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Department of Veterans Affairs

Health Services Research & Development Service Evidence-based Synthesis Program

Pharmacist-led Chronic 

Disease Management: A 

Systematic Review of 

Effectiveness and Harms 

Compared to Usual Care

October 2015

Prepared for:

Department of Veterans Affairs

Veterans Health Administration

Quality Enhancement Research Initiative

Health Services Research & Development Service

Washington, DC 20420

Prepared by:

Evidence-based Synthesis Program (ESP) 

Minneapolis VA Health Care System

Minneapolis, MN

Timothy J. Wilt, MD, MPH, Director

Investigators:

Principal Investigator: 

Nancy Greer, PhD

Contributing Investigators: 

Jennifer Bolduc, PharmD

Eric Geurkink, PharmD

Thomas Rector, PhD, PharmD

Kimberly Olson, MD

Research Associates:

Eva Koeller, BA

Roderick MacDonald, MS
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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PREFACE

The VA Evidence-based Synthesis Program (ESP) was established in 2007 to provide timely and 

accurate syntheses of targeted healthcare topics of particular importance to clinicians, managers, and 

policymakers as they work to improve the health and healthcare of Veterans. QUERI provides funding 

for four ESP Centers, and each Center has an active University affiliation. Center Directors are 

recognized leaders in the field of evidence synthesis with close ties to the AHRQ Evidence-based 

Practice Centers. The ESP is governed by a Steering Committee comprised of participants from VHA 

Policy, Program, and Operations Offices, VISN leadership, field-based investigators, and others as 

designated appropriate by QUERI/HSR&D.

The ESP Centers generate evidence syntheses on important clinical practice topics. These reports help: 

Develop clinical policies informed by evidence;

Implement effective services to improve patient outcomes and to support VA clinical practice 

guidelines and performance measures; and 

Set the direction for future research to address gaps in clinical knowledge.

The ESP disseminates these reports throughout VA and in the published literature; some evidence 

syntheses have informed the clinical guidelines of large professional organizations.

The ESP Coordinating Center (ESP CC), located in Portland, Oregon, was created in 2009 to expand the 

capacity of QUERI/HSR&D and is charged with oversight of national ESP program operations, program 

development and evaluation, and dissemination efforts. The ESP CC establishes standard operating 

procedures for the production of evidence synthesis reports; facilitates a national topic nomination, 

prioritization, and selection process; manages the research portfolio of each Center; facilitates editorial 

review processes; ensures methodological consistency and quality of products; produces “rapid response 

evidence briefs” at the request of VHA senior leadership; collaborates with HSR&D Center for 

Information Dissemination and Education Resources (CIDER) to develop a national dissemination 

strategy for all ESP products; and interfaces with stakeholders to effectively engage the program. 

Comments on this evidence report are welcome and can be sent to Nicole Floyd, ESP CC Program 

Manager, at Nicole.Floyd@va.gov.

Recommended citation: Greer N, Bolduc J, Geurkink E, Koeller E, Rector T, Olson K, MacDonald R, 

and Wilt TJ. Pharmacist-led Chronic Disease Management: A Systematic Review of Effectiveness and 

Harms Compared to Usual Care. VA ESP Project #09-009; 2015.

This report is based on research conducted by the Evidence-based Synthesis Program (ESP) Center located at 

the Minneapolis VA Medical Center, Minneapolis, MN, funded by the Department of Veterans Affairs, Veterans 

Health Administration, Office of Research and Development, Quality Enhancement Research Initiative. 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 the Department of Veterans Affairs or the 

United States government. Therefore, no statement in this article should be construed as an official position of the 

Department of Veterans Affairs. No investigators have any affiliations or financial involvement (eg, employment, 

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

royalties) that conflict with material presented in the report.
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TABLE OF CONTENTS 

EXECUTIVE SUMMARY .......................................................................................................... 1 

Introduction .............................................................................................................................................. 1 

Methods .................................................................................................................................................... 2 

Data Sources and Searches ................................................................................................................... 2 

Study Selection ..................................................................................................................................... 2 

Data Abstraction and Risk of Bias Assessment ................................................................................... 2 

Data Synthesis and Analysis ................................................................................................................ 2 

Results ...................................................................................................................................................... 3 

Results of Literature Search ................................................................................................................. 3 

Summary of Results ............................................................................................................................. 3 

Executive Summary Table 1. Summary of Included Studies ................................................................... 5 

Executive Summary Table 2. Number of Studies Reporting Each Outcome 

(and Study-Defined Primary Outcome) .................................................................................................... 6 

Executive Summary Table 3. Strength of Evidence ................................................................................. 7 

Discussion ............................................................................................................................................... 10 

Summary of Findings and Strength of Evidence ................................................................................ 10 

Applicability ....................................................................................................................................... 10 

Limitations/Research Gaps/Future Research ..................................................................................... 11 

Conclusions ........................................................................................................................................ 12 

Abbreviations Table ............................................................................................................................... 12 

INTRODUCTION .................................................................................................................................. 13 

Scope of Review ..................................................................................................................................... 15 

METHODS .............................................................................................................................................. 17 

Topic Development ................................................................................................................................ 17 

Search Strategy ....................................................................................................................................... 17 

Study Selection ....................................................................................................................................... 17 

Data Abstraction ..................................................................................................................................... 18 

Risk of Bias Assessment ......................................................................................................................... 18 

Data Synthesis ........................................................................................................................................ 18 

Rating the Body of Evidence .................................................................................................................. 18

Peer Review ............................................................................................................................................ 18 

RESULTS ................................................................................................................................................. 19 

Literature Flow ....................................................................................................................................... 19 

Overview of Included Studies ................................................................................................................ 19 
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Key Question: What are the effectiveness and harms of pharmacist-led chronic 

disease management compared to usual care? ........................................................................................ 22 

Cardiovascular Disease (4 RCTs, 2 Cohort Studies) ......................................................................... 22 

Chronic Kidney Disease (2 RCTs, 2 Cohort Studies) ........................................................................ 25 

Chronic Obstructive Pulmonary Disease (1 RCT) ............................................................................. 27 

Depression (3 RCTs, 1 non-RCT) ...................................................................................................... 28 

Diabetes Mellitus (12 RCTs, 2 CCTs, 10 Cohort Studies) ................................................................ 30 

Dyslipidemia (2 RCTs, 2 CCTs, 3 Cohort Studies) ........................................................................... 35 

Hypertension (13 RCTs, 1 CCT, 1 Case-Control Study) ................................................................... 36 

Intervention Frequency, Delivery Mode, and Number of Components ............................................. 41 

Quality of Evidence ............................................................................................................................ 42 

SUMMARY AND DISCUSSION ....................................................................................................... 44 

Summary of Findings and Strength of Evidence .................................................................................... 44 

Applicability ........................................................................................................................................... 45 

Limitations and Research Gaps/Future Research ................................................................................... 45 

Conclusions ............................................................................................................................................ 47 

REFERENCES ....................................................................................................................................... 48 

TABLES

Table 1. Summary of Included Studies ................................................................................................... 20 

Table 2. Number of Studies Reporting Each Outcome (and Study-defined 

Primary Outcome) .................................................................................................................................. 21 

Table 3. Goal Attainment - Cardiovascular Diseases (6 studies) ........................................................... 24 

Table 4. Goal Attainment - Chronic Kidney Disease (4 studies) ........................................................... 27 

Table 5. Goal Attainment - Diabetes Mellitus (24 studies) .................................................................... 33 

Table 6. Goal Attainment - Dyslipidemia (7 studies) ............................................................................. 36 

Table 7. Goal Attainment - Hypertension (15 studies) ........................................................................... 38 

Table 8. Goal Attainment - Polypharmacy/High Risk (3 studies) .......................................................... 40 

Table 9. Strength of Evidence ................................................................................................................ 43 

FIGURES

Figure 1. Components of Pharmacist-Led Chronic Disease Management ............................................. 14 

Figure 2. Analytic Framework ................................................................................................................ 16 

Figure 3. Literature Flow Chart .............................................................................................................. 19 

Figure 4. Non-adherence to Prescribed Medications, Proportion of Patients (RCTs Only) ................... 25 

Figure 5. Clinical Outcomes for Depression Trials ................................................................................ 29 

Figure 6. Goal Attainment for Diabetes, Dyslipidemia, Hypertension, and 

Polypharmacy Studies Based on Primary Outcome (RCTs Only) ......................................................... 34 
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APPENDIX A. Search Strategies ............................................................................................................ 54 

MEDLINE (Ovid)................................................................................................................................... 54 

CINAHL ................................................................................................................................................. 55 

Cochrane Library .................................................................................................................................... 55 

International Pharmaceutical Abstracts (IPA) ........................................................................................ 56 

APPENDIX B. Peer Review Comments/Author Responses ................................................................... 57 

APPENDIX C. Evidence Tables ............................................................................................................. 64 

Table 1. Study and Intervention Characteristics – Cardiovascular Disease Studies ............................... 64 

Table 2. Drug-related Problems Outcomes – Cardiovascular Disease Studies ...................................... 69 

Table 3. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – 

Cardiovascular Disease Studies .............................................................................................................. 71 

Table 4. Healthcare Utilization and Cost Outcomes – Cardiovascular Disease Studies ........................ 72 

Table 5. Goal Attainment Outcomes – Cardiovascular Disease Studies ................................................ 74 

Table 6. Study and Intervention Characteristics – Chronic Kidney Disease Studies ............................. 75 

Table 7. Drug-related Problems Outcomes – Chronic Kidney Disease Studies ..................................... 78 

Table 8. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – 

Chronic Kidney Disease Studies ............................................................................................................ 79 

Table 9. Healthcare Utilization and Cost Outcomes – Chronic Kidney Disease Studies ....................... 80 

Table 10. Goal Attainment Outcomes – Chronic Kidney Disease Studies ............................................ 81 

Table 11. Study and Intervention Characteristics – Chronic Obstructive Pulmonary 

Disease Studies ....................................................................................................................................... 82 

Table 12. Drug-related Problems Outcomes – Chronic Obstructive Pulmonary 

Disease Studies ....................................................................................................................................... 83 

Table 13. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – 

Chronic Obstructive Pulmonary Disease Studies ................................................................................... 83 

Table 14. Healthcare Utilization and Cost Outcomes – Chronic Obstructive 

Pulmonary Disease Studies .................................................................................................................... 84 

Table 15. Goal Attainment Outcomes – Chronic Obstructive Pulmonary Disease Studies ................... 84 

Table 16. Study and Intervention Characteristics – Depression Studies ................................................ 85 

Table 17. Drug-related Problems Outcomes – Depression Studies ........................................................ 87 

Table 18. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – 

Depression Studies ................................................................................................................................. 88 

Table 19. Healthcare Utilization and Cost Outcomes – Depression Studies .......................................... 90 

Table 20. Goal Attainment Outcomes – Depression Studies.................................................................. 91 

Table 21. Study and Intervention Characteristics – Diabetes Studies .................................................... 92 

Table 22. Drug-related Problems Outcomes – Diabetes Studies .......................................................... 109 

Table 23. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – 

Diabetes Studies ................................................................................................................................... 111 
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Table 24. Healthcare Utilization and Cost Outcomes – Diabetes Studies ............................................ 112 

Table 25. Goal Attainment Outcomes – Diabetes Studies.................................................................... 118 

Table 26. Study and Intervention Characteristics – Dyslipidemia Studies ........................................... 121 

Table 27. Drug-related Problems Outcomes – Dyslipidemia Studies .................................................. 126 

Table 28. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – Dyslipidemia 

Studies .................................................................................................................................................. 126 

Table 29. Healthcare Utilization and Cost Outcomes – Dyslipidemia Studies .................................... 126 

Table 30. Goal Attainment Outcomes – Dyslipidemia Studies ............................................................ 129 

Table 31. Study and Intervention Characteristics – Hypertension Studies ........................................... 130 

Table 32. Drug-related Problems Outcomes – Hypertension Studies .................................................. 140 

Table 33. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – 

Hypertension Studies ............................................................................................................................ 144 

Table 34. Healthcare Utilization and Cost Outcomes – Hypertension Studies .................................... 148 

Table 35. Goal Attainment Outcomes – Hypertension Studies ............................................................ 153 

Table 36. Study and Intervention Characteristics – Polypharmacy/High Risk Studies ........................ 155 

Table 37. Drug-related Problems Outcomes – Polypharmacy/High Risk Studies ............................... 158 

Table 38. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – 

Polypharmacy/High Risk Studies ......................................................................................................... 159 

Table 39. Healthcare Utilization and Cost Outcomes – Polypharmacy/High Risk Studies ................. 160 

Table 40. Goal Attainment Outcomes – Polypharmacy/High Risk Studies ......................................... 161 

APPENDIX D. Risk of Bias Tables ...................................................................................................... 162 

Table 1. Risk of Bias for Cardiovascular Disease, Dyslipidemia, Chronic Obstructive Pulmonary 

Disease, and Chronic Kidney Disease Studies ..................................................................................... 162 

Table 2. Risk of Bias for Depression Studies ....................................................................................... 163 

Table 3. Risk of Bias for Diabetes Studies ........................................................................................... 163 

Table 4. Risk of Bias for Hypertension Studies ................................................................................... 164 

Table 5. Risk of Bias for Polypharmacy Studies .................................................................................. 165 
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EXECUTIVE SUMMARY

INTRODUCTION

Increased involvement of clinical pharmacists in patient care may offer increased access to 

health care and improved patient outcomes. Defined by Hepler and Strand in 1989, 

pharmaceutical care involves pharmacist collaboration with health team members to optimize 

therapeutic outcomes by identifying, solving, and preventing actual and potential drug therapy 

problems. Since 1995, the Department of Veterans Affairs has allowed Clinical Pharmacy 

Specialists (CPS) an expanded scope of practice with independent prescribing privileges. In this 

capacity, CPS have been detailed to perform “pharmaceutical care” or comprehensive 

medication management along with chronic disease state management services, in addition to 

less complex services such as patient medication counseling or responding to drug information 

questions. In the VA primary care setting, CPS are likely to be responsible for therapeutic 

outcomes for a multitude of conditions for any patient referred to CPS or proactively identified 

by CPS as a high-risk patient. 

The purpose of this review is to determine the effectiveness and harms of pharmacist-led chronic 

disease management for community-dwelling adults. Chronic disease management aims to 

control symptoms and slow or stop disease progression. Chronic disease management is typically 

a multi-component intervention that includes medication therapy review, patient medication 

education, medication monitoring, immunizations, disease self-care and support, and/or 

prescribing authority. 

This topic was nominated by Heather Ourth, PharmD, VACO Pharmacy Benefits Management 

Program Manager, on behalf of the National Clinical Pharmacy Research Group, chartered by 

the VACO Clinical Pharmacy Practice Office of VACO Pharmacy Benefits Management (PBM).

We address the following key question developed with input from the topic nominator and a 

technical expert panel (TEP).

Key Question: What are the effectiveness and harms of pharmacist-led chronic disease 

management compared to usual care?

Population: Adults (age 18 or older) 

Interventions: Chronic disease management; pharmacist takes responsibility for some 

component of the management or prevention of one or more chronic diseases (eg, chronic 

obstructive pulmonary disease [COPD], congestive heart failure [CHF], diabetes, hypertension, 

cancer, chronic kidney disease [CKD], pain, depression) (ie, pharmacist-led care)

Comparator: Usual care without the services provided by the pharmacists to the intervention 

group 

Outcomes: 

• Clinical Outcomes (including intermediate clinical measures): disease-specific clinical 

events (ie, severe hypoglycemia or hypotension requiring additional interventions), 

depression, mortality, health related quality of life, patient satisfaction, disease specific 

intermediate goal attainment such as glycated hemoglobin [HbA1c], blood pressure, and lipid 

levels 

• Resource Use: office visits, urgent care or emergency room visits, hospitalizations, access 

to care, and costs 
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• Medications: appropriate medications and dosages, drug interactions, (non)adherence, other 

Timing: No minimum follow-up required

Setting: Interventions that take place within the United States and are provided to outpatients by 

pharmacists based in healthcare facilities

METHODS

Data Sources and Searches

We searched MEDLINE (Ovid), CINAHL, the Cochrane Library, and the International 

Pharmaceutical Abstracts (IPA) database for articles published from 1995 through June 2015. 

We obtained additional articles by hand-searching the reference lists of systematic reviews and 

included studies and we also received reference suggestions from peer reviewers.

Study Selection

Abstracts from MEDLINE were independently reviewed in duplicate by investigators and 

research associates. All other abstracts were reviewed by a single co-investigator or research 

associate. We included studies of any design that reported on the effectiveness or harms of 

pharmacist-led chronic disease management in adult outpatients with, or at risk for, a chronic 

disease. We excluded studies that did not test an intervention that was pharmacist-led (ie, where 

the pharmacist was responsible for a component of patient care), studies without a comparator, 

studies that did not take place in a healthcare facility in the US (eg, studies set in retail 

pharmacies), and studies of anticoagulation clinics because pharmacist management is 

considered standard care. 

Full-text reports of studies identified as potentially eligible based on abstract review were 

obtained for further review. Each article was independently reviewed by 2 investigators or 

research associates.

Data Abstraction and Risk of Bias Assessment

Study characteristics (target population, inclusion/exclusion criteria, intervention goal, follow-up 

duration, primary outcomes, pharmacist type, setting, and intervention and comparator 

descriptions) and outcomes (primary and secondary outcomes reported in the studies and broadly 

categorized as clinical, resource use, and medications) were extracted into evidence tables by one 

investigator or research associate and verified by another. We assessed the risk of bias based on 

the following criteria: allocation of subjects to comparison groups, allocation concealment, risk 

of bias from confounding (for non-randomized studies), blinding, completeness of outcome 

reports including losses to follow-up, and selective outcome reporting – a modification of the 

Cochrane approach to determining risk of bias. 

Data Synthesis and Analysis

We organized evidence tables by disease state of the study population. We described and 

qualitatively summarized the characteristics and findings of included studies. Outcomes data 

were pooled where possible. However, pooled analyses were not appropriate for many outcomes 

due to heterogeneity of interventions and outcome reporting. 
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We rated the overall strength of the body of evidence across chronic disease conditions for 

disease-specific clinical events, patient satisfaction, target goal attainment, urgent 

care/emergency department visits and hospitalizations, and medication adherence using the 

method reported by Owens et al. 

RESULTS

Results of Literature Search

We reviewed 1,342 abstracts, 504 from MEDLINE and the remaining from additional databases. 

We excluded 1,151 abstracts and reviewed the full text of 191 articles. During full-text review 

we excluded 134 articles leaving 57 eligible for inclusion. Hand-searching reference lists of 

pertinent trials and systematic reviews and peer reviewer suggestions identified an additional 13 

references. 

We included 70 papers representing 62 studies with 64 unique study populations (k) in 

cardiovascular diseases (k=6), chronic kidney disease (k=4), chronic obstructive pulmonary 

disease (k=1), depression (k=4), diabetes mellitus (k=24), dyslipidemia (k=7), hypertension 

(k=15), and polypharmacy/high risk (k=3). An overview of study characteristics is presented in 

Executive Summary Table 1. 

Summary of Results 

Overall findings: (Executive Summary Tables 1-3)

Most studied interventions included pharmacist-led medication monitoring, medication 

therapy review, prescribing authority, and/or disease self-care and support. 

Interventions were typically delivered by pharmacists in-person and over multiple times. 

However, interventions varied in composition, delivery mode, and intensity, making it 

difficult to draw conclusions about important intervention characteristics. 

Studies were generally short-term and designed to assess intermediate outcomes such as 

blood pressure, cholesterol, and/or glucose goal attainment in patients with diabetes, 

hypertension, or cardiovascular disease rather than other clinical or resource use outcomes. 

Many of the outcomes reported in this review were not primary study endpoints supported 

by rigorous research methods or statistical inferences. Findings based on analyses of 

outcomes other than the study-defined primary outcomes should be interpreted with 

caution. 

Most trials reporting disease-specific clinical events found pharmacist-led care and usual 

care to be similar. However, only 3 of the included studies were designed to assess clinical 

events, outcomes were sporadically and inconsistently reported, and there were few events

(low strength of evidence). Eight studies reported mortality with all finding similar 

mortality in the pharmacist-led care and control groups. 

Compared to usual care, pharmacist-led care was associated with similar incidences or 

rates of office, urgent care or emergency department visits, and hospitalizations (moderate 

strength of evidence) and medication adherence (low strength of evidence).
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There was insufficient evidence to evaluate the effect of pharmacist-led care on patient 

satisfaction. There was limited reporting of quality of life outcomes.

No studies reported typical measures of access to care (eg, wait time for appointment or 

percentage of appointments within a specified window of a desired appointment time). 

Four studies reported either patient satisfaction with reaching someone in an emergency or 

availability of advice about health condition (both significantly higher in the intervention 

group) or patient perceptions of communication with the care team and problems getting 

care (intervention and control groups similar). 

There was limited reporting of harms or other drug-related problems (defined for this 

review as inappropriate medication or dosage and drug interactions). Studies that reported 

harms often did not provide data for the control group participants. 

Reported cost outcomes included total costs, medication costs, cost savings per patient, and 

program costs, but few studies found significant differences between intervention and 

control groups. 

Patients in the pharmacist-led care groups generally received a greater number or dose of 

medications although it was difficult to evaluate whether increased number or dose of 

medications was an indicator of better care quality.

Compared to usual care, pharmacist-led care improved study-selected glycemic, blood 

pressure, and lipid goal attainment (moderate strength of evidence). 
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Executive Summary Table 1. Summary of Included Studies

Characteristic

(Risk of) Cardiovascular Disease

Chronic Kidney 

DiseaseChronic 

Pulmonary 

Obstructive 

Disease

Depression

Diabetes Mellitus

Dyslipidemia

Hypertension

Polypharmacy/ 

High Risk

Total

Total

Studies 6 4 1 4 24 7 15 3 64a

Total Patients 3,403 2,920 98 926 17,716 1,834 6,278 1,282 34,457

Design

RCT 4 2 1 3 12 2 13 3 40

Other 2 2 0 1 12 5 2 0 24

Setting

VA 1 2 1 0 4 4 4 1 17

Non-VA 5 2 0 4 20 3 11 2 47

Intervention

Medication Monitoring 6 4 1 3 22 6 14 2 58

Medication Therapy 

Review 2 2 0 3 13 3 10 2 35

Patient Medication 

Education 2 0 0 3 9 3 4 2 23

Prescribing Authority 3 2 0 3 12 5 7 1 33

Disease Self-care and 

Support 4 2 1 4 22 3 14 2 52

Immunizations 0 0 0 0 2 0 0 0 2

Delivery Mode

Remote 1 0 0 1 2 2 1 0 7

In-Person 4 3 0 0 14 4 8 2 35

Mixed 1 1 1 3 8 1 6 1 22

Intervention Frequency

One-time 2 0 0 0 4 1 0 0 7

Multiple 4 4 1 4 20 6 15 3 57

Risk of Bias

Low 1 1 0 1 5 0 2 1 11

Medium 3 3 1 2 15 3 12 2 41

High 2 0 0 1 4 4 1 0 12

RCT = randomized controlled trial; VA = Veterans Affairs

a 2 studies reported separate results for 2 different disease conditions
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Executive Summary Table 2. Number of Studies Reporting Each Outcome (and Study-Defined Primary Outcome)a 

Condition

(number of included 

studies)

Clinical Resource Use Medication

Clinical Events

Depression

All-Cause Mortality

Health-Related 

Quality of Life

Patient Satisfaction

Goal Attainment

Office Visits

Urgent 

Care/Emergency 

Room Visits

Hospitalizations

Access to Careb 

Costs

Inappropriate 

Dosage/

Prescription

Ineffectiveness

Drug Interactions

(Non)-adherence

Number/Dose of 

Medications

Appropriate 

Other

Cardiovascular Diseases

(k=6) 2 2 (1) 1 1 3 (2) 2 3 (1) 5 (1) 2 1 3 (1) 3 

Chronic Kidney Disease

(k=4) 2 2 1 1 3 (1) 1 3 1 1 4 

Chronic Obstructive 

Pulmonary Disease

(k=1)

 1 1 1 (1) 1 (1) 1 (1) 1 1 1 

Depression 

(k=4) 2 (2) 3 4 (1) 3 (1) 2 2 1 3 (2) 3 (1) 

Diabetes 

(k=24) 4 3 3 3 16 (10) 6 8 (1) 8 (1) 1 3 1 4 15 4 

Dyslipidemia

(k=7) 7 (3) 4 1 2 1 6 

Hypertension 

(k=15) 6 1 7 (2) 7 (1) 13 (8) 9 3 4 1 4 (1) 2 1 11 (1) 13 

Polypharmacy/ High-risk 

(k=3) 1 2 (2) 2 (1) 2 (1) 1 1 (1) 2 (1) 2 1 (1) 1 1 2 (2) 3 

TOTAL (64 unique study 

populations)

c 15 2 (2) 8 (1) 18 (4) 19 (3) 44 (25) 26 (2) 19 (4) 21 (4) 4 17 (1) 7 (1) 1 3 25 (6) 48 (1) 4 

a some studies didn’t have one of our outcomes as their primary outcome and some had more than one primary outcome; table entries are number of studies 

reporting that outcome as their primary outcome

b access to care assessed as patient satisfaction (reaching someone in an emergency, availability of advice) or patient perceptions (communication with the care 

team and problems getting care) 

c 2 studies reported separate results for 2 different disease conditions
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Executive Summary Table 3. Strength of Evidencea 

Outcome

Strength 

of 

Evidence

Direction Number of RCTs 

(N) Summary

Disease-specific 

clinical eventsb Low Similar 12 (3,355 )

Most trials found similar outcomes 

between pharmacist-led care and usual 

care. Outcomes were sporadically and 

inconsistently reported and there were 

few events. Overall risk of bias was 

moderate.

Patient 

satisfaction Insufficient Mixed 16 (12,793 )

Results were inconsistent for measures 

of patient satisfaction between 

pharmacist-led care and usual care. 

There was variation in how patient 

satisfaction was reported (scale score or 

proportions), some measures may not be 

validated, and some trials used a single 

item from a multi-item scale. Overall risk 

of bias was moderate. Given these 

limitations, conclusions regarding the 

strength of evidence for patient 

satisfaction cannot be determined.

Urgent care/ER

and 

hospitalizations

Moderate Similar

Urgent care/ER

16 (7,166 )

Hospitalizations

12 (7,455)

Incidence or rates of urgent care/ER 

visits or hospitalizations were similar 

between pharmacist-led care and usual 

care. Overall risk of bias was moderate.

Non-adherence to 

medications Low Similar 17 (5,933 )

In most trials medication non-adherence 

was similar between pharmacist-led care 

and usual care. Overall risk of bias was 

moderate. Pooled results from 7 

(n=1479) demonstrated a substantial 

relative reduction but findings were 

imprecise, not significant, and had 

substantial heterogeneity (RR 0.58 [95% 

CI 0.33, 1.01]; I2 = 82%).

Goal attainment Moderate

Improved in 

pharmacistled care 

groups

19 (5,816 )

Pharmacist-led care improved the 

proportion of patients achieving 

guideline- recommended laboratory or 

physiologic treatment goals versus usual 

care, 51% vs 34% (RR 1.56 [95% CI

1.37, 1.78]; I2 = 48%). Results were 

precise and fairly consistent. Cluster 

RCTs, CCTs, and cohort studies not 

included in the pooled analysis generally 

reported improved goal attainment in the 

pharmacist-led care group. Overall risk 

of bias was moderate. a Strength of evidence determined for specific outcomes across all chronic disease conditions

b ie, severe hypoglycemia or hypotension requiring additional interventions
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Condition-specific Findings

Cardiovascular Disease or Risk Factors (4 RCTs, 2 Cohort Studies) 

Pharmacist-led care

resulted in mortality and rates of disease-specific clinical events that were similar to 

usual care; only one study reported a clinical event as a primary outcome, 

was associated with mixed results for maintenance or attainment of HbA1c and blood 

pressure goals compared to usual care, 

resulted in hospitalization rates that were similar to usual care; there were mixed 

results for office visits, urgent care visits, and costs; only one study reported resource 

use as a primary outcome, and 

was associated with mixed results for medication use and adherence as compared to 

usual care. 

No studies reported on access to care, or drug interactions or other drug-related problems. 

Chronic Kidney Disease (2 RCTs, 2 Cohort Studies) 

Pharmacist-led care 

improved kidney disease-related quality of life at one year but not 2 years among 

patients at a university-affiliated dialysis center but resulted in similar quality of life 

for Veterans with CKD in primary care.

lowered medication use in the intervention group in the dialysis study, 

increased use of anti-hypertensive medications in the VA study with intervention and 

control groups similar on blood pressure goal attainment,

resulted in similar all-cause mortality between groups in both studies, and 

to manage anemia due to CKD was associated with a lower weekly dose of EPO 

(k=1), more medication adjustments if hemoglobin levels were low (but not high) 

(k=1), cost savings (k=2), and better attainment of target hemoglobin (k=2) and iron 

saturation values (k=1) versus usual care; intervention and control sites reported 

similar rates of adverse events (k=1).

No studies reported on office or emergency department visits, access to care, or drug 

interactions or other drug-related problems. 

Chronic Obstructive Pulmonary Disease (1 RCT)

Multifaceted pharmacist-led care from 8 VA Medical centers 

resulted in health-related quality of life, number of new medications, number of 

emergency department visits, and a rate of hospitalization that were similar to usual 

care,

decreased office visits, and 

resulted in mixed findings for patient satisfaction (ie, significant differences on some 

subscales). 

Effects on drug-related problems were reported only for the intervention group. 

All-cause mortality, disease-specific clinical events, access to care, and costs were not 

reported. 
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Depression (3 RCTs, 1 non-RCT) 

Pharmacist-led care

was similar to usual care for depressive symptoms and health-related quality of life,

was similar to usual care for medication adherence (2 RCTs reporting); self-reported 

use of antidepressant medications and changes in antidepressant medications were 

more frequent in the pharmacist-led care groups, 

resulted in numbers/rates of primary care or urgent care visits that were similar to 

usual care, and 

increased patient satisfaction with availability of advice. 

All-cause mortality, hospitalizations, costs, inappropriate prescriptions, drug interactions 

and other drug-related problems and harms were not compared. 

Diabetes (12 RCTs, 2 CCTs, 10 Cohort Studies) 

Pharmacist-led care 

resulted in all-cause mortality, disease-specific clinical events, and health-related 

quality of life that was similar to usual care, although few studies reported these 

outcomes, 

improved rates of goal attainment for HbA1c, blood pressure, and lipids; the 3 studies 

in VA settings reported increased attainment of HbA1c and blood pressure goals in 

patients receiving pharmacist-led care,

resulted in significantly higher numbers and/or doses of medications, and 

resulted in resource use (office visits, urgent care or emergency department visits, and 

hospitalizations) that was similar to usual care. 

One study reported access to care favoring the intervention group; no studies reported 

drug interactions or other drug-related problems. 

Dyslipidemia (2 RCTs, 2 CCTs, 3 Cohort Studies) 

Pharmacist-led care

improved goal attainment (typically LDL < 100 mg/dL) compared to usual care 

although pooled results from 2 RCTs showed groups were similar,

was associated with increased medication use; one study reported adherence in the 

intervention group but not the usual care group, and

led to mixed results for office visits and similar results for urgent care or emergency 

department visits and costs as usual care. 

No studies reported other clinical outcomes (ie, mortality, disease-specific clinical events, 

health-related quality of life, and patient satisfaction), hospitalizations, access to care, 

inappropriate prescriptions, or drug interactions or other drug-related problems. 

Hypertension (13 RCTs, 1 CCT, 1 Case-Control Study) 

Pharmacist-led care

resulted in similar health-related quality of life as usual care; patient satisfaction 

results were mixed and few studies reported other clinical outcomes, 

increased medication use but adherence was similar to usual care, 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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led to mixed results for resource use outcomes including office visits and costs; few 

studies reported urgent care or emergency room visits, and 

resulted in patient perceptions similar to usual care for “had problems getting needed 

care.” 

No studies reported drug interactions or other drug-related problems; one study reported 

inappropriate medications for the intervention group but not the control group. 

Polypharmacy/High Risk for Drug-related Problems (3 RCTs) 

Pharmacist-led care 

resulted in health-related quality of life; patient satisfaction, and rates/numbers of 

disease-specific clinical events that were similar to usual care; goal attainment was 

improved, 

resulted in similar medication use as usual care; results were mixed for medication 

adherence; significance of other medication findings could not be determined, and 

increased the number of office visits compared to usual care but decreased use of 

urgent care facilities; results were mixed for hospitalizations and costs.

No studies reported all-cause mortality or access to care.

DISCUSSION 

Summary of Findings and Strength of Evidence 

We rated strength of evidence for disease-specific clinical events (low strength of evidence that 

pharmacist-led care and usual care were similar), patient satisfaction (insufficient evidence), 

urgent care/emergency department visits and hospitalizations (moderate strength of evidence that 

pharmacist-led care and usual care were similar), non-adherence to medications (low strength of 

evidence that pharmacist-led care and usual care were similar), and goal attainment (moderate 

strength of evidence that pharmacist-led care increased the proportion of patients achieving 

glycemic, blood pressure, and cholesterol goals compared to usual care). While we did not 

formally assess strength of evidence on other outcomes we did find that pharmacist-led care was 

also similar to usual care for depression, health-related quality of life, all-cause mortality, and 

cost outcomes. However, due to differences in costs reported across studies (program costs, 

medication costs, visit costs), it is difficult to reach a conclusion about costs. Very few studies 

reported drug-related problems (inappropriate medication or dosage, drug interactions). Patients 

in the pharmacist-led care groups generally received a greater number or dose of medications

although it was difficult to evaluate whether increased number or dose of medications was an 

indicator of better care quality. 

Applicability

The chronic disease conditions addressed in the included studies (cardiovascular disease, chronic 

kidney disease, COPD, depression, diabetes mellitus, and hypertension) are common among 

Veterans. Seventeen studies were conducted in VA facilities. The model of pharmacist-led care 

reported in these studies varied but likely is similar to ongoing programs in VA. 
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Limitations/Research Gaps/Future Research

Many of the outcomes reported in this review were not the study-defined primary endpoints and 

therefore were not supported by rigorous research methods or statistical inferences. Among 

studies included in our review, sample sizes were too small and follow-up periods too short to 

detect differences in mortality. There was limited reporting of other clinical events, healthrelated quality of life, and patient satisfaction. When assessed, authors used varied methods for 

determining health-related quality of life and patient satisfaction. Scale scores were often not 

validated, of unknown clinical importance, or included selected findings from subscales.

Interventions varied in composition, delivery mode, and intensity as did the usual care 

comparator, making it difficult to draw conclusions about important intervention characteristics. 

One hypothetical benefit of pharmacist-led care for chronic diseases is increased access to care 

for patients. None of the included studies reported typical measures of access and only 4 studies 

(2 in patients with depression and one each in patients with hypertension or diabetes) reported 

patient satisfaction or patient perception measures related to access (eg, satisfaction with ability 

to reach someone in an emergency or satisfaction with availability of advice). Intervention-based 

increases in the number of scheduled visits or telephone calls may not represent improved 

access. Further research is needed with conventional measures of access.

A consistent definition of an office visits outcome is needed to distinguish regularly scheduled 

office visits, study-related office visits, and unplanned office visits. In many cases it was unclear 

whether the visit was with a pharmacist or primary care provider. Also, a consistently reported 

cost outcome that includes all of the important economic factors involved in pharmacist-led care 

would facilitate comparisons across studies and provide more accurate cost-effectiveness 

estimates.

There was limited reporting of important drug-related problems, in particular drug interactions 

and inappropriate medications and/or dosages. Some studies did report on adherence with mixed, 

inconclusive results. Despite existing definitions of polypharmacy, an isolated measure of the 

number of medications is not an indicator of quality of care as there are situations where adding 

medications and/or increasing dosages may be helpful. Similarly, de-prescribing medications that 

emerging evidence suggests are not beneficial and may provide harm may also be helpful. 

Further research is needed to define and describe these interventions and their association with 

patient outcomes and value. 

Finally, the demonstrated improvement in laboratory and physiologic goal attainment due to 

pharmacist-led care is potentially encouraging. Intervention group pharmacists successfully 

achieved the intended study objectives. The target goals were based, in part, on 

recommendations from selected existing clinical practice guidelines and performance measures. 

The results indicate that future pharmacist-led programs are likely to achieve intended goals. 

However, there is conflicting evidence that target goals for glycemic, blood pressure, or 

cholesterol control have long-term beneficial effects on patient outcomes including clinical 

events, satisfaction, access, hospitalizations, and costs. Therefore, future research needs to 

carefully assess whether the magnitude of effect on selected intermediate laboratory and 

physiologic goals translate to improved patient outcomes including clinical events, satisfaction, 

access, hospitalizations, and costs. Few studies reported differences in potential harms. Thus the 

available evidence does not answer the question about whether the benefits of pharmacy-led 
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interventions justify potential harms and costs. Ideally, future studies will be designed to fully 

and accurately address final patient outcomes and cost effectiveness. 

Conclusions 

Evidence is limited on the effectiveness and harms of pharmacist-led chronic disease 

management compared to usual care for clinical outcomes (ie, clinical events, all-cause 

mortality, patient satisfaction, quality of life, and resource utilization). Moderate-strength 

evidence indicates that pharmacist-led chronic disease management increases goal attainment for 

HbA1c, blood pressure, and cholesterol levels. Moderate- or low-strength evidence also indicates 

that pharmacist-led chronic disease management and usual care were similar for urgent care 

visits or hospitalizations, clinical events, and adherence to medications. Evidence was 

insufficient for patient satisfaction. There was little reporting of access to care and drug-related 

problems. These results suggest that future programs are likely to achieve intended laboratory 

and physiologic goals. However, to accurately assess health care value, future research studies 

and implementation projects that utilize intermediate laboratory and physiologic goals as 

measures of effectiveness need to be certain that these goals are clearly linked to improved 

patient outcomes including clinical events, satisfaction, access, hospitalizations, costs, 

medication adherence, and drug-related problems without undue harms and costs. 

