Loss to Follow-up (or Differential Loss to Followup) Assessed? 

No 

Statistical Methods Used to Assess Primary Outcomes 

Appropriate to Data? 

Partially (a great number of analyses conducted w/ multiple 

comparisons and several regressions; no description of primary 

outcomes; no sample size calculations; no adjustment for multiple 

comparisons; potential data mining) 

For Cohort Studies Only, If Outcome has Greater than 10% 

Prevalence, is Risk Ratio and Relative Risk Calculated 

Directly? 

No 

Does Study Report Appropriate Estimates of Random 

Variability in Data for Main Outcomes? 

Yes 

Conclusions Supported by Results? 

No (conclusions do not reflect potential biases in results) 

Quality Rating 

Poor 

C-178 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Wendell et al., 2003 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

NA 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

No 

Level of Detail in Describing Intervention/Exposure? 

Medium 

Is Usual Clinical Care Described? 

NA 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

Yes 

Could Variation from Protocol have Compromised 

Study Findings? 

Cannot determine 

Outcome Assessors Blinded to Intervention/Exposure 

Status of Participants? 

No 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

Objective measure, not validated 

Outcomes Measured in Valid and Reliable Manner? 

Objective measure, not validated 

Same Length of Follow-up or Adjustment for 

Different Length of Follow-up? 

NA 

Is Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

NA 

Did Attrition for Any Group Exceed 20% After 

Allocation of Treatment? 

NA 

Did Attrition Differ by More Than 15 Percentage 

Points After Allocation of Treatment? 

NA 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

Yes 

Does Analysis Control for Baseline Differences? 

NA 

Confounding and Modifying Variables Accounted 

for? 

Yes 

Analysis Conducted on ITT Basis? 

NA 

Impact of Loss to Follow-up (or Differential Loss to 

Follow-up) Assessed? 

NA 

Statistical Methods Used to Assess Primary 

Outcomes Appropriate to Data? 

Yes 

For Cohort Studies Only, If Outcome has Greater 

than 10% Prevalence, is Risk Ratio and Relative 

Risk Calculated Directly? 

NA 

Does Study Report Appropriate Estimates of 

Random Variability in Data for Main Outcomes? 

Yes 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Fair 

C-179 
Evidence Table C-3. Key Questions 1, 2, and 3: Quality Observational (continued) 

Study Characteristics 

Background 

Inclusion/Exclusion Criteria 

Randomization 

Interventions/Exposure 

Contamination 

Blinding 

Soundness of Information 

Follow-Up 

Analysis Comparability/Outcome 

Author Year 

Wilson et al., 2008 

Hypothesis/Aim/ Objective of Study Described? 

Yes 

Criteria Clearly Stated? 

No 

Power Analysis or Some Other Basis for Determining 

Adequacy of Study Group Sizes for Primary 

Outcome(s)? 

Yes 

Level of Detail in Describing Intervention/Exposure? 

Low 

Is Usual Clinical Care Described? 

NA 

Researchers Rule out Impact from Unintended 

Intervention/Exposure that Might Bias Results? 

No 

Could Variation from Protocol have Compromised 

Study Findings? 

NA 

Outcome Assessors Blinded to Intervention/Exposure 

Status of Participants? 

No 

Interventions/Exposures Measured in Valid and 

Reliable Manner? 

NR 

Outcomes Measured in Valid and Reliable Manner? 

retrospective self-report 

Same Length of Follow-up or Adjustment for 

Different Length of Follow-up? 

NA 

Is Length of Time Following Intervention/Exposure 

Sufficient to Support Conclusions? 

NA 

Did Attrition for Any Group Exceed 20% After 

Allocation of Treatment? 

NA 

Did Attrition Differ by More Than 15 Percentage 

Points After Allocation of Treatment? 

NA 

Baseline Characteristics Similar in 

Exposed/Comparison Cohorts? 

NR 

Does Analysis Control for Baseline Differences? 

NA 

Confounding and Modifying Variables Accounted 

for? 

No 

Analysis Conducted on ITT Basis? 

NA 

Impact of Loss to Follow-up (or Differential Loss to 

Follow-up) Assessed? 

NA 

Statistical Methods Used to Assess Primary 

Outcomes Appropriate to Data? 

Partially 

For Cohort Studies Only, If Outcome has Greater 

than 10% Prevalence, is Risk Ratio and Relative 

Risk Calculated Directly? 

NA 

Does Study Report Appropriate Estimates of 

Random Variability in Data for Main Outcomes? 

Yes 

Conclusions Supported by Results? 