ABBREVIATIONS TABLE

BP Blood pressure 

CCT Controlled clinical trial (non-randomized) 

CPS Clinical Pharmacy Specialist

HbA1c Hemoglobin A1c 

HTN Hypertension

HDL, HDL-C High density lipoprotein cholesterol

LDL, LDL-C Low density lipoprotein cholesterol 

MTM Medication Therapy Management

PharmD Doctor of Pharmacy 

RCT Randomized controlled clinical trial

RR Risk ratio

VA Veterans Affairs
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EVIDENCE REPORT

INTRODUCTION 

Increased involvement of clinical pharmacists in patient care may offer increased access to 

primary care services and improved health care for patients.1,2 Recently introduced bills H.R. 592 

and S. 314, the Pharmacy and Medically Underserved Areas Enhancement Act, are aimed to 

improve patient access to health care through pharmacists’ patient care services. The bills would 

help officially establish pharmacists as health care providers and enable coverage of pharmacists’ 

services through Medicare Part B in medically underserved communities. 

Furthermore, pharmacist involvement in patient care may help to reduce inappropriate 

medication use, specifically in the elderly. A study in 2007 revealed that more than 85% of 

Veterans over the age of 65 who received care in VA outpatient facilities were given a 

potentially inappropriate medication.3

 Inappropriate prescriptions cost the United States billions 

of dollars in healthcare expenditures annually and can result in increased morbidity, adverse drug 

events, hospitalization, and mortality.4,5 A study in Canada saw the proportion of patients 

receiving an inappropriate medication drop significantly after medication review and 

optimization by a team that included a pharmacist.6

Hepler and Strand defined pharmaceutical care as pharmacist collaboration with health team 

members to optimize therapeutic outcomes by identifying, solving, and preventing actual and 

potential drug therapy problems.7

 Since 1995, the Department of Veterans Affairs has allowed 

Clinical Pharmacy Specialists (CPS) an expanded scope of practice with independent prescribing 

privileges.8 In this capacity, CPS have been detailed to perform “pharmaceutical care” or 

comprehensive medication management along with disease state management services in 

addition to less complex services such as patient medication counseling or responding to drug 

information questions. In the VA primary care setting, CPS are likely to be responsible for 

therapeutic outcomes for a multitude of conditions for any patient referred to CPS or proactively 

identified by CPS as a high-risk patient. 

A 2014 systematic review of outpatient medication therapy management (MTM) interventions 

addressed 5 areas: 1) intervention components and features, 2) effectiveness in comparison to 

usual care, 3) factors under which outpatient-based MTM is effective and optimally delivered, 4) 

types of patients likely to benefit, and 5) types of patients at risk of harms from such programs.9

The review did not address MTM services provided by pharmacists shortly after hospital 

discharge, independent disease management services, or single episode contact. Interventions 

needed, at minimum, 3 elements to satisfy the inclusion criteria for the systematic review: 

comprehensive medication review, patient-directed education and counseling, and coordination 

of care, including prescriber-directed interventions. The MTM intervention criteria for the 

review were broader than the Medicare Part D MTM-defined interventions. Outpatient settings 

included long-term care settings, pharmacy call centers, and retail pharmacies. The review 

included interventions conducted in non-U.S. countries but published in English. Evidence was

insufficient for many patient-centered outcomes of interest; however, MTM interventions 

improved medication appropriateness, adherence, and percentage of patients achieving a 

threshold adherence level while medication dosing was reduced. For some patient conditions, 
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MTM interventions were associated with lowered odds of hospitalization and lower 

hospitalization costs. There was no observed benefit of MTM for patient satisfaction. 

The purpose of this review is to identify the effectiveness and harms of pharmacist-led chronic 

disease management for community-dwelling adults with chronic diseases. Chronic disease 

management is a type of care that can be provided by pharmacists and aims to control symptoms 

and slow or stop disease progression. Chronic disease management is a multi-component 

intervention. We categorized intervention components as medication monitoring, medication 

therapy review, patient medication education, immunizations, disease self-care and support, 

and/or prescribing authority as detailed in Figure 1. 

Figure 1. Components of Pharmacist-Led Chronic Disease Management

a Medication Monitoring: follow-up after prescription for medication effectiveness and safety, drug-related problems

b Medication Therapy Review: includes medication reconciliation

c Immunizations: pharmacist provides immunization; immunization was not an outcome of interest

d Disease Self-care and Support: facilitate access to other health care professionals; education about disease, lifestyle 

changes; aspirin therapy; tobacco cessation
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SCOPE OF REVIEW 

This review focused on chronic disease management for outpatients in health care facilities 

excluding retail pharmacies. We emphasized patient- or health system-centered outcomes but 

also addressed intermediate measures including achievement of recommended therapeutic goals. 

Due to differences in pharmacy practices in other countries, this review was limited to U.S. 

studies. 

We address the following key question developed with input from the topic nominator and a 

technical expert panel (TEP). The scope of the review is also depicted in an analytic framework 

(Figure 2).

Key Question: What are the effectiveness and harms of pharmacist-led chronic disease 

management compared to usual care?

Population: Adults (age 18 or older) 

Interventions: Chronic disease management; pharmacist takes responsibility for some 

component of the management or prevention of one or more chronic diseases (eg, chronic 

obstructive pulmonary disease [COPD], congestive heart failure [CHF], diabetes, hypertension, 

cancer, chronic kidney disease [CKD], pain, depression) (ie, pharmacist-led care)

Comparator: Usual care without the services provided by the pharmacists to the intervention 

group 

Outcomes: 

• Clinical Outcomes (including intermediate clinical measures): disease specific clinical 

events (ie, severe hypoglycemia or hypotension requiring additional interventions), 

depression, mortality, health related quality of life, patient satisfaction, disease specific 

intermediate goal attainment such as glycated hemoglobin [HbA1c], blood pressure, and lipid 

levels 

• Resource Use: office visits, urgent care or emergency room visits, hospitalizations, access 

to care, and costs

• Medications: appropriate medications and dosages, drug interactions, (non)adherence, other 

Timing: No minimum follow-up required

Setting: Interventions that take place within the United States and are provided to outpatients by 

pharmacists based in healthcare facilities
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Figure 2. Analytic Framework
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METHODS 

TOPIC DEVELOPMENT

This topic was nominated by Heather Ourth, PharmD, VACO Pharmacy Benefits Management 

Program Manager, on behalf of the National Clinical Pharmacy Research Group, chartered by 

the VACO Clinical Pharmacy Practice Office of VACO Pharmacy Benefits Management (PBM). 

The evidence review examines the effectiveness (both clinical and economic) of pharmacist-led 

chronic disease management compared to usual care.

SEARCH STRATEGY 

We searched MEDLINE (Ovid), CINAHL, the Cochrane Library, and the International 

Pharmaceutical Abstracts (IPA) database for articles published from 1995 through June 2015. 

Our search was designed to identify studies that included control groups and was limited to 

studies enrolling adults and published in the English language. The search included the MeSH 

terms pharmacists, disease management, patient care, case management, patient education as 

topic, medication therapy management, drug interactions, drug therapy, drug monitoring, 

medication reconciliation, and patient care management. The full search strategies are presented 

in Appendix A. We obtained additional articles by hand-searching the reference lists of 

systematic reviews and other reports and from peer reviewer suggested references. 

STUDY SELECTION

Abstracts from MEDLINE (n=504) were independently reviewed in duplicate by investigators 

and research associates. Abstracts from the CINAHL database (n=5 unique to CINAHL), IPA 

(n=588), and Cochrane (n=245) were reviewed by a co-investigator or research associate. We 

included studies of any design (including quality improvement projects) reporting on the 

effectiveness or harms of pharmacist-led care in outpatient adults with, or at risk for developing, 

a chronic disease. We excluded the following: 

Studies that did not include outpatient adults with or at risk for a chronic disease, 

Studies that did not test an intervention that was pharmacist-led, where the pharmacist 

was responsible for a component of patient care and, if part of a collaborative care team, 

the contribution of the pharmacist could be distinguished from other team members 

Studies that did not involve interventions intended to manage or prevent one or more 

chronic disease(s),

Studies without a comparator, 

Studies that did not take place in a healthcare facility in the US (eg, studies set in retail 

pharmacies), and 

Studies of anticoagulation clinics because pharmacist management is considered standard 

care.

Full-text reports of studies identified as potentially eligible were obtained for further review 

using the inclusion and exclusion criteria described above. Each article was independently 

reviewed by 2 investigators or research associates. Reasons for excluding a study at full text 

review were noted.
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DATA ABSTRACTION

Study characteristics (target population, inclusion/exclusion criteria, goal of intervention, 

primary outcome, duration/follow-up of study, type of pharmacist, study setting, intervention and 

comparator descriptions, and collaboration) as well as study-reported primary and secondary 

outcomes (drug-related problems, mortality, quality of life, access, patient satisfaction, 

healthcare utilization, cost, and goal attainment) were extracted onto evidence tables by one 

investigator or research associate and verified by another. 

RISK OF BIAS ASSESSMENT 

We assessed the risk of bias based on the following criteria: sequence generation, allocation 

concealment, risk of bias from confounding (for non-randomized studies), blinding, incomplete 

outcome reporting, and selective outcome reporting – a modification of the Cochrane approach 

to determining risk of bias. (Higgins JPT, Green S, eds. Cochrane Handbook for Systematic 

Reviews of Intervention Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 

2011. Available from www.cochrane-handbook.org.) Individual studies were rated as low, 

medium, or high risk of bias. Low risk of bias RCTs had adequate allocation concealment, 

blinding, and outcome reporting. Low risk of bias non-randomized studies also had low risk of 

bias from confounding. 

DATA SYNTHESIS

We organized evidence tables by disease state of the study population. We described and 

qualitatively compared the characteristics and findings of included studies. If pooling was 

feasible, data were analyzed in RevMan 5.3 (The Nordic Cochrane Center, Copenhagen, 

Denmark). Random effects models (DerSimonian-Laird) were used to calculate pooled risk 

ratios (RR) with 95% confidence intervals (CI) for categorical outcomes. However, pooled 

analyses were not possible for many outcomes due to heterogeneity of interventions and outcome 

reporting across studies. Therefore, most findings are summarized in narrative form. 

RATING THE BODY OF EVIDENCE

We rated the overall strength of the body of evidence for clinical events, patient satisfaction, 

target goal attainment, urgent care/emergency department visits and hospitalizations, and 

medication adherence using the method reported by Owens et al.10

PEER REVIEW

A draft version of this report was reviewed by content experts as well as clinical leadership. 

Reviewer’s comments and our responses are presented in Appendix B and the report has been 

modified as needed. 
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RESULTS

LITERATURE FLOW

We reviewed 1,342 abstracts, 504 from MEDLINE, 588 from IPA, and the remaining from 

Cochrane and CINAHL. We excluded 1,151 abstracts and reviewed the full text of 191 

references. During full-text review we excluded 134 articles leaving 57 eligible for inclusion. 

Hand-searching pertinent trials and systematic reviews identified an additional 11 references. 

Two additional references were suggested by a peer reviewer. Figure 3 details the process. 

Figure 3. Literature Flow Chart

OVERVIEW OF INCLUDED STUDIES

We included 70 papers representing 62 studies with 64 unique study populations (k) in 

cardiovascular diseases (k=6), chronic kidney disease (k=4), chronic obstructive pulmonary 

disease (k=1), depression (k=4), diabetes mellitus (k=24), dyslipidemia (k=7), hypertension 

(k=15), and polypharmacy/high risk (k=3). Characteristics of the included studies are 

summarized in Table 1. 

Search Results

Ovid: 504 abstracts

Cochrane: 245 abstracts

CINAHL: 5 abstracts

IPA: 588 abstracts

Total: 1,342 abstracts

Full Text Review:

191 References

Hand Search:

11 References

Reviewer 

Suggestion:

2 References

Abstracts Excluded:

1,151

Excluded: 134 References

Population: 6 References

Intervention: 31 References

Study Design: 32 References

Outcomes: 9 References

Setting: 56 References

Included: 

70 References (62 

studies with 64 unique 

study populations)
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Table 1. Summary of Included Studies

Characteristic

(Risk of) Cardiovascular Disease

Chronic Kidney 

DiseaseChronic 

Pulmonary 

Obstructive 

Disease

Depression

Diabetes Mellitus

Dyslipidemia

Hypertension

Polypharmacy/ 

High Risk

Total

Total

Studies 6 4 1 4 24 7 15 3 64a

Total Patients 3,403 2,920 98 926 17,716 1,834 6,278 1,282 34,457

Design

RCT 4 2 1 3 12 2 13 3 40

Other 2 2 0 1 12 5 2 0 24

Setting

VA 1 2 1 0 4 4 4 1 17

Non-VA 5 2 0 4 20 3 11 2 47

Intervention

Medication Monitoring 6 4 1 3 22 6 14 2 58

Medication Therapy 

Review 2 2 0 3 13 3 10 2 35

Patient Medication 

Education 2 0 0 3 9 3 4 2 23

Prescribing Authority 3 2 0 3 12 5 7 1 33

Disease Self-Care and 

Support 4 2 1 4 22 3 14 2 52

Immunizations 0 0 0 0 2 0 0 0 2

Delivery Mode

Remote 1 0 0 1 2 2 1 0 7

In-Person 4 3 0 0 14 4 8 2 35

Mixed 1 1 1 3 8 1 6 1 22

Intervention Frequency

One-time 2 0 0 0 4 1 0 0 7

Multiple 4 4 1 4 20 6 15 3 57

Risk of Bias

Low 1 1 0 1 5 0 2 1 11

Medium 3 3 1 2 15 3 12 2 41

High 2 0 0 1 4 4 1 0 12

RCT = randomized controlled trial; VA = Veterans Affairs a 2 studies reported separate results for 2 different disease conditions

Table 2 depicts all outcomes of interest reported in the studies (with study-defined primary 

outcomes in parentheses). Goal attainment (ie, reaching target goals for HbA1c, blood pressure, 

and/or cholesterol levels) was the primary outcome for 25 of the 64 unique population studies. 

Few studies identified other clinical, resource use, or medication outcomes as their primary 

outcome. 
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Table 2. Number of Studies Reporting Each Outcome (and Study-defined Primary Outcome)a

Condition

(number of included 

studies)

Clinical Resource Use Medication

Clinical Events

Depression

All-Cause Mortality

Health-Related 

Quality of Life

Patient Satisfaction

Goal Attainment

Office Visits

Urgent 

Care/Emergency 

Room Visits

Hospitalizations

Access to Careb 

Costs

Inappropriate 

Dosage/

Prescription

Ineffectiveness

Drug Interactions

(Non)-adherence

Number/Dose of 

Medications

Appropriate 

Other

Cardiovascular Diseases

(k=6) 2 2 (1) 1 1 3 (2) 2 3 (1) 5 (1) 2 1 3 (1) 3 

Chronic Kidney Disease

(k=4) 2 2 1 1 3 (1) 1 3 1 1 4 

Chronic Obstructive 

Pulmonary Disease

(k=1)

 1 1 1 (1) 1 (1) 1 (1) 1 1 1 

Depression 

(k=4) 2 (2) 3 4 (1) 3 (1) 2 2 1 3 (2) 3 (1) 

Diabetes 

(k=24) 4 3 3 3 16 (10) 6 8 (1) 8 (1) 1 3 1 4 15 4 

Dyslipidemia

(k=7) 7 (3) 4 1 2 1 6 

Hypertension 

(k=15) 6 1 7 (2) 7 (1) 13 (8) 9 3 4 1 4 (1) 2 1 11 (1) 13 

Polypharmacy/ High-risk 

(k=3) 1 2 (2) 2 (1) 2 (1) 1 1 (1) 2 (1) 2 1 (1) 1 1 2 (2) 3 

TOTAL (64 unique study 

populations)c 15 2 (2) 8 (1) 18 (4) 19 (3) 44 (25) 26 (2) 19 (4) 21 (4) 4 17 (1) 7 (1) 1 3 25 (6) 48 (1) 4 

a some studies didn’t have one of our outcomes as their primary outcome and some had more than one primary outcome; table entries are number of studies 

reporting that outcome as their primary outcome

b access to care assessed as patient satisfaction (reaching someone in an emergency, availability of advice) or patient perceptions (communication with the care 

team and problems getting care) 

c 2 studies reported separate results for 2 different disease conditions
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KEY QUESTION: WHAT ARE THE EFFECTIVENESS AND HARMS OF 

PHARMACIST-LED CHRONIC DISEASE MANAGEMENT COMPARED 

TO USUAL CARE?

Cardiovascular Disease (4 RCTs, 2 Cohort Studies)

Key Findings

Pharmacist-led care

resulted in mortality and rates of disease-specific clinical events that were similar to 

usual care; only one study reported a clinical event as a primary outcome,

was associated with mixed results for maintenance or attainment of HbA1c and blood 

pressure goals compared to usual care,

resulted in hospitalization rates that were similar to usual care; there were mixed 

results for office visits, urgent care visits, and costs; only one study reported resource 

use as a primary outcome, and 

was associated with mixed results for medication use and adherence as compared to 

usual care.

No studies reported on access to care, or drug interactions or other drug-related problems. 

Characteristics of Studies (Appendix C, Table 1)

We identified 2 studies of pharmaceutical care for patients with cardiovascular disease or risk 

factors for cardiovascular disease,11,12 2 studies of care for patients with coronary artery 

disease,13,14 and 2 studies of patients with congestive heart failure.15,16 A total of 3,403 patients 

were enrolled; study sample sizes ranged from 117 to 2,170. Overall, we rated one study as low 

risk of bias, 3 as medium risk of bias, and 2 as high risk of bias. 

The studies of patients with cardiovascular disease or risk factors included a 12-month RCT 

conducted in a cardiovascular risk reduction clinic (CRRC) at a VA Medical Center11 and a 

retrospective cohort study from a university-affiliated cardiology group.12 In the VA study, 

patients had achieved HbA1c, blood pressure, and LDL goals and were randomized upon 

discharge from the CRRC to either group medical visits facilitated by a clinical pharmacist, 

individual sessions with a clinical pharmacist, or standard primary care.11 Both clinical 

pharmacist interventions were multifaceted. In the cohort study, the goal was to optimize blood 

pressure medication management and patients participated in either a multifaceted program 

based on a collaborative care model or usual care.12 The patients were followed until they 

maintained therapy goals for several months. 

One study of patients with coronary artery disease was a 2-year RCT with a multifaceted 

pharmacist intervention delivered via telephone compared to usual care.14 The goal was to 

maintain lipid control. The second study was a retrospective cohort study from an outpatient 

pharmacy clinical service and focused on improving medication adherence.13 Patients identified 

as non-adherent and not at clinical goals for HbA1c and LDL-C had either a pharmacist consult 

at the time of prescription pick-up or usual care. Follow-up was one year. 

The studies of patients with CHF, both RCTs, involved multifaceted interventions – education, 

medication recommendations, and telephone follow-up in one15 and protocol-driven education 

and medication monitoring in the other.16 Both studies focused on optimizing heart failure 
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therapy. In one study, median follow-up was 6 months.15 The other study included a 9-month 

intervention period and a 3-month post-intervention assessment. 

Clinical Outcomes (Appendix C, Table 3)

Two studies (n=602) reported all-cause mortality, finding intervention and control groups to be 

similar.

14,15 However, in one of these studies, the primary outcome was a combination of allcause mortality and non-fatal heart failure events.15 There was a significant difference between 

groups for the composite outcome favoring the intervention group (OR 0.22 [95% CI 0.06, 

0.63]). 

Quality of Life and Patient Satisfaction Scale Scores (Appendix C, Table 3) 

One of the CHF studies reported similar improvement in health-related quality of life from 

baseline for the intervention and control groups.16 Satisfaction with pharmacy services improved 

significantly from baseline for the intervention group relative to the control group.16

Goal Attainment (Appendix C, Table 5) 

The VA-based cardiovascular disease/risk factors RCT reported maintenance of HbA1c, blood 

pressure, and LDL goals.

11 Failure rates for HbA1c and blood pressure per quarter were 

significantly lower for intervention patients in either the individual or group pharmacist 

interventions relative to control. Adherence to LDL guidelines was lowest in the individual 

pharmacist intervention patients. In the cohort study of high cardiac-risk patients, blood pressure 

goals were achieved in a significantly higher percentage of patients in the intervention group.12

In the study of patients with coronary artery disease, the study groups were similar in the

percentages of patients maintaining LDL goals (either less than 100 mg/dL or less than 70 

mg/dL) or blood pressure less than 130/80 mmHg.14 Significantly more patients in the control 

group achieved the blood pressure goal of less than 140/90 mmHg. Neither of the CHF studies 

reported a goal attainment outcome. Goal attainment findings are summarized in Table 3. 

Medications (Appendix C, Table 2)

Few studies reported on drug-related problems. A study of patients with coronary artery disease 

reported persistence with lipid-lowering therapy, finding the intervention and control groups to 

be similar.

14 Figure 4 is a forest plot of adherence outcomes from the RCTs. Another study, 

focused on adherence, reported a significantly lower medication possession ratio (MPR) at one 

year in the intervention group compared to control (0.70 vs 0.74) but the percentage of patients 

defined as adherent at one year was similar in the 2 groups (37% vs 38%).13

One of the CHF studies reported the fraction of target ACE inhibitor dose taken.15 Patients in the 

intervention group were taking a significantly higher fraction of the target dose than were 

patients in the control group. The other CHF study reported the incidence of adverse events or 

medication errors to be similar for the intervention and control groups but higher refill adherence 

in the intervention group.16
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Table 3. Goal Attainment - Cardiovascular Diseasesa (6 studies)

Author, year

Attained Goals for 

HbA1c Levels

Attained Goals for 

Blood Pressure

Attained Goals for 

Lipid Levels

Spence, 201413

Taveira, 201411 ↑ ↑ ↔

Irons, 201212 ↑

Olson, 200914 ↕b ↔

Murray, 200716

Gattis, 199915

↑ = significantly higher proportion of intervention group reached goal compared to control group (P<.05)

↔ = results not significant

↕ = mixed results

Bold indicates a study-defined primary outcome a Cardiovascular disease or risk factors for cardiovascular disease, coronary artery disease, and congestive heart 

failure

b Goal of BP <140/90 mmHg reached by a significantly higher proportion of control group; proportion of patients in 

each group reaching goal of <130/80 mmHg was similar

The RCT enrolling patients with cardiovascular disease or risk factors assigned to individual or 

group pharmacist interventions reported no change in medications from baseline for patients in 

the individual intervention group but significantly increased use of blood pressure and antihyperglycemic medications in the group intervention patients. A significant decrease in 

cholesterol and anti-hyperglycemic medications from baseline was noted for the control group.11

The cohort study of patients with cardiovascular disease or risk factors reported a significant 

difference in the number of antihypertensive medications with greater use in the intervention 

group.12 One RCT of patients with CHF reported a similar percentage of patients receiving an 

ACE inhibitor at follow-up for the intervention and control groups. More patients in the 

intervention group were receiving an ACE alternative.15 

Resource Use (Appendix C, Tables 3 and 4)

Each of the studies reported a measure of resource use. Results were mixed for office visits with 

no differences between intervention and control groups in primary care visits in the VA RCT,11

while more clinic visits or blood pressure assessments outside of scheduled appointments were 

noted for the intervention group in a retrospective cohort study.12 Two studies (one RCT from 

the VA and one cohort study) reported no differences between groups in urgent care/emergency 

department visits,

11,13 while a study of patients with CHF reported fewer all-cause emergency 

department visits in the intervention group but similar numbers of emergency department visits 

for heart failure between study groups.

16 Hospitalizations (reported in 4 studies) were similar 

between study groups11,13,14,16 but one heart failure study reported a lower readmission rate in the 

intervention group.15 Two studies reported costs outcomes. The one-time pharmacist consult to 

improve adherence resulted in cost savings such that approximately $5.79 was saved for every 

dollar spent on the intervention program.13 This result was based on data from implementing the 

intervention for patients with diabetes and patients with coronary artery disease. A study of 

patients with CHF reported lower outpatient and inpatient costs in the intervention group; the 

statistical significance was not reported.16 No studies reported on access to care.
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Figure 4. Non-adherence to Prescribed Medications, Proportion of Patients (RCTs Only)

Chronic Kidney Disease (2 RCTs, 2 Cohort Studies) 

Key Findings

Pharmacist-led care 

improved kidney disease-related quality of life at one year but not 2 years among 

patients at a university-affiliated dialysis center but resulted in similar quality of life 

for Veterans with CKD in primary care.

lowered medication use in the intervention group in the dialysis study, 

increased use of anti-hypertensive medications in the VA study with intervention and 

control groups similar on blood pressure goal attainment, 

resulted in similar all-cause mortality between groups in both studies, and 

to manage anemia due to CKD was associated with a lower weekly dose of EPO 

(k=1), more medication adjustments if hemoglobin levels were low (but not high) 

(k=1), cost savings (k=2 s), and better attainment of target hemoglobin (k=2) and iron 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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saturation values (k=1) versus usual care; intervention and control sites reported 

similar rates of adverse events (k=1).

No studies reported on office or emergency department visits, access to care, or drug 

interactions or other drug-related problems. 

Characteristics of Studies (Appendix C, Table 6)

Four studies (reported in 6 papers) enrolled patients with CKD.17-19,20,21,22 One was a medium 

risk of bias RCT conducted at a university-affiliated dialysis clinic and focused on drug-related 

problems, drug use and costs, and hospitalizations.18 Another was a high risk of bias 

retrospective cohort conducted at a nephrology clinic and addressing use of epoetin alfa (EPO).19

A more recent low risk of bias RCT, based in VA community-based outpatient clinics (CBOCs) 

focused on care for patients with CKD, especially blood pressure control.20 The last was a 

medium risk of bias cohort study done a VA Medical Centers.21,22 The goal was improved 

quality of erythropoiesis-stimulating agent (ESA) prescribing for non-dialysis dependent CKD 

patients. 

The interventions varied. In a dialysis clinic-based RCT, pharmacists conducted one-on-one indepth drug therapy review meetings with patients every 8 weeks.18 Pharmacists also provided 

health care provider and patient education. The comparator was usual care which included drug 

therapy reviews by dialysis nursing staff. The study enrolled 57 intervention group and 47 

control group patients. However, 53% of the intervention group and 45% of the control group 

did not complete the 2-year study due to death, transplant, or transfer to another dialysis 

facility.18 In the RCT based in VA CBOCs, the goal was increased pharmacist interaction with 

patients (primarily telephone-based) and communication of recommendations to primary care 

physicians.

20 The one-year study enrolled 2,199 patients; 870 had blood pressure values greater 

than 130/80 mmHg at baseline. Among the cohort studies, one (n=141) involved a protocoldriven program to manage anemia of CKD.19 Maximum follow-up was one year. Patients in the 

intervention group also received intravenous sucrose while the control group received only EPO. 

The other compared clinics (10 clinics, n=314) where pharmacists managed dosing and 

monitored ESA therapy to clinics (6 clinics, n=167) where physicians managed care.21,22 Followup was 6 months. 

Clinical Outcomes (Appendix C, Table 8)

Both RCTs reported clinical outcomes. In the larger study (n=2,199), at one year follow-up, allcause mortality was 4.7% in the intervention group and 6.6% in the control group (P=.06).20 In 

the second study (n=104), all-cause mortality was 26% at 2 years in both the intervention and 

control groups.18 The cohort study comparing pharmacist-managed ESA clinics to usual care 

clinics reported that adverse event rates (thromboembolic events, heart failure, uncontrolled 

hypertension) were similar between the clinic types.21

Quality of Life and Patient Satisfaction Scale Scores (Appendix C, Table 8) 

The study of drug-related problems found a significant difference in health-related quality of life 

between groups at one year (with higher quality of life in the intervention group) but no 

difference was observed at 2 years.17 The study of care for CKD found the intervention and 

control groups had similar results for measures of quality of life.20 This study also reported that 

92% of the intervention patients surveyed responded that the pharmacists provided useful 

information and they would recommend the program to others.20
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Goal Attainment (Appendix C, Table 10) 

The EPO study reported a significantly higher percentage of measured hemoglobin and iron 

saturation values within target ranges in the intervention groups (Table 4).

19 Similarly the study 

of ESA prescribing found a higher proportion of patients with hemoglobin values within range in 

the pharmacist-managed group.21 The RCT of CKD care reported the groups were similar in 

blood pressure goal attainment.

20

Table 4. Goal Attainment - Chronic Kidney Disease (4 studies)

Author, year Attained Goals for 

Iron Saturation

Attained Goals for 

Hemoglobin

Attained Goals for 

Blood Pressure

Pai, 200918

Bucaloiu, 200719 ↑ ↑

Aspinall 201221 ↑

Cooney 201520 ↔

↑ = significantly higher proportion of intervention group reached goal compared to control group (P<.05)

↔ = results not significant

Medications (Appendix C, Table 7)

The RCT focused on drug-related problems reported results only for the intervention group.18 Of 

530 identified drug-related problems, 14% were related to sub-therapeutic dosage, 25% for 

untreated indications, and 5% for overdose. The RCT of CKD care found patients in the 

intervention group were prescribed significantly more classes of anti-hypertensive drugs than the 

control group. The intervention and control groups were similar in medication adherence.20 The 

ESA prescribing study found significantly more adjustments to medications if hemoglobin levels 

were low in the intervention clinics; the frequency of medication adjustments if hemoglobin 

levels were high was similar in the intervention and usual care clinics.21

Resource Use (Appendix C, Tables 8 and 9)

The RCT focused on drug-related problems reported significantly fewer all-cause 

hospitalizations, lower number of medications, and lower mean drug costs (significantly lower at 

one of the drug reviews) in the intervention group.18 The EPO study reported a significantly 

lower weekly dose of EPO in the intervention group with estimated annual cost savings per 

patient of $3,860.19 The study of pharmacist-managed ESA clinics modeled costs over 5 years 

and found lower costs (drug, laboratory test, clinic visit, and hospitalization costs were included) 

in the pharmacist-managed clinics.22 No study reported access to care.

Chronic Obstructive Pulmonary Disease (1 RCT)

Key Findings

Multifaceted pharmacist-led care from 8 VA Medical Centers 

resulted in health-related quality of life, number of new medications, number of 

emergency department visits, and a rate of hospitalization that were similar to usual 

care,

decreased office visits, and 

resulted in mixed findings for patient satisfaction (ie, significant differences on some 

subscales).
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Effects on drug-related problems were reported only for the intervention group. 

All-cause mortality, disease-specific clinical events, access to care, and costs were not 

reported. 

Characteristics of Studies (Appendix C, Table 11) 

One medium risk of bias RCT (reported in 2 papers), conducted at 8 VA Medical Centers, 

enrolled 98 patients with COPD.23,24 The intervention consisted of regularly scheduled 

therapeutic and educational interventions with pharmacists responsible for implementing the care 

plan, educating and counseling patients, and performing patient assessments. The comparator 

was usual care. Outcomes were assessed at 6 months follow-up. 

Clinical Outcomes (Appendix C, Table 13)

No clinical outcomes were reported. 

Quality of Life and Patient Satisfaction Scale Scores (Appendix C, Table 13) 

A global symptom assessment and quality of life were similar for intervention and control groups 

although bodily pain was significantly worsened from baseline to 6 months in the control 

group.23,24 On a 10-item Pharmaceutical Care Questionnaire, intervention group patients had 

more favorable responses than control group patients for all items; the difference was significant 

for 7 of the 10 items. 

Goal Attainment (Appendix C, Table 10) 

No goal attainment outcomes were reported.

Medications (Appendix C, Table 12)

The study reported drug-related problems for the intervention group only. 

Resource Use (Appendix C, Tables 13 and 14)

There were significantly fewer office visits in the intervention group but similar incidence 

compared to usual care control for emergency department visits, hospitalizations, or new 

medications.23,24 Access to care was not reported. 

Depression (3 RCTs, 1 non-RCT)

Key Findings 

Pharmacist-led care

was similar to usual care for depressive symptoms and health-related quality of life,

was similar to usual care for medication adherence (2 RCTs reporting); self-reported 

use of antidepressant medications and changes in antidepressant medications were 

more frequent in the pharmacist-led care groups, 

resulted in numbers/rates of primary care or urgent care visits that were similar to 

usual care, and

increased patient satisfaction with availability of advice. 

All-cause mortality, hospitalizations, costs, inappropriate prescriptions, drug interactions, 

and other drug-related problems and harms were not reported. 
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Characteristics of Studies (Appendix C, Table 16)

Three RCTs of pharmacists’ interventions in primary care clinics (reported in 4 articles) were 

reviewed.25-28 In addition, we included a non-randomized comparison group pilot study.29 A total 

of 926 patients were enrolled with samples sizes ranging from 7426,27 to 507.25 None of the 

studies was conducted at VA facilities. All of the studies tested multifaceted interventions 

provided in multiple contacts over 6 to 12 months by experienced Doctors of Pharmacy 

(PharmD). The pharmacists’ interventions included medication histories and reviews, patient 

education and frequent monitoring (primarily by telephone), dose titration, and changes in 

antidepressant medications. The interventions were compared to usual care. In one study, usual 

care included access to services of the same clinic pharmacists.26,27 The targeted patient 

population was newly diagnosed or treated episodes of depression. Patients with complicating 

mental co-morbidities were excluded from all studies. The primary patient outcome in 2 of the 

RCTs was one or more measure of symptoms of depression.25-27 The third RCT focused on the 

intermediate outcome of antidepressant adherence, but included a measure of symptoms of 

depression.28 The non-randomized study focused on medication adherence, patient satisfaction, 

and resource utilization.29 We rated one study as low risk of bias, 2 as medium risk of bias, and 

one as high risk of bias. 

Clinical Outcomes (Appendix C, Table 18)

Two RCTs looked at reduction in severity of depression as a clinical outcome – a reduction of at 

least 50% in a symptom score.26,28 The pharmacist-led intervention and usual care control groups 

were similar (Figure 5). The pooled risk ratio for at least 50% reduction in a symptom score in 

the intervention group compared to usual care was 0.91 (95% CI 0.73, 1.14). One of the studies 

also reported the percent achieving remission (a Brief Inventory for Depressive Symptoms score 

of less than 9); the study groups were similar.28

Figure 5. Clinical Outcomes for Depression Trials

Quality of Life and Patient Satisfaction Scale Scores (Appendix C, Table 18) 

All 3 RCTs reported health-related quality of life measures, finding groups to be similar.25-28

Each of the studies reported on patient satisfaction. One reported that intervention and control 

groups expressed similar satisfaction with depression care and overall health care.26 Two 

reported mixed results for a single question about patient satisfaction with treatment of 

depression, finding either higher satisfaction in the intervention group28 or similar satisfaction in 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

30

the 2 groups.29 The fourth study reported that patients expressed high satisfaction with the 

pharmacist intervention but results for the intervention and control groups were not reported 

separately.25 

Goal Attainment (Appendix C, Table 20) 

No goal attainment outcomes were reported.

Medications (Appendix C, Table 17)

Two RCTs reported medication adherence (Figure 4). One observed similar adherence between 

pharmacist-led care and usual care.

26 The second, which specified adherence as the primary 

study endpoint, reported significantly greater adherence in the intervention group.28 However, 

the medication possession ratio was similar in the 2 groups (0.83 vs 0.77, P=.26).28 The largest 

RCT reported a significant 12% higher percentage of intervention group patients on 

antidepressants at 3 and 6 months.25 Two studies (one RCT and the non-randomized trial) 

reported more changes in antidepressants in the intervention groups.28,29 The non-randomized 

study reported a significantly higher medication possession ratio at 6 months and significantly 

higher use of antidepressants at 3 months in the intervention group.29

Resource Use (Appendix C, Tables 18 and 19)

Two RCTs reported the intervention and control groups were similar in primary care provider 

visits26,28 although the non-randomized study reported a significantly greater decrease in primary 

care provider visits in the pharmacist-led care group.29 In 2 RCTs reporting, there were no 

differences in urgent care visits.26,28 No study reported hospitalizations. Both the RCT and the 

non-randomized pilot study from the same research group reported greater availability of advice 

in the intervention groups.28,29 One study reported drug costs were similar between groups.

26 

Diabetes Mellitus (12 RCTs, 2 CCTs, 10 Cohort Studies)

Key Findings

Pharmacist-led care 

resulted in all-cause mortality, disease-specific clinical events, and health-related 

quality of life that was similar to usual care, although few studies reported these 

outcomes, 

improved rates of goal attainment for HbA1c, blood pressure, and lipids; the 3 studies 

in VA settings reported increased attainment of HbA1c and blood pressure goals in 

patients receiving pharmacist-led care,

resulted in significantly higher numbers and/or doses of medications, and 

resulted in resource use (office visits, urgent care or emergency department visits, and 

hospitalizations) that was similar to usual care. 

One study reported access to care favoring the intervention group; no studies reported 

drug interactions or other drug-related problems. 

Characteristics of Studies (Appendix C, Table 21)

We included 24 trials (12 RCTs or cluster RCTs, 2 CCTs, 10 cohort studies) in 25 papers of 

pharmacist-led care interventions for patients with diabetes mellitus. Four were conducted at VA 

facilities.

30-32,33,34 A total of 17,716 patients were enrolled. All studies used multifaceted 
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31

interventions. In one study the intervention consisted of a single session,

13 one study did not 

specify the frequency of the intervention,35 and the remaining studies were conducted over one to 

24 months. The pharmacist had some level of collaboration with other healthcare professionals in 

19 studies, typically the patient’s primary care provider (16 studies). The comparator groups 

received usual care generally delivered by their primary care provider. In all studies, the primary 

outcomes included physiological markers (blood pressure, HbA1c, or cholesterol) – either 

achieving control, change in level, or rate of testing. Fifteen studies were rated medium risk of 

bias; of the remaining 9 studies, 5 were rated low risk of bias and 4 as high risk of bias. 

Clinical Outcomes (Appendix C, Table 23)

Four studies reported on clinical events.

36-39 One study reported the pharmacist-led intervention 

and usual care groups were similar for rates of hypoglycemic or hypotensive episodes.39 Another 

study reported an increase in hypoglycemic events in the intervention group compared to the 

usual care group but significance could not be determined.37 One study reported one severe 

hypoglycemic event in the intervention groups but events were not documented in the control 

group.36 Another study reported no adverse events caused by the study protocol.38

Three studies assessed mortality with 2 reporting the study groups were similar in all-cause 

mortality32,39 and one reporting no diabetes-related deaths.30 

Quality of Life and Patient Satisfaction Scale Scores (Appendix C, Table 23) 

No significant findings were reported for health-related quality of life.32,37,40 Three studies 

reported patient satisfaction with care with 2 of the 3 reporting a significantly higher level of 

satisfaction in the intervention groups.39,40 

Goal Attainment (Appendix C, Table 25) 

Most of the included studies measured attainment of goals for HbA1c, blood pressure, and lipid 

levels (Table 5, Figure 6). Fifteen studies reported attainment of HbA1c goals, typically an 

HbA1c less than 7%. Twelve studies found improved goal attainment in the intervention groups 

compared to the usual care groups although the difference was significant in just 8 of the 

studies.30-32,36,41-44 Three found lower goal attainment in intervention groups compared to 

controls with significant differences in 2 of the studies.45,46 All 3 VA studies reporting on HbA1c 

goal attainment showed that pharmacist-led care significantly improved goal attainment.

30-32

Pooled results from the RCTs (Figure 6) showed significantly greater HbA1c goal attainment in 

the intervention groups (RR 1.83 [95% CI 1.44, 2.33]). 

Twelve studies reported on attainment of blood pressure control, typically defined as blood 

pressure less than 130/80 mmHg. Of these, 10 showed increased attainment of blood pressure 

goals in the intervention groups compared to controls with 6 finding significant 

differences.

31,32,40,42-44 Two studies found study groups were similar.41,45 All 3 VA studies 

reporting this outcome saw increased goal attainment in patients in the intervention group 

compared to patients in the control group with significant results in 2 studies.31,32

Lipid goal attainment (LDL-C <100mg/dL) was measured in 11 studies. Pharmacist-led care 

increased goal attainment compared to usual care with significant findings in 6 studies.42,43,45-48

The 3 VA studies found the study groups were similar.

30-32 
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Medications (Appendix C, Table 22)

Thirteen studies reported number and/or dose of medications. In 9 studies, patients in 

intervention groups had significantly higher medication use than patients in control groups.30-

32,38-40,45,48,49 Two studies reported medication use was similar between groups 41,46 and 

significance was not reported for 2 studies.36,47 All 3 of the studies at VA facilities reported a 

significant increase in medication use and/or dose in patients receiving pharmacist-led care.30-32

Five studies reported on use of medications for diabetes (eg, insulin). All 5 found significantly 

more medication use in patients being cared for by pharmacists.30-32,36,49 Two reported on 

hypertension medications and found significantly higher medication use and/or dose in 

intervention group patients as compared to controls.30,32 Four studies reported on lipid 

medications with 3 finding significantly higher use in the intervention group31,32,48 and one 

reporting no difference. 30
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Table 5. Goal Attainment - Diabetes Mellitus (24 studies)

Author, year Attained goals for 

HbA1c levels

Attained goals 

for blood 

pressure

Attained goals for 

lipid levels

McAdam-Marx 201553

Skinner 201535

Chung, 201450

Spence, 201413

Brummel, 201346 ↓a ↔ ↑+

Ip, 201343 ↑ ↑ ↑

Jacobs, 201238 ↔ ↔ ↔

Salvo, 201249 ↔

Cohen, 201132 ↑ ↑ ↔

Padiyara, 201145 ↓ ↔ ↑

Pape, 201148 ↔ ↔ ↑

Taveira, 201130 ↑ ↔ ↔

Heisler, 2010/201233,34

Jameson, 201036 ↑

Johnson, 201042 ↑ ↑ ↑

Taveira, 201031 ↑ ↑ ↔

Fox, 200947 ↑

Scott, 200640 ↔ ↑b

Odegard, 200551 ↔

Rothman, 200539

Shane-McWhorter, 200541 ↑ ↔ ↔

Stroup, 200352

Kelly, 200044 ↑ ↑b

Jaber, 199637

↑ = significantly higher proportion of intervention group reached goal compared to control group (P<.05)

↓ = significantly higher proportion of control group reached goal compared to intervention group (P<.05)

↔ = results not significant + = significant change from baseline

Bold indicates a study-defined primary outcome a HbA1c goal attainment was significantly improved from baseline to end of study and end of follow-up by 

intervention but at the end of follow-up the proportion of patients at goal HbA1c was significantly lower in the 

intervention group.

b Significantly more people in the intervention group met the goal for systolic blood pressure but groups were similar

for diastolic blood pressure. 

No studies reported on ineffectiveness or drug interactions. Only one study reported on 

medication inappropriateness finding mean medication appropriateness index scores were similar 

to usual care after 6 or 12 months of pharmacist-led care.51 Four studies measured nonadherence13,32,35,51 finding that patients receiving pharmacist-led care had higher adherence to 

their prescribed regimens; the difference was significant in 2 of the studies.13,35 Out of 6 studies 

that measured aspirin use, 2 found significantly higher use in patients receiving care from 

pharmacists,39,45 2 found groups to be comparable,31,46 and 2 did not report significance.40,41 Two 

studies looked at the total number of medications that patients were prescribed and found groups 

were similar.38,47
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Figure 6. Goal Attainment for Diabetes, Dyslipidemia, Hypertension, and Polypharmacy Studies 

Based on Primary Outcome (RCTs Only) 

Resource Use (Appendix C, Tables 23 and 24)

Six studies measured office visits,

30,32,34,39,51,53 including 3 studies in VA settings.30,32,34 Office 

visits were similar between intervention and control groups in 3 studies while one found 

increased outpatient utilization in the intervention group.53 Seven studies looked at 

hospitalizations with similar results for intervention and control groups.13,30,34,37,39,50,52,53 Two 

studies reported decreased urgent care or emergency room visits in intervention group patients 

compared to control group patients13,52 while 6 other studies found study groups were 

similar.

30,34,39,40,50,53 One study found that patients under a pharmacist’s care were significantly 

more satisfied with their ability to reach somebody in an emergency.

48 Three studies reported 

cost outcomes with one finding a lower increase in total patient charges (inpatient and outpatient)
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over the study period for the intervention group53 and 2 not reporting the significance of their

findings.13,47

Dyslipidemia (2 RCTs, 2 CCTs, 3 Cohort Studies)

Key Findings

Pharmacist-led care

improved goal attainment (typically LDL < 100 mg/dL) compared to usual care 

although pooled results from 2 RCTs showed groups were similar, 

was associated with increased medication use; one study reported adherence in the 

intervention group but not the usual care group, and 

led to mixed results for office visits and similar results for urgent care or emergency 

department visits and costs as usual care. 

No studies reported other clinical outcomes (ie, mortality, disease-specific clinical events, 

health-related quality of life, and patient satisfaction), hospitalizations, access to care, 

inappropriate prescriptions, or drug interactions or other drug-related problems. 

Characteristics of Studies (Appendix C, Table 26)

We included 7 studies (total n=1,834) of pharmaceutical care for dyslipidemia.54-60 There was 

one RCT,

59 2 controlled clinical trials,57,60 one prospective cohort study,55 and 2 retrospective 

cohort studies.54,56 The remaining study was a sub-study of an RCT.58 Follow-up ranged from 4 

weeks to 46 months. Four studies were conducted at VA clinics.54,56,58,60 All studies enrolled 

patients from primary care (ie, family medicine, general medicine) clinics. In one study, although 

the intervention group consisted of family medicine center patients, the control group was from 

family medicine, cardiology, and endocrinology clinics.55 We rated 3 studies as medium risk of 

bias and 4 as high risk of bias. 

Intervention components included medication evaluation,54,56,58,59 medication prescription and 

adjustment,54,56-58 therapeutic conversion,55 ordering and reviewing of laboratory results,54,57,59

patient education,55,57,60 follow-up contacts,54,56,60 physician collaboration,55,57,59,60 identification 

and prevention of drug-related problems,58 and referral to other resources (ie, smoking 

cessation).57The comparator was usual care in all studies.

Clinical Outcomes (Appendix C, Table 28)

None of the studies reported all-cause mortality or clinical events. 

Quality of Life and Patient Satisfaction Scale Scores (Appendix C, Table 28) 

None of the studies reported health-related quality of life or patient satisfaction outcomes. 

Goal Attainment (Appendix C, Table 30) 

Each of the studies reported a goal attainment outcome (Table 6, Figure 6). Significantly more 

patients in the intervention groups achieved LDL goals in 5 studies.54,56,57,59,60 Another study 

reported a significant increase in goal attainment from before to after therapeutic conversion in 

the intervention group and a significant decrease during that time period in the control group.55

The last study reported significant improvements in goal attainment for both the intervention and 

control groups but groups were similar at the end of the study.58 Pooled results from the 2 RCTs 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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(Figure 6)58,59 showed the effect of pharmacist-led care on goal attainment was similar to usual 

care (RR 1.41 [95% CI 0.83, 2.40]). 

Table 6. Goal Attainment - Dyslipidemia (7 studies)

Author, year Attained Goals for Lipid Levels

Smith, 201354 ↑

Miller, 200855 ↑+

Mazzolini, 200556 ↑

Straka, 200557 ↑

Ellis, 200058 ↔

Bogden, 199759 ↑

Konzem, 199760 ↑

↑ = significantly higher proportion of intervention group reached goal compared to control group (P<.05)

↔ = results not significant + = significant change from baseline

Bold indicates a study-defined primary outcome

Medications (Appendix C, Table 27)

Number and/or dose of medications was significantly higher in the pharmacist-led care groups 

compared to control groups in 3 of 5 studies reporting this outcome.56,57,60 Significance was not 

reported in 2 other studies55,59 One study reported significantly more medication interventions 

per patient in the intervention group.54 The study of therapeutic conversion reported more 

patients in the intervention group received an equivalent dose post-conversion while more 

patients in the control group received a lower dose.55 One study reported compliance for the 

intervention group but not the control group.60 

Resource Use (Appendix C, Tables 28 and 29)

Three studies reported office visits with 2 finding intervention and control groups were 

similar54,56 and one finding more office visits in the intervention group.59 One study reported that 

the frequencies of emergency department visits were similar between groups.59 None of the 

studies reported hospitalizations. Two studies reported costs finding similar changes from the 

baseline period between intervention and control groups for hospitalization, clinic visit, and drug 

costs58 or medication costs.59

Hypertension (13 RCTs, 1 CCT, 1 Case-Control Study) 

Key Findings

Pharmacist-led care

resulted in similar health-related quality of life as usual care; patient satisfaction 

results were mixed and few studies reported other clinical outcomes, 

increased medication use but adherence was similar to usual care, 

led to mixed results for resource use outcomes including office visits and costs; few 

studies reported urgent care or emergency room visits, and 

resulted in patient perceptions similar to usual care for “had problems getting needed 

care.” 
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No studies reported drug interactions or other drug-related problems; one study reported 

inappropriate medications for the intervention group but not the control group. 

Characteristics of Studies (Appendix C, Table 31)

We identified 13 randomized controlled trials (RCTs) reported in 15 papers that evaluated the 

effect of pharmacist-led care for the management of uncontrolled hypertension (HTN). Four 

trials were cluster-randomized (ie, trials that randomized clinics and not patients).61-64 We also 

included one controlled clinical trial65 and one case-control study.66 The studies enrolled a total 

of 6,278 patients. Four studies included patients from Veterans Affairs Medical Centers.23,24,66-68

In 5 studies, pharmacists had the ability to initiate and change medical therapy for HTN 

management although some physician oversight may have been involved.62,66-70 In 6 studies, 

pharmacists provided guidance and made recommendations to the patient’s physician or worked 

directly with the physician (team-based or co-management care) on how to best implement the 

medical therapy for HTN management.

61,63,64,71-73 Usual care was typically continued care with 

the patient’s primary care physician although in one study, some control group patients were 

provided with home blood pressure monitors.71,74 Study periods ranged from 6 to 24 months. 

One study also included a 6-month follow-up period after the 12-month intervention to observe 

the maintenance of any affects following the discontinuation of the intervention.

62 Overall risk of 

bias was medium; 2 studies were rated low risk of bias.66,71,74

Clinical Outcomes (Appendix C, Table 33)

Overall, the included trials were short-term, underpowered, or not designed to evaluate the 

impact of a pharmacist component of patient care on all-cause mortality or other clinical events.

One trial reported deaths during the study period – one in the pharmacist component arm due to 

cardiac arrest and none in the usual care arm.71 Other trials reported clinical events in the 

intervention and control groups were similar,

62,64,71 or the significance of the findings was not 

provided.69,75

Quality of Life and Patient Satisfaction Scale Scores (Appendix C, Table 33) 

Patient satisfaction with care was evaluated in 8 trials. Two studies reported a clinical patient 

satisfaction outcome. One study reported a significantly higher percentage of patients reporting 

high satisfaction with their hypertension care in the pharmacist component group compared with 

the usual care group (58% vs 42%, P< .001).70 The other reported the percentage of patients very 

satisfied with pharmacy services to be similar between groups (88% vs 68%, P=.098).68 The 

other studies reported scale score changes with mixed results.23,24,62,69,71,72,74 Health-related 

quality of life was evaluated in 7 trials.23,24,62,65,68,71,72,75 Patient health-related quality of life did 

not differ between the pharmacist component and usual care groups.

Goal Attainment (Appendix C, Table 35) 

Nearly all trials reported the proportion of patients who attained controlled BP, typically defined 

as a systolic BP <140 mm Hg and diastolic BP < 90 mm Hg (Table 7, Figure 6). Ten studies 

reported greater goal attainment in the intervention group compared to the usual care group 62-

64,66,68-73 while 3 reported the groups to be similar.

61,65,67 Pooled data from 7 RCTs showed the 

proportion of patients who attained controlled BP was significantly greater in the pharmacist-led 

care group (54%) compared with the usual care group (38%) (RR 1.45 [95% CI 1.24 1.70]) 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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(Figure 6). There was a moderate level of heterogeneity (I2= 58%) Similar to the findings for all 

patients, greater attainment in controlled blood pressure was also observed in the pharmacist 

intervention group for the subgroup of patients with diabetes with or without chronic kidney 

disease.63,64,70

Table 7. Goal Attainment - Hypertension (15 studies)

Author, year Attained Goals for Blood 

Pressure

Carter 201561 ↔

Zillich 201566 ↑

Hirsch, 201469 ↑

Magid, 201370 ↑

Margolis, 201362 ↑

Magid, 201167 ↔

Carter, 200963 ↑

Carter, 200864 ↑

Green, 2008, Ralston 

201471,74 ↑

Hunt, 200872 ↑

Borenstein, 200373 ↑

Vivian, 200268 ↑

Okamoto, 200175

Solomon 1998, Gourley, 

199823,24

Erickson, 199765 ↔

↑ = significantly higher proportion of intervention group reached goal compared to control group (P<.05)

↔ = results not significant 

Bold indicates a study-defined primary outcome

Medications (Appendix C, Table 32)

No trial reported inappropriate dosage/prescription or omission, ineffectiveness, or drug 

interactions for both the pharmacist-led care group and the usual care group. One study reported 

drug-related problems including need for additional therapy, need for dose increase, and adverse 

drug reaction data for intervention group.69 Poor or less than perfect adherence to the prescribed 

regimen, determined from the inverse of typically self-reported good adherence, was not 

significantly different between study groups in 6 trials.62-64,67,68,71,72,74 One trial reported better 

compliance in the intervention group23,24 and 2 trials only reported results for the intervention 

group.69,70 Pooled data from 2 RCTs (Figure 4) showed no difference in adherence (RR 0.87 

[95% CI 0.49, 1.54]). The case-control study reported that medication possession ratios and the 

percentage of patients with possession ratios of at least 80% for all blood pressure medications 

were similar between the intervention and control groups.66 

Significant increases in medication use associated with a pharmacist component in patient care 

were reported in 9 trials.61-64,67,70-73 Compared with usual care patients, pharmacist component 

patients were prescribed more antihypertensive medications during the intervention intervals. 

Four trials reported similar medication use between intervention and control groups.65,66,68,75 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Resource Use (Appendix C, Tables 33 and 34)

Health care utilization results were mixed. Three trials reported patients in the pharmacist-led 

care groups had significantly fewer primary care visits compared with usual care patients.

69,72,73

However, in one trial, with the addition of pharmacy visits, total visits were comparable with or 

greater than those in the usual care group.72 Four trials reported the numsber of primary care 

visits to be similar between study groups65,68,70,71 and one reported a significantly greater number 

of clinic visits in the pharmacist-led care group.75 Pharmacist-led care and usual care were 

similar in the number of urgent care or emergency room visits and hospitalizations although few 

studies reported these outcomes. 

Four trials provided estimates of costs associated with pharmacist-led care. One study estimated 

that direct program costs would total about $1,350 per patient but did not provide costs for usual 

care.62 In a publication76 based on data from a cluster randomized trial,64 the adjusted total costs 

per patient were $775 in the pharmacist-led care group compared to $446 in the control group 

(difference $329, P<.001). However, a cost-benefit analysis was not done to determine if the 

financial savings related to potentially reduced morbidity and mortality achieved from lower 

blood pressure outweighed the costs of the pharmacist component. Another study reported that 

the average provider visit costs per patient were lower in the pharmacist component group 

compared to usual care ($160 and $195, respectively; P=.04).73 These costs were based on 

average number of visits to the primary care physician during the study which were lower in the 

pharmacist-led care group (3.4 compared with 6.6 for usual care patients; P<.01) and lower 

provider visit costs for pharmacists ($20 for a 30-minute appointment) than physicians ($35 for a 

15-minute appointment). Average monthly drug costs were similar at the end of the study period. 

The fourth study reported drug costs per patient and total costs per patient did not differ between 

study groups.

75 Clinical visit costs (based on the salary of the provider – pharmacist or physician) 

were significantly higher in the pharmacist-led care group. 

Polypharmacy/High Risk for Drug-related Problems (3 RCTs) 

Key Findings

Pharmacist-led care 

resulted in health-related quality of life; patient satisfaction, and rates/numbers of 

disease-specific clinical events that were similar to usual care; goal attainment was 

improved, 

resulted in similar medication use as usual care; results were mixed for medication 

adherence; significance of other medication findings could not be determined, and 

increased the number of office visits compared to usual care but decreased use of 

urgent care facilities; results were mixed for hospitalizations and costs.

No studies reported all-cause mortality or access to care.

Characteristics of Studies (Appendix C, Table 36)

We identified 3 RCTs (in 4 papers) of clinical pharmacist interventions in primary care clinics 

for patients judged to be at high risk for drug-related problems.

77-80 The studies enrolled a total of 

1,282 patients (range 69 to 1054). One study was rated low risk of bias and 2 were rated medium 

risk of bias. Two studies targeted ambulatory adults with multiple risk factors for drug-related 

problems78-80 and one study targeted ambulatory adults aged 65 years or older with 

polypharmacy (4 or more medications).77 Patients were considered at high risk due to use of 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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multiple medications, multiple changes in medications in the past year, multiple concurrent 

diseases, a history of non-compliance, and/or use of medications requiring therapeutic 

monitoring. One study was conducted at VA primary care clinics.79,80 Patients were excluded 

from the trials if they had cognitive impairment, lived in nursing homes, had life expectancy less 

than 12 months, or had other problems with verbal or written communication. All 3 studies 

tested multifaceted interventions delivered by a clinical pharmacist over 6- to 12-month periods. 

The comparator groups received routine care by physicians and nurses in clinic without contact 

with a clinical pharmacist. In one of the studies, the RCT phase followed a 6-month cohort phase 

in which all patients received the intervention. Patients were then randomized to continue the 

intervention or return to usual care follow-up.77

Clinical Outcomes (Appendix C, Table 38)

No study reported all-cause mortality. In one study, the percentage of patients with at least one 

“medication misadventure” was similar between the study groups (2.8% intervention vs 3.0% 

control, P=.73).78Another study noted less decline in the “change in health” component in the 

intervention group patients but the difference between intervention and usual care groups was 

not clinically meaningful (defined as a 5-point difference).80 

Quality of Life and Patient Satisfaction Scale Scores (Appendix C, Table 38) 

Two studies, including the VA-based study, found health-related quality of life (assessed with 

the SF-36) to be similar between intervention and usual care groups.78,80 The VA study reported 

no differences in patient satisfaction at baseline or over the course of the study.80 Another study 

reported significantly higher pharmacy-related satisfaction in the usual care group although the 

reporting is unclear.78 

Goal Attainment (Appendix C, Table 40) 

One study found statistically significant improvements in goal attainment for hypertension, 

diabetes mellitus, and dyslipidemia but similar anticoagulation goal attainment between groups

(Table 8, Figure 6).78The trial comparing on-going pharmacist intervention to usual care found a 

higher percentage of patients with medication adherence at greater than 80% at the end of the 

randomized trial phase in the intervention group.77 The VA study did not report goal attainment. 

Table 8. Goal Attainment - Polypharmacy/High Risk (3 studies)

Author, year

Attained Goal for 

Medication 

Adherence

Attained Goal for 

Hypertension

Attained Goal 

for Diabetes

Attained Goal 

for 

Dyslipidemia

Attained Goal 

for 

Anticoagulation

Lee, 200677 ↑

Taylor 200378 ↑ ↑ ↑ ↔

Malone 2000 

and 200179,80

↑ = significantly higher proportion of intervention group reached goal compared to control group (P<.05)

↔ = results not significant 

Bold indicates a study-defined primary outcome
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Medications (Appendix C, Table 37)

In one study, pharmacist-led interventions were associated with fewer inappropriate dosage 

prescriptions (13% vs 64%), fewer inappropriate indication prescriptions (16% vs 48%), fewer

ineffective prescriptions (14% vs 45%), and fewer drug-drug (6% vs 23%) and drug-disease (9% 

vs 20%) interactions at 12 months compared to the usual care group.78 The statistical 

significance of the findings was not reported. Study groups were similar for compliance (100% 

intervention, 89% usual care) (Figure 4). The study of improvement maintenance reported 

significantly greater medication adherence in the group that continued the intervention compared 

to the group that received usual care (Figure 4).

77 The VA study reported groups were similar for 

the increase in drug fills over the course of the study.79,80 Another study reported mean number 

of anti-hypertensive medications was similar77 while the third study reported a significantly 

lower number of prescribed medications in the intervention group.78

Resource Use (Appendix C, Tables 38 and 39)

A significant increase in office visits but not hospitalizations was reported in the VA pharmacistled care group compared to VA usual care.79,80 Another study reported a significant decrease in 

urgent care visits and hospitalizations during the study period in the intervention group compared 

to the usual care group.78 Cost outcomes included a similar mean cost for the pharmacist 

intervention (including clinic visits, drug costs, laboratory costs, and hospitalizations) compared 

to usual care in the VA study79,80 and a determination that a lower percentage of patients in the 

intervention group had the least expensive drug option following the intervention compared to 

the usual care group.78 No study reported on access to care.

Intervention Frequency, Delivery Mode, and Number of Components

To examine the effects of intervention frequency, delivery mode, and number of components, we 

compared the results from one-session interventions, the remotely delivered (no in-person 

contact) interventions, and the interventions with one or 2 components to the overall data set. 

Frequency (one-time compared to pooled total)

Four studies used one-time interventions and 3 of these defined a pooled outcome, goal 

attainment or non-adherence, as their primary outcome. In general, the results of studies without 

follow-up visits agreed with the trends seen in the pooled analysis. The 2 studies reporting LDL 

goal attainment both found better goal attainment in the group receiving pharmacist-led care48,55

and one of them reported a significant between group difference.48 Pooled data for dyslipidemia 

resulted in a non-significant improvement in goal attainment (RR 1.41 [95% CI 0.83, 2.40]). The 

other outcome was only reported by one study. Murray 2007 found that a one-time pharmacist 

intervention significantly decreased medication non-adherence.16 The pooled data followed this 

trend but did not reach significance (RR 0.72 [95% CI 0.51, 1.08]). Results of the one-time 

studies did not always have as strong of an effect as seen in the pooled data. However, having 

only a one-time intervention did not change the direction of effect on goal attainment or nonadherence.

Delivery Mode (remotely delivered compared to pooled data) 

Seven studies used a remote intervention, with no in-person contact between pharmacist and 

patient; 6 of them had goal attainment as their primary outcome. Overall, the results of these 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

42

studies were not different than the pooled data. Five of the studies looked at attaining LDL 

control. The pooled data showed that pharmacist-led care tended to increase attainment of LDL 

control, although the effect was not significant. Four studies of remote interventions47,48,55,57 also 

found greater LDL goal attainment in the intervention groups and 3 of them had a significant 

result.

47,48,57 The fifth found the groups were similar.14 A remote intervention seemed to have the 

same effect as the pooled data, if not more of an impact. Only one study using a remote 

intervention reported goal attainment for hypertension as its primary outcome.

71 This study had 

results consistent with the pooled data; the group receiving pharmacist-led care had a larger 

proportion of patients with blood pressure control.71 This data suggest that the effect of a 

pharmacist-led care may be weakened without in-person contact but that pharmacist involvement 

is still beneficial. 

Number of Components (one or 2 component interventions compared to pooled data) 

Thirteen studies used interventions with just one or 2 of our 6 defined components. Of these, 4 

specified goal attainment or non-adherence as a primary outcome. Three reported goal 

attainment including one in dyslipidemia, and one in hypertension. Goal attainment for blood 

pressure was shown in pooled data to be significantly improved by pharmacist-led care (RR 1.38 

[95% CI 1.18, 1.62]). The study reporting on blood pressure goal attainment had the same result, 

significantly better blood pressure control in the intervention group as compared to the control.63

The pooled data showed a non-significant improvement in lipid goal attainment with pharmacistled care and the study reporting on dyslipidemia also did not report a significant difference, 

although the trend was in the same direction.55 For non-adherence the pooled data showed that 

pharmacist care led to less non-adherence but the difference was not significant (RR 0.72 [95% 

CI 0.49, 1.06]). Lee 2006, however, found the proportion of patients’ adherent was significantly 

greater in the intervention group.77 Having fewer components did not decrease the effect of the 

pharmacists’ interventions on goal attainment or non-adherence.

Quality of Evidence

Strength of evidence for key outcomes is summarized in Table 9. 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 9. Strength of Evidencea 

Outcome

Strength 

of 

Evidence

Direction Number of RCTs 

(N) Summary

Disease-specific 

clinical eventsb Low Similar 12 (3,355 )

Most trials found similar outcomes 

between pharmacist-led care and usual 

care. Outcomes were sporadically and 

inconsistently reported and there were 

few events. Overall risk of bias was 

moderate.

Patient 

satisfaction Insufficient Mixed 16 (12,793 )

Results were inconsistent for measures 

of patient satisfaction between 

pharmacist-led care and usual care. 

There was variation in how patient 

satisfaction was reported (scale score or 

proportions), some measures may not be 

validated, and some trials used a single 

item from a multi-item scale. Overall risk 

of bias was moderate. Given these 

limitations, conclusions regarding the 

strength of evidence for patient 

satisfaction cannot be determined.

Urgent care/ER

and 

hospitalizations

Moderate Similar

Urgent care/ER

16 (7,166 )

Hospitalizations

12 (7,455)

Incidence or rates of urgent care/ER 

visits or hospitalizations were similar 

between pharmacist-led care and usual 

care. Overall risk of bias was moderate.

Non-adherence to 

medications Low Similar 17 (5,933 )

In most trials medication non-adherence 

was similar between pharmacist-led care 

and usual care. Overall risk of bias was 

moderate. Pooled results from 7 

(n=1479) demonstrated a substantial 

relative reduction but findings were 

imprecise, not significant, and had 

substantial heterogeneity (RR 0.58 [95% 

CI 0.33, 1.01]; I2 = 82%).

Goal attainment Moderate

Improved in 

pharmacistled care 

groups

19 (5,816 )

Pharmacist-led care improved the 

proportion of patients achieving guideline 

recommended laboratory or physiologic 

treatment goals versus usual care, 51% 

vs 34% (RR 1.56 [95% CI 1.37, 1.78]; I2

= 48%). Results were precise and fairly 

consistent. Cluster RCTs, CCTs, and 

cohort studies not included in the pooled 

analysis generally reported improved 

goal attainment in the pharmacist-led 

care group. Overall risk of bias was 

moderate. a Strength of evidence determined for specific outcomes across all chronic disease conditions

b ie, severe hypoglycemia or hypotension requiring additional interventions
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SUMMARY AND DISCUSSION 

SUMMARY OF FINDINGS AND STRENGTH OF EVIDENCE 

We identified 70 papers (published from 1995 to 2015) representing 62 studies of 64 unique 

study populations (including 40 RCTs) and enrolling 34,457 patients. Fifty-two of the unique 

populations studied (81%) were adults with cardiovascular disease, diabetes, dyslipidemia, or 

hypertension; other conditions included depression, chronic kidney disease, chronic obstructive 

pulmonary disease, and polypharmacy. Seventeen studies were conducted, at least in part, at VA 

Medical Centers. Most pharmacist-led interventions were multifaceted, conducted in person, and 

included multiple contacts between pharmacists and patients. Most studies were not primarily 

designed to evaluate the effect of pharmacist-led care on clinical or resource use outcomes. 

Intermediate measures were the most frequently reported outcome with the most common (k=45) 

being target goal attainment for HbA1c, blood pressure, and cholesterol levels. We included a 

wide range of studies (randomized controlled trials, controlled trials, interrupted time series, and 

cohort studies) in order to evaluate a diverse body of literature related to system-level quality 

improvement projects and pharmacist-led care.

We rated strength of evidence for disease-specific clinical events (low strength of evidence that 

pharmacist-led care and usual care were similar), patient satisfaction (insufficient evidence), 

urgent care/emergency department visits and hospitalizations (moderate strength of evidence that 

pharmacist-led care and usual care were similar), non-adherence to medications (low strength of 

evidence that pharmacist-led care and usual care were similar), and goal attainment (moderate 

strength of evidence that pharmacist-led care increased the proportion of patients achieving 

glycemic, blood pressure, and cholesterol goals compared to usual care). While we did not 

formally assess strength of evidence on other outcomes we did find that pharmacist-led care was 

also similar to usual care for depression, health-related quality of life, all-cause mortality, and 

cost outcomes. However, due to differences in costs reported across studies (program costs, 

medication costs, visit costs), it is difficult to reach a conclusion about costs. Very few studies 

reported drug-related problems (inappropriate medication or dosage, drug interactions). Patients 

in the pharmacist-led care groups generally received a greater number or dose of medications 

though it was difficult to evaluate whether increased number or dose of medications was an 

indicator of better care quality. 

We identified one additional study that attempted to address the gap in reporting of adverse 

events.81 In a post-hoc analysis, the authors achieved a larger sample size by pooling data from 2 

similarly conducted RCTs comparing pharmacist-led interventions to usual care for patients with 

heart failure16 and hypertension. Adverse drug events and medication errors were secondary 

outcomes in the original trials. There were 75 events in the intervention groups and 135 events in 

the control groups. The risk ratio for all events (adverse drug events, preventable adverse drug 

events, potential adverse drug events, and medication errors) was 0.66 (95% CI 0.50, 0.88) 

favoring the intervention groups over the control groups. Risk ratios for the individual event 

categories were similar although not significant for preventable or potential adverse drug events. 

Our results concur with findings from other recent systematic reviews. Viswanathan et al, in a 

review for the Agency for Healthcare Research and Quality (AHRQ), focused on MTM and 

required interventions to include at least 3 elements: comprehensive medication review, patientdirected education and counseling, and coordination of care.9

 They found low strength of 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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evidence for a benefit of MTM for health plan expenditures (based on 3 RCTs) although the 

evidence from non-randomized trials and cohort studies was rated as insufficient strength. There 

was also a benefit of MTM for hospitalization risk for diabetes (based on one cohort study) but 

not CHF or COPD (insufficient evidence). There were mixed results for number of 

hospitalizations with 3 RCTs finding no benefit and one cohort finding a benefit of MTM. Only 

5 studies were included in both the AHRQ review and our review. However, both reviews found 

limited reporting of outcomes such as clinical events, mortality, adverse drug events, and drugrelated problems. The authors of the AHRQ review also commented on difficulty interpreting 

findings as higher values for some outcomes (eg, office visits, medication use) may indicate 

better care for some patients and poorer care for others and many sources of variability are not 

accounted for in the data analyses. 

Another review focused exclusively on blood pressure control in patients with or without 

diabetes.82 Included studies were RCTs with interventions delivered by a pharmacist alone or in 

collaboration with other healthcare professionals. In pooled analyses, pharmacist interventions 

were associated with reductions in systolic and diastolic blood pressure although heterogeneity 

was high (I2

=67% for the systolic blood pressure analysis, I2=83% for the diastolic blood 

pressure analysis). Subgroup analyses by the type of pharmacist intervention showed greater 

changes in systolic and diastolic blood pressure with pharmacist-led care compared to 

collaborative care. No other outcomes were reported. 

A 2010 review included studies of interventions, conducted in the US, where the pharmacist was 

involved in direct patient care (with a “discernable contribution”).83 Outcomes of interest were 

categorized as therapeutic (eg, blood pressure, hospitalizations, mortality, appropriate medication 

use, eye exams), safety (eg, adverse drug events, medication errors), or humanistic (eg, patient 

adherence, patient knowledge, quality of life). The authors reported the percentage of studies 

reporting an outcome with favorable, non-favorable, mixed, no effect, and unclear findings then 

performed meta-analyses with data from RCTs if more than 4 RCTs reported the outcome. The 

therapeutic outcomes eligible for meta-analysis were HbA1c, LDL, and blood pressure. Pooled 

standard mean difference data favored the pharmacist involvement. Data on adverse drug events 

(safety outcome) were pooled with an odds ratio favoring the pharmacist involvement (OR 0.53 

[95% CI 0.33, 0.83]). Standard mean difference data could also be pooled for 6 humanistic 

outcomes. Significant differences favoring pharmacist involvement were noted for medication 

adherence, patient knowledge, and quality of life (general health). Non-significant findings were 

reported for patient satisfaction and 2 quality of life dimensions – physical functioning and 

mental health.

APPLICABILITY

The chronic disease conditions addressed in the included studies (cardiovascular disease, chronic 

kidney disease, COPD, depression, diabetes mellitus, and hypertension) are common among 

Veterans. Seventeen studies were conducted in VA facilities. The model of pharmacist-led care 

reported in these studies varied but likely is similar to ongoing programs in VA. 

LIMITATIONS AND RESEARCH GAPS/FUTURE RESEARCH

Many of the outcomes reported in this review were not the study-defined primary endpoints and 

therefore not supported by rigorous research methods or statistical inferences. Among studies 

included in our review, sample sizes were too small and follow-up periods too short to detect 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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differences in mortality. There was limited reporting of other clinical events, health-related 

quality of life, and patient satisfaction. When assessed, authors used varied methods for 

determining health-related quality of life and patient satisfaction. Scale scores were often not 

validated, of unknown clinical importance, or included selected findings from subscales. 

Interventions varied in composition, delivery mode, and intensity as did the usual care 

comparator, making it difficult to draw conclusions about important intervention characteristics. 

One hypothetical benefit of pharmacist-led care for chronic diseases is increased access to care 

for patients. None of the included studies reported typical measures of access and only 4 studies 

(2 in patients with depression and one each in patients with hypertension or diabetes) reported 

patient satisfaction or patient perception measures related to access (eg, satisfaction with ability 

to reach someone in an emergency or satisfaction with availability of advice). Intervention-based 

increases in the number of scheduled visits or telephone calls may not represent improved 

access. Further research is needed with conventional measures of access.

A consistent definition of an office visits outcome is needed to distinguish regularly scheduled 

office visits, study-related office visits, and unplanned office visits. In many cases it was unclear 

whether the visit was with a pharmacist or primary care provider. Also, a consistently reported 

cost outcome that includes all of the important economic factors involved in pharmacist-led care 

would facilitate comparisons across studies and provide more accurate cost-effectiveness 

estimates.

There was limited reporting of important drug-related problems, in particular drug interactions 

and inappropriate medications and/or dosages. Some studies did report on adherence with mixed, 

inconclusive results. Despite existing definitions of polypharmacy, an isolated measure of the 

number of medications is not an indicator of quality of care as there are situations where adding 

medications and/or increasing dosages may be helpful. Similarly, de-prescribing medications that 

emerging evidence suggests are not beneficial and may provide harm may also be helpful. 

Further research is needed to define and describe these interventions and their association with 

patient outcomes and value 

Finally, the demonstrated improvement in laboratory and physiologic goal attainment due to 

pharmacist-led care is potentially encouraging. Intervention group pharmacists successfully 

achieved the intended study objectives. The target goals were based, in part, on 

recommendations from selected existing clinical practice guidelines and performance measures. 

The results indicate that future pharmacist-led programs are likely to achieve intended goals. 

However, there is conflicting evidence that target goals for glycemic, blood pressure, or 

cholesterol control have long-term beneficial effects on patient outcomes including clinical 

events, satisfaction, access, hospitalizations, and costs. Therefore, future research needs to 

carefully assess whether the magnitude of effect on selected intermediate laboratory and 

physiologic goals translate to improved patient outcomes including clinical events, satisfaction, 

access, hospitalizations, and costs. Few studies reported differences in potential harms. Thus the 

available evidence does not answer the question about whether the benefits of pharmacy-led 

interventions justify potential harms and costs. Ideally, future studies will be designed to fully 

and accurately address final patient outcomes and cost effectiveness.
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CONCLUSIONS

Evidence is limited on the effectiveness and harms of pharmacist-led chronic disease 

management compared to usual care for clinical outcomes (ie, clinical events, all-cause 

mortality, patient satisfaction, quality of life, and resource utilization). Moderate-strength 

evidence indicates that pharmacist-led chronic disease management increases goal attainment for 

HbA1c, blood pressure, and cholesterol levels. Moderate- or low-strength evidence also indicates 

that pharmacist-led chronic disease management and usual care were similar for urgent care 

visits or hospitalizations, clinical events, and adherence to medications. Evidence was 

insufficient for patient satisfaction. There was little reporting of access to care and drug-related 

problems. These results suggest that future programs are likely to achieve intended laboratory 

and physiologic goals. However, to accurately assess health care value, future research studies 

and implementation projects that utilize intermediate laboratory and physiologic goals as 

measures of effectiveness need to be certain that these goals are clearly linked to improved 

patient outcomes including clinical events, satisfaction, access, hospitalizations, costs, 

medication adherence, and drug-related problems without undue harms and costs. 
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22. Aspinall SL, Smith KJ, Good CB, et al. Incremental cost effectiveness of pharmacistmanaged erythropoiesis-stimulating agent clinics for non-dialysis-dependent chronic kidney 

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32. Cohen LB, Taveira TH, Khatana SA, Dooley AG, Pirraglia PA, Wu WC. Pharmacist-led 

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46. Brummel AR, Soliman AM, Carlson AM, de Oliveira DR. Optimal diabetes care outcomes 

following face-to-face medication therapy management services. Popul Health Manag. 