Yes 

Quality Rating 

Poor 

C-180 
Evidence Table C-4. Key Questions 4 and 4a 

Study Characteristics 

Setting Community Health Worker 

Author Year 

Balcazar et al., 2006 

Trial Name 

Salud Para Su Corazon-NCLR 

Objective or Aim 

To promote heart-healthy behaviors 

among Latinos 

Geography 

Escondido CA, Chicago IL, Ojo Caliente 

NM 

Organization 

Latino communities 

Type of Community 

Latino communities 

Start Date 

2000 

Health Condition of Interest 

Cardiovascular disease 

Title of CHW 

Promotora 

Relationship with Community 

NR 

CHW (N) 

29 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Education sessions 

Type of Educational Materials Used 

Handouts, recipes, videos, actor scripts, games 

Duration of Interaction with Clients 

7 2-hour sessions over 6 months 

Length of Follow-up 

1 year 

C-181 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Training Characteristics 

Eligibility for CHW Training 

NR 

Input of CHW in Curriculum Development 

None 

Training on Cultural Competency 

NR (curriculum does offer "cultural and language appropriate instructional methods" but details NR) 

Training on Recruitment/Retention Process 

NR 

Training on Intake/Assessment 

NR 

Training on Protocol Delivery 

NR 

Training on Health Topic 

NR 

Training on Evaluation 

NR 

Other Training 

NR 

Other Training Content; Instructional Method; Number of Sessions; Testing 

NR 

Name of Curriculum 

Your Heart, Your life 

Availability of Curriculum 

Available online 

Evaluation and Testing Results of Curriculum 

closed-format pre-post test scores reported a score of 74% for pretest and 100% correct for posttest (n = 11). 

Differences in pre-post promotora knowledge scores changes (N = 29) were statistically (P < 0.05) but data reported 

in bar graph only. 

Certification 

NR 

Other Pertinent Information 

NA 

Are Particular Training Characteristics Associate with Improved Outcomes? 

NR 

C-182 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Study Characteristics 

Setting Community Health Worker 

Author Year 

Beck et al., 2007 

Trial Name 

Center for Health Communities' cancer 

education program 

Objective or Aim 

Train trainer in cancer education 

Geography 

Milwaukee County 

Organization 

African- American churches 

Type of Community 

African- American churches 

Start Date 

2002 

Health Condition of Interest 

Cancer prevention 

Title of CHW 

Church Health Action Team (CHAT) member 

Relationship with Community 

Respected member of church congregation 

CHW (N) 

6 (2 from each of 3 participating churches) 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Small group educational presentations 

Type of Educational Materials Used 

PowerPoint slides, handouts, brochures 

Duration of Interaction with Clients 

4 60-minute presentations 

Length of Follow-up 

NR 

C-183 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Training Characteristics 

Eligibility for CHW Training 

Member of congregation, well-respected, formal or informal leader, expressed enthusiasm for project 

Input of CHW in Curriculum Development 

None 

Training on Cultural Competency 

NR 

Training on Recruitment/Retention Process 

NR 

Training on Intake/Assessment 

NR 

Training on Protocol Delivery 

NR 

Training on Health Topic 

NR 

Training on Evaluation 

NR 

Other Training 

2 90-minute train-the-trainer workshops 

Other Training Content; Instructional Method; Number of Sessions; Testing 

NR 

Name of Curriculum 

NR 

Availability of Curriculum 

NR 

Evaluation and Testing Results of Curriculum 

Pre-post % correct 

Ability to define cancer: 

(1)General 89/93 (2)Breast 79/86 

(3)Colon 15/57 (4)Prostate 80/75 

Ability to identify signs/symptoms of cancer: 

(1) NA/NA (2) 71/88 

(3) 81/93 (4) 40/75 

Ability to identify screening recommendations: 

(1) NA/NA (2) 67/67 

(3) NA/NA (4) 80/75 

Ability to identify risk factors: 

(1) 59/85 (2) 54/92 

(3) 19/89 (4) 40/75 

Ability to identify strategies to reduce cancer risk: 

(1) 70/78 (2) 8/33 

(3) 92/96 (4) 20/75 

Certification 

"Certificate of completion" at 2nd training session 

Other Pertinent Information 

Results reported for 1 church only; CHWs presented 3 of modules while pastor presented 4th 

Are Particular Training Characteristics Associate with Improved Outcomes? 

NR 

C-184 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Study Characteristics 

Setting Community Health Worker 

Author Year 

Bell, et al., 1999 

Trial Name 

Abuela Project 

Objective or Aim 

To train Hispanic women to make queso 

fresco that was authentic in taste and 

texture but did not use raw milk in an 

effort to reduce incidence of Salmonella 

serotype Typhimurium infections resulting 

from eating queso fresco made from raw 

milk. 