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47. Fox D, Ried LD, Klein GE, Myers W, Foli K. A medication therapy management program's 

impact on low-density lipoprotein cholesterol goal attainment in Medicare Part D patients 

with diabetes. J Am Pharm Assoc. 2009;49(2):192-199. 

48. Pape GA, Hunt JS, Butler KL, et al. Team-based care approach to cholesterol management in 

diabetes mellitus: two-year cluster randomized controlled trial. Arch Intern Med. 

2011;171(16):1480-1486. 

49. Salvo MC, Brooks AM. Glycemic control and preventive care measures of indigent diabetes 

patients within a pharmacist-managed insulin titration program vs standard care. Ann

Pharmacother. 2012;46(1):29-34. 

50. Chung N, Rascati K, Lopez D, Jokerst J, Garza A. Impact of a clinical pharmacy program on 

changes in hemoglobin A1c, diabetes-related hospitalizations, and diabetes-related 

emergency department visits for patients with diabetes in an underserved population. J 

Manag Care Pharm. 2014;20(9):914-919. 

51. Odegard PS, Goo A, Hummel J, Williams KL, Gray SL. Caring for poorly controlled 

diabetes mellitus: a randomized pharmacist intervention. Ann Pharmacother. 

2005;39(3):433-440. 

52. Stroup J, Kane, M.P., Busch, R.S., Bakst, G., Hamilton, R.A. The Diabetes Home Visitation 

Program. Am J Pharm Educ. 2003;67(1-4).

53. McAdam-Marx C, Dahal A, Jennings B, Singhal M, Gunning K. The effect of a diabetes 

collaborative care management program on clinical and economic outcomes in patients with 

type 2 diabetes. J Manag Care Spec Pharm. 2015;21(6):452-468. 

54. Smith MC, Boldt AS, Walston CM, Zillich AJ. Effectiveness of a pharmacy care 

management program for veterans with dyslipidemia. Pharmacotherapy. 2013;33(7):736-

743. 

55. Miller AE, Hansen LB, Saseen JJ. Switching statin therapy using a pharmacist-managed 

therapeutic conversion program versus usual care conversion among indigent patients. 

Pharmacotherapy. 2008;28(5):553-561. 

56. Mazzolini TA, Irons BK, Schell EC, Seifert CF. Lipid levels and use of lipid-lowering drugs 

for patients in pharmacist-managed lipid clinics versus usual care in 2 VA Medical Centers. J 

Manag Care Pharm. 2005;11(9):763-771. 

57. Straka RJ, Taheri R, Cooper SL, Smith JC. Achieving cholesterol target in a managed care 

organization (ACTION) trial. Pharmacotherapy. 2005;25(3):360-371. 

58. Ellis SL, Carter BL, Malone DC, et al. Clinical and economic impact of ambulatory care 

clinical pharmacists in management of dyslipidemia in older adults: the IMPROVE study. 

Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans 

Affairs Medical Centers. Pharmacotherapy. 2000;20(12):1508-1516. 

59. Bogden PE, Koontz LM, Williamson P, Abbott RD. The physician and pharmacist team. An 

effective approach to cholesterol reduction. J Gen Intern Med. 1997;12(3):158-164. 

60. Konzem SL, Gray DR, Kashyap ML. Effect of pharmaceutical care on optimum colestipol 

treatment in elderly hypercholesterolemic veterans. Pharmacotherapy. 1997;17(3):576-583. 

61. Carter BL, Coffey CS, Ardery G, et al. Cluster-randomized trial of a physician/pharmacist 

collaborative model to improve blood pressure control. Circulation. Cardiovascular quality 

and outcomes. 2015;8(3):235-243. 
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62. Margolis KL, Asche SE, Bergdall AR, et al. Effect of home blood pressure telemonitoring 

and pharmacist management on blood pressure control: a cluster randomized clinical trial. 

JAMA. 2013;310(1):46-56. 

63. Carter BL, Ardery G, Dawson JD, et al. Physician and pharmacist collaboration to improve 

blood pressure control. Arch Intern Med. 2009;169(21):1996-2002. 

64. Carter BL, Bergus GR, Dawson JD, et al. A cluster randomized trial to evaluate 

physician/pharmacist collaboration to improve blood pressure control. J Clin Hypertens. 

2008;10(4):260-271. 

65. Erickson SR, Slaughter R, Halapy H. Pharmacists' ability to influence outcomes of 

hypertension therapy. Pharmacotherapy. 1997;17(1):140-147. 

66. Zillich AJ, Jaynes HA, Bex SD, et al. Evaluation of pharmacist care for hypertension in the 

Veterans Affairs patient-centered medical home: a retrospective case-control study. Am J 

Med. 2015;128(5):539 e531-536. 

67. Magid DJ, Ho PM, Olson KL, et al. A multimodal blood pressure control intervention in 3 

healthcare systems. Am J Manag Care. 2011;17(4):e96-103. 

68. Vivian EM. Improving blood pressure control in a pharmacist-managed hypertension clinic. 

Pharmacotherapy. 2002;22(12):1533-1540. 

69. Hirsch JD, Steers N, Adler DS, et al. Primary care-based, pharmacist-physician collaborative 

medication-therapy management of hypertension: a randomized, pragmatic trial. Clin Ther. 

2014;36(9):1244-1254. 

70. Magid DJ, Olson KL, Billups SJ, Wagner NM, Lyons EE, Kroner BA. A pharmacist-led, 

American Heart Association Heart360 Web-enabled home blood pressure monitoring 

program. Circ Cardiovasc Qual Outcomes. 2013;6(2):157-163. 

71. Green BB, Cook AJ, Ralston JD, et al. Effectiveness of home blood pressure monitoring, 

Web communication, and pharmacist care on hypertension control: a randomized controlled 

trial. JAMA. 2008;299(24):2857-2867. 

72. Hunt JS, Siemienczuk J, Pape G, et al. A randomized controlled trial of team-based care: 

impact of physician-pharmacist collaboration on uncontrolled hypertension. J Gen Inter Med. 

2008;23(12):1966-1972. 

73. Borenstein JE, Graber G, Saltiel E, et al. Physician-pharmacist comanagement of 

hypertension: a randomized, comparative trial. Pharmacotherapy. 2003;23(2):209-216. 

74. Ralston JD, Cook AJ, Anderson ML, et al. Home blood pressure monitoring, secure 

electronic messaging and medication intensification for improving hypertension control: a 

mediation analysis. Appl Clin Inform. 2014;5(1):232-248. 

75. Okamoto MP, Nakahiro RK. Pharmacoeconomic evaluation of a pharmacist-managed 

hypertension clinic. Pharmacotherapy. 2001;21(11):1337-1344. 

76. Kulchaitanaroaj P, Brooks JM, Ardery G, Newman D, Carter BL. Incremental costs 

associated with physician and pharmacist collaboration to improve blood pressure control. 

Pharmacotherapy. 2012;32(8):772-780. 

77. Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence 

and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized 

controlled trial. JAMA. 2006;296(21):2563-2571. 
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78. Taylor CT, Byrd DC, Krueger K. Improving primary care in rural Alabama with a pharmacy 

initiative. Am J Health Syst Pharm. 2003;60(11):1123-1129. 

79. Malone DC, Carter BL, Billups SJ, et al. An economic analysis of a randomized, controlled, 

multicenter study of clinical pharmacist interventions for high-risk veterans: the IMPROVE 

study. Impact of Managed Pharmaceutical Care Resource Utilization and Outcomes in 

Veterans Affairs Medical Centers. Pharmacotherapy. 2000;20(10):1149-1158. 

80. Malone DC, Carter BL, Billups SJ, et al. Can clinical pharmacists affect SF-36 scores in 

veterans at high risk for medication-related problems? Med Care. 2001;39(2):113-122. 

81. Murray MD, Ritchey ME, Wu J, Tu W. Effect of a pharmacist on adverse drug events and 

medication errors in outpatients with cardiovascular disease. Arch Intern Med. 

2009;169(8):757-763. 

82. Santschi V, Chiolero A, Colosimo AL, et al. Improving blood pressure control through 

pharmacist interventions: A meta-analysis of randomized controlled trials. J Am Heart Assoc. 

2014;3(2):e000718. 

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on patient care: systematic review and meta-analyses. Med Care. 2010;48(10):923-933. 
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APPENDIX A. SEARCH STRATEGIES 

MEDLINE (OVID)

1. Pharmacists/ or pharmacist:.ti,ab.

2. (pharmaceutical care or pharmaceutical services or community pharmac: or clinical pharmac:).ti,ab.

3. 1 or 2

4. Patient care/ or patient care management/

5. Collaborative care.mp. or exp patient care planning/ or intervention:.mp.

6. Case management/ or case management.mp. or care management.mp

7. Disease management/ or disease management.mp. or (disease adj3 prevent:).mp.

8. (chronic disease adj3 management).mp.

9. (chronic disease adj3 prevent:).mp.

10. Chronic care improvement.mp.

11. 4 or 5 or 6 or 7 or 8 or 9 or 10

12. 3 and 11

13. Chronic disease/

14. (chronic adj3 condition:).mp.

15. Exp pulmonary disease, chronic obstructive/

16. Congestive heart failure.mp. or heart failure/ or exp heart failure/

17. Dyslipidemia.mp. or exp dyslipidemia/

18. Diabetes.mp.

19. Hypertension.mp. or exp hypertension/

20. Cancer.mp. or exp neoplasms/

21. Kidney disease.mp. or kidney diseases/ or exp kidney diseases/ or kidney failure.mp.

22. Chronic pain.mp.

23. Depression.mp. or exp depressive disorder/

24. 12 or 14 or 15 or 16 or 18 or 19 or 20 or 21 or 22 or 23

25. Outpatient/ or outpatient:.mp. or outpatient.ti,ab.

26. Ambulatory.mp.

27. Assisted living facilities/ or assisted living.mp.

28. Primary care:.mp.

29. Primary health care/

30. Community pharmac:.mp.

31. Outpatient clinics, hospital/ or clinic.mp.

32. Office visits/ or community health services/ or clinics.mp.

33. 25 or 26 or 27 or 28 or 29 or 30 or 31 or 32

34. 12 and 24 and 33

35. Limit 34 to (English language and yr=”1995-current”)

36. Limit 35 to “all child (0 to 18 years)”

37. Limit 36 to “all adult (19 plus years)”

38. 36 not 37

39. 35 not 38

40. Limit 39 to (meta analysis or systematic reviews)

41. Limit 39 to (controlled clinical trial or randomized controlled trial)

42. Comparative study/

43. 39 and 42

44. Control group.mp.

45. (control: or compar: or random:).ti,ab.

46. 44 or 45

47. 39 and 46

48. 41 or 43 or 47
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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CINAHL

1. Pharmacist* OR MH pharmacists

2. (pharmaceutical W1 (care or service?)) OR ((community or clinical) W1 pharmac*) OR collaborative W1 

care OR intervention* OR ((care or case) W1 management)

3. Disease N1 management OR disease N3 prevent* OR ((chronic W1 disease) N3 (management or 

prevent*)) OR chronic W1 care W1 improvement

4. (MH “Case Management”) OR (MH “Disease Management”)

5. 2 or 3 or 4

6. Chronic N3 condition* OR congestive W1 heart W1 failure OR dyslipidemia OR diabetes OR hypertension 

OR cancer

7. Kidney N1 disease* OR kidney N1 fail* OR chronic N1 pain OR depression

8. (MH “Kidney Diseases+”) OR (MH “Chronic Pain”) OR (MH “Depression+”)

9. 6 or 7 or 8

10. Outpatient* OR ambulatory OR assisted W1 living OR primary W1 care OR community W1 pharmac* OR 

clinic?

11. (MH “Outpatients”) OR (MH “Ambulatory Care”) OR (MH “Ambulatory Care Facilities+”) OR (MH 

“Assisted Living”) OR (MH “Primary Health Care”) OR (MH “Community Health Centers”)

12. 10 or 11

13. 1 and 5

14. (MH “Office Visits”)

15. Office W1 visit*

16. 12 or 14 or 15

17. 9 and 13 and 16

18. 9 and 13 and 16 (limiters- randomized controlled trials, Search modes-find all my search terms

19. “meta analysis” OR “systematic review” OR “controlled clinical trial” OR :comparative study” OR 

“control group” OR control* OR compar* OR random* (limiters-randomized controlled trials, search 

modes- find all my search terms)

20. (MH “Meta Analysis”) OR (MH “Systematic review”) OR (MH “Clinical Trials+”) OR (MH “Comparative 

Studies”) OR (MH “Control Group”)

21. 19 or 20

22. 17 and 21

23. 18 or 22

24. 18 or 22 (limiters- published date: 19950101-20150131; English Language; Exclude MEDLINE records; 

Human; Age Groups: All Adult, search modes-Find all my search terms)

COCHRANE LIBRARY

1. Pharmacist*

2. Pharmaceutical next (care or service)

3. Collaborative next care

4. Intervention*

5. (care or case) next management

6. Disease near management

7. Disease near prevent*

8. (chronic next disease) near (management or prevent*)

9. Patient care:kw

10. MeSH descriptor: [Chronic Disease] explode all trees

11. MeSH descriptor: [Patient Care Planning] explode all trees

12. #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11

13. #1 and #12

14. Chronic near condition?

15. Congestive next heart next failure

16. Dyslipidemia or diabetes or hypertension or cancer?

17. Kidney next disease?

18. Kidney next fail*

19. Chronic next pain

20. Depression
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21. MeSH descriptor: [heart Failure] explode all trees

22. MeSH descriptor: [Pulmonary Disease, Chronic Obstructive] explode all trees

23. MeSH descriptor: [Dyslipidemias] explode all trees

24. MeSH descriptor: [Diabetes Mellitus] explode all trees

25. MeSH descriptor: [Neoplasms] explode all trees

26. MeSH descriptor [kidney diseases] explode all trees

27. MeSH descriptor: [depressive disorder] explode all trees

28. #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22 or #23 or #24 or #25 or #26 or #27

29. #13 and #28

30. Outpatient? Or ambulatory or clinic?

31. Assisted near living

32. Primary next care

33. Community next pharmac*

34. Primary health care:kw

35. Outpatient clinics, hospital:kw

36. Office visits:kw

37. Community health services:kw

38. #30 or #31 or #32 or #33 or #34 or #35 or #36 or #37

39. #29 and #38

Publication Year from 1995 to 2015

INTERNATIONAL PHARMACEUTICAL ABSTRACTS (IPA)

1. pharmacists/ or pharmacist:.ti,ab.

2. (pharmaceutical care or community pharmacy or clinical pharmac:).ti,ab.

3. 1 or 2

4. patient care/ or patient care management/

5. case management/ or case management.mp. or care management.mp.

6. patient education as topic/ or counsel:.mp.

7. disease management/ or disease management.mp. or (disease adj3 prevent:).mp.

8. medication therapy management/ or (medication adj3 management).mp.

9. (prescription adj3 management).mp.

10. medication optimiz:.mp. or drug interactions/ or therapeutic plan.mp.

11. prescription optimiz:.mp.

12. dt.fs. or drug therapy/ or medication counseling.mp.

13. prescription counseling.mp.

14. drug monitoring/ or prescription monitor:.mp. or drug monitor:.mp.

15. medication surveillance.mp. or medication reconciliation/ or prescription reconciliation.mp.

16. ((medication adj3 review) or (prescription adj3 review) or (drug adj3 review)).mp.

17. 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16

18. 3 and 17

19. limit 18 to (english language and yr="1995 -Current")

20. limit 19 to journal articles

21. Comparative Study/

22. control group.mp.

23. (control: or compar: or random:).ti,ab.

24. study design.ti,ab.

25. 22 or 23 or 24

26. 20 and 25

27. outpatient/ or outpatient:.mp.

28. ambulatory.mp.

29. urgent care.mp.

30. emergency:.mp.

31. assisted living facilities/ or assisted living.mp.

32. primary care:.mp.

33. community:.mp.

34. 27 or 28 or 29 or 30 or 31 or 32 or 33

35. 26 and 34
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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APPENDIX B. PEER REVIEW COMMENTS/AUTHOR RESPONSES

Reviewer Comments Export

Pharmacist-led Chronic Disease Management: A Systematic Review of Effectiveness and Harms Compared to Usual Care

Question Text Comment Response

Are the 

objectives, 

scope, and 

methods for this 

review clearly 

described?

Yes Thank you

Yes

Yes 

Yes 

Yes 

Yes 

Is there any 

indication of bias 

in our synthesis 

of the evidence?

No Thank you

No 

Yes - only in the Executive Summary Please see below for our response

Yes - Description of bias noted in review comments Please see below for our response

No Thank you

No 

Are there any 

published or 

unpublished

studies that we 

may have 

overlooked?

Yes - Based on your search strategy, I would have thought that a VA 

study which compared pharmacist-managed ESA clinic (for CKD) 

would have been included in the section of CKD. References below. 

(disclosure- I am one of the authors. Having said that, I really don't 

care if this study is included, if there is good reason why it should not 

be included.)

1. Aspinall SL, Cunningham FE, Zhao X, Boresi JS, Tonnu-Mihara IQ, 

Smith KJ, Stone RA, Good CB. Impact of pharmacist-managed 

erythropoiesis-stimulating agents clinics for non-dialysis chronic 

kidney disease patients. Am J Kidney Dis 2012; 60 (3): 371-9. PMID 

22633556

2. Aspinall SL, Smith KJ, Good CB, Zhao X, Stone RA, Tonnu-Mihara 

IQ, Cunningham R, for the ESA Clinic Study Group. Incremental costeffectiveness of pharmacist-managed erythropoietin-stimulating agent 

clinics for non-dialysis-dependent chronic kidney disease. Appl Health 

Econ and Health Policy 2013; 11:653-660.

Thank you for identifying this study. We have added the 2 articles to 

our review.

No 

No 

Yes - Recommendations noted in review comments. Thank you. Please see below for our response.

No 

No 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Additional 

suggestions or 

comments can 

be provided 

below. If 

applicable, 

please indicate 

the page and line 

numbers from 

the draft report.

Three Comments

1) The report mentions in several sections the concern that while 

attaining many targets better in pharmacy intervention arms, 

compared to control- those targets have not been shown to improve 

clinical outcomes, and may actually be associated with harm. I find 

this somewhat curious- indeed, this is true. But, it is true in hindsightat the time most of these studies were done, it was generally 

accepted that these targets were clinically relevant (for instance, that 

HBA1C of less than 7 was an important target). So, to criticize those 

intermediate outcomes seems unfair. Indeed, the pharmacists in 

those studies accomplished what they were asked to accomplish. 

Today, we would design those studies differently, but we have 

evidence that came after the referenced studies were done.

Furthermore, the fact that most of the studies only demonstrate 

intermediate outcomes really reflects the roll of the clinical pharmacist 

in the clinic. Most of the studies were relatively short term, reflecting 

the reason patients are sent for clinical pharmacist input- usually goal 

directed (improve blood pressure control, etc). 

2. I did not have time to pull individual articles, but I did pull several. 

Randomly, I looked at the Gattis article. It is published in a reputable

journal. In the text, the study is referenced as showing no significant 

difference in clinical outcomes (overall mortality) but the study reports 

sig decrease in mortality plus heart failure events. If this outcome was 

not valid, I feel it should have been clear in the report that while the 

study reported a clinically relevant improvement in outcome, these 

were not accepted because of......(In the tables, it shows up under 

hospitalizations...being significantly less).

3. The review was also intended to evaluate harms. However, "harms" 

is almost never mentioned throughout the report. Harms are not 

specifically mentioned in the Executive Summary, and in the individual 

sections, adverse events are identified as a gap area. However, this is 

not clearly articulated as seeking evidence for "harms". Suggest 

explicitly discussing "harms"- which I assume that there is little 

evidence to address in the review.

1) We have limited our review to the findings of the studies, and 

rephrased our Limitations and Conclusions

2. The combination outcome from the Gattis article was reported on 

the Evidence Table in the Appendix but was not carried forward 

accurately to the report. We have made that change.

3. Although systematic reviews do have different criteria for evidence 

of harm, there was insufficient evidence on harms as most studies 

didn’t report harms and those that did often didn’t report data for the

control group. 

The information presented in the report is well constructed and 

comprehensive in its review of the topic.

The research question is concise and well formulated.

The summary and analysis of reviewed/considered data upon which 

an attempted answer to the question is based is objectively and 

accurately presented.

As a reader/reviewer, I was generally able to understand the 

Thank you.

We have added some examples of “clinical events” in the listing of 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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distinctions between various measured/evaluated parameters. 

However, the listing of one or two relevant examples of the authors' 

"definition" of "clinical events" (within a disease being examined) in 

relationship to the broader "clinical outcomes" of interest across all 

disease types (which are explicitly stated) would likely be helpful to 

future readers and users of the report. That is, what specific thing 

might qualify as an example of a "clinical event" in the care and 

treatment of a patient with the specified disease under scrutiny. Most 

other definitions, measures, and examples are more clearly detailed.

outcomes of interest and as a footnote to the Strength of Evidence 

tables.. 

My impression from this systematic review is that pharmacists are not 

yet good at designing studies and choosing or measuring the 

outcomes the reviewers deem important. It may be that pharmacistled team have not been numerous enough or in existence long 

enough to reach important mortality end points. A more complete 

description of the evolution of pharmacists from product preparation to 

patient providers may be helpful. The papers they reviewed were very 

heterogeneous and not powered to detect the outcomes this review 

considered most important (e.g. mortality, resource use, access, 

satisfaction). Nevertheless, they show that pharmacist provided care 

is for the most part not different from non-pharmacist with goal 

attainment (LDL, HgbA1c, BP) being better with pharmacist provided 

care. In the executive summary these facts were presented in a very 

negative light. For example, on actual page 35, study page 23 

paragraph 1 under key findings: they drew conclusions about 

pharmacist-led care not improving outcomes for depression but 

specifically stated “studies were not always adequately designed or 

analyzed for these outcomes”. If that is the case, state lack of study 

design but do not move to a broader conclusion.

My global impression is that this systemic review including 

categorization, inclusion/exclusion etc. is sound but the way the 

results are interpreted and the wording of their 

summary/discussion/conclusion can be improved. The way it is now 

stated, can be misinterpreted and shed a negative light on what 

pharmacists have done to date. Specifically, the part on goal 

attainment which actually showed that pharmacists provided care did 

better in this category. But, this is undermined by saying that these 

goals are less strict now anyway and there isn’t a strong evidence that 

attaining these goals are clinically meaningful. While this may be true, 

it did not represent the evidence/guidance at the time which is a more 

global issue. 

Edits: 

Actual page 54, study page 41, paragraph 4, line 3: “further study is 

needed” change to- further studies are needed

Actual page 38, study page 26, paragraph 4, line 4: “Two studied 

We agree that published studies were not designed to assess 

mortality and clinical events or authors did not report these findings 

We would note that most of the included studies looked at the addition 

of pharmacist-led care to usual care, not pharmacist-led care versus 

non-pharmacist care.

We have rephrased the conclusions about the depression studies.

We have modified the wording of the Limitations and Conclusions 

sections. 

Edits: Thank you. We have made changes to these sentences.
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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reported no significant differences” change to- Two studies reported

The authors have conducted an extensive evidence-based review of 

Pharmacist-led Chronic Disease Management, particularly as it 

relates to effectiveness of care. The technical accuracy of the 

effectiveness of care review meets the evidence-based standards 

described in the report’s methodology. It is noted that the findings of 

this effectiveness of care review are similar to the 2014 systematic 

review of outpatient medication therapy management (MTM) 

interventions conducted by Viswanathan, et. al. (2014 AHRQ review). 

These similarities would be expected as both analyses used similar 

evidence-based criteria arriving at a conclusion of difficulty 

interpreting findings due to heterogeneity of services and 

interventions. 

The purpose of this review is to provide the authors, and the Veterans 

Health Administration, with suggestions and recommendations for 

improving this ESP review as it pertains to the methodology 

employed, and implications and applicability of the evidence-based 

findings contained in this review 

-First, it would be helpful to the reader to frame the findings of this 

review in the context of evidence-based reviews of physicians, and 

other health professionals, chronic disease management services. In 

its present state, there is no frame of reference or context for 

understanding the findings of this report. Are these results similar or 

different than other evidence-based findings of chronic disease 

management provided by other health care professionals, as well as 

team-based care? 

-Second is a critique of the Review of Harms. It is greatly appreciated 

that the report’s Conclusions highlight the importance of achieving 

patient-specific treatment goals by noting that; ‘studies of pharmacistled care generally achieved intermediate target thresholds designed 

to achieve a “goal attainment” that should be done cautiously to 

provide patient-centered high value health care.’ This is the essence 

of comprehensive team-based medication management in an era of 

accountable health care. However, it is repeatedly stated in the report 

that, “achieving target goals for HbA1c, blood pressure, and 

cholesterol reported in the included studies have not been 

convincingly demonstrated to improve health outcomes but can 

increase harms and costs.” If this statement is to be made, the 

evidence supporting this finding needs to be presented. The authors 

will need to summarize the results of other studies in which achieving 

intermediate target thresholds can cause harms (e.g. A1c < 7% in the 

elderly, LDL < 70 mg/dl in octogenarians, etc.). In fact, unless 

additional evidence-based studies describing harms from aggressively 

achieving intermediate target thresholds can be described, then it is 

strongly recommended that the report title be corrected to remove the 

1) Our findings were based on the available evidence regarding 

pharmacist-led clinics. Other disease management clinics also 

frequently use measures such as “goal attainment.” We believe we 

have assessed the most clinically relevant endpoints and initially 

discussed these with our Technical Expert Panel. 

There are few studies comparing pharmacist-led chronic disease 

management to other health care professionals. Thus, we hesitate to 

draw any conclusions about whether pharmacists provide more or 

less value. 

2) We have modified the Limitations and Conclusions. 

Regarding harms, please see response above. 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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word HARMS, because a systematic evidence-based review of harms 

is not apparent in this analysis.

-Third, is an inherent bias in the report pertaining to use of an 

outcome measure without a published taxonomy or official 

nomenclature. It is understood that the term, “Drug-related Problems” 

is commonly used in the literature, however there is no published 

classification system for this term. On the other hand, a published 

taxonomy of Drug Therapy Problems is available in the National 

Library of Medicine. One suggestion for improving the report is to 

utilize the four main published categories of Drug Therapy Problems 

(e.g. indication, effectiveness, safety, and convenience/adherence) to 

frame the analysis of drug-related problems. And one other item, on 

page 14, line 28 there is a statement in regards to the CKD RCT that 

“drug-related problems were not reported for the control group.” 

Without clarification this may be an irresponsible statement. No 

human subjects protection program or Institutional Review Board 

would approve a study in which drug therapy problems were identified 

in a control group without taking appropriate actions to resolve drug 

therapy problems in the control group of patients. In Medicine, this 

would be analogous to identifying a medical condition in a control 

patient and not doing anything about it. 

-Fourth, it is noted that the evaluation approach employed in this 

analysis is deeply vested in experimental design that dominates the 

toolkit of evidence-based medicine. This evaluation approach has 

been summarized by Pawson and Tilley as an, OXO design: observe 

a system (O), introduce a perturbation/intervention (X) to some 

participants but not others, and then observe again (O). [1] Pawson 

and Tilley assert that when studies use the OXO paradigm to evaluate 

social programs (including most system improvements in medicine), 

the result is almost always “a heroic failure, promising so much and 

yet ending up in ironic anticlimax. The underlying logic seems 

meticulous, clear-headed and militarily precise, and yet findings seem 

to emerge in a typically non-cumulative, low-impact, prone-toequivocation sort of way.” The usual conclusion and assertion from 

traditional OXO evaluations of quality-improvement efforts in health 

care is either that nothing works or that the results are inconsistent 

and more research is needed. [1] Dr. Don Berwick, former CMS 

Administrator and champion of the Science of Quality Improvement, 

has stated that the OXO paradigm most commonly applied in the 

traditional toolkit of evidence-based medicine is, “a powerful, perhaps 

unequaled, research design to explore the efficacy of conceptually 

neat components of clinical practice—tests, drugs, and procedures. 

For other crucially important learning purposes, however, it serves 

less well.” [2] The introduction of interprofessional and interdisciplinary 

3) Our list of medication outcomes of interest was approved by our

Technical Expert Panel members. We have defined our meaning of 

“drug-related problems” and removed the term “drug therapy 

problems” from the review. 

We have modified the text so the statement about drug-related 

problems in the control group has been deleted. It would have been 

more accurate to state that the drug related problems in the control 

group were not reported in the manuscript. 

4) We evaluated studies that were specifically designed to assess the

effectiveness of pharmacist-led chronic disease management. We 

included many study types including those often used in quality 

improvement initiatives (as many of these were). We disagree that we 

held pharmacist-led CDM to “too demanding” quality. Our charge was 

to conduct a systematic review focusing on the highest quality 

evidence available, ie, controlled clinical trials. Implementation should 

require evidence of effectiveness that exceeds harms and costs (ie,

high value). The studies we reviewed did not provide convincing

evidence about the value of pharmacist-led care. 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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chronic care management systems for establishing a rational 

medication use system in which pharmacists work with patients to 

achieve their goals of therapy with zero tolerance for preventable 

medication harms is a complex, multicomponent intervention—

essentially a process of social change. Pawson and Tilley claim that 

the reason the OXO model fails in this context is because, 

“experimentalists have pursued too single-mindedly the question of 

whether a program works at the expense of knowing why it works.” [1]

The fifth and final area of improvement relates to the implications and 

applicability of findings within the Veterans Health Administration 

system. This is to say, that it would be very helpful to address the, “so 

what question” of the report’s findings. In many of the VISN regions of 

the VA system, there are exemplary pharmacist-led chronic care 

advances and innovations supported by evidence of improved quality 

of care. One of the most important topics that is not addressed in this 

report is reducing pharmacist-led care process variations across the 

VA VISN’s. The science of continuous quality improvement (e.g. 

statistical process controls, run charts, etc.) provides the tools, 

techniques and measures to achieve this urgent national need in the 

care of this country’s Veterans.

Thank you for the opportunity to serve as an external review for this 

Evidence-based Report. 

References:

1.) Pawson R, Tilley N. Realistic Evaluation. London, England: Sage 

Publications Ltd; 1997.

2.) Berwick DM. The Science of Improvement. JAMA. 

2008;299(10):1182-1184. 

doi:10.1001/jama.299.10.1182.

5) We agree that implications and applicability are important,

however, our purpose is to provide a review of evidence for VA policy 

makers. It is also outside of the scope of this review to address the 

question of variation in practice across VA VISNs. We highlighted 

studies conducted in the VA system and are not aware of any other 

evidence of improved quality of care.

This is excellent work. My only comment is that I continue to urge the 

authors to phrase their findings carefully to avoid giving the 

impression that pharmacist-led care has been shown not to improve

outcomes such as mortality. Rather, as the aphorism goes, absence 

of evidence should not be construed as evidence of absence. That is, 

the studies have not been done to evaluate those outcomes. This 

should be made clear.

Thank you. We agree and have reviewed our wording to be clear on 

the absence of evidence for key outcomes.

This is a very thorough and well done report. Several comments:

1. Pg. 5, lines 11-12 It is important to clarify these statements to state

that in certain patients the more intensive treatment targets may 

cause harm, but not all patients as the statement reads now. Also, not 

all patients require less intensive treatment targets. Those 

recommendations apply to certain high-risk patients (especially in 

diabetes) whereas this statement implies that all patients would 

require less intensive targets.

Thank you.

1. We have modified this section.
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

63

2. Pg. 19, Table 3, line 12 The 1 does not have a key corresponding

with this and I believe it should be a 'b' instead.

3. Pg. 23, line 24-25 This statements says there were 3 RCT's but

lists 4 references and again in lines 38 & 39 it talks about 2 studies 

but lists 3 references. Clarification here would be helpful.

4. Pg. 28, Figure 6 The placement of this figure is a bit confusing as it

is in the middle of the diabetes study discussion but it combines the 

lipids, hypertension and polypharmacy studies with the diabetes. It 

may make more sense to put at the end after review of each of those 

sections.

5. Pg. 29, line 54 The dyslipidemia heading lists 2 RCTs, 2 CCTs, and

2 Cohort studies while the text discusses 7 studies (line 54).

6. Pg. 33, line 14 "in the" is written twice.

7. Pg. 39, lines 28-31. See comment #1 above as the same applies in

this section and also on Pg. 42, lines 21 & 22.

2. We have made the correction

3. The 3 RCTs were reported in 4 papers. We have clarified this at the

start of the paragraph.

4. We have placed Figure 6 in the Diabetes section because that is

where the first reference to the figure is located. We again refer to 

Figure 6 in the lipids, hypertension, and polypharmacy sections.

5. We have corrected/clarified the count of studies for the

Dyslipidemia section.

6. Thank you, we have made this edit.

7. We have modified the wording on treatment targets throughout the

report.
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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APPENDIX C. EVIDENCE TABLES

Table 1. Study and Intervention Characteristics – Cardiovascular Disease Studies

Author, 

year

Study 

design

Type of 

Clinic* 

Target 

Population

Duration of 

study/

follow-up

Inclusion/ Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Cardiovascular Disease or Risk Factors for Cardiovascular Disease

Taveira 

201411

RCT

Cardiovascular 

Risk 

Reduction 

Clinic 

(CRRC) at 

VAMC

Adults with 

cardiovascular 

disease risk 

factors

12 months

Inclusion: 

-actively enrolled in the 

CRRC clinic (documented 

CVD or DM) 

-achieved discharge 

criteria(HbA1c <7%), BP 

(DM <140/80 non-DM 

<140/90), and LDL goals 

(<2.59 mmol/L))

Exclusion: 

-conditions that may limit 

long-term adherence to 

study visits

-life-expectancy < 1 year

Maintenance of 

cardiovascular 

risk factor 

control once it 

has been 

obtained

Time to failure 

for guideline 

goals of HbA1c 

(failure is >7%) 

and blood 

pressure (with 

DM failure is 

>140/80 without 

>140/90) over 

12-month study 

period

Clinical 

pharmacists 

who were 

diabetes core 

content 

experts and 

certified as 

diabetes 

educators

1) N=72

-Education

-Behavioral and pharmacological 

interventions

-Individualized cardiovascular risk report 

card 

-Medications initiated or titrated 

-Individualized homework and behavior 

change goals

-Coaching of self-care skills

Mode/Frequency:

-Group medical visits (120 minute 

sessions every 3 months for 1 year; 

facilitated by pharmacist) plus standard 

primary care 

2) N=73

-Assessed adherence

-Titrated medications

-Referred to nutrition or physical therapy 

as needed

-Obtained vitals and lab parameters

Mode/Frequency:

-Quarterly CRRC individual clinic visits 

plus standard primary care (30 minute 

visit with clinical pharmacist every 2-6 

weeks until cardiovascular risk control 

attained)

N=55 

Standard 

primary care 

(3-4 visits per 

year with 

primary care 

provider; 

referrals for 

nutrition and 

physical 

therapy 

available)

Not reported
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Author, 

year

Study 

design

Type of 

Clinic* 

Target 

Population

Duration of 

study/

follow-up

Inclusion/ Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator intervention Collaboration

Irons 

201212

Cohort 

(retro) 

University 

Cardiology Group

High cardiac 

risk patients

Patients 

followed until 

at goal for 

several 

months

Inclusion: 

-CAD (history of MI, CABG, 

angioplasty, coronary stent 

placement, stable angina, 

evidence of ≥50% stenosis 

of any major coronary 

artery, or significant CAD 

risk equivalent)

-baseline SBP >135 mmHg

-age 40-85 years 

-established care with 

physician from group 

-≥2 visits with clinical 

pharmacists (intervention) 

or cardiologist (control) 

during study period

Exclusion: 

-history of systolic heart 

failure (EF < 40%)

-significant renal disease

-documented nonadherence with 

appointments (<70% 

compliance)

Optimize HTN 

medication 

management to 

improve blood 

pressure control 

Difference 

within and 

between the 2 

groups in 

percentage of 

patients who 

obtained BP < 

130/80 mmHg 

during last 

documented 

clinic visit within 

time frame 

evaluated

Clinical 

pharmacists

N=59

Collaborative care model; scheduled 

patient clinic appointments with clinical 

pharmacists

-Adjustment of drug regimens (add, 

delete, or change HTN medications)

-Change dosages of existing HTN 

medications 

-Obtain appropriate laboratory 

measurements

-Provide limited physical assessment

-Educate referred patients

-Follow-up based on adverse events and 

blood pressure control

No specific formulary or algorithms used

Mode/Frequency:

-Minimum of 2 visits with the clinical 

pharmacist

-Initial visit, subsequent follow-up visits 

were scheduled within 1-4 weeks

-If patient was at goal without 

complications they were scheduled for 

follow-up in 3 months

N=58

unmatched, 

met same 

inclusion 

criteria; usual

care in same 

cardiology 

clinic

Cardiologist 

referred 

patients to HTN 

service at his 

discretion

Written 

collaborative 

practice 

agreements in 

place

Consulted for 

changes of 

nonhypertensive 

medications
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Author, 

year

Study 

design

Type of 

Clinic* 

Target 

Population

Duration of 

study/

follow-up

Inclusion/ Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator intervention Collaboration

Coronary Artery Disease

Spence 

201413

Cohort 

(retro) 

Outpatient 

pharmacy 

clinical 

service of 

integrated 

health 

care 

service

Nonadherent 

diabetes 

mellitus or 

CAD patients 

with HbA1c 

or LDL-C 

outside 

clinical goals

1 year 

follow-up

Inclusion: 

-age ≥18

- pharmacy benefit ≥1 year 

before and 1 year after 

index date

-included in diabetes or 

CAD registries

- non-adherent (MPR < 

0.80) on ≥1 oral medication 

for diabetes or dyslipidemia

-HbA1c ≥8% or LDL-C 

≥100 mg/dL

Exclusion:

-active insulin prescription

-resided in skilled nursing 

facility >10 days or 

received hospice care 

during study period

-declined consult

Improve 

medication 

adherence

Primary 

outcome not 

stated

Pharmacists 

who received 

training on 

diabetes and 

dyslipidemia, 

consultation 

methodology 

including 

motivational 

interviewing, 

and workflow 

training

109 

pharmacists 

participated 

in OPCS 

consultations

N=359 with diabetes; N=1,121 with 

dyslipidemia

Outpatient Pharmacy Clinical Service 

(OPCS); consult (B-SMART 

methodology) with patients meeting 

OPCS criteria during prescription pick-up

-Identify barriers to medication nonadherence and solutions to these 

barriers

-Motivate patients

-Recommend adherence tools

-Triage patient if needed to improve 

medication adherence and outcomes

Mode/Frequency:

-One-time

-Face-to-face

N=428 with 

diabetes; 

N=1,049 with 

dyslipidemia 

matched

Usual care; 4 

usual care 

patients 

matched to 

each 

intervention 

patient by age, 

gender, and 

disease 

(diabetes or 

dyslipidemia)

Not reported

Olson 

200914

RCT

Non-profit 

HMO in 

urban 

area

Patients with 

prior 

coronary 

artery 

disease 

(acute MI, 

percutaneous coronary 

intervention, 

or coronary 

artery 

bypass graft 

surgery)

2 years

Inclusion: 

-required only yearly 

follow-up per CPCRS 

protocol

-≥2 consecutive LDL-C and 

non-HDL-C values at goal 

(1 measure within 6 

months of enrollment) 

-controlled blood pressure 

within 6 months 

Exclusion: 

-HbA1c ≥9% in past 6 

months 

-dementia

-death within 30 days of 

randomization

-life expectancy <3 years

Maintain lipid 

control following 

discharge from 

cardiac disease 

management 

program

% of patients 

maintaining 

LDL-C goal at 

study end

Clinical 

pharmacy 

specialists

N=214

-Pharmacists telephoned patients to 

review results of annual fasting lipid 

profile, blood pressure measurements, 

and medications and adherence

-Counsel on diet and exercise

-Make medication adjustments to 

maintain treatment goals 

-Order follow-up lab tests

-Patients scheduled for follow-ups and 

notified of results

Mode/Frequency:

-Telephone

-Letters informing patients of test results

-Scheduled for follow-up fasting lipid 

profile

N=207

Usual care; 

fasting lipid 

profile ordered 

for 1 year in 

future; results 

to be returned 

to physician 

who 

addressed 

results and 

ordered followup tests as 

needed; 

laboratory 

reminders sent

Intervention 

patient contacts 

were 

documented in 

EMR for other 

healthcare 

providers to 

review
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Author, 

year

Study 

design

Type of 

Clinic* 

Target 

Population

Duration of 

study/

follow-up

Inclusion/ Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator intervention Collaboration

Congestive Heart Failure (CHF)

Murray 

200716

RCT

Universityaffiliated 

inner-city 

ambulatory care

Low income 

patients with 

CHF

12 months (9 

months 

active 

intervention, 

3 months 

postintervention 

assessment)

Inclusion:

-age 50 and older

-receive all care (including 

medications) through same 

health care system

-diagnosis of CHF 

confirmed by primary care 

physician

-regularly used at least 1 

medication for HF

-did not use or were not 

planning to use medication 

container adherence aid

-access to working 

telephone

-hearing in normal range

-clinically stable

Exclusion: 

-dementia

Improve 

adherence to 

CHF 

medications, 

reduce 

exacerbations 

requiring ED 

visits or 

hospitalizations, 

improve 

disease-specific 

QOL, increase 

patient 

satisfaction, 

reduce health 

care costs

Medication 

adherence and 

clinical 

exacerbations 

requiring ED 

visit or 

hospitalization

Trained by 

interdisciplinary 

team 

(pharmacist, 

physician, 

geriatrician) 

with 

guidelines for 

treating CHF, 

key concepts 

in 

pharmaceutical care of 

older adults, 

communication 

techniques, 

and pharmacotherapy of 

drugs for 

CHF

N=122

-Protocol for intervention based on 

problem (eg, low medication adherence, 

knowledge)

-Baseline medication history assessment 

of patient knowledge and skills

-Patient-centered verbal instruction and 

written materials about medications 

(each medication category assigned an 

icon)

-Monitoring of medication use, health 

care encounters, body weight, other 

relevant data

-Communicated, as needed, with clinic 

nurses and primary care physicians

Mode/Frequency:

-Baseline interview at enrollment, not 

with pharmacist

-Verbal and written instructions when 

dispensing medications

N=192 

(intentionally 

randomized 

more to usual 

care)

Usual care; 

received 

prescription 

services from 

pharmacists 

who did not 

receive 

specialized 

training

Information 

about patients 

was 

communicated 

as needed to 

clinic nurses 

and PCPs
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Author, 

year

Study 

design

Type of 

Clinic* 

Target 

Population

Duration of 

study/

follow-up

Inclusion/ Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator intervention Collaboration

Gattis 

1999(PHA

RM 

study)15

RCT

General 

cardiology 

faculty 

clinic

Heart failure

(HF)

24 weeks/

median 

follow-up 6 

months

Inclusion: 

-diagnosis of HF based on 

signs and symptoms of HF 

and Left Ventricle EF<45%

Exclusion: 

-life expectancy <6 months

-current participant in 

investigational drug trial

-resident of skilled nursing 

facility 

-marked dementia or 

another psychological 

disorder preventing patient 

education and follow-up

Optimize HF 

therapy 

(including use 

and dose of 

ACE inhibitors 

or alternatives, 

avoiding digoxin 

toxicity, 

avoiding 

contraindicated 

drugs or drug 

interactions, 

recommending 

other 

medication 

changes)

Combined allcause mortality 

and heart 

failure, clinical 

events

Clinical 

pharmacist

N=90

-Questionnaire to assess symptoms and 

response to therapy

-Discussed patient’s case and verbally 

provided therapeutic recommendations 

regarding optimization of therapy to 

attending physician

-Recommendations based off patient 

interview, history, and current drug 

regimen

-Discussed changes in drug therapy with 

patient (purpose of each drug, 

importance of adherence)

-Provided written information on 

directions for use and potential adverse 

events 

-Provided patients with telephone 

number to contact if questions or 

problems

-Telephone follow-up at 2, 12, and 24 

weeks with instruction to contact 

physician if continued or worsening 

symptoms (pharmacist also contacted 

physician to discuss these cases)

Mode/Frequency:

-Telephone follow after initial clinic visit

-Written information on medication 

-Provided telephone number to contact if 

questions or problems

-Clinical pharmacist discussed changes 

made in drug therapy with the patient

N=91

Usual care (no 

pharmacist 

recommendations or patient 

education; 

physician 

and/or 

physician 

assistant/nurs

e practitioner 

did patient 

assessment 

and education)

-Pharmacist 

contacted 

patients at 12 

and 24 weeks 

to identify 

clinical events

Attending 

physician, 

nurses, social 

workers, 

dietitians

-Discussed 

patient’s case 

and verbally 

provided 

therapeutic 

recommendatio

ns regarding 

optimization of 

therapy to 

attending 

physician

*Record whether primary care or specialty, if academic affiliated, if rural or urban

CHF = congestive heart failure; CPCRS = Clinical Pharmacy Cardiac Risk Service; ED = emergency department; EMR = electronic medical record; HF = heart failure; LDL-C = 

low-density lipoprotein cholesterol; EF = ejection fraction; HDL-C = high-density lipoprotein cholesterol; QOL = quality of life; TSH = thyroid-stimulating hormone; 

CAD=coronary artery disease; HTN=hypertension; HbA1c=glycosylated hemoglobin; ACE=angiotensin converting enzyme; BP=blood pressure; ESRD=end stage renal disease; 

DRP=drug related problem
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 2. Drug-related Problems Outcomes – Cardiovascular Disease Studies

Study 

Interventio

n (n)

Control (n)

Inappropriate 

dosage/prescription 

or omission 

% (n/N)

Ineffectiveness% (n/N)

Drug-drug or drugdisease interaction 

(describe) % (n/N)

Non-adherence to prescribed 

regimen

% (n/N)

Clinical/adverse event % 

(n/N)

Pharmacy 

component Control Pharmacy component Control Pharmacycomponent Control Pharmacy component Control Pharmacy component Control

Cardiovascular Disease or Risk Factors for Cardiovascular Disease

No studies reporting

Coronary Artery Disease

Spence 

201413

IG=1,121

CG=1,049 

NR NR NR NR NR NR Adherence at 1 

year 

MPR

0.70

% adherent

37 (419/1121)

MPR

0.74 (P=.003 vs 

pharm)

% adherent

38 (403/1049) 

(P=.62 vs

pharm)

NR NR

Olson 

200914

IG=214

CG=207

NR NR NR NR NR NR Persistence with 

lipid-lowering 

therapy

86.5%

85.5%

(P=.78) 

Coronary 

Event

3.3%

5.8%

(P=.21) 

Congestive Heart Failure

Gattis 

199915

IG=90

CG=91

Fraction of 

target ACE 

inhibitor 

dosea 

1.0 (0.5, 1.0)

0.5 (0.19, 

1)

(P<.001)

NR NR NR NR NR NR NR NR

Murray 

200716

IG=122

CG=192

NR NR NR NR NR NR “Taking 

adherence” 

during 

intervention

79% (71% at 

follow-up)

“Scheduling 

adherence” 

during 

intervention

53% (49% at 

follow-up)

“Refill 

adherence” 

during study 

period 109%

68% (67% 

during followup)

47% (49% 

during followup)

105% P=.007

Adverse 

event or 

medication 

error 

38% (42/112)

47% 

(91/192)

(P=.11) 

a Median (25th

, 75th percentiles)
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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CG = control group; IG = intervention group; MPR = medication possession ratio; NR = not reported
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 3. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – Cardiovascular Disease Studies

Study; 

Intervention (n)

Control (n)

All-cause mortality

% (n/N)

Health-related quality of 

life (describe)

Access to care 

(describe)

Patient satisfaction with 

care (describe)

Pharmacy 

component Control Pharmacy 

component Control

Pharmacy 

component Control Pharmacy 

component Control

Cardiovascular Disease or Risk Factors for Cardiovascular Disease

No studies reporting

Coronary Artery Disease

Olson 200914

IG=214

CG=207

8.4% 7.7% 

(P=.80) 

NR NR NR NR NR NR

Congestive Heart Failure

Gattis 199915

IG=90

CG=91

3% (3/90)a 5% (5/91)a

OR 0.59 

(95% CI 

0.12, 2.49) 

(P=.48)

NR NR NR NR NR NR

Murray 200716

IG=122

CG=192

NR NR Disease 

specific, 

improvement 

from 

baseline

6 months: 

0.28

12 months: 

0.39

6 months: 

0.21

(P=.52) 

12 

months: 

0.24

(P=.21) 

NR NR Satisfaction 

with pharmacy 

services, 

improvement 

from baseline 

to 12 months: 

1.0

0.7

(P=.02) 

a Primary outcome was all-cause mortality and nonfatal heart failure; OR 0.22 (95% CI 0.06, 0.63); P=.005

CG = control group; IG = intervention group
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 4. Healthcare Utilization and Cost Outcomes – Cardiovascular Disease Studies

Study; 

Intervention 

(n) 

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other (describe)

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component

Control

Pharmacy 

component Control

Pharmacy 

component Control

Cardiovascular Disease or Risk Factors for Cardiovascular Disease

Taveira 201411

IG=73 

Individual 

IG=72 Group 

CG=55

Mean # of PCP 

visitsa (SD) 

Individual: 

2.8 (1.1)

Group: 

3.0 (1.2)

2.8 (1.0)

(P=.46 

overall)

Mean # of 

visitsa 

Individual: 

0.4 (0.8)

Group: 

0.6 (1.0)

0.6 (1.1)

(P=.35) 

Mean # of 

visitsa 

Individual: 

0.3 (0.7)

Group: 

0.4 (0.8)

0.2 (0.5)

(P=.18 

overall)

Individual: no 

change in 

cholesterol 

(0.9 to 1.1), BP 

(2.3 to 2.4), or 

antihyperglycemic meds 

(1.9 to 1.9) 

from baseline

Group: 

increase in BP 

(2.1 to 2.3) and 

antihyperglycemic meds 

(1.7 to 1.8) 

from baseline 

(P<.05)

Decrease in 

cholesterol 

(1.3 to 1.2) 

and antihyperglycemic meds 

(1.9 to 1.8) 

from baseline 

(P<.05) 

NR NR

Irons 201212

IG=59

CG=58

Clinic visits or 

BP assessment 

(outside of 

scheduled 

appointments) 

per year of 

follow-up

10.7 (9.52, 

12.09)

3.45 (3.01, 

4.12)

P<.0001

NR NR NR NR Number of 

antihypertensive 

agents 

(median)

3.0 (3.0, 4.0)

2.0 (2.0, 3.0)

P=.0001

NR NR

Coronary Artery Disease

Spence 201413

IG=1,121 CAD

CG=1,049 

CAD

NR NR 1-year followup

4.6% 

(51/1121)

4.5% 

(47/1049) 

(P=.94 vs 

pharm)

1-year 

follow-up

1.3% 

(15/1121)

2.1% 

(22/1049) 

(P=.17 vs 

pharm)

NR NR Cost savings 

(system)b

$11,640,296

Cost of 

program: 

$1,713,468

Approximately 

$5.79 saved 

for every $1 

spent on 

program

NR
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study; 

Intervention 

(n) 

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other (describe)

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component

Control

Pharmacy 

component Control

Pharmacy 

component Control

Olson 200914

IG=214

CG=207

NR NR NR NR 33.6% 27.1%

(P=.14) 

NR NR NR NR

Congestive Heart Failure

Gattis 199915

IG=90

CG=91

NR NR NR NR Readmission 

rate 

29%

Readmission 

rate 

42%

P=.03 

Receiving ACE 

inhibitor at 

follow-up

87% (78/90)

Receiving ACE 

alternative 

75% (9/12)

79% (72/91)

(P=.18) 

26% (5/19)

(P=.02)

NR NR

Murray 200716

IG=122

CG=192

NR NR All-cause

2.2 (3.3)

Heart failure

0.3 (1.0)

2.7 (4.9)

IRR 0.82 

(0.70, 0.95)

0.3 (1.3) 

IRR 1.09 

(0.42, 2.87)

All cause 

0.8 (1.7)

Heart 

failure 0.1 

(0.5)

1.0 (1.8)

IRR 0.81 

(0.64, 1.04)

0.2 (0.6)

IRR 0.77 

(0.28, 2.10)

NR NR Total 

outpatient 

costs (mean)

$5483 (SD 

$6434)

Total inpatient 

costs (mean)

$5550 (SD 

$13847)

$6373 

(SD 

$6501)

$7827 

(SD

$20413)

a Results are for patients with diabetes only (n=178 of 200 patients enrolled)

b From reduced ER visits and hospitalizations for DM and CAD patients

CG = control group; IG = intervention group
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 5. Goal Attainment Outcomes – Cardiovascular Disease Studies

Study;

Intervention (n)

Control (n)

Patient Goal Attainment definition

Percentage of patients attaining goal (n/N) 

Pharmacy component Control

Cardiovascular Disease or Risk Factors for Cardiovascular Disease

Taveira 201411

IG=73 Individual 

IG=72 Group 

CG=55

Maintenance of HbA1c ≤ 7%, BP ≤140/80 mmHg, LDL 

cholesterol ≤ 2.59 mmol/l

HbA1c failure rates per quartera (95% CI)

Individual: 0.24 (0.18, 0.33)

(/156 person-quarters)

Adj HR (vs control) 0.34 (0.21, 0.53)

Group: 0.36 (0.28, 0.47)

(/129 person-quarters) 

P=.07 to individual

Adj HR (vs control) 0.49 (0.32, 0.75)

BP failure rates per quartera

Individual: 0.22 (0.16, 0.30)

(/166 person-quarters)

Adj HR (vs control) 0.43 (0.27, 0.68)

Group: 0.31 (0.23, 0.41)

(/140 person-quarters)

Adj HR (vs control) 0.62 (0.41, 0.95)

LDL guideline adherenta

Individual: 75.0%

Group: 88.5%

HbA1c:

0.82 (0.69, 0.96)

(/60 person-quarters)

(P<.001 compared to intervention)

BP: 

0.53 (0.40, 0.71)

(/87 person-quarters)

(P<.002)

LDL adherent:

84.3%

(P=.12)

Irons 201212

IG=59

CG=58

Blood pressure < 130/80 mmHg

(Note: goal was not specified for the control group)

49% (29/59) 31% (18/58)

(P=.0456)

Coronary Artery Disease

Olson 200914

IG=214

CG=207

LDL < 100 mg/dL non-HDL <130 mg/dL

diabetes, multi-vessel coronary disease, at least 1 

recurrent coronary event, or current smoker had LDL 

goal < 70 mg/dL non-HDL goal <100 mg/dL 

Blood pressure < 140/90 mmHg diabetes or chronic 

kidney disease had goal < 130/80 mmHg

LDL < 100 mg/dL: 91.0%

LDL < 70 mg/dL: 68.6%

Non-HDL-C 88.7%

BP < 140/90 mmHg: 75.0%

BP < 130/80 mmHg: 60.0%

LDL < 100 mg/dL: 93.1% (P=.46)

LDL < 70 mg/dL: 56.8% (P=.23)

Non-HDL-C 88.2% (P=.89)

BP < 140/90 mmHg: 84.2% (P=.03)

BP < 130/80 mmHg: 54.5% (P=.71)

Congestive Heart Failure

No studies reporting a Results are for patients with diabetes only (n=178 of 200 patients enrolled); results for patients without diabetes (n=22) were described narratively due to small number of patients 

per group

CG = control group; IG = intervention group
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 6. Study and Intervention Characteristics – Chronic Kidney Disease Studies

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

study/

follow-up

Inclusion/ Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Cooney 

201520

RCT

CBOCs 

within 

Cleveland 

VA 

Patients with 

CKD

Study period 

was 1 year; 

patients 

were called 

before 

appointment 

and after 

(with lab 

results, etc.)

Inclusion:

-moderate to severe 

CKD (eGFR<45)

-GFR<60 between 90 

days and 2 years 

prior 

-≥1 primary care visit 

in year prior to study

Exclusion:

-ESRD 

-ever referred for 

hospice care

-<18 or >85 years old

Improve CKD 

care 

Last clinical 

systolic BP 

for patients 

with poorly 

controlled 

HTN at 

baseline 

Clinical 

pharmacists 

with ability 

to order and 

review labs 

and 

prescribe 

medications

N=1070

-Delivery system redesign: 

a. engaging pharmacists to interact with

patients and collaborate electronically with 

PCPs 

b. self-management support for patients

(informational pamphlet)

c. CKD registry to identify patients with CKD

not receiving guideline adherent care, for 

decision support during phone call, and to 

facilitate documentation of intervention

-Phone contact prior to appointment to 

discuss CKD, HTN

-Reviewed medications and lifestyle 

modifications, ordered recommended labs, 

arranged nephrology consults if severe CKD

-Called patients to review abnormal results 

and initiate appropriate non-HTN medication 

changes

-Recommended HTN management tactics 

to PCPs

Mode/Frequency:

-Phone-based, 2 calls

N=1129

Usual care from 

PCPs 

Recommendations 

for HTN 

management given 

to PCPs in 

progress notes
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

study/

follow-up

Inclusion/ Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Aspinall

2012/2013

21,22

Historical 

cohort

16 VA 

Medical 

Centers

Receiving 

ESAs for 

NDD-CKD

6 month 

follow-up

Inclusion:

-50 randomly 

selected outpatients 

from each site

-NDD-CKD defined 

as eGFR<60 

mL/min/1.73m2

-receiving ESA on 

long-term basis

Compare 

quality of 

ESA 

prescribing 

and 

monitoring 

with and 

without 

pharmacistmanaged 

clinics

Quality of 

ESA 

prescribing, 

(ie, proportion 

of 

hemoglobin 

values within

10-12g/dL)

Pharmacists 

with scope 

of practice 

that allowed 

them to 

dose and 

monitor ESA 

therapy

N=314 (10 clinics) NOTE: an additional 91 

patients categorized as receiving usual care 

at ESA clinic sites 

-Independently dose and monitor ESAs 

(guidelines in place)

Mode/Frequency:

Not reported

N=167 (6 clinics)

-Usual care 

(physician-based) 

None reported

Pai 200918

Pai 200917

RCT (pilot)

Non-profit 

universityaffiliated 

dialysis 

clinic

ESRD 

patients

2 years

Inclusion:

-English speaking

->18 years old

-stable hemodialysis 

regimen for ≥3 

months

Effect of 

pharmaceutic

al care on 

DRPs, drug 

use, drug 

costs, 

hospitalizations

Primary: 

change in 

quality of life 

(Renal 

Quality of Life 

Profile – 

RQLP)

Nephrologytrained 

clinical 

pharmacist 

or 

pharmacists 

completing 

postdoctoral 

training in 

nephrology 

pharmacotherapy

N=57 (30/57 [53%] did not complete study)

-One-on-one in-depth drug therapy review 

conducted by clinical pharmacist

-At meetings approximately every 8 weeks: 

-patient interview

-generate drug therapy profile

-identify and address DRPs 

-provide health care provider and patient 

education

-review labs

Mode/Frequency:

-In clinic, one-on-one

-Every 8 weeks during the 2 year study 

period

N=47 (21/47 [45%] 

did not complete 

study) 

Usual care (brief drug 

therapy reviews by 

dialysis nursing staff 

as mandated by clinic 

policy)

Physician, fellow, 

nurse, social 

worker, dietitian 

involved in monthly 

formal patient 

reviews

-pharmacist gave 

provider education
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

study/

follow-up

Inclusion/ Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Bucaloiu 

200719

Retro 

cohort

Nephrology clinic

Anemia of 

CKD

Minimum of 

6 months; 

maximum of 

1 year

Inclusion:

-adults

-anemia of CKD

-treated with 

outpatient EPO

-followed for ≥6 

months

Exclusion: 

-managed by 

hematology-oncology 

or another 

nephrology group

-on dialysis

Clinical and 

economic 

benefits

Primary 

outcome not 

specified

NR N=62

Protocol-driven pharmacist-managed 

program to manage anemia of CKD

Received epoetin alfa and sucrose 

intravenously per protocol

Mode/Frequency:

-Patients followed between 6 months and 1 

year

-Hemoglobin/iron saturation measured at 

least monthly

N=74 matched

Managed by PCPs 

(no protocol or 

pharmacist oversight)

Received epoetin alfa

NR

CG = control group; CKD = chronic kidney disease; DRP = drug-related problem; EPO = epoetin alfa; ESA = erythropoiesis-stimulating agents; ESRD=end stage renal disease; 

HTN = hypertension; IG = intervention group; NDD = non-dialysis-dependent; NR = not reported; PCP = primary care physician
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 7. Drug-related Problems Outcomes – Chronic Kidney Disease Studies

Study 

Intervention 

(n) 

Control (n)

Inappropriate 

dosage/prescription 

or omission 

% (n/N)

Ineffectiveness% (n/N)

Drug-drug or drugdisease interaction 

(describe) % (n/N)

Non-adherence to 

prescribed regimen

% (n/N)

Clinical/adverse events

% (n/N)

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Cooney 201520

IG=1,070

CG=1,129

NR NR NR NR NR NR Medication 

Adherence 

6.8 (1.2)

6.7 (1.2) 

P=.70 

NR NR

Aspinall 

2012/201321,22

IG=314

CG=67

(Additional 91 

patients 

receiving usual 

care at ESA 

clinic)

NR NR NR NR NR NR NR NR Thromboembolisma

n=6 

(0.02/180 

pt-days)

Heart 

Failureb 

n=18 

(0.06/180 

pt-days)

Uncontrolled 

HTNc 

n=185 

(0.66/180 

pt-days)

Thromboembolism

n=7

(0.05/180 

pt-days)

Heart 

Failure

n=9 

(0.06/180 

pt-days)

HTN n=73 

(0.48/180 

pt-days)

All “clinically 

similar”

Pai 200918

IG=57

CG=47

Sub-therapeutic 

dosage:

14% of 530 

DRPs identified

Untreated 

indication:

25%

NR NR NR NR NR NR NR Overdose:

5% of 530 

DRPs 

identified

NR

Bucaloiu 200719

IG=62

CG=74

NR NR NR NR NR NR NR NR NR NR

CG = control group; DRP = drug-related problem; HTN = hypertension; IG = intervention group; pt-days = patient days a Thromboembolic event (myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism) resulting in an emergency department visit or hospitalization

b Resulting in an emergency department visit or hospitalization

c Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 8. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – Chronic Kidney Disease Studies

Study; 

Intervention (n)

Control (n)

All-cause mortality

% (n/N)

Health-related quality of 

life (describe)

Access to care 

(describe)

Patient satisfaction with 

care (describe)

Other 

Outcomes

Pharmacy 

component Control Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Cooney 201520

IG=1,070

CG=1,129

50/1070 

4.7%

74/1129 

6.6%

P=.06 

No sig diff between 

intervention and control for 

SF12MCS, SF12PCS, 

KDQOL Burden, KDQOL 

Effects

NR NR 92% of 

participants 

surveyed 

felt 

pharmacist

s provided 

useful 

information 

and would 

recommend 

program to 

others

NR NR

Pai 200917,18

IG=57

CG=47

15/57 26% 12/47 26% Total RQLP

Baseline: 

71.9 (40)

1 year

71.4 (33.6)

2 years

56.5 (32.6)

Baseline: 

74.5 

(33.5)

1 year

ES 0.08

87.5 

(30.4)a 

ES 0.53

2 years

68.8 

(35.8)

ES 0.34

NR NR NR NR NR

a P<.05 vs pharmacist intervention

CG = control group; ES = effect size; IG = intervention group; KDQOL = Kidney Disease Quality of Life; NR = not reported; RQLP = renal quality of life profile (higher score = 

worsening quality of life); SF12 = Short Form; MCS = mental component score; PCS = physical component score
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 9. Healthcare Utilization and Cost Outcomes – Chronic Kidney Disease Studies

Study; 

Intervention (n)

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other 

(describe)

Pharmacy 

component

Control

Pharmacy 

component

Control

Pharmacy 

component

Control

Pharmacy 

component

Control

Pharmacy 

component

Control

Cooney 201520

IG=1,070

CG=1,129

NR NR NR NR NR NR Classes of 

antihypertensives: P=.02 

(subjects in IG prescribed 

more classes of anti-HTN 

meds)

ESRD

26/1070 

(2.4%)

ESRD

20/1129 

(1.8%) 

P=.28 

Aspinall 

2012/201321,22

IG=314

CG=67

(Additional 91 

patients receiving 

usual care at ESA 

clinic)

NR NR NR NR NR NR Medication 

adjustment 

based on 

hemoglobina 

Increased 

176/305 

(57.7%) 

Withheld or 

Decreased 

80/131 

(61.1%)

Increased 

30/105 

(28.6%)

(P=.009)

Withheld or 

Decreased

37/108 

(34.3%) 

(P=.09) 

Costb

$13,412

QALYs 

2.096

Cost 

$16,173

QALYs

2.093

Pai 200918

IG=57

CG=47

NR NR NR NR Significantly (P=.02) fewer 

all-cause hospitalizations 

in intervention group 

(overall 42% fewer 

hospitalizations in 

intervention group)

Mean number of drugs 

significantly (P<.05) lower 

in intervention group at 

each medication review 

(overall 14% fewer drugs in 

intervention group)

Mean drug costs were 

lower among patients in 

intervention group; 

difference significant 

(P<.05) only at 3rd drug 

therapy review (overall $6 

less in intervention group)

Bucaloiu 200719

IG=62

CG=74

NR NR NR NR NR NR Weekly dose 

of EPO

6,698 units

12,000 

units 

(P=.001)

Estimated annual cost 

savings per patient

$3,860

CG = control group; EPO = epoetin alfa; ESA = erythropoiesis-stimulating agents; IG = intervention group; NR = not reported; QALYs = quality-adjusted life years a Proportion of hemoglobin tests resulting in change in ESA dose

b Modeled over 5 years
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 10. Goal Attainment Outcomes – Chronic Kidney Disease Studies

Study;

Intervention (n)

Control (n)

Patient Goal Attainment definition

Percentage of patients attaining goal (n/N) 

Pharmacy component Control

Cooney 201520

IG=1,070

CG=1,129

BP Control <130/80mmHg 185/441 (42.0%)a 177/429 (41.2%)a

(P=.84) 

Aspinall 2012/201321,22

IG=314

CG=67

(Additional 91 patients 

receiving usual care at 

ESA clinic)

Hemoglobin 10-12g/dL Proportion of values within range

1284/1807 (71.1%)

Proportion of values within range

345/606 (56.9%)

(P<.001)

Bucaloiu 200719

IG=62

CG=74

Hemoglobin in goal range (11-12.9 mg/dL)

Average iron saturation (T-sat) in goal range (20%-

50%)

69.8% of measured values

64.8% of measured values

43.9% of measured values

(P=.0001)

40.4% of measured values

(P=.043)

BP = blood pressure; CG = control group; IG = intervention group; NR = not reported a Denominators are patients with BP > 130/80mmHg at baseline
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 11. Study and Intervention Characteristics – Chronic Obstructive Pulmonary Disease Studies

Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

study/

follow-up

Inclusion/ 

Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Solomon 

199823

Gourley 

199824

RCT

10 VA 

Medical 

Centers; 1 

University 

Hospital

(8 sites 

participate 

in COPD 

trial)

Patients 

with COPD

6 months

Inclusion: 

-ambulatory COPD 

patient

-pulmonary function 

tests for diagnosis

-currently treated for 

COPD (≥1 inhaler)

-capable of using 

inhaler

-read & write 

English 

-≥40 years old

-access to 

telephone

Exclusion:

-history of 

severe/lifethreatening COPD

-life-expectancy < 6 

months

-hospitalized or ED 

visit past 2 weeks

-lung infection past 

2 weeks 

-CHF class III or IV

-other lung disease 

except asthma

-alcohol or drug 

abuse

-investigational drug 

trial within past 30 

days

Improve 

compliance, 

patient 

satisfaction, 

knowledge, 

and quality of 

life

Patient 

knowledge, 

medication 

compliance, 

health 

resource use

Clinical 

pharmacists

N=43

Standardized patient assessment 

and a series of regularly 

scheduled therapeutic and 

educational interventions 

designed for optimal disease 

management

-Implement care plan

-Educate patients

-Counsel patients

-Patient assessment and followup

Focused on management of 

COPD patients relative to:

-Symptom control

-Patient compliance

-Drug product selection

-Use of resources

-Patient satisfaction with care

-Disease and disease 

management

-Knowledge

-Quality of life

Mode/Frequency:

-6-month treatment period with 

scheduled visits for treatment 

patients at enrollment and then at 

one-month intervals (4-6 wks) for 

a total of 5 visits

-Telephone follow-up

N=55

Usual care (no 

supplemental 

education or 

assessment of 

needs beyond 

what was 

customarily 

offered at each 

site)

Collaborate with 

physicians to 

implement a 

patient-specific, 

optimized, stepcare approach

CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department
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Table 12. Drug-related Problems Outcomes – Chronic Obstructive Pulmonary Disease Studies

Study 

Intervention 

(n) 

Control (n)

Inappropriate 

dosage/prescription 

or omission 

% (n/N)

Ineffectiveness% (n/N)

Drug-drug or drugdisease interaction 

(describe) % (n/N)

Non-adherence to 

prescribed regimen

% (n/N)

Clinical/adverse 

events % (n/N)

Pharmacy 

component Control Pharmacy component Control Pharmacy component Control

Pharmacy 

component Control

Pharmacy 

component Control

Solomon 1998

Gourley 

199823,24

IG=43

CG=55

Drug needed not 

prescribed 4.5% 

(15/336 problems 

identified by 

pharmacists)

Drug not needed 

but prescribed

1.5% (5/336)

Dose problem

1.2% (4/336)

NR NR NR Risk of 

interaction

8.9% (30/336 

problems 

identified by 

pharmacists)

NR NR NR NR NR

CG = control group; IG = intervention group; NR = not reported

Table 13. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – Chronic Obstructive Pulmonary Disease Studies

Study; 

Intervention (n)

Control (n)

All-cause mortality

% (n/N)

Health-related quality of life 

(describe)

Access to care 

(describe)

Patient satisfaction with 

care (describe)

Pharmacy 

component Control Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Solomon 1998

Gourley 199823,24

IG=43

CG=55

NR NR Global Symptom 

Assessmenta

Baseline: 3.4 (1.1)

6 months: 3.2 

(1.2)

Quality of Lifeb

 (8 

items)

No significant 

changes from 

baseline; no 

differences from 

control group

Baseline: 3.4 (1.3)

6 months: 3.3 

(1.5)

Significant 

worsening of 

“bodily pain” 

dimension from 

baseline to 6 

months (P=.03)

NR NR PCQ – 10 items

Intervention group patients 

had more favorable 

response to pharmacist 

than control for all 10 items; 

differences were significant 

(P<.05) for 7 of 10 items

a Patient rating of overall status with respect to control of COPD: 0 = no symptoms present, 5 = symptoms so severe that one could not perform normal daily activities

b Health Status Questionnaire 2.0 

CG = control group; IG = intervention group; NR = not reported; PCQ = Pharmaceutical Care Questionnaire (developed for the study and addressing technical-professional 

competency, patient knowledge, and interpersonal relationship)
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Table 14. Healthcare Utilization and Cost Outcomes – Chronic Obstructive Pulmonary Disease Studies

Study; 

Intervention (n)

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other 

(describe)

Pharmacy

component

Control

Pharmacy 

component

Control

Pharmacy 

component

Control

Pharmacy 

component Control

Pharmacy 

component

Control

Solomon 1998

Gourley 199823,24

IG=43

CG=55

Mean (std)

0.81 (0.93)a 1.17 (1.03)(P<.05) 

Mean (std)

0.15 (0.36)a 0.17 (0.48)(P=NS) 

Mean (std)

0.10 (0.37)a 0.13 (0.34)(P=NS) 

New 

medicationsa

Mean (std)

0.51 (0.93)

0.36 (0.71) NR NR

a At 6 month follow-up

CG = control group; IG = intervention group; NR = not reported; NS = not statistically significant

Table 15. Goal Attainment Outcomes – Chronic Obstructive Pulmonary Disease Studies

Study;

Intervention (n)

Control (n)

Patient Goal Attainment definition

Percentage of patients attaining goal (n/N) 

Pharmacy component Control

No studies reporting
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

85

Table 16. Study and Intervention Characteristics – Depression Studies

Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

study/

follow-up

Inclusion/ 

Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Adler, 

200425

RCT

Primary 

care clinics:

5 

academic, 

2 suburban, 

and 1 

urban

Positive screen 

for depression 

or dysthymia

6 months

Inclusion:

-met DSM-IV 

diagnostic criteria for 

major depressive 

disorder and 

dysthymia

-no terminal illness, 

pregnancy, 

alcoholism, bipolar or 

psychotic disorder

-English language 

literate

-age ≥18

-patient consent

Increase 

antidepressant 

(AD) use

AD use & 

changes in 

severity of 

depression as 

measured by a 

modified Beck 

Depression 

Inventory (mBDI)

Experienced 

clinical 

pharmacists 

with 

PharmD 

N=258

-Medication history 

-Assess drug-related problems

-Monitor drug efficacy & toxicity

-Patient education & 

encouragement

-Communicate findings to 

primary care provider

-General social support, help 

overcoming system 

inadequacies, encourages 

patients, facilitates referrals

Mode/Frequency:

-At least 9 contacts in18 months

-Initial contact by telephone to 

set up appointment

N=249

Standard Primary 

care physician 

(PCP) care

Information sharing 

with PCP

Capoccia,

200426

Boudreau, 

200227

RCT

University 

urban 

family 

practice

Referred to 

study after a 

new DSM-IV 

diagnosis of 

depression & 

Rx for AD

12 months

Inclusion:

-no terminal illness, 

substance abuse, 

psychosis, 

pregnancy, suicide 

attempt;

-English language

-age ≥18

-patient consent

Improve 

outcomes

Reduction in 

depression as 

measured by no 

longer meeting 

diagnostic criteria 

and improvement 

in symptom 

checklist (SCL-20) 

Experienced 

staff clinical 

pharmacist 

and PharmD 

resident

N=41

-As many as 13 follow-up 

telephone calls to assess 

symptoms, concerns, and side 

effects; titrate doses; discontinue 

or change medication; manage 

Ads; patient education & 

motivation

-Facilitated appointments with 

mental health

-Additional therapy for other 

issues (ie sexual 

dysfunction/insomnia)

-Provide support

Mode/Frequency:

-Weekly calls first 4 weeks, 

every 2 weeks through week 12, 

every other month from 4-12 

months

-Subjects encourage to visit PCP 

at weeks 4 and 12

N=33

Usual care

(encouraged to 

use available 

resources which 

included 

pharmacists)

Primary care & 

psychiatrist case 

review with 

physicians
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

study/

follow-up

Inclusion/ 

Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Finley, 

200328

RCT

Urban 

primary 

care clinics 

of HMO

Primary care 

initiation of AD

6 months

Exclusion: 

-AD used in prior 6 

months

-concurrent 

psychiatric or 

psychological 

treatment

-mania or bipolar 

disorder

-psychotic symptoms

-eminent suicidality

-substance abuse or 

dependence

-psychiatric treatment 

indicated

Improve drug 

adherence, 

patient outcomes, 

provider and 

patient 

satisfaction, and 

medical resource 

utilization

Antidepressant 

adherence 

measured as 

medication 

possession ratio 

(MPR) & 

continued 

antidepressant 

between 3-6 

months

Experienced 

clinical 

pharmacists 

with 

PharmD 

N=75

-Intake interview: drug, medical, 

& psychiatric history; 

contraindications

-Patient education: use of ADs, 

treatment options

-Titration of ADs

-Prescribe ancillary medications

-Recommend changes in ADs

-Follow-up for adherence, drug 

benefits and side effects, other 

social factors

-Assess severity of condition

-Identified stressors, other key 

factors

Mode/Frequency:

-Intake interview

-5 follow-up contacts by phone 

and 2 clinic visits & on-call

N=50

Usual care - brief 

counseling on the 

prescribed drug, 

therapeutic end 

points, and side 

effects

Psychiatrist mentor 

met with clinical 

pharms to discuss 

and update on 

patients and 

consult

Approval needed 

from PCP to 

change drug

Finley, 

200229

Nonrandomized 

comparison 

group; pilot 

study

Urban 

primary 

care clinics 

of HMO

Primary care 

initiation of AD

6 months

Inclusion: 

-identified by PCP as 

suffering from 

depression

-received prescription 

for AD medication 

Exclusion:

-AD use past 6 

months

-under care of 

psychiatrist in HMO

-imminent suicidality

-psychotic symptoms

-active substance 

abuse/dependence

-history of manic 

episodes

Increase 

medication 

adherence and 

patient 

satisfaction

Medication 

adherence rates, 

patient 

satisfaction, and 

resource 

utilization patterns

Experienced 

clinical 

pharmacists 

with 

PharmD and 

psychiatric 

experience

N=91

-Intake interview including: 

medication, medical, social, and 

mental health history; symptoms; 

and environmental stressors

-Patient education including 

disease information, use of ADs, 

treatment options, importance of 

adherence, and potential 

adverse effects

-Pharmacists could prescribe 

ancillary medications and 

recommend changes in ADs 

Mode/Frequency:

-Intake interview

-5 follow-up contacts by phone 

and 2 clinic visits & on-call

N=129 unmatched

Usual care 

(treated by PCP)

Psychiatrist 

mentor, 

recommended 

medication 

changes to PCP

AD = antidepressant medication; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; HMO = health maintenance organization; mBDI = modified Beck 

Depression Inventory; MPR = medication possession ratio; PCP = primary care provider; PharmD = Doctor of Pharmacy; RCT = randomized controlled trial; Rx = prescription; 

SCL-20 = Symptom Checklist Depression Scale
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

87

Table 17. Drug-related Problems Outcomes – Depression Studies

Study 

Intervention 

(n) 

Control (n)

Inappropriate 

dosage/prescription 

or omission 

% (n/N)

Ineffectiveness% (n/N)

Drug-drug or drugdisease interaction 

(describe) % (n/N)

Non-adherence to prescribed 

regimen

% (n/N)

Clinical/

adverse events % (n/N)

Pharmacy 

componen

t

Control

Pharmacy 

componen

t

Control

Pharmacy 

componen

t

Control Pharmacy 

component Control Pharmacy component Control

Capoccia 

200426

IG=41

CG=33

3 outcome 

assessments 

over 12 months; 

extracted 12 

month data

NR NR NR NR NR NR 12 months

Patient reported 

use <25 of last 

30 days

41%

Patient 

reported use 

<25 of last 30 

days

43%

NR NR

Finley 200328

IG=75

CG=50

NR NR NR NR NR NR 3 month 

compliance

76%; 

MPR 0..92

6 month 

compliance 

67%; 

MPR 0.83

3 month 

compliance

60%; MPR 0.89

(P=.48) 

6 month 

compliance

48%; MPR 0.77

(P=.26)

NR NR

Finley 200229

IG=91

CG=129

NR NR NR NR NR NR 6 month MPR 

0.81

Use of ADs 

after 3 months 

76%

6 month MPR 

0.66

(P<.005)

Use of ADs 

after 3 months 

51%

(P=.001)

NR NR

AD = antidepressant medication; CG = control group; IG = intervention group; m=months; MPR = medication possession ratio; NR = not reported
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

88

Table 18. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – Depression Studies

Study; 

Intervention 

(n) 

Control (n)

All-cause mortality

% (n/N)

Health-related quality of life 

(describe)

Access to care 

(describe)

Patient satisfaction with 

care (describe) Depression

Pharmac

y 

compone

nt

Control Pharmacy 

component Control Pharmacy 

component Control Pharmacy 

component Control Pharmacy 

component Control

Adler 200425

IG=258

CG=249

NR NR SF-12 Mental 

component (MCS)

40.4

Physical 

Component (PCS)

42.9 

MCS

38.6 (P=.19)

PCS

42.9 (P=NS)

NR NR “Based on exit interviews 

patients expressed high 

satisfaction with the 

pharmacist intervention”

NR NR

Capoccia 

200426

IG=41

CG=33

3 outcome 

assessments 

over 12 

months; 

extracted 12 

month data

NR NR Mean SLC-20 NS difference

(P=.92) 

Mean SF-12 mental NS difference 

(P=.46) 

Mean SF-12 physical NS 

difference (P=.18)

NR NR Good or 

excellent 

quality of 

care (12 

months): 

80%

No overall 

difference in 

satisfaction 

with 

depression 

care (P=.19) 

or overall 

healthcare 

(P=.48) 

between 

groups

Good or 

excellent 

quality of 

care: 77%

Diagnosis of 

major 

depression: 

Groups

similar

(P=.32) 

at 12 

months

at least 50% 

decrease in 

SCL-20: 

72%

at 12 

months

at least 50% 

decrease in 

SCL-20: 

80%

(P=.39) 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

89

Study; 

Intervention 

(n) 

Control (n)

All-cause mortality

% (n/N)

Health-related quality of life 

(describe)

Access to care 

(describe)

Patient satisfaction with 

care (describe) Depression

Pharmac

y 

compone

nt

Control Pharmacy 

component Control Pharmacy 

component Control Pharmacy 

component Control Pharmacy 

component Control

Finley 200328

IG=75

CG=50

NR NR 56% reduction in 

WSDS (n=54)

67% 

reduction in 

WSDS (n=24) 

(P=.36)

Mean of one

5-point 

question 

about 

availability 

of advice 

(higher=

more 

satisfied)

4.3 (n=59)

3.8 (n=33) 

(P<.05) 

Mean of one

5-point 

question 

about 

treatment of 

depression, 

(higher=

more 

satisfied)

4.2 (n=59)

Significantly 

more 

satisfied 

with 6 out of 

11 aspects 

of care 

(P<.05)

3.8 (n=33) 

Students ttest: P=.06

X2 test 

paired data: 

P=.066

Wilcoxon 

score: 

P=.023

41% with 

50% 

reduction in 

BIDS 

Percent 

achieving 

remission 

(BIDS score 

<9) 55.6% 

(n=54)

54% with 

50% 

reduction in 

BIDS 

(P=.27) 

58.3% 

(n=24)

(P=.36) 

Finley 200229

IG=91

CG=129

NR NR NR NR Mean of one 

5-point 

question

about 

availability 

of advice 

(higher=

more 

satisfied)

4.3 (n=56)

3.7 (n=55)

(P=.003)

Mean of one

5-point 

question 

about 

treatment of 

depression, 

(higher=

more 

satisfied)

3.9 (n=56)

4.0 (n=59) 

(P=.581)

NR NR

AD = antidepressant medication; BIDS = Brief Inventory for Depressive Symptoms; CG = control group; IG = intervention group; NR = not reported; NS = not significant; SCL = 

symptom check list; SF-12 = Medical Outcomes Study Short Form 12; WSDS= Work and Social Disability Scale
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 19. Healthcare Utilization and Cost Outcomes – Depression Studies

Study; 

Intervention (n) 

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other 

(describe)

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Adler 200425

IG=258

CG=249

NR NR NR NR NR NR Patient on 

ADs

3 months: 

61% 

6 months: 

58%

3 months: 

49% 

(P=.024)

6 months: 

46% 

(P=.025)

NR NR

Capoccia 200426

IG=41

CG=33

3 outcome 

assessments over 

12 months; 

extracted 12 month 

data

Median(range)

All provider 

visits:

median 9 

range 

(0 to 42)

Visits to 

PCP 

median 4 

range

(0 to 21)

median 9 

range 

(0 to 60) 

(P=.99) 

median 5

range 

(0 to 17) 

(P=.88)

median 0

range 

(0 to 2)

median 0

range 

(0 to 2)

(P=.27) 

NR NR NR NR NR NR

Finley 200328

IG=75

CG=50

PCP visits 

decreased 

15% 

increased 

2%

(P=.14)

Increased 

7% 

Increased 

119%

(P=.10)

NR NR Changed 

ADs 19% 

(14/75)

4% (2/50) 

(P=.016)

Drug cost 

42% higher

(P=.18)

Finley 200229

IG=91

CG=129

To PCP 

decreased 

39% (335 

to 203) 

decreased 

12% (411 

to 361)

difference 

between 

changes 

(P=.007)

NR NR NR NR Changed 

ADs

24% 

(22/91)

5% (7/129)

(P=.001)

NR NR

AD = antidepressant medication; CG = control group; IG = intervention group; NR = not reported; PCP = primary care provider
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 20. Goal Attainment Outcomes – Depression Studies

Study;

Intervention (n) 

Control (n)

Patient Goal Attainment definition

Percentage of patients attaining goal (n/N) 

Pharmacy component Control

No studies reporting

CG = control group; IG = intervention group; NR = not reported
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

92

Table 21. Study and Intervention Characteristics – Diabetes Studies 

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

McAdamMarx 

201553

Retrospective 

cohort

Universityowned 

communitybased 

primary 

care clinics

Patients with 

inadequately 

controlled 

T2DM 

(HbA1c<7%)

Follow-up: 

max of18 

months

Inclusion:

-Intervention group: 

patients referred to 

diabetes collaborative 

care management 

(DCCM) by PCP; age ≥ 

18; T2DM; treated at 

community clinic offering 

DCCM; treated ≥180 days 

prior to index date; followup care in clinic 3 to 18

months after index date

-Control group: adults with 

T2DM treated at clinic 

without DCCM

Exclusion:

-HbA1c <7%

Improve patient 

outcomes

Glycemic control 

(HbA1c) during 

18 months postindex date

Clinical 

pharmacist

N=303

-Pharmacists able to prescribe and modify 

diabetes medication therapy, adjust 

insulin dosing, order HbA1c and lipid 

monitoring tests, and provide diabetes 

education 

- Follow-up visits included dose 

adjustments, adherence and disease 

education, and addressing patient 

questions

Mode/Frequency: Initial in-person visit 

then telephone and in-person visits every 

1-2 weeks until goals met or patient no 

longer engaged in program

N=394 Usual 

care 

Referred to 

DCCM program 

by PCP; 

pharmacists 

worked under 

collaborative 

practice 

agreement with 

physicians and 

advanced 

practice 

clinicians

Skinner 

201535

Retrospective 

casecontrol

Community 

health clinic

Uncontrolled 

diabetes

12-month 

study period

Inclusion:

-age ≥ 18

-diabetes diagnosis

-≥1 documented 

HbA1c>7%

-a risk factor for diseaserelated microvascular 

complications

-referred to MTM by PCP 

-clinical data from at least 

3 clinic visits during a 

consecutive 12m period

Improve 

medication 

adherence and 

diabetes health 

outcomes

Clinical 

pharmacist

N=29

Medication Therapy Management

-pharmacist reviewed patient’s T2DM 

medication regimen

-verbal education and training on 

medication delivery and best 

administration sites 

-education on health-promoting behaviors

-patients asked to teach back the 

information to confirm understanding

Mode/Frequency: mode not reported;

frequency data not collected

N=29 (Matched 

sample – age, 

gender, race, 

ethnicity, BMI)

-Usual care/no 

contact with 

clinical 

pharmacist

Referred to 

pharmacist for 

MTM by PCP
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

93

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Chung 

201450

Retrospective 

review via 

EMR

CommUnity 

Care, 

outpatient 

clinics in 

Austin

Type1 or 2 

diabetes 

mellitus

4-year study 

period

1 year 

follow-up for 

each patient

Inclusion:

-age 18-89

-diagnosis of T1 or 2 DM

-documentation of HbA1c 

≥9% at baseline (3 

months before or after 

index visit)

-≥ 3 visits with clinical 

pharmacist or usual care 

provider

-eligible for ≥ 1 yr before 

and after index dates

-documented follow-up

HbA1c

Exclusion:

-clinical pharmacy visit for

any disease state before 

study initiation

-diagnosis of cancer or 

HIV

-pregnant

-diagnosis code for motor 

vehicle accident or 

chronic pain

Assess the effect 

of clinical 

pharmacist 

involvement in a 

federally 

qualified health 

center on the 

change in A1c 

and frequency of 

diabetes related 

hospitalizations 

and ED visits

1 year post index 

change in A1c, 

diabetes-related 

hospitalizations, 

diabetes-related 

ED visits

Pharmacists 

who have 

completed at 

least 1 year 

of a 

postdoctoral 

residency 

training 

program

N=225 (matched N=220)

-Implementing new medications

-Titrating medications

-Ordering laboratory panels

-Counseling on lifestyle modification

-Providing diabetes education

-Managing associated comorbid 

conditions

Mode/Frequency:

-30 minute visit as often as needed or 

necessary to meet goals and/or for patient 

safety

N=557 (matched 

N=220) 

Usual care, 

followed by PCP 

and no 

appointments 

with a clinical 

pharmacist 

during study 

period

None 

mentioned
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

94

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Spence 

201413

Retrospective 

cohort 

Kaiser 

Permanent 

Southern 

California 

(KPSC) 

Region – 

outpatient 

pharmacy 

service

Nonadherent 

diabetes 

mellitus 

patients with 

HbA1c 

outside 

clinical goals 

1 year after 

index date

Inclusion:

-in KPSC’s diabetes 

registry 

-non-adherent (Medication 

Possession Ratio <0.8)

-on ≥1 oral medication for 

DM

-at or above the HbA1c 

target of 8%

-age >18

-enrolled with a pharmacy 

benefit for ≥1 year before 

and after index date

Excluded:

-active insulin prescription

-resided in skilled nursing 

facility for >10 days or had 

received hospice care

-OPCS patients that 

declined the consult

Improve 

medication 

adherence and 

likelihood of 

achieving clinical 

goals

Not specified

Pharmacists 

participated 

in 5.5 hours 

of online and 

face to face 

training

N=359

Outpatient pharmacy clinical service

(OPCS) program

-B-SMART medication optimization 

process (identify barriers and assess 

readiness to change, provide solutions to 

adherence challenges, motivation, 

adherence tools, identify roles of health 

care team members, direct patients to 

other resources)

-Pharmacist consult at time of prescription 

pick-up

-Printing of a care management summary 

sheet

-Spontaneous identification of nonadherent patients at the time the patient 

arrives at the pharmacy

Mode/Frequency:

-Face-to-face

-One time (at prescription pick-up)

N=428 matched 

Did not receive 

an OPCS 

consultation

None noted

Brummel 

201346

Nonrandomized 

controlled 

trial 

Fairview 

Pharmacy 

Services, 

MN, 

Healthcare 

system 

Diabetes

1 year of 

intervention 

and 1 year 

follow-up

Inclusion:

-attended one of the 

clinics and decided to opt 

in to MTM program

-all information on 

medications was available 

at baseline and all 

outcome measures were 

available for 2006, 2007, 

and 2008

-Control – those who 

didn’t opt in to MTM 

program

Identify and 

resolve drug 

therapy problems 

and promote 

optimal patient 

outcomes

Achieving 

optimal diabetes 

clinical 

management, 

determined with 

5 component

diabetes 

measure (D5)

MTM 

pharmacist

N=121

-Provided consultations using validated, 

standardized process

-Pharmacists’ responsibilities included 

assessing patient’s medications, 

identification of patient’s drug-related 

needs, resolution and prevention of drugrelated problems, determining appropriate 

follow-up measures, and documentation 

of intervention outcomes

-Initiate, modify, or discontinue drug 

therapy and order laboratory tests related 

to diabetes, hypertensions, and 

hyperlipidemia

Mode/Frequency:

-Primarily face-to-face

N=103

Usual care, not 

in MTM program

None 

mentioned
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Ip 201343

Dualcentered 

retrospective 

study

2 Kaiser 

Permanent

e (KP) 

medical 

centers

Type 2 

diabetes

12 months

Inclusion:

-HbA1c >7%

-type 2 diabetes

-age > 18

-under the pharmacist’s 

care for ≥ 2 months

Exclusion: 

-type 1 diabetes

-HbA1c<7%

-patients who dis-enrolled 

from KP health insurance 

during the study time 

frame 

Investigate the 

impact of 

pharmacist 

interventions on 

short-term 

clinical markers 

and long-term 

cardiovascular 

risk 

Change in 

HbA1c, LDL-C, & 

BP; rates of goal 

attainment; and

change in 

predicted 10yr 

risk of coronary 

heart 

disease/stroke

Credentialed 

as certified 

diabetes 

educator and 

pharmacother

apy specialist

N=147

-Initial in-person visit with follow-up until 

therapeutic goals were met

-Evaluated diabetes status and CV 

comorbidities

-Pharmacotherapy modifications 

(prescribing and dosage adjustments)

-Laboratory monitoring

-Dietary and physical activity 

recommendations

-Provision of diabetes self-care education

-Physical assessments

-Immunizations

-Specialist referrals

-Followed up for further care 

Mode/Frequency:

-45-min face-to-face initial visit with 

follow-up in person or via telephone

N=147

PCP care (no 

pharmacist visit)

Referred by 

and discharged 

from program to 

PCP
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

96

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Heisler 

2010/20123

3,34

cRCT 

effectivenes

s study 

(team 

clusters 

randomized 

then patient 

randomized 

within 

team)

3 VA (2 

academicall

y affiliated) 

2 KP 

facilities, 

primary 

care teams

Diabetes

14-month 

intervention 

period, 

patient 

discharged 

when 

adherence 

issues were 

addressed, 

BP was at 

target, statin 

was 

prescribed if 

indicated, 

and 

glycemic 

control 

addressed. 

Patients 

received a 

median of 9 

weeks 

follow-up. 

Data also 

collected for 

the 6 

months prior 

to and after 

the 

intervention 

period 

Inclusion:

In last 12 months

-1 hospitalization or 2 

outpatient visits with 

diabetes related code or 

≥1 prescription for 

diabetes medication 

-most recent SBP≥140 

and mean SBP (last 9 

months) >140 or most 

recent SBP ≥150 and no 

other BP measures for 

last 9 months

-poor refill adherence 

(gaps totaling ≥20% of 

days supply of ≥1 BP 

medication over prior year 

or insufficient medication 

intensification within 30 

days prior to or any time 

after last BP (increase in 

number drug classes, 

daily dosage, or switch to 

another medication))

Exclusion:

-pregnant

-age < 18 or > 100

-impaired decision-making

-KP patients excluded if 

on “no contact” list, 

hospitalized, nursing 

home resident, hospice or 

home health care; < 12 

months of active drug 

benefit

BP control

Relative change 

in systolic BP

Clinical 

pharmacist, 

trained in 

motivational 

interviewing 

and 

authorized to 

adjust BP 

and lipid 

medications

8 teams, N=2,319 with 1,797 activated

-Proactive case identification using 

medication management tool database

-Pharmacists referred to database which 

assisted in tracking and scheduling 

patient encounters and assessing 

adherence 

-Adherence counseling and assessment

-Medication management

-Recent clinical indicators discussed

-Labs ordered

-Medication changes could be made

-Patients made/discussed goals

-Pharmacist constructed specific, shortterm action plan

Mode/Frequency:

-In-person or by telephone 

-Continued until patient was discharged 

from intervention program

8 teams, 

N=2,303

Usual care 

enhanced by 

information given 

to providers 

about patients’ 

adherence and 

intensification 

problems; 

access to care 

manager and 

non-study clinical 

pharmacy 

services

All patients; inperson or 

telephone intake 

by pharmacist 

plus welcome 

packet with 

educational 

materials

Copied provider 

on all clinical 

notes; alerted 

PCP when 

patient declined 

program, 

entered 

program or was 

discharged 

from program; 

pharmacists 

required to 

consult with 

PCP if patient 

was on 3 antihypertensives
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

97

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Jacobs 

201238

RCT

Ambulatory 

general 

internal 

medicine 

setting 

(Lahey 

clinic) in 

Burlington, 

MA

Type 2 

diabetes

1 year

Inclusion:

-age > 18

-documented HbA1c > 8% 

obtained more than 6 

months earlier

Exclusion:

-receive primary care 

outside of Lahey Clinic 

Burlington campus

-type 1 diabetes

-HbA1c < 8% within 6 

months

-enrolled in another 

pharmacy or diabetes 

study

-diabetes management by 

an outside endocrinologist

-unable to adhere to study 

schedule

Improve glucose, 

lipid, and blood 

pressure control 

Achieving targets 

for HbA1c, LDL 

cholesterol, and 

blood pressure

5 clinical 

pharmacist 

practitioners 

who had 

PharmD 

degrees and 

minimum of 

post-graduate 

residency 

training with 

emphasis on 

ambulatory 

care practice 

with direct 

care for 

patients with 

chronic 

disease

N=72

Pharmacist visit included:

-comprehensive medication review

-targeted physical assessment 

-education on diabetes pathophysiology 

and importance of control

-ordering laboratory tests

-reviewing, modifying, and monitoring 

patients’ medication therapy

-detailed counseling on all therapies

-facilitating self-monitoring of blood 

glucose

-providing reinforcement of dietary 

guidelines and exercise 

-facilitate referrals to other clinicians

Mode/Frequency:

-Required to attend at least 3 clinic visits 

with pharmacist (baseline, 6 and 12 

months)

N=92

Usual care as 

directed by 

physician 

according to 

current standard 

of practice

Therapy, 

monitoring, and 

referral 

recommendations required 

approval by the 

patient’s 

physician
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

98

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Salvo 

201249

Retrospective 

cohort 

Countyfunded 

health 

center, St. 

Louis

“Indigent” 

(low-income, 

minority) 

with 

diabetes (1 

or 2) using 

insulin

2-year time 

frame 

Inclusion

-using insulin

-ambulatory

-speak English

-age 18-64

-diabetes diagnosis

Exclusion:

-seeing an endocrinologist

-from standard care if had 

current or previous 

interactions regarding 

diabetes management 

with pharmacy team

Glycemic control 

and preventive 

care measures

Change in 

HbA1c between 

groups between 

baseline and 

various end 

points

Boardcertified 

residencytrained 

pharmacist, 

full-time 

faculty 

member of 

the St. Louis 

College of 

Pharmacy 

and 

pharmacy 

resident and 

students

N=69

Pharmacist-managed insulin titration 

program

-Initially meeting: discuss diabetes 

management, role of preventive care 

measures, self-monitored blood glucose, 

complications, and pharmacist program

-Review medical record to determine 

need for medication initiation, adjustment 

or discontinuation, lab monitoring, and 

preventive care measures

-Follow-up (telephone) every 1-2 weeks: 

patient reports insulin regimen, selfmonitored blood glucose, adverse events. 

-Assess adherence, educate on lifestyle 

modifications and medication adherence, 

adjust insulin dosage

-Preventive care assessment at each 

interaction

-Schedule appointments with specialists 

(podiatrist, dietician)

Mode/Frequency:

-Initial in-person meeting then telephone 

follow-up every 1-2 weeks

N=57 matched

Standard care

Pharmacist 

notifies PCP of 

insulin 

adjustments 

and reminds of 

overdue lab 

work/vaccines
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

99

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Cohen 

201132

RCT (VAMEDIC-E) 

Primary 

care, VA, 

urban 

(Providence

) 

Type 2 

diabetes

6 months

Inclusion:

-type 2 diabetes -

HbA1c>7%; 

LDL>100mg/dL or 

>70mg/dL if CAD; 

BP>130/80 mmHg (each 

documented in last 6 

months)

-willing to discuss 

diabetes and cardiac risk 

factors in group setting

Exclusion:

-gestational diabetes

-unable to attend sessions

-condition precluding 

diabetes self-care

CV Risk 

Reduction

Primary 

Outcome: 

change in 

proportion of 

participants 

achieving target 

glycemic and 

cardiac risk 

factor goals 

Clinical 

pharmacist, 

trained in 

diabetes 

education 

with 

prescribing 

privileges

N=50

Regular visits with PCP plus

-Education

-Behavioral and pharmacologic 

interventions for hypertension, 

hyperlipidemia, hyperglycemia, and 

tobacco use

-Received CV report card and exercise 

prescription, set diet and activity goals

-Medication regimens discussed and 

evaluated, doses titrated

-Referrals

Mode/Frequency:

-4 once-weekly 2-hour educational 

sessions (1 hour education, 1 hour 

behavioral and pharmacologic 

interventions)

-5 monthly booster sessions

N=49

Standard 

Primary care, 

average. once 

every 4 months, 

20-60 minute 

appointments, 

may include 

referrals 

Education 

session 

provided by 

pharmacist, 

dietitian, nurse 

and physical 

therapist

-also saw PCP

Padiyara 

201145

Retrospective 

EMR 

review

Primary 

care clinic 

affiliated 

with multispecialty 

medical 

group; 

suburban 

metropolita

n area

Diagnosed 

with 

diabetes 

mellitus

1 year

Inclusion

-age ≥18 

-2 or more visits with the 

pharmacist-managed 

diabetes clinic during 

study period (control 

group had at least 2 PCP 

visits and no pharmacist 

clinic visits)

Educate and 

directly manage 

drug therapy and 

preventive care 

services

3 universityaffiliated 

pharmacists

N=321

-Emphasized the ADA guidelines

-Pharmacists have autonomy in:

-assessing patients

-providing disease-state education

-reviewing current medication lists

-initiating or adjusting medication therapy

-ordering laboratory tests

-determining appropriate follow-up

Mode/Frequency

-45-minute initial meeting; 30-minute visits 

for returning patients; had at least 2 

pharmacist or PCP visits to be included in 

study

N=321 randomly 

selected

Usual care 

includes 

provision of 

preventive care 

services and 

screenings; 

medication 

management; 

education of 

patient by PCP, 

or other staff; 

and referral to 

other specialist if 

appropriate

Some patients 

referred to 

pharmacist 

clinic by PCP
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

100

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Pape 

201148

Prospective 

cRCT 

(clinics 

randomized

) 

 

Providence 

Primary 

Care 

Research 

Network, 

internal 

medicine/

family 

practice 

clinics 

(Oregon)

Diabetes Inclusion:

-problem list entry of 

diabetes on EMR

-age ≥ 18 

Exclusion: 

-no evidence of medical 

chart activity within 3 

years

Cholesterol 

management in 

diabetes

Proportion of 

participants in 

each arm 

achieving a 

target LDL-C 

level < 100mg/dL 

Clinical 

pharmacists

6 clinics, N=4,160

Health IT resources plus

-Reviewed medical charts of patients with 

elevated LDL-C level

-Developed individualized, evidencebased treatment recommendations to 

include medication therapy and follow-up 

laboratory monitoring

-Treatment plan sent to PCP for review

-Physician could ignore recommendation, 

act on it or approve intervention by 

pharmacist

Mode/Frequency:

-If intervention approved: pharmacist 

contacted patient by phone, education 

provided to support a shared decisionmaking process for treatment plan 

3 clinics, 

N=2,069

Clinics 

randomized to 

control had 

access to 

CareManager 

disease 

management 

software which 

provided 

automated 

quality reporting, 

benchmarking, 

and robust care 

opportunity 

decision support 

Treatment plan 

shared with 

PCP who could 

decide how to 

react

Pharmacist 

supported by 

medical 

assistant who 

triaged lab 

results, ordered 

overdue labs, 

scheduled 

appointments, 

and facilitated 

mailings (by 

protocol)
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

101

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Taveira30

2011

RCT (VAMEDIC-D)

Providence 

VA Medical 

Center

Type 1 or 

Type 2 

diabetes 

AND 

depression

6 months

Inclusion:

-type 1 or 2 diabetes

-age ≥ 18

-HbA1c >6.5% within last 

6 months

-concomitant depression

-willing to discuss 

diabetes and 

cardiovascular risk factors 

in group setting

Exclusion:

-gestational DM

-unable to attend group 

session

-disease condition, 

psychiatric instability, or 

organic brain injury 

precluding diabetes selfcare 

Management of 

diabetes and CV 

risk factors

Change in 

proportion of 

participants who 

attained a goal 

HbA1c of <7% at 

6 months

Clinical 

pharmacist 

with 

prescribing 

authority and 

certified 

diabetes 

educator

N=44

-Regular visits with PDP and standard 

visits with mental health provider

-Education part of session: interactive 

lectures presented by a nurse, nutritionist, 

or clinical pharmacists, focused on selfcare behaviors (eg, goal setting, 

promoting healthy problem solving)

-Food logs reviewed by pharmacist and 

participants reminded of nutritional goals

-Pharmacological and Behavioral 

intervention: conducted by clinical 

pharmacist, group assessment to 

determine degree to which patients felt 

they could manage their diabetes care 

daily, group counseling, reinforcement to 

enhance self-efficacy

-Participants provided with CV risk report 

cards with medical history, medications, 

vitals, and laboratory values, reviewed 

during week 1 session, updated regularly

-Medications titrated and initiated (no 

changes to psychiatric medications)

-Individualized homework for medication 

changes and behavior change goals

Mode/Frequency:

-4 once-weekly sessions of 2 hours, then 

5 monthly booster sessions held in 

classroom with 4-6 participants 

N=44

-regular visits 

with primary care 

provider, 

approximately 30 

minutes

-referral to 

Diabetes Selfmanagement 

Education 

Program (4 

weekly education 

visits and 

monthly 90 

minute follow-up 

appointments)

-continue 

standard care 

with mental 

health providers

Education part 

of session 

presented by 

nurse or 

nutritionist too
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

102

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Jameson 

201036

RCT

Community 

based 

primary 

care group 

(Advantage 

Health 

Physician 

Network) 

13 offices, 

3 urban, 9 

suburban 1 

rural 

Diabetes

12 months

Inclusion:

-age ≥18

-HbA1c ≥9% or no office 

visit within 12 months

Exclusion:

-being seen by an 

endocrinologist

-not expected to live for 

duration of study

Improved 

management

Change in 

HbA1c after 1 

year

Boardcertified 

pharmacotherapy 

specialist with 

diabetes 

management 

and 

education 

training

N=52 

Targeted patient outreach plus

-assessment of adherence, barriers to 

optimizing blood glucose levels, and 

medication regimen

-individualized education on selfmanagement (diet, exercise, blood 

glucose level testing, medications, insulin)

-followed guidelines of the Management 

of Type 2 Diabetes, including changing 

medication

Mode/Frequency:

-Initial home visit with study nurse to 

determine eligibility

-In-person session with pharmacist at 

primary care site

-Follow-up visits supplemented with 

phone calls

N=51

Usual care 

including 

registries to 

identify and track 

patients and 

targeted patient 

outreach

PCP approved 

any changes in 

medication or 

therapy

Johnson 

201042

Retrospective 

chart 

review

“safety net” 

clinic 

medical 

homes, 

major urban 

city 

Uninsured or 

underinsure

d with type 2 

diabetes

2 years

(mean 1.2 

years for 

intervention 

group; 1.4 

years for 

control 

group)

Inclusion:

-HbA1c >9%

-had a clinic visit during 

enrollment period

-Age > 18

-second visit with HbA1c 

within 2 years of index 

visit

-for intervention group: 

referred to pharmacist by 

usual provider

Disease 

management

Change in A1c 

from baseline to 

last measured 

post-treatment 

A1c and whether 

or not the patient 

achieved the 

treatment goal of 

a final A1c<7%

Clinical 

pharmacist

N=222

-Reviewing medical, laboratory, and 

medication histories

-Evaluating and modifying drug therapy 

under an established protocol

-Ordering routine laboratory tests (HbA1c, 

lipid panel, metabolic panel, renal and 

liver function)

-Monitoring adherence to drug therapy 

regimens

-Educating patients

-Providing follow-up care 

Mode/Frequency:

-At least 2 clinic visits with laboratory 

value measurements

N=262 not 

matched

Usual care no 

pharmacist

Referred by 

PCP
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

103

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Taveira 

201031

RCT (VAMEDIC)

Providence 

VA Medical 

Center

Type 2 

diabetes

1 monthlong 

intervention, 

follow-up at 

4 months (3 

months 

post)

Inclusion:

-type 2 diabetes

-age ≥18

-HbA1c 7% to 9% within 

previous 6 months

-Willing to discuss 

diabetes and 

cardiovascular risk factors 

in group settings

Exclusion:

-unable to attend group 

settings

-disease condition 

precluding diabetes selfcare 

Reduce cardiac 

risk factors

Improve 

achievement of 

target goals in 

hypertension, 

hyperglycemia, 

hyperlipidemia, 

and tobacco use

Clinical 

pharmacists 

with 

prescriptive 

authority; 

certified in 

diabetes 

education 

and physical 

assessment 

with 6 months 

supervised 

pharmacy 

management

N=58

Regular PCP appointments plus

-educational part of session: interactive 

lectures provided by nurse, nutritionist, 

physical therapist, or clinical pharmacist 

focused on diabetes self-care behaviors

-behavior and pharmacological portion of 

session with clinical pharmacist: 

discussed and titrated medication 

regimens based on algorithms, wrote 

down medication changes, help with 

tobacco cessation, patients taught to 

carry CV risk report cards (see above)

Mode/Frequency:

-4 weekly, 2-hr sessions in a classroom 

setting with approximately 4-8 participants

N=51

Saw primary 

care provider at 

VA medical 

center through 

individual clinic 

visits, average 

frequency 4 

months

Educational 

sessions also 

provided by 

nurse, 

nutritionist, and 

physical 

therapist

Fox 200947

Nonequivalent 

group, 

quasiexperiment

al study

Florida 

Healthcare 

Plans HMO

Diabetes 

and 

Medicare 

part D, MTM 

eligible (≥ 3 

chronic 

diseases 

and ≥ 4 

maintenance 

medication 

and likely 

Part D 

medication 

costs ≥ 

$4000/year

1 year

Inclusion:

-Medicare Part D member

-eligible for 

comprehensive diabetes 

care (CDC) according to 

HEDIS

-MTM eligible (3 or more 

chronic diseases and 4 or 

more maintenance 

medications and likely to 

have Medicare part D 

costs of >$4,000/yr) and 

chose to participate 

Improve HEDIS 

LDL-C quality 

measures for 

CDC

Presence of 

LDL-C 

screening, LDLC values, and 

LCL-C control

Staff clinical 

pharmacists

N=255

-Medication therapy review and 

evaluation, sent to PCP; included:

-drug-drug and drug-disease interactions

-OTC drug therapy

-medication monitoring, recommending 

changes if indicated

-adherence to HEDIS comprehensive 

diabetes care guidelines and goals (LDLC control and HbA1c, BP, and weight)

-medication cost reduction

-adherence counseling

-adverse events, education

-medication optimization, reducing cost 

and consolidating (not limited to lipidlowering medications)

Mode/Frequency:

-Telephone interview with pharmacist and 

follow-up calls if recommendations made 

(at least 3 calls)

Usual care – 2 

groups

1) N=56 who did 

not participate in 

MTM

2) N=1,803 

enrollees not 

eligible for MTM

Recommendations shared 

with physician
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

104

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Scott 

200640

RCT

Siouxland 

Community 

Health 

Center in 

Sioux City, 

Iowa

Type 2 

diabetes

Intervention 

for 3 

months, total 

of 9 month 

follow-up

Inclusion:

-SCHC members

-age >18 

-diagnosis of type 2 

diabetes

-referred by PCP

Exclusion:

-patient foresaw difficulty 

completing the study

-migrant worker

-drug abuse

Manage patients’ 

diabetes

Reduction of 

HbA1c levels

Clinical 

pharmacist 

with 1 year 

primary care 

residency 

program

N=76

-Appointments focused on disease 

management, lifestyle adjustments, and 

goal setting

-Group sessions: reviewed nutrition and 

basic diabetes management (nurse and 

dietitian participated)

-pharmacist provided other therapeutic 

interventions (eg, aspirin therapy, 

influenza vaccine) and reminded patients 

about appointments

Mode/Frequency:

-Appointments every 2 weeks

-Group-session appointments and 

telephone follow-up when necessary

N=73

Standard 

diabetes care, 

managed by a 

nurse

All patients had 

appointments at 

baseline and 3, 

6, & 9 months;

incentive 

package for 

attending study 

appointments

Group 

appointments 

involved a 

pharmacist, 

dietitian, and 

nurse; 

medication 

change 

recommendatio

ns were given 

to provider and 

implemented by 

provider or 

pharmacist

Odegard 

200551

RCT

University 

of WA 

neighborhood 

primary 

care clinics, 

greater 

Seattle 

area

Type 2 

diabetes

6 month 

intervention 

plus 6 month 

follow-up 

after 

intervention 

ended

Inclusion:

-age ≥ 18

-type 2 diabetes

-taking at least one oral 

diabetes medication

-HbA1c ≥9%

Exclusion:

-non-English speaking

-unstable psychiatric 

condition

-terminal prognosis (within 

6 months)

Improving 

diabetes control

HbA1c levels

Primary care 

pharmacist

N=43

-Development of a diabetes care plan

-Regular pharmacist-patient 

communication on diabetes care progress

-Pharmacist-provider communication on 

diabetes care progress

-Medication-related problems requiring 

intervention identified

Mode/Frequency:

-Initial in-person appointment then weekly 

in-person or telephone contact 

(decreased to monthly once care needs 

were progressing)

N=34

Baseline 

interview and 

continue normal 

care with PCP

Diabetes care 

plan was 

communicated 

to PCP through 

EMR notation, 

communication 

between 

pharmacist and 

PCP
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

105

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Rothman 

200539

cRCT 

(clinics 

matched 

and 

randomized

) 

University 

of NC 

General 

Internal 

Medicine 

Practice 

Vulnerable 

patients with 

poorly 

controlled 

type 2 

diabetes

February 

2001 to April 

2003, 

patients 

followed for 

1 year

Inclusion:

-age ≥ 18

-diagnosed with type 2 

diabetes

-followed for diabetes care 

in the practice

-referred by provider

-poor glucose control 

(HbA1c≥8%)

-spoke English

-life expectancy >6 

months

Improve 

cardiovascular 

risk factors and 

HbA1c levels

Blood pressure, 

A1c levels, 

cholesterol level, 

and aspirin use

Clinical 

pharmacist 

who could 

initiate and 

increase use 

of blood 

pressure-, 

cholesterol-, 

and glucoselowering 

medications

N=105 Usual care plus

-Management session: diabetes 

education, treatment recommendations to 

PCP

-Intensive education sessions, counseling

-Medication management

-Evidence-based algorithms to initiate and 

increase use of blood pressure, 

cholesterol, and glucose lowering 

medications

-Proactive management of clinical 

parameters

-Diabetes care coordinator to address 

issues related to health behavior and 

education, remind of appointments, and 

help address barriers to care

Mode/Frequency:

-1 hour management session

-Dedicated clinical slots for intervention 

group patients

-Pharmacist contacted patients at least 

every 2-4 weeks

N=112

Management 

session plus 

usual care from 

PCP

Results from 

sessions with 

pharmacists 

shared with 

PCP

Medication 

adjustments 

approved 

(before or after 

as requested by 

PCP) 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

106

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

ShaneMcWhorter 

200541

Retrospective 

review

Community 

health 

center, 

Utah; 

clinical 

pharmacy 

demonstration project

Diabetes

Charts were 

reviewed for 

all patients 

who 

received 

diabetes 

education 

from August 

2000-June 

2002

Outcomes 

collected 

over 1-3 

years

Inclusion:

-received at least one 

education session (IG)