Geography 

Yakima County, Washington 

Organization 

Hispanic communities 

Type of Community 

Hispanics 

Start Date 

1997 

Health Condition of Interest 

Salmonella 

Title of CHW 

Abuela educators 

Relationship with Community 

Shared ethnicity 

CHW (N) 

15 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Workshop, After training, each CHW singed contract indicating 

willingness to teach at least 15 members of community 

Type of Educational Materials Used 

Pamphlet, 

Duration of Interaction with Clients 

1 workshop 

Length of Follow-up 

NR 

C-185 
Evidence Table C-4. Key Question 4 and 4a (continued) 

Training Characteristics 

Eligibility for CHW Training 

Older Hispanic women from Yakima County 

Input of CHW in Curriculum Development 

None; however, curriculum was developed with input from respected Hispanic woman from Yakima community 

Training on Cultural Competency 

NR 

Training on Recruitment/Retention Process 

NR 

Training on Intake/Assessment 

NR 

Training on Protocol Delivery 

NR 

Training on Health Topic 

NR 

Training on Evaluation 

NR 

Other Training 

Workshops on how to make new queso fresco recipe (i.e., w/o raw milk) 

Other Training Content; Instructional Method; Number of Sessions; Testing 

Training sessions were hands-on and interactive; participants encouraged to ask questions & make comments 

Other Training Content; Instructional Method; Number of Sessions; Testing 

NR 

Name of Curriculum 

Abuela Project 

Availability of Curriculum 

Pamphlet available 

Evaluation and Testing Results of Curriculum 

Pretraining/ post-training: recognized health risks associated with eating unpasteurized milk and cheese: 10/14; 

14/15 

Make queso fresco with fresh unpasteurized milk: 6/12; 1/15. 

Certification 

No 

Other Pertinent Information 

NA 

Are Particular Training Characteristics Associate with Improved Outcomes? 

NR 

C-186 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Study Characteristics 

Setting Community Health Worker 

Author Year 

Kuhajda et al., 2006 

Trial Name 

Pine Apple Heart Disease and Stroke 

Project 

Objective or Aim 

To train CHWs for heart disease and 

stroke and in skills for counseling and 

assessing high-risk women in Pine Apple 

clinic. 

Geography 

Pine Apple, Alabama 

Organization 

African American women in rural southern 

community 

Type of Community 

African American women in rural southern 

community 

Start Date 

NR 

Health Condition of Interest 

Cardiovascular disease 

Title of CHW 

Counseling CHW; Assessment CHW 

Relationship with Community 

African American women with experience as community health 

volunteers in county 

CHW (N) 

4 

Supervision of CHW 

NR 

Prior Training 

Trained as community health advisors through U of AlabamaBirmingham; all had 10 yrs experience as community health volunteers 

Type of Service 

Counseling CHWs counseled clinic patients using project manual; 

Assessment CHWs assessed future patients before and after 

counseling sessions 

Type of Educational Materials Used 

NR 

Duration of Interaction with Clients 

NR 

Length of Follow-up 

NR 

C-187 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Training Characteristics 

Eligibility for CHW Training 

Chosen from a pool of CHWs trained as community health advisers through U of Alabama; expert advisory panel 

member assisted in selection 

Input of CHW in Curriculum Development 

CHWs shared ideas and concerns about training content and implementation of training sessions at a preliminary 

planning meeting 

Training on Cultural Competency 

NR 

Training on Recruitment/Retention Process 

NR 

Training on Intake/Assessment 

NR 

Training on Protocol Delivery 

Health education counseling; role-played cancer screening counseling sessions and CVD counseling sessions 

Training on Health Topic 

NR 

Training on Evaluation 

Topics addressed in training included CVD; Developing action plans (heart attack, congestive heart failure, stroke); 

High blood pressure; tobacco control; Cancer (lung, colorectal , breast, cervical) 

Other Training 

NR 

Name of Curriculum 

Training used revised revised Women's Wellness Sourcebook Module III: Heart and Stroke 

Availability of Curriculum 

Yes--revised manuals on cancer & stroke served as guide for training 

Evaluation and Testing Results of Curriculum 

Counseling CHWs' responses on pre-post training questionnaires showed increases in knowledge and self-reported 

behaviors in each of following areas: heart disease and stroke prevention strategies, cancer prevention strategies, 

heart attack or stroke signs and symptoms, cancer signs and symptoms, current heart disease and stroke 

prevention activities, current cancer prevention activities. Data reported in bar graph only. 

Certification 

NR 

Other Pertinent Information 

4 week training period; counseling CHWs required to be present for entire 4-wk period (except 2 half days devoted 

to training assessment CHWs). A variety of media and text materials usd to simulate active participation 

Are Particular Training Characteristics Associate with Improved Outcomes? 

NR 

C-188 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Study Characteristics 

Setting Community Health Worker 

Author Year 

Martinez-Bristow et al., 2006 

Trial Name 

Tobacco Free El Paso 

Objective or Aim 

To train Spanish speaking counselors to 

deliver tobacco cessation interventions. 

Geography 

El Paso 

Organization 

Neighborhood clinics 

Type of Community 

Spanish-speaking populations 

Start Date 

2003 

Health Condition of Interest 

Tobacco cessation 

Title of CHW 

Promotores 

Relationship with Community 

Spanish speaking members of community 

CHW (N) 

NR (89 participants in total, but 5% were healthcare professionals; 

baseline data collected for 74) 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Counseling 

Type of Educational Materials Used 

NR 

Duration of Interaction with Clients 

NR 

Length of Follow-up 

NR 

C-189 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Training Characteristics 

Eligibility for CHW Training 

NR (training was open to employees of certain clinics, healthcare professionals as well as promotores) 

Input of CHW in Curriculum Development 

Curriculum taken from University of Arizona's Healthcare Partnership which was developed in 1996 

Training on Cultural Competency 

NR 

Training on Recruitment/Retention Process 

Client recruitment was addressed in level 2 (Treatment Specialist) training; content, method, # of sessions NR 

Training on Intake/Assessment 

NR 

Training on Protocol Delivery 

NR 

Training on Health Topic 

Nicotine addiction 

Training on Evaluation 

NR 

Other Training 

5 days of training for each level of certification 

Other Training Content; Instructional Method; Number of Sessions; Testing 

NR 

Name of Curriculum 

NR 

Availability of Curriculum 

Available through U of Arizona developed website; no separate curriculum developed for Tobacco Free El Paso--

curriculum "borrowed" directly from U of A 

Evaluation and Testing Results of Curriculum 

Results from pre-posttest measuring self-confidence suggest that participants understood training material; however 

data NR. 

Mean satisfaction scores (1 = definitely not confident to 5 = definitely confident) high for recipients of each 

certification: beginner: 4.8, intermediate: 4.7, advanced: 4.6 

Certification 

3 certifications offered: introductory (Basic Skills to Stop Using Tobacco); intermediate (Treatment Specialist); 

advanced (Leave Addiction) 

Other Pertinent Information 

NA 

Are Particular Training Characteristics Associate with Improved Outcomes? 

NR 

C-190 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Study Characteristics 

Setting Community Health Worker 

Author Year 

Navarro et al., 2007 

Trial Name 

Por La Vida Cuidandome 

Objective or Aim 

Train community health advisors to 

conduct interactive educational group 

sessions and train-the-trainer (through 

"learning partners" 

Geography 

San Diego, CA 

Organization 

Latino communities 

Type of Community 

Women with low level of acculturation in 

low socioeconomic Latino communities 

Start Date 

1996 

Health Condition of Interest 

Breast & cervical cancer 

Title of CHW 

Consejeras 

Relationship with Community 

Part of local Latino community 

CHW (N) 

17 consejeras, 285 primary participants, 222 learning partners 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Interactive educational group sessions, recruiting women from local 

community to be primary participants in these sessions 

Type of Educational Materials Used 

Manual to guide sessions 

Duration of Interaction with Clients 

12 weekly sessions 

Length of Follow-up 

6 months after pretest 

C-191 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Training Characteristics 

Eligibility for CHW Training 

NR 

Input of CHW in Curriculum Development 

Developed over time & preveiously implement, so no 

Training on Cultural Competency 

NR 

Training on Recruitment/Retention Process 

There were 5 2-hour sessions covering recruitment strategies and role playing practice to lead sessions 

Training on Intake/Assessment 

NR 

Training on Protocol Delivery 

NR 

Training on Health Topic 

Manual had sessions for understanding female body, breast cancer, Pap test, breast health, risks 

Training on Evaluation 

NR 

Other Training 

Referral, communication skills 

Other Training Content; Instructional Method; Number of Sessions; Testing 

NR 

Name of Curriculum 

Por La Vida Cuidandomje, Taking Care of Myself: Women and Cancer 

Availability of Curriculum 

NR 

Evaluation and Testing Results of Curriculum 

Changes in knowledge & behavior pre/post test for primary participants; & learning partners 

Names following test for breast/cervical cancer early detection: 

BSE 58.6/74.7; 46.4/56.3 

Clinical breast exam: 29.1/28.8; 28.8/20.7 

Mammography: 49.8/71.2; 45.0/63.1 

Pap test 84.6/91.9/79.3/85.1 

Knows BSE: 90.5/99.3; 82.4/93.2 

Knows mammography recs: 32.3/55.8; 27.4/38.1 

Names ≥1 breast cancer symptom: 75.1/96.8; 70.3/94.1 

Names ≥1 txt for breast cancer: 40.0/65.6; 27.9/45.0 

Names ≥1 risk factor: 8.1/16.5; 6.8/7.2 

Names ≥1 factor for cervical cancer: 30.9/59.6; 24.3/35.1 

BSE in pasat month: 62.3/87.4; 55.9/71.5 

Mammography ever: 63.3/70.0; 66.7/68.3 

Pap test ever: 92.3/97.9; 88.3/92.8 

Certification 

No 

Other Pertinent Information 

14 program sessions (12 weekly sessions + 2 monthly session) plus 5 additional 2-hour sessions covering 

recruitment strategies and role playing practice to lead sessions 

Are Particular Training Characteristics Associate with Improved Outcomes? 

NR 

C-192 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Study Characteristics 

Setting Community Health Worker 

Author Year 

Perez, 2006 

Trial Name 

Northern Manhattan Community Voices 

Collaborative 

Objective or Aim 

To train community health workers, 

focusing on facilitating insurance 

enrollment, child immunization, and 

asthma management 

Geography 

Northern Manhattan 

Organization 

Neighborhoods 

Type of Community 

Northern Manhattan - Washington 

Heights, Inwood, and Harlem, comprising 

low income communities and/or racial and 

ethnic minorities (Dominican, AfricanAmerican) 

Start Date 

2000 

Health Condition of Interest 

(1) health insurance 

(2) child immunizaations 

(3) asthma management 

Title of CHW 

CHW 

Relationship with Community 

Live in community or a nearby neighborhood; share cultural & ethnic 

traditions with program participants 

CHW (N) 

# trained between 2000 & 2005: 

(1) 88 

(2) 792 

(3 624 

Supervision of CHW 

NR 

Prior Training 

NR 

Type of Service 

Community-wide health promotion activities; serve as bridge to primary 

health care provider 

Type of Educational Materials Used 

NR 

Duration of Interaction with Clients 

NR 

Length of Follow-up 

varied 

C-193 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Training Characteristics 

Eligibility for CHW Training 

Reside in community; shared culturual & enthic traditions with those they'll be serving; experience with programs 

offered by organization; good people skills; committed to community development 

Input of CHW in Curriculum Development 

NR 

Training on Cultural Competency 

Yes but not described 

Training on Recruitment/Retention Process 

NR 

Training on Intake/Assessment 

Yes but not described 

Training on Protocol Delivery 

Yes but not described 

Training on Health Topic 

Yes but not described 

Training on Evaluation 

Yes but not described (one of 7 core modules) 

Other Training Content; Instructional Method; Number of Sessions; Testing 

NR 

Name of Curriculum 

NR 

Availability of Curriculum 

NR 

Evaluation and Testing Results of Curriculum 

Gains in competency and knowledge (pre/post): 

(1) 24%/72% (gain = 48%; % change = 200; n tested = 61) 

(2) 83%/96% (gain-48%; %change = 16; n tested = 472) 

(3) 63%/83% (gain = 20%; %change = 32; n tested = 499) 

Certification 

NR 

Other Pertinent Information 

NA 

Are Particular Training Characteristics Associate with Improved Outcomes? 

NR 

C-194 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Study Characteristics 

Setting Community Health Worker 

Author Year 

Williams, 1996 

Trial Name 

NR 

Objective or Aim 

To raise awareness of & increase 

participation of older African-Americans in 

health promotion activities 

Geography 

Atlanta & Fort Valley Georgia 

Organization 

Older African-Americans 

Type of Community 

large urban & small township 

Start Date 

1992 

Health Condition of Interest 

Health promotion & education 

Title of CHW 

Lay health educator 

Relationship with Community 

Older adult community members 

CHW (N) 

47 

Supervision of CHW 

Program outreach coordinators 

Prior Training 

NR 

Type of Service 

Conduct or facilitate at least 1 health promotion session/month & 

disseminate health ed materials through at least 1 of grassroots 

channels 

Type of Educational Materials Used 

Leaflets, brochures, pamphlets 

Duration of Interaction with Clients 

1 group session/month 

Length of Follow-up 

NR 

C-195 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Training Characteristics 

Eligibility for CHW Training 

Older ( > 55) living in target communities; expected to be knowledgeable about community, have history of 

volunteering, demonstrate good communication skills & ability to establish rapport with target population; 

nonsmokers of moderate weight, have at least 8th grade education 

Input of CHW in Curriculum Development 

None 

Training on Cultural Competency 

NR 

Training on Recruitment/Retention Process 

NR 

Training on Intake/Assessment 

NR 

Training on Protocol Delivery 

NR 

Training on Health Topic 

NR 

Training on Evaluation 

NR 

Other Training 

Training divided into 3 categories: chronic disease education & self-care, lifestyle education, and consumer 

education. Topics for these categories developed into 12 training modules 

Other Training Content; Instructional Method; Number of Sessions; Testing 

NR 

Name of Curriculum 

NR 

Availability of Curriculum 

NR 

Evaluation and Testing Results of Curriculum 

Obtained score ≥80 on pre and posttest for hypertension & diabetes training sessions: 

G1: 32%/60% 

G2: 11%/72% 

G3: 28%/93% 

Certification 

No 

Other Pertinent Information 

NA 

Are Particular Training Characteristics Associate with Improved Outcomes? 

NR 

C-196 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Study Characteristics 

Setting Community Health Worker 

Author Year 

Yu et al., 2007 

Trial Name 

NR 

Objective or Aim 

To inrease self-efficacy of HLAs in 

conducting breast cancer screening 

promotion 

Geography 

Southeast Michigan 

Organization 

Chinese communities 

Type of Community 

Chinese American women 

Start Date 

Health Condition of Interest 

Breast cancer 

Title of CHW 

Lay health advisor (LHA) 

Relationship with Community 

Shared language 

CHW (N) 

79 

(10 others were eligible but unable to complete training program) 

Supervision of CHW 

NR 

Prior Training 

NR with respect to breast cancer screening; however-- 

Graduate degree: 67.4% 

College degree: 30.3% 

High school education: 2.2% 

Type of Service 

NR 

Type of Educational Materials Used 

NR 

Duration of Interaction with Clients 

NR (Phase I only) 

Length of Follow-up 

NR 

C-197 
Evidence Table C-4. Key Questions 4 and 4a (continued) 

Training Characteristics 

Eligibility for CHW Training 

Adults bilingual in English & Chinese; at least a high school diploma; demonstrated enthusiasm for helping others 

Input of CHW in Curriculum Development 

Community leaders gave input to training materials; first-tier LHAs pretested training manual & Web site and 

provided comments for final version 

Training on Cultural Competency 

NR (but point out critical imporantance of a culturally competent program for this population) 

Training on Recruitment/Retention Process 

NR 

Training on Intake/Assessment 

NR 

Training on Protocol Delivery 

NR 

Training on Health Topic 

NR 

Training on Evaluation 

NR 

Other Training 

Training manual had 9 chapters + 5 appendices (1 was a bilingual glossary of medical terms); content includes 

socieodemographi characteristics & special health concerns, outreach strategies, effective communication skills for 

promoting screening. Also a web site, PowerPointslides and audio recordings available 

Other Training Content; Instructional Method; Number of Sessions; Testing 

3-month self-study of training materials. program included both on-site instruction and materials on paper as well as 

on Web sites or CDs for self-paced study. 

Name of Curriculum 

Name of Curriculum 

Training manual: Helping Women Fight Breast Cancer 

Availability of Curriculum 

Through U of Michigan HAAP 

Evaluation and Testing Results of Curriculum 

Change in trainees' knowledge & self-efficacy 

Knowledge-Mean # of correct answers pre (SD)/post (SD): 6 (1.4)/8 (1.1), P < 0.001 

Self-efficacy-mean score pre (SD)/post (SD): 61.0 (11.5)/65.0 (9.2), P = 0.016 

Certification 

No 

Other Pertinent Information 

NA 

Are Particular Training Characteristics Associate with Improved Outcomes? 

NR 

 

C-198 
C-199 

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Appendix D: Excluded Studies

D-1 
CHW EXCLUDED STUDIES 

Non-US population

1. Brieger WR, Ramakrishna J, Adeniyi JD, Kale OO, Pearson CA. Improving recognition of onchocerciasis in primary care--2: 

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2. Bullock LF, Wells JE, Duff GB, Hornblow AR. Telephone support for pregnant women: outcome in late pregnancy. N Z Med 

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6. Dennis CL. Breastfeeding peer support: maternal and volunteer perceptions from a randomized controlled trial. Birth 

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7. Gillam S, Levenson R. Linkworkers in primary care: an untapped resource. Br Med J 1999;319(7219):1215-1215. 

8. Gyapong JO, Webber RH, Bennett S. The potential role of peripheral health workers and community key informants in the 

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9. Heller RF, Lim L, Valenti L, Knapp J. A randomised controlled trial of community based counselling among those discharged 

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10. Horiuchi S, Kataoka Y, Eto H, Oguro M, Mori T. The applicability of women-centered care: two case studies of capacitybuilding for maternal health through international collaboration. Jpn J Nurs Science 2006;3(2):143-150. 

11. Jackson C. Community mothers: trick or treat? Health Visitor 1992;65(6):199-201. 

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13. Leigh G, Hodgins DC, Milne R, Gerrish R. Volunteer assistance in the treatment of chronic alcoholism. Am J Drug Alcohol 

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17. McNeil JK. Effects of nonprofessional home visit programs for subclinically unhappy and unhealthy older adults. J App 

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22. Rissel C, Salmon A, Hughes AM. Evaluation of a (pilot) stage-tailored brief smoking cessation intervention among hospital 

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23. Rowe AK, Lama M, Onikpo F, Deming MS. Health worker perceptions of how being observed influences their practices 

during consultations with ill children. Trop Doct 2002;32(3):166-7. 

24. Salleras Sanmarti L, Alcaide Megias J, Altet Gomez MN, Canela Soler J, Navas Alcala E, Sune Puigbo MR, et al. Evaluation 

of the efficacy of health education on the compliance with antituberculosis chemoprophylaxis in school children. A 

randomized clinical trial. Tubercle Lung Dis 1993;74(1):28-31. 

25. Tudiver F, Myers T, Kurtz RG, Orr K, Rowe C, Jackson E, et al. The talking sex project: Results of a randomized controlled

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26. Williams S, Brown A, Patton R, Crawford MJ, Touquet R. The half-life of the 'teachable moment' for alcohol misusing 

patients in the emergency department. Drug Alcohol Depend 2005;77(2):205-8. 

27. Woodard GRB, Edouard L. Reaching out: a community initiative for disadvantaged pregnant women. Can J Public Health 

1992;83(3):188-190. 

No health or economic outcomes

28. Baffour TD, Jones MA, Contreras LK. Family health advocacy: an empowerment model for pregnant and parenting African 

American women in rural communities. Fam Comm Health 2006;29(3):221-228. 

29. Baker EA, Kreuter M, Homan SM, Starkloff-Morgan S, Schonhoff R, Francioni A. Using community-based participatory 

processes to bring health education technology to communities. Health Promot Pract 2002;3(1):83-94. 

D-1 
30. Bigby J, Ko LK, Johnson N, David MMA, Ferrer B. A community approach to addressing excess breast and cervical cancer 

mortality among women of African descent in Boston. Public Health Rep 2003;118(4):338-347. 

31. Bishop C, Earp JA, Eng E, Lynch KS. Implementing a natural helper lay health advisor program: lessons learned from 

unplanned events. Health Promot Pract 2002;3(2):233-244. 

32. Blumenthal C, Eng E, Thomas JC. STEP sisters, sex, and STDs: a process evaluation of the recruitment of lay health 

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33. Boyd NR, Windsor RA. A formative evaluation in maternal and child health practice: the Partners for Life Nutrition 

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34. Brown DR, Hernandez A, Saint-Jean G, Evans S, Tafari I, Brewster LG, et al. A participatory action research pilot study of

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35. Castro FG, Elder J, Coe K, Tafoya-Barraza HM, Moratto S, Campbell N, et al. Mobilizing churches for health promotion in 

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37. DeCastro J, Stone B. Improving therapeutic outcomes in BPH through diagnosis, treatment and patient compliance. Am J 

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39. Dumas JE, Lynch AM, Laughlin JE, Phillips Smith E, Prinz RJ. Promoting intervention fidelity. Conceptual issues, methods, 

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41. Eng E, Smith J. Natural helping functions of lay health advisors in breast cancer education. Breast Cancer Res Treat 

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42. Flaskerud JH, Anderson N. Disseminating the results of participant-focused research. J Transcult Nurs 1999;10(4):340-349. 

43. Haraldson SS. Community health aides for sparse populations. World Health Forum 1988;9(2):235-8. 

44. Haraldson SS. The Alaskan community health aide scheme. A successful rural health program. N Y State J Med 

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45. Hatch JW. Outreach in Chatham County. N C Med J 1987;48(12):633-5. 

46. Heller BR, Walsh FJ, Wilson KM. Seniors helping seniors: training older adults as new personnel resources in home health 

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47. Hiatt RA, Pasick RJ, Stewart S, Bloom J, Davis P, Gardiner P, et al. Community-based cancer screening for underserved 

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48. Jaros L, Eaker ED, Remington PL. Women's Health Alliance Intervention Study: description of a breast and cervical cancer 

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49. Jessee PO, Cecil CE. Evaluation of social problem-solving abilities in rural home health visitors and visiting nurses. Matern 

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50. Kelly J. Continuing medical education for community health aides/practitioners. Int J Circumpolar Health 1998;57 Suppl 

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51. Kim MJ, Cho H, Cheon-Klessig YS, Gerace LM, Camilleri DD. Primary health care for Korean immigrants: sustaining a 

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52. Larson K. The evolution of a village-based health education project. Arctic Med Res 1991;Suppl:153-6. 

53. Mack M, Uken R, Powers J. People improving the community's health: community health workers as agents of change. J 

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54. Murphy MJ, Smiciklas-Wright H, Heasley DK, Hamilton LW. Impact of EFNEP on some nutrition-related practices. 

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55. Patton S. Empowering women: improving a community's health. Nurs Manage 1995;26(8):36-7, 41. 

56. Persky V, Turyk M, Piorkowski J, Coover L, Knight J, Wagner C, et al. Inner-city asthma: the role of the community. Chest 

2007;132(5 Suppl):831S-839S. 

57. Ramos RL, Hernandez A, Ferreira-Pinto JB, Ortiz M, Somerville GG. Promovision: designing a capacity-building program 

to strengthen and expand the role of promotores in HIV prevention. Health Promot Pract 2006;7(4):444-9. 

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59. Rogers D, Petereit DG. Cancer disparities research partnership in Lakota Country: clinical trials, patient services, and 

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60. Saavedra-Embesi M. Healthy Smiles for a Lifetime: a dental health training curriculum for promotores. Migrant Health 

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61. Schulz AJ, Israel VA, Parker EA, Lockett M, Hill Y, Wills R. The East Side Village Health Worker Partnership: integrating 

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D-2 
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63. Sherrill W, Crew L, Mayo RB, Mayo WF, Rogers BL, Haynes DF. Educational and health services innovation to improve 

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Appendix E: Acknowledgments
Appendix E. Acknowledgments 

This study was supported by Contract 290200710056I from the Agency for Healthcare 

Research and Quality (AHRQ), Task No.3, Work Assignment 1. We acknowledge the continuing 

support of Beth Collins Sharp, Ph.D., R.N. Acting Director of the AHRQ Evidence-Based 

Practice Center (EPC) Program and the AHRQ Task Order Officer for this project. 

The investigators deeply appreciate the considerable support, commitment, and contributions 

of the EPC team staff at RTI International and the University of North Carolina (UNC). From 

UNC, we thank EPC Co-Director, Timothy S. Carey, M.D., M.P.H.; EPC Literature Search 

Specialist, B. Lynn Whitener, Ph.D. We express our gratitude to Linda Lux, M.P.A., EPC 

Coordinator, Jennifer Drolet, EPC Editor, and Loraine Monroe, EPC publication specialist at 

RTI International. 

Technical Expert Panel 

We extend our appreciation to the members of our Technical Expert Panel (TEP), who 

provided advice and input during our research process. The RTI-UNC EPC team solicited the 

views of TEP members from the beginning of the project. TEP members also provided insights 

into and reactions to work in progress and advice on substantive issues or possibly overlooked 

areas of research. TEP members participated in refining the analytic framework and key 

questions and discussing the preliminary assessment of the literature, including 

inclusion/exclusion criteria, and also provided input on the information and categories, including 

evidence tables. The TEP was both a substantive resource and a “sounding board” throughout the 

study. It was also the body from which expertise was formally sought at several junctions. 

TEP Member Affiliation 

Andrea Cherrington, M.D. University of Alabama at Birmingham 

Birmingham, AL 

Michael Gibbons, M.D., M.P.H. Johns Hopkins Bloomberg School of Public Health 

Baltimore, MD 

Susan Norris, M.D. Oregon Health & Science University 

Portland, OR 

Barbara Israel, Ph.D. University of Michigan 

Ann Arbor, MI 

James Krieger, M.D., M.P.H. University of Washington, Seattle 

Seattle, WA 

Ross Owen, M.P.A. Minnesota Department of Human Services 

St. Paul, MN 

Mary Pohl, M.D. Minnesota Department of Human Services 

St. Paul, MN 

E-1 
E-1 

Peer Review 

Peer reviewers read and provided feedback on a draft version of the report. We revised the report 

as appropriate in response to their suggestions. 

Peer Reviewers Affiliation 

Ross Owen, M.P.A. Minnesota Department of Human Services 

St. Paul, MN 

Lenore Coover, R.N. Private consultant 

Sally Findley, Ph.D. Mailman School of Public Health 

Columbia University 

60 Haven 

New York, NY 10032