-diabetes

Enhancing 

patient care in 

the area of drug 

therapy and 

disease 

management

No primary 

outcome 

specified

College of 

Pharmacy 

faculty 

clinician, 

certified 

diabetes 

educator

N=176 

-Initial chart review: assess drug therapy, 

need for test/monitoring, health care 

maintenance needs, establish plan of 

action/education plan, evaluate 

appropriateness of drug therapies to look 

for potential interactions/adverse 

reactions

-In-person patient education regarding 

diabetes, hypertension, hyperlipidemia, 

drug therapy, lifestyle modifications, ADA 

as components of self-management 

education 

-Individualized recommendations 

regarding drug therapy, lab testing, and 

healthcare maintenance

-Obtained a detailed medical and drug 

therapy history

-Needs assessment

-Recommendations for provider regarding 

maintaining, changing, or adding drugs, 

certain tests, health care maintenance 

(made in chart note)

-Follow-up education to document 

changes made by patient in nutrition or 

exercise, provide drug therapy education, 

information about health care 

maintenance and complications, 

determine if any tests still required

-Chart reviews on continuing basis to 

track outcomes and provide 

recommendations

Mode/Frequency:

-In person

-Monitoring 3 times/year (chart review)

N=176 randomly 

selected

Access to a nonpharmacist 

health educator

Made 

recommendations to 

physician
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

107

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Stroup 

200352

RCT

The 

Endocrine 

Group, 

Albany NY, 

associated 

with the 

Albany 

College of 

Pharmacy 

Poorly 

controlled 

diabetes 

mellitus

2 years

Inclusion:

-patient at The Endocrine 

Group

-minimum 1 year duration 

of HbA1c values greater 

than 10%

-physician approved

Improve 

glycemic control

Average HbA1c 

values over a 2yr 

period

2 consecutive 

groups of 6 

fourth-year 

pharmacy 

students who 

had 

completed a 

1-semester 

didactic 

program and 

shadowed a 

faculty 

member or 

more 

experienced 

student

N=30

-Students reviewed with each patient: 

-compliance with therapies

-side effects, recent ED visits or 

hospitalizations

-blood glucose monitoring

-blood sugar logs

-hypoglycemic management including 

insulin therapy and dosage adjustment

-goals of therapy

-diabetes complications

-patient-initiated questions

-diet, exercise, and weight loss

-Notes from visit were typed and delivered 

to endocrinologist and submitted into 

EMR

Mode/Frequency:

-Monthly hour-long visits in patients’ home

N=40

See physician as 

typically 

scheduled (every 

3-4 months)

Acute problems 

immediately 

communicated 

verbally to 

patients’ 

endocrinologists; notes 

from visit 

delivered to 

endocrinologist 

Kelly 

200044

CCT

Richmond 

Health Care 

Group, a 

managed 

careaffiliated 

physicians 

group in 

Virginia 

Diabetes

9 months

Inclusion:

-diabetic patients taking 

oral diabetic agents or 

insulin

-chosen by their providers 

to participate

-documented HbA1c >8%, 

systolic >130mm Hg or 

diastolic >85mmHg, or 

LDL-c >120% of goal

Achieving near 

normoglycemia, 

lowering blood 

pressure, and 

LDL <130 mg/dL 

in patients with 2 

or more CV risk 

factors or <100 

mg/dL for 

patients with 

established 

disease

HbA1c, 

SBP,DBP, and 

smoking 

cessation

Clinical site 

included one 

full-time 

clinical 

pharmacist/

faculty 

member, one 

pharmacy 

resident, and 

fourth-year 

Doctor of 

Pharmacy 

students

N=32

-Assessment/consultation on diabetes 

self-management

-Complete medical history

-Laboratory tests

-Develop management plan, create shortand long-term goals, assess medication 

issues, and review nutrition 

recommendations, lifestyle changes, and 

blood-glucose monitoring instructions

-Follow-up: reviewed goals, selfmanagement plan, medications, 

hypoglycemic events, test results and 

lifestyle changes

-Continuing education on selfmanagement topics

Mode/Frequency:

-One-on-one assessment/consultation

-Follow-up scheduled based on degree of 

monitoring required (usually monthly)

N=16 matched

Historical 

controls, one 

year prior to 

implementation 

of clinical service

Dosage 

adjustments 

made in 

collaboration 

with PCP
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

108

Author, 

year

Study 

design

Type of 

Clinic 

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Jaber 

199637

RCT

Universityaffiliated 

internal 

medicine 

outpatient 

clinic, 

urban, 

Detroit

Urban 

AfricanAmericans 

with noninsulindependent 

diabetes 

mellitus 

(NIDDM)

4 months

Inclusion:

-urban African-American 

patients

-NIDDM

-attending outpatient clinic

Exclusion:

-insulin-dependent DM

-renal dysfunction

-hepatic disorder

-significant cardiac 

complications within 6 

months

-mental incompetence 

-history of non-compliance 

with regular clinic visits in 

past 2 years

Manage NIDDM 

diabetes in 

AfricanAmericans

Fasting plasma 

glucose and 

glycated 

hemoglobin 

concentrations

Pharmacist 

with fullprescribing 

authority for 

hypoglycemic 

agents

N=28 randomized

-Diabetes-specific pharmacotherapeutic 

evaluation and dosage adjustment

-Comprehensive and individualized 

patient education on diabetes and its 

complications

-Training on the recognition and treatment 

of hypoglycemia and hyperglycemia

-Medication counseling

-Specific instructions on dietary regulation 

and an exercise plan

-Training for self-monitoring of blood 

glucose

-Adjusted or titrated hypoglycemic 

therapeutic regimens

Mode/Frequency:

-Follow-up on scheduled weekly basis 

until targeted glycemic control reached, 

then clinic visit every 2-4 weeks

N=17 

randomized

-reported to clinic 

for initial 

assessment and 

final exit visit

-instructed to 

continue to 

receive standard 

care from PCP 

(every 3-4 

months)

None reported

T2DM = type 2 diabetes; CAD = coronary artery disease; cRCT = cluster randomized controlled trial; CV = cardiovascular; LDL = low-density lipoprotein; VA = Veterans 

Affairs; KP = Kaiser Permanente; BP = blood pressure; DM = diabetes mellitus; SBP = systolic blood pressure; EMR = electronic medical record; SCHC = Siouxland Community 

Health Center; NIDDM = non-insulin-dependent diabetes mellitus; OTC = over the counter; PCP = primary care provider; HEDIS = healthcare effectiveness data and information 

set; HbA1c = glycosylated hemoglobin; ADA = American diabetes association; ED = emergency department; MTM = medication therapy management; DBP = diastolic blood 

pressure; RCT = randomized controlled trial
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 22. Drug-related Problems Outcomes – Diabetes Studies

Study 

Intervention 

(n) 

Control (n)

Inappropriate 

dosage/prescription 

or omission 

% (n/N)

Ineffectiveness% 

(n/N)

Drug-drug or drugdisease interaction 

(describe) % (n/N)

Non-adherence to prescribed 

regimen

% (n/N)

Clinical/adverse events % (n/N)

Pharmacy 

componen

t

Control

Pharmacy 

componen

t

Control

Pharmacy 

componen

t

Control Pharmacy 

component Control Pharmacy component Control

Skinner 2015

IG=2935

CG=29

NR NR NR NR NR NR Medication 

adherent 

(refilled at 

least 85% of 

the time)

62%

7%

(P<.001)

NR NR

Spence 201413

IG=359

CG=428

NR NR NR NR NR NR 53.5% 

(192/359) 

adherent

Mean MPR

0.78 (0.2)

Discontinued 

11.7% 

(42/359)

37.4% 

(160/428) 

adherent 

(P=.001)

Mean MPR 

0.74 (0.2)

(P=.091)

Discontinued

35.5% 

(152/428) 

(P=.001)

NR NR

Jacobs 201238

IG=72

CG=92

NR NR NR NR NR NR NR NR No adverse events caused by 

study protocol

Cohen 201132

IG=50

CG=49

NR NR NR NR NR NR Totala

medication 

possession 

ratio: 0.87

0.83 

(P=.19) 

NR NR

Jameson 

201036

IG=52

CG=51

NR NR NR NR NR NR NR NR 1 severe hypoglycemic event in 

intervention group (events could 

not be assessed in control 

group)
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study 

Intervention 

(n) 

Control (n)

Inappropriate 

dosage/prescription 

or omission 

% (n/N)

Ineffectiveness% 

(n/N)

Drug-drug or drugdisease interaction 

(describe) % (n/N)

Non-adherence to prescribed 

regimen

% (n/N)

Clinical/adverse events % (n/N)

Pharmacy 

componen

t

Control

Pharmacy 

componen

t

Control

Pharmacy 

componen

t

Control Pharmacy 

component Control Pharmacy 

component Control

Odegard 200551

IG=43

CG=34

Diabetes 

Medications

Mean (SD) 

MAI scores 

at baseline:

1.1 (1.5) 

6 months: 

0.6 (0.7)

1 year:

0.8 (1.0)

Mean MAI 

scores at 

baseline: 

0.8 (1.0) 

6 months:

0.8 (1.4)

1 year:

0.6 (0.7)

Appropriateness of 

diabetes 

medications

: P=.65 

between 

groups over 

study period

NR NR NR NR Intervention had no effect on 

improving adherence during study 

period

NR NR

Rothman 

200539

IG=112, 

6months 105, 

1yr 99

CG=105, 

6months 99, 1yr 

95

NR NR NR NR NR NR NR NR Rate of events 

from 6-12 

months followup

Hypoglycemic 

episodes 1.3

Hypotensive 

episodes 0.1

Hypoglycemic 

episodes 1.0

(Rate ratio 1.3 

[0.6, 2.5])

Hypotensive 

episodes 0.2 

(Rate ratio 0.3 

([0.1, 1.6])

Jaber 199637

IG=17

CG=22

NR NR NR NR NR NR NR NR 17 

hypoglycemic 

reactions (mild 

to moderate; 

self-treated)

2 

hypoglycemic 

reactions (mild 

to moderate; 

self-treated)

CG=control group; IG=intervention group; MAI=medication appropriateness index; NR = not reported a Antihypertensive, cholesterol, and diabetes medications 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 23. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – Diabetes Studies

Study; 

Intervention (n)

Control (n)

All-cause mortality

% (n/N)

Health-related quality of life 

(describe) Access to care (describe) Patient satisfaction with care (describe)

Pharmacy 

component Control Pharmacy component Control Pharmacy component Control Pharmacy component Control

Cohen 201132

IG=50

CG=49

4% (2/50) 2% (1/49)

P = NSb VR-36Mean 

change: 

Physical 

1.65

Mental 0.48 

(both P=NS 

from 

baseline)

Physical

-1.95

Mental 0.78 

(both P=NS 

from baseline)

NR NR NR NR

Pape 201148

IG=3 clinics, 23 

physicians, 2069 

patients

CG=6 clinics, 45 

physicians, 4160 

patients

NR NR NR NR Satisfaction with 

reaching 

someone in an 

emergencya 

84%

77%

(P=.04) 

Overall satisfaction a

5.4 (0.9)

5.2 (1.1)

(P=.15) 

Taveira 201130

IG=44

CG=44

All-cause NR

No diabetes-related death in 

either group

NR NR NR NR NR NR

Scott 200640

IG=64

CG=67

NR NR Total DQOL 

score - 

change from 

baseline to 

month 9

24.4

14.8

(P=NR)

NR NR DQOL score -

satisfaction measure 

- change from 

baseline to month 9

13.7

6.4

(P=.007)

Rothman 200539

IG=112, 6months 

105, 1yr 99

CG=105, 6months 

99, 1yr 95

1.8% 

(2/112)

3.8% (4/105)

(P=.43)b NR NR NR NR DTSQ+8 over 12 months 

of intervention

+4 over 12 

months of 

intervention

Difference:

+3 (1, 6)

(P<.05)

Jaber 199637

IG=17

CG=22

NR NR Groups similar for any domain 

of Health Status Questionnaire 

(version 2.0)

NR NR NR NR

ADA = American Diabetes Association; CG = control group; DQOL=Diabetes Quality of life Questionnaire; DTSQ = Diabetes Treatment Satisfaction Questionnaire; IG = 

intervention group; NR = not reported; NS = not statistically significant; VR-36 = SF-36 for Veterans a Assessed using ADA and National Committee for Quality Assurance Provider Recognition Program Modified Patient Satisfaction Survey

b Calculated P value (not reported in study)
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 24. Healthcare Utilization and Cost Outcomes – Diabetes Studies

Study; 

Intervention (n)

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other (describe)

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

component Control

Pharmacy 

component Control

McAdam-Marx 

201553

IG=303

CG=394

Outpatient 

utilization:

Mean (SD) 

difference 

pre to post 

intervention

1.16 (6.81)

0.61 (3.93)

(P<.001)

between 

groups

Mean (SD) 

difference 

pre to post 

intervention

0.07 (1.28)

0.04 (0.35)

(P=.78) 

between 

groups 

Inpatient 

utilization 

Mean (SD) 

difference 

pre to post 

intervention

-0.01 (0.69)

0.01 (0.30) 

(P=0.56)

between 

groups

NR NR Total patient 

charges

Mean (SD) 

difference pre 

to post 

intervention

$251 

($18,173)

$1,341 

($14,475)

(P=0.04) 

between 

groups

Chung 201450

IG=220

CG=220

NR NR Increase of 

4 visits per 

220 

patients 

from preindex to 

post-index 

year (mean 

0.018)

Increase of 

16 visits per 

220 

patients 

(mean 

0.073) 

(P=.18) 

Decrease 

of 1 

hospitalization for 

220 

patients 

from preindex to 

post-index 

year (mean 

-0.005)

Increase of 

8 hospitalizations for 

220 

patients 

(mean 

0.036) 

(P=.06) 

NR NR NR NR

Spence 201413

IG=359

CG=428

NR NR 1.7% 

(6/359)

14.2% 

(18/428)

(P=.04) 

0.6% 

(2/359)

1.4% 

(6/428) 

(P=.24) 

NR NR $5.79 saved for every dollar 

spent on program

(including coronary artery 

disease program)

Brummel 201346

IG=121

CG=103

NR NR NR NR NR NR Daily Aspirin 

use

Baseline 

97.5%

Post 

intervention 

100%

Follow-up 

99.2%

Baseline 

93.3%

Post 

Intervention 

98.1%

Follow-up

99.0% 

(all P=NS 

between 

groups)

NR NR
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study; 

Intervention (n)

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other (describe)

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

component Control

Pharmacy 

component Control

Ip 201343

IG=147

CG=147

NR NR NR NR NR NR NR NR 10 year CHD 

risk: 

decreased 

from 16.4 to 

9.3%

10 year 

stroke risk: 

decreased 

from 7.6 to 

6.8%

10 year 

CHD risk: 

decreased 

from 17.4 to 

14.8% 

(P<.001 vs 

intervention)

10 year

stroke risk: 

no change 

(P=.001 vs 

intervention)

Heisler 

2010/201233,34

IG=1797 

patients, 8 

primary care 

teams

CG=2303

patients, 8 

primary care 

teams

Primary 

care visits

mean (SD)

4.6 (5.9)

4.3 (6.1) 

(P=.10) 

24% 

(434/1797)

23% 

(532/2303)

(P=.43) 

13% 

(227/1797)

13% 

(300/2303)

(P=.71) 

Proportion of 

patients with 

BP 

medication 

changes

69.7% 

(1253/1797)

Proportion of 

patients with 

BP medication 

changes

63% 

(1451/2303)

(P<.01) 

NR NR

Jacobs 201238

IG=72

CG=92

NR NR NR NR NR NR Increase in 

number of 

meds during 

study period: 

1.2

Number of 

meds at end 

of study: 7.1

Increase in 

number of 

meds during 

study period: 

0.9 (P=NS)

Number at end 

of study: 6.0 

(P=.03)

NR NR
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study; 

Intervention (n)

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other (describe)

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

component Control

Pharmacy 

component Control

Salvo 201249

IG=69

CG=57

NR NR NR NR NR NR Increase in 

total daily 

insulin dose: 

33 units 

(mean) 

(P=.004 

compared to 

control at end 

of study) 

Bolus insulin 

added for 11 

patients

Bolus insulin 

added for 1 

patient

(P=NR)

Influenza 

vaccine 70%

(48/69)

Pneumococcal 

vaccine 67%

(46/69)

Dietitian visit 

39% (27/69)

Influenza 

52% (30/57) 

(P=.03) 

Pneumococ

cal 40%

(23/57)

(P=.003)

Dietitian 

16% (9/57)

(P=.003)

Cohen 201132

IG=50

CG=49

PCP visits 

in 6 months 

(mean) 

1.56

1.65 

(P=NR)

NR NR NR NR At 6 months: 

Total 

antihypertensive meds 

2.34 (1.22)

Diabetes 

meds 1.64 

(0.78)

Cholesterol 

meds 1.00 

(0.49)

At end: Total 

antihypertensive meds 

1.94 (1.18) 

(P<.001)

Diabetes meds 

1.41 (0.73) 

(P=.03) 

Cholesterol 

meds 0.86 

(0.41) 

(P=.006)

NR NR

Padiyara 201145

IG=321

CG=321

NR NR NR NR NR NR Take an 

aspirin at 

least 

15x/month

280/321)

42.4% 

(136/321)

(P<.001)

NR NR

Pape 201148

IG=3 clinics, 23 

physicians, 2069 

patients

CG=6 clinics, 45 

physicians, 4160 

patients

NR NR NR NR NR NR Any lipid 

lowering 

medication

77%

Statin 

prescription

75%

Any lipid 

lowering 

medication

63% (P=.04)

Statin 

prescription

60% (P=.01)

NR NR
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study; 

Intervention (n)

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other (describe)

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

component Control

Pharmacy 

component Control

Taveira 201130

IG=44

CG=44

0.3 (0.6) 0.3 (0.6)

(P=.70) 

All cause 

39.5%

Diabetesrelated 

2.3%

All cause

39.5%

(P=NS) 

Diabetesrelated 

4.7% 

(P=.60) 

14% 16.3%

(P=.80) 

No 

admissions 

were 

diabetesrelated

Dose 

increase or 

initiation: 

antihypertensive 68.2%

antihyperglycemic 

agent 81.8%

antihyperlipidemic 

52.3%

antidepressants 29.6%

Dose increase 

or initiation: 

antihypertensive 34.9% 

(P=.003) 

antihyperglycemic agent 

58.1% 

(P=.02) 

antihyperlipidemic 

39.5% (P=.28)

antidepressants 25.0% 

(P=.81)

Over 6 

months: 

Mean of 6.6 

medical 

appointments

Mean of 1.2 

(0.8) PCP 

visits

Mean of 1.3 

(0.9) PCP 

visits

Mean of 0.6 

(1.2) 

Diabetes 

SelfManagemen

t Education 

visits 

(P=NR)

Jameson 201036

IG=52

CG=51

NR NR NR NR NR NR Basal-bolus 

insulin started 

28.8% (15/52)

Discontinued 

oral

medication 

28.8% (15/52)

Basal-bolus 

insulin started 

2% (1/51) 

(P=.0002)a 

Discontinued 

oral 

medication 2% 

(1/51) 

(P=.0002)a

NR NR

Taveira 201031

IG=58

CG=51

NR NR NR NR NR NR Aspirin added 

5.3%

Statin added 

7%

Insulin added 

15.8%

Niacin added 

17.5%

Aspirin added 

4.0% (P=NS 

between 

groups)

Statin added 

5.9% (P<.05)

Insulin added 

2% (P<.05)

Niacin added 

2% (P<.05)

NR NR
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study; 

Intervention (n)

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other (describe)

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

component Control

Pharmacy 

component Control

Fox 200947

IG (MTM 

participants)=255

CG1 (MTM nonparticipants)=56

CG2 (Not MTM 

eligible, 

CDC)=1,803

NR NR NR NR NR NR Change in

number of 

prescriptions 

per month 

during year 

post 

intervention

-4.08%

-2.84%

(P=NR)

Change in 

year following 

intervention

Total drug 

costs

-18.4%

Total Part D 

copay

-4.0%

Total copay

-5.5%

Total drug 

costs

-7.0%

Total Part D 

copay

4.2%

Total copay

-1.5%

(P=NR)

Scott 200640

IG=64

CG=67

NR NR Urgent Care:

RR 0.8 (0.4, 1.6)

ER: RR 0.8 (0.5, 1.4)

NR NR Aspirin 

therapy 

achieved:

81% (52/64)

46% (31/67)

(P=.02) 

NR NR

Odegard 200551

IG=43

CG=34

Mean (SD)

3.2 (1.5) 

over 12 

months

5.4 (2.4) 

over 12 

months

(P=NR)

NR NR NR NR NR NR NR NR

Rothman 200539

IG=112, 6months 

105, 1yr 99

CG=105, 

6months 99, 1yr 

95

Rate of 

event from 

6-12 month 

follow-up

2.0

1.9

(Rate ratio 

1.1 [0.9, 

1.3])

Rate of 

event from 

6-12 month 

follow-up, 

Urgent care 

0.2

ED visits 

0.4

Urgent care 

0.2 (Rate 

Ratio 0.8 

[0.4, 1.6])

ED visits 

0.5 (Rate 

Ratio 0.8 

[0.5, 1.4])

Rate of 

event from 

6-12 month 

follow-up

0.2

0.2 (Rate 

Ratio 1.1 

[0.6, 2.0])

Use of aspirin 

at 12 months 

91% (87/96)

Use of aspirin 

58% (54/93)

(P<.0001)

NR NR

ShaneMcWhorter 

200541

IG=176

CG=176

NR NR NR NR NR NR Aspirin 

prescribed 

55.1% 

(97/176)

64.7% 

(114/176) 

(P=.08)a 

Immunizations

1.25/pt

DM education 

documented 

100% 

(176/176)

0.95/pt 

(P<.006)

19.3% 

(34/176) 

(P<.001)
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study; 

Intervention (n)

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other (describe)

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

component Control

Pharmacy 

component Control

Stroup 200352

IG=30

CG=40

NR NR 6.7% (2/30) 

had 2 visits 

over 2 

years - both 

diabetes 

related

27.5% 

(11/40) had 

16 visits 

(P=.03) 

8 patients 

had 

diabetesrelated 

visits

(P=.115)

14 

admissions 

in 13/30 

patients 

(43%)

8 patients 

had 

diabetesrelated 

admissions

32 

admissions 

in 20/40 

patients 

(50%)

14 patients 

had 

diabetesrelated 

admissions

(P=.58 for 

admissions; 

P=.29 for 

DM related)

NR NR NR NR

Jaber 199637

IG=17

CG=22

NR NR NR NR 5.6% (1/17) 

hospitalizati

on (chest 

pain)

9.1% (2/22) 

hospitalizati

ons (nonDM related) 

(P=NS)a 

38 pharmacotherapeutic 

interventions 

(mean 2.2/pt)

9 pharmacotherapeutic

interventions 

(mean 0.4/pt)

(P=NR)

NR NR

BP = blood pressure; CG = control group; CHD = coronary heart disease; DM = diabetes mellitus; ED=emergency department; IG = intervention group; NR = not reported; PCP = 

primary care provider; SD = standard deviation a Calculated P value (not reported in study)
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 25. Goal Attainment Outcomes – Diabetes Studies

Study;

Intervention (n)

Control (n)

Patient Goal Attainment definition

Percentage of patients attaining goal (n/N) 

Pharmacy component Control

Brummel 201346

IG=121

CG=103

HbA1c<7%

LDL <100mg/dL

BP <130/80 mmHg

Tobacco Free

Optimal Score

HbA1c

Baseline 43.8%b

Post intervention 73.55%a

Follow-up 42.15%ab

LDL

Baseline 63.64%

Post intervention 83.47%a

Follow-up 79.34%

Blood Pressure

Baseline 66.12%

Post intervention 71.07%

Follow-up 76.03%

Tobacco Free

Baseline 85.95% Post intervention 91.74%ab

Follow-up 91.74%b 

Optimal Score

Baseline 21.49%

Post Intervention 45.45% (P<.001)

Follow-up 25.62% (P=.0002)

HbA1c

Baseline 63.11%

Post Intervention 72.82%

Follow-up 59.22%

LDL 

Baseline 65.05%

Post Intervention 73.79%

Follow-up 73.79%

Blood Pressure

Baseline 61.17%

Post Intervention 72.82%

Follow-up 69.9%

Tobacco Free

Baseline 79.61%

Post Intervention 81.55%

Follow-up 82.52%

Optimal Score

Baseline 24.27%

Post intervention 39.81% 

(P=.0002)

Follow-up 30.10% (P=.08)

Ip 201343

IG=147

CG=147

HbA1c <7%

LDL <100mg/dL

BP <130/80 mm Hg

All three goals

At 12 months

HbA1c 62.6% (OR 3.9, P<.0001)

LDL 85% (OR 2.0, P=.02)

BP 61.9% (OR 2.0, P=.002)

All 3 36.7% (OR 3.2, P=.0004)

P<.001 for each of the three, NSR for “all 3”

At 12 months

HbA1c 28.6%

LDL 57.5%

BP 43.5%

All 3 9.5%

Jacobs 201238

IG=72

CG=92

HbA1c<7%

LDL-C <100mg/dL

BP<130/80 mm Hg

HbA1c

12 months 35% (19/55)

LDL-C 

12 months 62% (32/52)

SBP 

12 months 51% (29/57)

DBP

12 months 84% (48/57)

HbA1c

12 months 21% (14/67) (P=.11)

LDL-C 

12 months 55% (24/44) (P=.54)

SBP 

12 months 43% (30/70) (P=.38)

DBP

12 months 77% (54/70) (P=.37)

Salvo 201249

IG=69

CG=57

HbA1c <7% 20.3% 14% p=.48

Cohen 201132

IG=50

CG=49

Recommended by the ADA:

SBP<130mm Hg

LDL<100mg/dL

HbA1c<7%

HbA1c 40.8% (OR 2.73 [1.03, 7.26])

SBP 58% (OR 3.06 [1.31, 7.16])

LDL 82%

Combined 16.0%

HbA1c 20.4% (P=.03)

SBP 32.7% (P=.02)

LDL 65.3% (P=.06)

Combined 4.1% (P=.049)
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study;

Intervention (n)

Control (n)

Patient Goal Attainment definition

Percentage of patients attaining goal (n/N) 

Pharmacy component Control

Padiyara 201145

IG=321

CG=321

BP<130/80 mm Hg

LDL-C <100mg/dL

HbA1c <7%

Documented A1c in last 6 months

Received formal diabetes education

44.6% (120/269)

76% (244/321)

50.8% (163/321)

100% (321/321)

93.4% (300/321)

48% (123/256) P=.43

59.2% (190/321) P<.001

71% (228/321) P<.001

99.7% (320/321) P=.317

40.2% (129/321) P<.001

Pape 201148

IG=3 clinics, 23 

physicians, 2069 

patients

CG=6 clinics, 45 

physicians, 4160 

patients

LDL-C <100mg/dL

HbA1c <7%

BP <130/80mm Hg

LDL-C 78% (OR 2.8 [2.2, 3.7])

HbA1c 51%

BP 55%

LDL-C 50% (P=.003)

HbA1c 49% (P=.81)

BP 49% (P=.22)

Taveira 201130

IG=44

CG=44

ADA guidelines

HbA1c<7%

SBP<130 mm Hg, DBP<80 mmHg

Total cholesterol <200mg/dL

HDL cholesterol<130mg/dL

LDL cholesterol<100mg/dL

Change in proportion attaining goal:

HbA1c 29.6% (P=.04) (OR 4.3 [1.2, 15.9])

SBP 31.8%

LDL-C 18.2%

Non-HDL-C 27.9%

Change in proportion attaining goal:

HbA1c 11.9%

SBP 14% (P=.10)

LDL-C 13.6% (P=.53)

Non-HDL-C 22.7% (P=.39)

Jameson 201036

IG=52

CG=51

HbA1C decreased by at least 1% 67.3% (35/52) 41.2% (21/51) (P=.02)

Johnson 201042

IG=222

CG=262

HbA1c <7%

HbA1c <8%

BP <130/80 mmHg

LDL-C <100mg/dL

BMI 18.5-24.9 kg/m2

HbA1c <7% 43/222 (19.37%) (OR 4.04 [2.16, 

7.56])

HbA1c< 8% 116/222 (52.25%) (OR 5.13 [2.22, 

7.89])

BP <130/80 106/136 (77.94%)

LDL-C 118/148 (79.73%)

BMI 41/115 (35.65%)

HbA1c <7% 17/162 (6.49%) P<.001

HbA1c <8% 52/262 (19.85%) P<.001

BP<130/80 156/251 (62.15%) P=.002

LDL-C<100 85/182 (46.7%)P<.001

BMI 113/248 (45.56%) P=.08

Taveira 201031

IG=58

CG=51

ADA guidelines

HbA1c<7%

SBP<130 mm Hg, DBP<80 mmHg

Non-HDL cholesterol<130mg/dL

LDL cholesterol<100mg/dL

HbA1c 40.4%

SBP 65.5%

DBP 87.9%

Non-HDL cholesterol 70.2%

LDL cholesterol 77.2%

HbA1c 21.6% (P<.05)

SBP 39.9% (P<.05)

DBP 68.6% (P<.05)

Non-HDL cholesterol 62.8% (P=NS)

LDL cholesterol 77.5% (P=NS)

Fox 200947

IG (MTM 

participants)=255

CG1 (MTM nonparticipants)=56

CG2 (Not MTM 

eligible, 

CDC)=1,803

LDL-C <100mg/dL 69% (176/255) CG1= 50% (28/56)

CG2= 54.1% (976/1803) (P<.001)

Scott 200640

IG=64

CG=67

HbA1c <7%

SBP <130 mmHg

HbA1c 67.2% (43/64)

SBP 78% (50/64)

HbA1c 35.8% (24/67) (P=.05)

SBP (numbers not reported) (P=.04)
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study;

Intervention (n)

Control (n)

Patient Goal Attainment definition

Percentage of patients attaining goal (n/N) 

Pharmacy component Control

Odegard 200551

IG=43

CG=34

American Diabetes Association target for 

diabetes control (HbA1c <7%)

8% 13% (P=.69)

Shane-McWhorter 

200541

IG=176

CG=176

HbA1c <7%

SBP <130 mmHg

DBP <80 mm Hg

Total cholesterol <200mg/dL

LDL<100 mg/dL

TG <150mg/dL

HDL >40mg/dL

HbA1c 58 (38.4%)

SBP 66 (39.8%)

DBP 65 (39.2%)

TC 52 (61.9%)

LDL 42 (53.2%)

TG 28 (35.4%)

HDL 41 (51.9%)

HbA1c 48 (27.7%) P=.04

SBP 74 (42.1%) P=.67

DBP 80 (45.5%) P=.24

TC 45 (47.4%) P=.13

LDL 28 (42.4%) P=.20

TG 26 (28.5%) P=.42

HDL 59 (66.3%) P=.06

Kelly 200044

IG=32

CG=16

HgA1c HbA1c <7%

SBP <130mmHg

DBP <85mmHG

HbA1c 31.3% (10/32)

SBP 43.8% (14/32)

DBP 65.6% (21/32)

HbA1c 6.3% (1/16) (P=.03)

SBP 12.5% (2/16) (P=.01)

DBP 62.5% (10/16) (P=.78)

ADA = American Diabetes Association; BP = blood pressure; CG = control group; DBP = diastolic blood pressure; HbA1c = glycosylated hemoglobin; HDL(-C) = high-density 

lipoprotein (cholesterol); IG = intervention group; LDL(-C) = low-density lipoprotein (cholesterol); NR = not reported; SBP = systolic blood pressure; SMBG = self- monitored 

blood glucose; TC = total cholesterol; TG = triglycerides

a significant change from year before 

b significantly different between groups
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 26. Study and Intervention Characteristics – Dyslipidemia Studies

Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

study/

follow-up

Inclusion/ Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Smith 

201354

Retro 

Cohort

Primary 

Care (VA)

Patients with 

uncontrolled 

LDL 

cholesterol

based on 

NCEP/

ATPIII goal

Maximum of 

46 months 

(patients 

followed from 

index visit 

until LDL goal 

achieved or 

end of study 

period)

Inclusion:

-patient seen in 

intervention or usual care 

(study) clinic

-cholesterol-lowering 

medication changed or 

initiated during study 

period

-random sample (~15%) 

chosen for study (225 in 

each group)

Exclusion

-index or final cholesterol 

values were missing

More effective 

and efficient 

lipid 

management 

compared to 

usual care

Primary 

outcome: 

differences in 

mean final 

measured 

values of lipids 

and 

triglycerides 

between 

intervention and 

control cohorts

Clinical 

pharmacist, 

at least 1 

year postgrad 

residency 

training

N=213

-Patients referred by clinician for 

further evaluation and 

adjustment of therapy

-Pharmacists reviews results 

from laboratory tests and 

adjusted medications as 

necessary

-Patient discharged from 

program when they reach 

individual NCEP/ATPIII goal

Mode/Frequency:

-patients seen by pharmacist for 

at least one visit

-follow-up visits at 6- to 8-week 

intervals as needed

N=219 unmatched, 

groups randomly 

chosen from same 

population

-Pharmacists provide 

drug information 

services and perform 

chart review for 

formulary 

management and 

cost-saving initiatives

-Teaching clinic so 

patients followed more 

frequently (approx. 6- 

to 8-weeks)

-No care management 

services

Physicians, 

nurse 

practitioners

Pharmacists 

work with a 

group of 

practitioners to 

provide care 

management 

and drug 

information 

services

Miller 

200855

Prospective cohort

Family 

medicine 

and other 

ambulatory care 

(university

-based)

Patients with 

dyslipidemia 

treated with 

atorvastatin

4 to 52 weeks 

(first fasting 

lipid panel 

after 

conversion to 

new statin 

regimen)

Inclusion:

-enrolled in Colorado 

Indigent Care Program

-diagnosis of dyslipidemia

-treated with atorvastatin 

(prescribed by study clinic 

provider)

Exclusion: 

-taking amiodarone, 

verapamil, cyclosporine, 

and/or gemfibrozil

-history of transplantation 

or HIV

-no fasting lipid panel 

before statin conversion

-not adherent (based on 

refill history) with 

atorvastatin, or refused 

conversion

Improve 

outcomes 

following statin 

conversion

Reduction in 

concentration of 

LDL and LDL 

goal attainment

Clinical 

pharmacy 

specialists 

and year-2 

resident

N=30

Family medicine center patients:

-Conducted individual medical 

review to identify goal

-Reviewed patient LDL goal 

(NCEP ATP III); made 

therapeutic conversion to 

simvastatin, rosuvastatin, or 

ezetimibe-simvastatin (dose 

based on whether or not patient 

had achieved LDL goal on 

atorvastatin)

Mode/Frequency:

-Pharmacist did medication 

review, contacted patients to 

explain changes made

-Patients asked to see PCP at 3 

months (lipid panel, other tests)

N=87 unmatched

Internal medicine, 

cardiology, and 

endocrinology clinic 

patients

Usual care

When refill request for 

atorvastatin received, 

pharmacy contacted 

provider to 

recommend 

equipotent conversion 

Recommendation was 

optional and final 

selection was made by 

provider

Pharmacist 

collaborated 

with prescribing 

physician to 

approve new 

regimen
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

study/

follow-up

Inclusion/ Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Mazzolini 

200556

Retro 

cohort

Outpatient 

clinics 

(VA) 

Dyslipidemia

Reviewed 

charts until 

reached goal 

of 115 

patients in 

each group

Followed at 

least 6 

months after 

index visit

Inclusion:

Intervention group

-referred by primary care; 

referral is voluntary

-randomly selected study 

patients from all attending 

lipid education class

Control group 

-randomly selected from 

patients seen in primary 

care with diagnosis of 

dyslipidemia

Both groups 

-diagnosis of dyslipidemia 

-≥3 visits with pharmacist 

or primary care

-followed ≥6 months 

-enrolled in VA ≥1 year

Exclusion:

-documented noncompliance with 

appointments

-TSH > 4.5 m IU/ml any 

time during study period

Compare 

outcomes with 

pharmacistmanaged clinic 

vs care by other 

health 

professionals

Primary: 

Absolute values 

and percentage 

changes in 

LDL; proportion 

attaining LDL 

goal

Clinical 

pharmacists 

with 

prescribing 

authority for 

all VA 

formulary 

lipidlowering 

agents; 

perform all 

changes to 

lipidlowering 

medications 

once patient 

enrolls in 

lipid clinic

N=115

-Assessed and treated 

dyslipidemia to achieve goals 

based on NCEP ATP III 

guidelines and recent 

recommendations

-Education including treatment of 

dyslipidemia and therapeutic 

lifestyle modifications

-Follow-up visits: discuss 

patient’s lifestyle; changes in 

health status and current lipid 

profile reviewed; medication 

changes made if needed

-Discharged if goal lipid levels 

maintained for 2 or more 

consecutive clinic visits

Mode/Frequency:

-Initial visit at clinic including 

class session 

-Scheduled for follow-up visits in 

the clinic

N=115

unmatched, randomly 

selected

Usual care

Physicians, 

physician 

assistants, 

nurse 

practitioners

Dietitians 

(education 

sessions)
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Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

study/

follow-up

Inclusion/ Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Straka 

200557

CCT

Staffmodel 

HMO 

clinics

Coronary 

heart disease 

(CHD)

At least 6 

months 

follow-up after 

enrollment

Post-study 

follow-up of 

18 months to 

assess 

sustainability

Inclusion:

-age ≥18 

-CHD and LDL levels not at 

goal (<100 mg/dL)

Intervention group included 

1st 166 patients (of 359 

eligible) who signed 

consent form (16 

subsequently excluded)

Control group included all 

eligible patients

Manage hypercholesterolemia 

in patients with 

CHD

Primary: 

changes in 

magnitude of 

LDL, 

percentage 

achieving goal 

LDL levels

Clinical 

pharmacists

N=150

-Pharmacist and primary care 

provider cooperatively developed 

patient-specific care plan 

(implemented if physician 

approved and patient consented)

-Pharmacist implemented plan: 

-prescribing and adjusting 

dosages 

-obtaining fasting lipid panel 

-evaluating and setting up all 

lipid panels 

-working through dosage 

titrations 

-communicating actions, 

recommendations, findings to 

physician

-educating patients about 

risk/benefits of new or adjusted 

dosages

-providing advice about 

aspirin, diet, weight loss, 

exercise

-referring to other resources 

(smoking cessation, dietary 

counseling)

Mode/Frequency:

-Pharmacist met with PCP to 

come up with plan

-Patients contacted by telephone 

to follow-up for tests, to notify 

them of changes, and for 

education

-Lipid panel/liver tests at 

baseline and then every 6 

weeks, after stabilizing liver tests 

every 3-6 months, fasting lipid 

panel annually

N=331

Usual care (no clinical 

pharmacist providing 

oversight)

-Pharmacist 

and primary 

care provider 

cooperatively 

developed 

patient-specific 

care plan 

(implemented if 

physician 

approved and 

patient 

consented)

-Communicated 

actions, 

recommendations, findings 

to physician
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

study/

follow-up

Inclusion/ Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Ellis 

200058

RCT – 

IMPROVE 

substudy 

Primary 

care at 9 

VA 

Medical 

Centers

Dyslipidemia

12 months

IMPROVE Inclusion: 

-high risk for drug-related 

adverse events (meeting 

3+ of following a. ≥5 drugs 

in regimen, b. ≥12 

doses/day, c. ≥4 drug 

changes in past year, d. ≥3 

concurrent diseases, e. 

history of noncompliance, f. 

treatment with drugs 

requiring monitoring)

-VAMC patient ≥12 months

-expected to continue 

VAMC care

-residence close to VAMC 

-working telephone

SUB-STUDY:

-diagnosis of dyslipidemia

Exclusion: 

-seen in pharmacistmanaged clinics in past 12 

months

-life expectancy <12 

months

-psychiatric diagnosis 

requiring services of 

mental health clinic

-poor English

-visually impaired

LDL < 100 

mg/dl for 

secondary 

prevention in 

patients with 

coronary artery 

disease or

diabetes

LDL < 130 

mg/dl for all 

others

Primary 

outcome not 

specified

Ambulatory 

care clinical 

pharmacists

N=208 with dyslipidemia

Pharmaceutical care in addition 

to usual medical care

-Drug assessments

-Adjustments to medications to 

improve care and disease 

control

-Identify and prevent drugrelated problems

-Exact role varied depending on 

scope of practice (eg, adjust 

drug therapy, order lab tests) 

(NOTE: pharmacist intervention 

not limited to dyslipidemia)

Mode/Frequency:

-Initial visit

-Follow-up at least 3 times for at 

least 12 months

-Intervention continued until 

goals were met (patient-specific 

goals developed with physician 

and pharmacist)

N=229 with 

dyslipidemia

Usual care

Patient goals 

developed with 

physician
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

study/

follow-up

Inclusion/ Exclusion 

Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Bogden 

199759

RCT

University

-affiliated 

primary 

care 

teaching 

clinic

High total 

cholesterol

6 months

Inclusion: 

-total cholesterol ≥ 240 

mg/dL within 6 months 

before randomization

Exclusion:

-minors 

-patients unable to sign 

consent form

Lower 

cholesterol 

levels and meet 

NCEP goals 

(pharmacist and 

physician 

teamwork)

Change in total 

cholesterol from 

baseline level

NR N=50

-Recommendations to 

physicians on dosage, drug 

selection (eg, least costly 

regimen), monitoring

-Meeting prior to PCP visit

-medication history

-answer questions

-encourage compliance

-review laboratory data

Mode/Frequency:

-30-minute meeting with patients 

before their physician visit

-Clinic visits at 0 and 6 months, 

interim visits also occurred

N=50

Usual care (including 

access to pharmacy 

clerk at patient 

request)

Pharmacist 

gave 

recommendations to 

physician

Konzem 

199760

CCT

Primary 

care (VA)

Patients with 

hypercholeste

rolemia

52 weeks

Inclusion:

-Diagnosis of hypercholesterolemia

-prescribed colestipol 

hydrochloride oral 

suspension

-not presently receiving 

any other lipid-lowering 

drugs

-fasting lipid profile within 1 

month before starting 

colestipol 

Enhance 

patient 

acceptance and 

compliance with 

therapy and 

improve 

outcomes

Primary 

outcome not 

specified

Pharmacists 

who had 

received 

training on 

intervention 

tasks

N=17 (3 lost to follow-up)

-Therapy managed by 

pharmacist and physician 

(referred by physician)

-Pharmacist provided

-education 

-titrated dosages

-dietary analysis

-Telephone contacts to 

encourage compliance and 

evaluate acceptance of regimen

-Data collection at 26, 52 weeks

Mode/Frequency:

-Initial visit

-Contacted patients by telephone 

2, 4, and 6 weeks after initial visit

-Follow-up visit at 8 weeks to 

evaluate lab results and 

acceptance

N=20

Usual care, provided 

by physician; received 

drug counseling (what 

agent is for, 

instructions for taking) 

but no other contact 

from pharmacist

Physicians

ACE = angiotensin converting enzyme; BP = blood pressure; CAD = coronary artery disease; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; 

CPCRS = Clinical Pharmacy Cardiac Risk Service; DRP = drug related problem; ED = emergency department; EF = ejection fraction; EMR = electronic medical record; ESRD = 

end stage renal disease; HbA1c = glycosylated hemoglobin; HF = heart failure; HTN = hypertension; LDL-C = low-density lipoprotein cholesterol; HDL-C = high-density 

lipoprotein cholesterol; QOL = quality of life; TSH = thyroid-stimulating hormone
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 27. Drug-related Problems Outcomes – Dyslipidemia Studies

Study 

Intervention 

(n) 

Control (n)

Inappropriate 

dosage/prescription or omission 

% (n/N)

Ineffectiveness% (n/N) Drug-drug or drug-disease

interaction (describe) % (n/N)

Non-adherence to 

prescribed regimen (n/N)

Clinical/adverse 

events % (n/N)

Pharmacy 

componen

t

Control

Pharmacy 

componen

t

Control

Pharmacy 

componen

t

Control

Pharmacy 

componen

t

Control

Pharmacy 

componen

t

Control

Konzem 199760

IG=17

CG=20

NR NR NR NR NR NR Compliance

89% (9.2%) 

n=14

NR NR NR

CG = control group; IG = intervention group

Table 28. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – Dyslipidemia Studies

Study; 

Intervention (n)

Control (n)

All-cause mortality% (n/N) Health-related quality of life 

(describe) Access to care (describe) Patient satisfaction with care (describe)

Pharmacy 

component Control Pharmacy component Control Pharmacy component Control Pharmacy component Control

No studies reported

CG = control group; IG = intervention group 

Table 29. Healthcare Utilization and Cost Outcomes – Dyslipidemia Studies

Study; 

Intervention (n)

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other (describe)

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

component Control

Pharmacy 

component Control

Smith 2013

IG=21354

CG=219

Mean 

number of 

visits per 

patient

2.0 (1.3)

2.0 (1.3)

P = .77

NR NR NR NR Mean 

number of 

interventions 

per patient 

(eg, 

medication 

changes)

1.1 (1.8)

0.7 (1.1)

(P=.002)

NR NR
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study; 

Intervention (n)

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other (describe)

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

component Control

Pharmacy 

component Control

Miller 200855

IG=30

CG=87

NR NR NR NR NR NR Postconversion 

change in 

potency

Higher: 23%

Equivalent: 

70%

Lower 7%

Higher: 16%

Equivalent: 

48%

Lower: 36%

NR NR

Mazzolini 200556

IG=115

CG=115

Annual 

visits

2.97

2.98 

(P=.06) 

NR NR NR NR Use of lipidlowering 

agent

94% 

(108/115)

24% 

(28/115)

(P<.0001)a 

NR NR

Straka 200557

IG=150

CG=331

NR NR NR NR NR NR Use of lipid 

lowering 

therapy

Preintervention: 

57% 

(86/150)

Post: 

78% 

(117/150)

Preintervention: 

48% 

(158/331)

Post: 44% 

(146/331)

(P<.0001 

between 

groups postintervention)

NR NR

Ellis 200058

IG=208

CG=229

Physician 

visits

Baseline

769

12 months

799

Physician 

visits

Baseline 

850

12 months

925

NR NR NR NR NR NR Mean changes 

in costs from 

year before to 

year after 

randomization

Total: $1583

Hospitalizations

: $710

Clinic visits: 

$302

All drugs:

$269

Total: $1213 

Hospitalizations: $670

Clinic visits: 

$372

All drugs:

$106

All 

differences in 

change in 

mean

(P>.05)
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study; 

Intervention (n)

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other (describe)

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

component Control

Pharmacy 

component Control

Bogden 199759

IG=50

CG=50

Mean of 12 

clinic visits

Mean of 9 

visits

(P<.05) 

Reported frequencies of 

ER visits did not differ 

significantly between 

groups

NR NR 27 

medications 

started

21 

medications 

discontinued

16 dose 

increases

NR Mean 

medication 

charge in last 

month

$11.40 

decrease per 

patient from 1st

month

$3.82 

increase

(P=NS) 

Konzem 199760

IG=17

CG=20

NR NR NR NR NR NR Percent 

continuing 

colestipol

8 weeks: 

80%

52 weeks: 

65%

Mean (std) 

dosage 

(g/day) at 8 

weeks: 

18 (4)

52 weeks: 

13 (5)

Continuing

8 weeks: 

70%

52 weeks: 

40%

(P<.05 at 52 

weeks)

Dosage

8 weeks: 

10 (3)

52 weeks: 

9 (2)

(both P<.05)

NOTE: 

discontinued 

because of 

side effects, 

noncompliance, and 

dissatisfaction

NR NR

CG = control group; IG = intervention group

a Calculated P value (not reported in study)
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 30. Goal Attainment Outcomes – Dyslipidemia Studies

Study;

Intervention (n)

Control (n)

Patient Goal Attainment definition

Percentage of patients attaining goal (n/N) 

Pharmacy component Control

Smith 201354

IG=213

CG=219

Individually set LDL goals based on NCEP/ATP III 

guidelines

80.3%

OR 2.6 (95% CI 1.6, 4.3), P<.001

65.3%

Miller 200855

IG=30

CG=87

LDL goal based on risk factors Pre-conversion: 80%

Post: 97% 

(P=.04, pre vs post)

Pre-conversion: 90%

Post: 75%

(P=.01, pre vs post)

Mazzolini 200556

IG=115

CG=115

LDL goal

TC

HDL

TG

64.3%

Change: 45.2% to 82.6% P<.001

43.5% to 23.5% P=.002

56.5% to 65.2% P=.224

15.7% (P<.001)

Straka 200557

IG=150

CG=331

LDL < 100 mg/dl 72%

Difference remained significant after 18 months 

post-intervention follow-up

18% (P<.001)

Ellis 200058

IG=208

CG=229

LDL < 100 mg/dl Baseline: 26% (23/89)

Follow-up: 40% (49/124)

Baseline: 22% (24/107)

Follow-up: 35% (40/116)

P=.97 for difference between groups 

at end of study

Bogden 199759

IG=50

CG=50

LDL goals based on comorbid conditions and risk 

factors (< 160 mg/dL, < 130 mg/dL, or < 100 mg/dL)

Total Group:

43% (20/27)

Goal of <160 or <130 mg/dL

38% (13/34)

Goal of < 100 mg/dL

54% (7/13)

21% (10/47) (P<.05)

14% (5/36) (P<.05)

45% (5/11) (P>.05)

Konzem 199760

IG=17

CG=20

LDL goal at week 8

LDL goal at week 52

42%

29%

15%

5% (P<.05)

CG = control group; IG = intervention group; LDL = low-density lipoprotein; OR = odds ratio 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

130

Table 31. Study and Intervention Characteristics – Hypertension Studies

Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Carter 

201561

CAPTION 

cRCT

32 primary 

care offices

Uncontrolled 

hypertensio

n (focus on 

minorities)

Randomized by office, office 

must have had an onsite clinical 

pharmacist

Inclusion:

-English or Spanish speaking

-age >18 years

-uncontrolled BP (>140/90mmHg 

or >130/80 mmHg for patients 

with DM or CKD)

Exclusion:

-current signs of hypertensive 

emergency (acute angina, 

stroke, or renal failure)

-systolic >200mmHg or diastolic 

>114mmHg

-history of MI, stroke, or angina 

(past 6 months)

-systolic dysfunction (LVEF 

<35%)

-GFR <20mL/min

-cirrhosis

-hepatitis B or C infection or 

laboratory abnormality in past 6 

months

-pregnancy

-pulmonary hypertension or 

sleep apnea (unless treated)

-life expectancy < 2 years

-residence in nursing home or 

dementia

-inability to give consent or 

impaired cognitive function

BP control

Blood 

pressure 

control at 9 

months

Clinical 

pharmacist

N=194 Brief intervention (9 months) 

N=207 Sustained intervention (24 months)

Interventions were the same

-Medical record reviewed by pharmacist

-Structured interview

-Medication history

-Assessment of knowledge of BP

medications, dosages, timing, potential 

side effects, barriers to adherence

-Create care plan with recommendations

for physician to adjust therapy and 

recommendations for patients for

medication education, improving 

adherence, and strategies for lifestyle 

modification

Mode/Frequency:

-Phone call at 2 weeks

-Structured face-to-face visits at baseline, 

1,2, 4, 6, and 8 months with options for 

additional visits

N=224

Usual care: 

Pharmacists 

instructed to 

avoid 

intervention 

for study 

participants 

but could 

provide usual 

care curbside 

consultations

if physicians 

specifically 

asked; 

control offices 

participated 

in an 

alternative 

distracter 

intervention 

for asthma

-Pharmacist 

created care 

plan; shared 

with physician 

who could 

accept, reject, 

or modify 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

131

Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Zillich 

201566

Retrospective 

case-control

Urban 

Midwest VA 

Medical 

Center, 

primary care 

clinics with 

PACT 

teamlets

HTN, 

referred to 

care 

management 

program

12 months

Cases: patients with HTN 

referred to care management 

program

Controls: patients with HTN not 

referred to program

Evaluate 

pharmacists 

HTN care 

management 

program with 

PCMH

Differences in 

systolic and 

diastolic BP 

levels at 6 

and 12 

months 

follow-up

Clinical 

pharmacists

N=465

Scope of practice allowed pharmacists to: 

-meet individually with patients

-provide patient education

-initiate, change, and discontinue 

medications

Mode/Frequency:

-Initial face-to-face visit with pharmacist

-Patient discharged from program when BP 

goals attained

-No information provided on mode or 

frequency of contacts after initial visit

N=1268 

(Matched 

[maximum of 

3:1] on 

physician, 

age, gender, 

diagnosis of 

DM and CKD, 

baseline 

systolic BP, 

number of 

HTN 

medications)

Usual care

PCP referred 

patients to 

pharmacist

Hirsch 

201469

RCT 

(pragmatic)

Universitybased

primary care 

clinic

Uncontrolled

HTN

6 and 9 

months

Inclusion: 

-age ≥18 years

-diagnosis of HTN with most 

recent BP measurement 

≥140/≥90 mm Hg (≥130/≥80 mm 

Hg for DM)

-current treatment with ≥1 antiHTN medication

-continuous active status with 

the clinic (defined as having a 

record of at least 1 visit in the 6 

months before screening)

Exclusion: 

-did not meet provisions of the 

clinical collaborative-practice 

protocol 

BP control

Mean change 

in BP from 

baseline

Clinical with 

>1y of 

pharmacy 

practice 

residency 

training and 

>7y 

experience 

in 

ambulatory 

care 

N=75

Medication-therapy management (MTM) 

-Pharmacist could initiate, change, or 

discontinue medication therapy for 

management of uncontrolled HTN

-Assessed patient knowledge of HTN and 

current treatment

-Reviewed treatment goals, self-monitoring 

behavior, medical and medication history

-Helped patient set goals. 

-Follow-up - reviewed progress toward 

goals, lab values, and adherence

Therapeutic decisions and timing of 

patients’ laboratory testing and follow-up 

visits left to pharmacists’ clinical opinion, in 

consultation with physician if needed

Mode/Frequency: 

-4 30-minute pharmacist visits (baseline, 3, 

6, & 9 months), independent of PCP visits, 

and other contacts (clinic or telephone) as 

needed for follow-up with pharmacist 

N=91

Usual care 

Internal 

medicine 

physician

-visits 

documented in 

EMR and 

shared
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

132

Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Magid 

201370

RCT 

(pragmatic)

HMO based

primary care 

clinic

HTN with 

higher than 

recommend

ed BP

6 months

Inclusion: 

-age 18 to 79 years

-diagnosis of HTN - 2 most 

recent BP readings ≥140/≥90 

mm Hg (≥130/≥80 mm Hg for 

DM or CKD)

-prescribed ≤3 anti-HTN 

medications 

-had computer/internet access.

Exclusion: 

-limited life expectancy

-recent MI, stroke, percutaneous 

coronary intervention, or 

coronary artery bypass graft 

surgery

-ESRD 

-not English speaking

BP control

Proportion of 

patients who 

attained their 

goal BP at 

the 6-month 

clinic visit

Clinical N=175 

American Heart Association Heart360 

Web-enabled home BP monitoring 

intervention

-Educational materials

-Pharmacist met with patient and reviewed 

medication regimen, home BP 

measurements and adherence to anti-HTN 

medications 

-Made medication adjustments/changes as 

needed

-Counseled on lifestyle changes

Mode/Frequency:

-Baseline and 6 months visits plus weekly 

review of BP summary reports

N=173 

Usual care 

PCP followup and 

educational 

materials

Primary care 

physician, 

medication 

changes 

communicated 

via EMR

Margolis 

201362

RCT 

(cluster) 

HMO based

primary care 

clinic

Uncontrolled

HTN

12 months

Plus 6 

months 

postintervention 

follow-up

Inclusion: 

-uncontrolled HTN (≥140/≥90 

mm Hg or ≥130/≥80 mm Hg for 

DM or CKD) at 2 most recent 

primary care visits in previous 

year

Exclusion: 

-stage 4/5 kidney disease or 

ratio of albumin to creatinine of 

≥700 mg/g

-acute coronary syndrome, 

coronary revascularization, or 

stroke ≤3 months 

-known secondary causes of 

HTN

-NYHA class III or IV CHF

-known left ventricular ejection 

fraction <30%

-pregnant

BP control 

Proportion of 

patients who 

attained their 

goal BP

Trained 

clinical 

N=228, 8 clinics 

Intervention patients received home BP 

telemonitors 

-Transmitted BP data to pharmacists; antihypertensive therapy adjusted accordingly

-1 hour in-person visit: reviewed history, 

education

-Patient given individualized home BP goal

-Telephone visits (every 2-4 wks)

-pharmacists emphasized lifestyle 

changes and medication adherence

-assessed and adjusted antihypertension therapy (with algorithms)

-managed adverse effects

Mode/Frequency:

-First 6 months: met every 2 weeks via 

telephone until BP control sustained for 6 

weeks; then monthly visits 

-During intervention months 7 through 12, 

telephone visits occurred every 2 months

N=222, 8 

clinics

Usual care 

Primary care 

physicians
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

133

Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Magid 

201167

RCT

VA, City/ 

county, and 

HMO based

primary care 

clinics

HTN

6 months

Inclusion: 

- HTN 

-taking ≤4 anti-HTN meds

-elevations in 2 of 3 most recent 

electronic BP measurements 

(>140/>90 mm Hg; for patients 

with DM/CKD, >130/80 mm Hg)

BP control

Proportion of 

patients who 

attained their 

goal BP and 

mean change 

in BP from 

baseline

Clinical N=174

Clinical pharmacist management of HTN 

with physician oversight

-Patient education

-Counseling on healthy therapeutic lifestyle 

changes

-Pharmacist practiced under pre-approved 

drug therapy management protocols

-Pharmacists reviewed home BP 

measurements, adherence to meds 

-Made medication adjustments as needed

Mode/Frequency:

-Baseline and 6 months visits plus weekly 

review of BP summary reports; if essential 

HTN, average home readings >135/85 mm 

Hg triggered pharmacist intervention 

(>125/75 mm Hg if diabetes or CKD)

N=164

Usual care 

Primary care 

physician, 

notified of 

changes via 

EMR/phone 

Carter 

200963 

RCT

(prospective 

cluster)

Communitybased family 

medicine 

residency 

program 

clinics

HTN

6 months

Inclusion: 

-age ≥21 years 

-essential HTN

-taking 0-3 anti-HTN meds

-if no DM: clinic systolic BP 140-

179 mm Hg or clinic diastolic BP 

90-109 mm Hg (130-179 mm Hg 

or 80-109 mm Hg with DM)

Exclusion:

-BP medication or dose change 

≤4 weeks prior to base-line visit

-BP >180/110 mm Hg 

-evidence of hypertensive 

urgency or emergency 

-recent MI or stroke (within 6 

months before enrollment)

-NYHA class III/IV CHF, unstable 

angina, renal/hepatic disease

-life expectancy <3 years

-dementia/cognitive impairment

BP control

Change in 

guideline 

adherence 

scores, % of 

patients with 

controlled 

BP, 

difference in 

mean systolic 

and diastolic 

BPs 

Clinical

-Residency 

in primary 

care 

N=192, 3 clinics

Pharmacists were encouraged to: 

-Assess medications and BP at baseline 

and at 1 month, at 3 months, and more 

frequently if necessary 

-Pharmacists made recommendations 

consistent with national guidelines

Mode/Frequency:

-Baseline, 3, and 6 months

-Pharmacists were encouraged to assess 

medications and BP more frequently if 

necessary

N=210, 3 

clinics

Usual care 

(Passive 

observation 

group

(intervention 

sites only)

n=191)

Physicians 

(and research 

nurses) 

-Collaboration 

on how to best 

implement 

intervention

-Pharmacists 

almost always 

provided faceto-face 

recommendations to PCP

-Physician 

education if 

necessary

-All therapy 

changes 

approved by 

physician
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

134

Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Carter 

200864

RCT 

prospective 

(cluster) 

Universitybased

primary care 

clinics

HTN

9 months

Inclusion: 

-age 21-85 years 

-HTN: if no DM clinic BP 145-

179 mm Hg/ 95-109 mm Hg 

(135-179 mm Hg or 85-109 mm 

Hg for patients with DM)

Exclusion: 

-BP medication or dose change 

≤4 weeks prior to baseline visit

-enrollment in 24-hour BP 

monitoring consult service ≤ 6 

months

-stage 3 HTN (BP >180/110 mm 

Hg)

-evidence of hypertensive 

urgency or emergency 

-recent MI or stroke (within 6 

months before enrollment)

-NYHA class III or IV CHF, 

unstable angina, serious renal or 

hepatic disease 

-poor prognosis (life expect. <3 

years)

-dementia or cognitive 

impairment

BP control

Difference in 

mean systolic 

and diastolic 

BPs and 

proportion of 

patients with 

controlled BP 

Clinical N=101, 2 clinics

Patient interview at baseline by clinical 

pharmacist

-Assessed patient’s regimen, suggested 

goal BP value, and provided 

recommendations to improve BP control 

-Primary focus of pharmacist was to 

address suboptimal medication regimens

-Recommended adherence aids

-Educated patients and/or taught them 

home monitoring

-Made patient-specific recommendations

-Recommend therapies consistent with 

JNC 7 guidelines

Mode/Frequency:

-Pharmacists encouraged to attend each 

clinic visit (2, 4, 6, and 8 months) and 

encouraged to initiate additional visits or 

telephone contact if BP remained 

uncontrolled

N=78, 3 

clinics

Usual care

Physicians 

(and nurses)

-Pharmacist 

educated 

physician and 

made 

recommendations

-Pharmacists 

could not 

independently 

prescribe 

therapy; all 

changes 

approved by 

physician

-Most 

recommendations to 

physician 

performed 

face-to-face 

during patient 

visit; some 

physicians 

provided 

authority for 

pharmacists to 

make dosage 

changes and 

inform PCP 

immediately 

after visit
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

135

Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Green 

200871

Ralston 

201474* 

RCT

Nonprofit, 

HMO-based 

primary care 

clinics

*Sub-study 

with n=186 

(intervention 

group), 

n=197 

(control 

group – all 

home BP 

and Web)

HTN

12 months

Inclusion: 

-age 25-75 years 

-HTN diagnosis 

-taking antihypertensive meds

-no diagnoses of DM, CVD or 

renal disease, or other serious 

conditions

Eligible and willing patients were 

invited to 2 screening visits at 

their clinic. If mean diastolic BP 

(last 2 of 3 BP recordings, with 

the first measurement dropped) 

was between 90-109 mm Hg or 

mean systolic BP was between 

140-199 mm Hg at both 

screening visits, participant was 

eligible for the study

BP control

Difference in 

mean systolic 

and diastolic 

BPs and 

proportion of 

patients with 

controlled BP

Clinical N=261

Pharmacist care plus home BP monitoring, 

and web training

-1 planned telephone visit to obtain a more 

detailed medication history and review 

allergies, intolerances, and CV risk factors 

-Introduced patient to action plan, a 

template with 5 components: 

1) instructions for home BP monitoring 

2) list of current medications 

3) ≥1 patient-selected lifestyle goal(s) from 

the list in the Group Health HTN pamphlet

4) recommended medication changes 

based on stepped medication protocols

5) follow-up plan

-Planned communication occurred over 

web every 2 weeks until BP controlled

-Responded to patients with specific 

recommendations (including medication 

changes)

Mode/Frequency:

-Baseline and 12 months

-All planned communications occurred over 

web every 2 weeks until BP controlled and 

less often thereafter

1) N=258 

Usual care 

2) N=259 

Home BP 

monitoring 

and web 

training only 

Pharmacist 

communicated 

with physician, 

all clinical 

concerns or 

potential 

deviations 

from the 

medication 

protocol were 

referred back 

to PCP
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

136

Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Hunt 200872

RCT

Nonprofit 

integrated 

system, 

primary care 

clinics

HTN and 

uncontrolled 

blood 

pressure

12 months

Inclusion: 

-HTN and uncontrolled BP, 

-office visit within past 2 years 

(problem list entry of 

hypertension (ICD-9 of 410.*)

-last systolic BP ≥160 mm Hg 

and/or a last diastolic BP ≥100 

mm Hg)

Exclusion: 

-no BP reading in chart in 

previous 2 years

-attended a visit with a pharmacy 

practitioner in previous 6 months

BP control

Difference in 

mean systolic 

and diastolic 

BPs 

Clinical N=230

Pharmacists:

-Reviewed subjects’ medications and 

lifestyle habits 

-Assessed vital signs

-Screened for adverse drug reactions

-Identified barriers to adherence

-Provided education

-Optimized anti-HTN regimen (titrating 

dose of existing medication, adding new 

agent, switching medication, or 

consolidating anti-HTN therapy)

-Follow-up appointments as needed

-Accessed patients’ medical records to 

assist medication selection and dosing

Mode/Frequency:

-Baseline visit with pharmacist

-Follow-up appointments as necessary 

N=233

Usual care 

Physician 

available to 

discuss HTN 

treatment 

plan/other 

medical issues 

as needed; 

notes from 

visit 

communicated 

via EMR

Borenstein 

200373

RCT

Community 

hospital

HTN

uncontrolled

12 months

Inclusion: 

-age ≥18 years 

-capitated medical insurance

-diagnosis code for HTN

-uncontrolled HTN (>140/90 of 

<65 years old or >160/90 if >65 

years old) based on last 

recorded measure(s)

Exclusion: 

-advanced dementia, terminal 

illness, organ transplantation, or 

secondary hypertension 

-absence of recorded blood 

pressure measurements

BP control

Difference in 

mean systolic 

and diastolic 

BPs 

Clinical N=98

-Pharmacists:

-Determined BP

-Collected patient assessments for 

adherence, potential drug side effects, 

and relevant patient habits (tobacco use, 

diet, and exercise), per JNC V guidelines

-During clinic, pharmacists reviewed drug 

side effects and provided education 

regarding individualized dietary and 

lifestyle modifications

-Called patient’s physician/covering 

physician, with findings and made 

treatment recommendations in accordance 

with evidence-based treatment algorithm

Mode/Frequency: 

-Follow-up visits every 2-4 weeks at 

discretion of pharmacist (as often as 

necessary until BP control achieved)

N=99 

Usual care 

Physician; 

physicians 

made all final 

treatment 

decisions
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

137

Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Vivian 

200268

RCT

Veterans 

Affairs 

Medical 

Center

HTN

6 months

Inclusion: 

-stage 1, 2, or 3 hypertension as 

defined by JNC VI (>140 systolic 

or >90 diastolic)

-age ≥18

-receiving anti-hypertension drug 

therapy

-not receiving care at 

pharmacist-managed clinic

Exclusion: 

-secondary cause of 

hypertension (CKD, 

renovascular disease, 

pheochromocytoma, Cushing’s 

syndrome, and primary 

aldosteronism)

-missed >3 appointments in last 

year

-were in hypertensive crisis 

(systolic BP >210 mm Hg or

diastolic BP >110 mm Hg) 

-NYHA class III or IV CHF, 

ESRD, psychiatric disorder, 

severe hepatic dysfunction, 

terminal cancer, or other 

condition with life expectancy to 

<1 year

BP control

Difference in 

mean systolic 

and diastolic 

BPs and 

proportion of 

patients with 

controlled BP

Clinical N=27

Pharmacist

-Prescribing authority

-Made appropriate drug therapy changes 

(in both drug selection and dosage) for 

blood pressure control in accordance with 

JNC VI 

-Did not make any changes in patients’ 

other drugs that may adversely affect blood 

pressure (eg, venlafaxine, sibutramine)

-Drug counseling provided at each visit 

(thorough discussion about side effects, 

recommended lifestyle changes, an 

assessment of compliance)

Mode/Frequency:

-Saw pharmacist 1 time/month

N=29

Usual care 

-Traditional 

pharmacist 

services (eg, 

distribution)

Not reported
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

138

Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Okamoto 

200175

RCT

General 

medicine 

clinics within 

a managed 

care facility

HTN

6 months

Inclusion:

-age ≥18 years

-diagnosed with essential HTN

-member of the managed care 

organization for ≥1 year

-fill prescriptions at managed

care organization’s pharmacies

-taking targeted anti-HTN drugs 

nifedipine, verapamil, captopril, 

diltiazem, clonidine, terazosin, 

propranolol, or lisinopril, or 

taking ≥3 prescription anti-HTN 

drugs

Exclusion: 

-secondary HTN (secondary to 

drugs or comorbid diseases 

including but not limited to CKD, 

cancer, Cushing’s syndrome, 

primary aldosteronism, or aortic 

coarctation) 

-significant end-organ disease 

(hospitalization likely within next 

few months)

-baseline blood pressure > 200 

mm Hg/105 mm Hg

BP control

Difference in 

mean systolic 

and diastolic 

BPs, quality 

of life, costs

Clinical N=164

-Pharmacist

-informed patients that effort would be 

made to decrease number of drugs for 

HTN or alter therapy by administering 

more appropriate/less expensive drugs 

to achieve similar or improved BP control

-determined most appropriate anti-HTN 

regimen for patient and ordered 

laboratory tests as needed 

-provided education on nonpharmacologic ways to control BP

Mode/Frequency: 

-visits at baseline and 6m

-pharmacist and physician could schedule 

additional appointments if necessary

N=166 

Usual care

Physicianmanaged

Not reported

Solomon 

199823

Gourley 

199824

RCT

Veterans 

Affairs 

Medical 

Center and 

university 

medical 

center

HTN

6 months

Inclusion:

-age ≥18 years

-receiving dihyropyridine or 

dihyropyridine and diuretic 

therapy for HTN

Exclusion: 

-symptomatic heart failure 

-taking any anti-HTN agent other 

than dihyropyridine

-evidence of alcohol or drug 

abuse

-participated in investigational 

drug trial within 30 days of 

enrollment

Evaluate 

effects of 

pharmacy 

care on 

humanistic 

outcomes

Compliance, 

knowledge, 

health 

resource use, 

QoL, 

satisfaction 

with care

Clinical N=63

Pharmacist care defined as 

-standardized patient assessment activities 

(physical assessment)

-regularly scheduled therapeutic and 

educational interventions

Mode/Frequency:

-5 clinic visits, every 4 to 6 weeks

N=70

Usual care 

(traditional 

pharmacy 

care) (n=70)

Not reported
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

139

Author, 

year

Study 

design

Type of 

Clinic

Target 

Population

Duration of 

Study/ 

Follow-up

Inclusion/Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

Pharmacist Pharmacist Intervention Comparator 

Intervention Collaboration

Erickson 

199765

CCT

University 

medical 

center

HTN

5 months

Inclusion:

-age ≥18 years

-read and speak English 

-diagnosis of essential HTN 

(baseline diastolic > 90 mm Hg 

and/or systolic > 140 mm

Hg) documented on their 

medical record, and be

-taking a prescribed 

antihypertensive drug

Exclusion: 

-secondary HTN (drug induced, 

pheochromocytoma, chronic 

renal disease or renovascular 

disease, Cushing’s syndrome, 

primary aldosteronism, 

coarctation of the aorta)

BP control

Primary 

outcome not 

specified

Clinical N=40

-Reviewed medical records

-Took drug history including current and 

previous prescription and nonprescription

therapy and presence of side effects

-Assessed patient-specific drug issues (ie, 

access to pharmacy services, concerns 

and beliefs about taking drugs), 

prescription drug coverage; compliance; 

patient knowledge about hypertension, 

lifestyle modification, and drug therapy

-Consulted with physicians about potential 

or observed drug-related problems

-Counseled patients regarding new or 

continued drug therapy; reinforcing the 

importance of lifestyle modification 

-Monitored drug therapy via interview and 

laboratory data

-Taking and/or interpreting blood pressure 

measurements

Mode/Frequency:

-Regularly scheduled clinic visits during 

study period

N=40

Usual care 

Not matched

Not reported

BP = blood pressure; CHF = congestive heart failure; CKD = chronic kidney disease; CV = cardiovascular; DM = diabetes mellitus; EMR= electronic medical record; ESRD = 

end-stage renal disease; HTN = hypertension; JNC V = Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure; MI = myocardial infarction; 

NYHA = New York Heart Association; PACT = patient-aligned care team; PCMH = patient-centered medical home; PCP = primary care provider; QoL= quality of life
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 32. Drug-related Problems Outcomes – Hypertension Studies

Study 

Intervention 

(n) 

Control (n)

Inappropriate 

dosage/prescription or 

omission % (n/N)

Ineffectiveness% (n/N)

Drug-drug or drug-disease

interaction (describe) % 

(n/N)

Non-adherence to 

prescribed regimen

% (n/N)

Clinical/adverse events % 

(n/N)

Pharmacy 

Component Control Pharmacy Component Control Pharmacy Component Control Pharmacy Component Control Pharmacy Component Control

Carter 201561

IG=194 (Brief)

IG=207 

(Sustained)

CG=224

NR NR NR NR NR NR NR NR No overall differences in the

frequency of subjects reporting 

any serious adverse event 

across the 3 groups

Zillich 201566

IG=465

CG=1,268

NR NR NR NR NR NR MPR at 12m

All BP meds

0.71 (0.19)

MPR >/=80% 

at 12m all BP 

meds

35%

0.71 (0.20) 

(P=.89) 

32% 

(P=.69)

NR NR

Hirsch 201469

IG=75

CG=91

Of patients with 

a drug problem:

Need for 

additional 

therapy

Baseline

42% (14/33)

6 months

58% (7/12)

9 months

25% (1/4)

Need for dose 

increase

Baseline

33% (11/33)

6 months

25% (3/12)

9 months

25% (1/4)

NR NR NR NR NR Of patients 

with a drug 

problem:

Nonadherence:

Baseline

15% (5/33)

6 months

8% (1/12)

9 months

25% (1/4)

NR Of patients 

with a drug 

problem:

Adverse drug 

reaction

Baseline

6% (2/33)

6 months 

16% (2/12)

9 months 

0 

NR

Magid 201370

IG=175

CG=173

NR NR NR NR NR NR Mean MPR

Baseline 0.86

6m 0.87 

(P=.93) 

Adherence to 

home BP 

monitoring

30% (49/162)

NR NR NR
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study 

Intervention 

(n) 

Control (n)

Inappropriate 

dosage/prescription or 

omission % (n/N)

Ineffectiveness% (n/N)

Drug-drug or drug-disease

interaction (describe) % 

(n/N)

Non-adherence to 

prescribed regimen

% (n/N)

Clinical/adverse events % 

(n/N)

Pharmacy 

Component Control Pharmacy Component Control Pharmacy Component Control Pharmacy Component Control Pharmacy Component Control

Margolis 201362

IG=228

CG=222

NR NR NR NR NR NR 6 monthsa

23%

12 monthsa 

31%

18 monthsa 

28%

6 monthsa

39%

(P=.04) 

12 monthsa 

36%

(P=.33) 

18 monthsa 

37%

(P=.06) 

Total: 49 

events

Hypotension, 

dizziness, or 

loss of 

conscious:

6 events

HTN related:

1 event

Stroke: 

2 events

Atrial 

fibrillation:

1 event

Angina: 

1 event

Total: 60 

events

Allergic 

reactions

attributed to 

HTN 

medicine: 

2 events

Hypotension, 

dizziness, or 

loss of 

conscious:

1 event

HTN-related:

4 events

Stroke: 

5 events

TIA: 

3 events

Atrial 

fibrillation: 

1 event

MI: 1 event

Cardiac 

bypass 

surgery:

2 events

Magid 201167

IG=174

CG=164

NR NR NR NR NR NR 6 monthsa

30%

6 monthsa

31%

(P=.93) 

based on 

subset of 

224 patients

NR NR

Carter 200963

IG=192

CG=210

NR NR NR NR NR NR Baseline

17%

(SD 28%)

6 months

15%

(SD 25%)

Baseline

19%

(SD 22%)

6 months

15%

(SD 21%)

(P=.98)

NR NR
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study 

Intervention 

(n) 

Control (n)

Inappropriate 

dosage/prescription or 

omission % (n/N)

Ineffectiveness% (n/N)

Drug-drug or drug-disease

interaction (describe) % 

(n/N)

Non-adherence to 

prescribed regimen

% (n/N)

Clinical/adverse events % 

(n/N)

Pharmacy 

Component Control Pharmacy Component Control Pharmacy Component Control Pharmacy Component Control Pharmacy Component Control

Carter 200864

IG=101

CG=78

NR NR NR NR NR NR Baseline

29%

9 monthsa 

6%

Baseline

11%

9 monthsa 

8%

(P=.369)

Adverse 

event scoreb 

Baseline

28.8

9 months

22.2

Adverse 

event scoreb

Baseline

26.5

9 months

18.3

(P=.135)

Green 200871

IG=261

Home BP and 

Web only 

CG=259

Usual care 

CG=258

Ralston 201474

(sub-study)

IG=186

CG=197 Home 

BP and Web

NR NR NR NR NR NR Adherence at 

least 80%

176/186 

(95%)

179/197 

(91%)

(P=.224)

(Ralston 

2014)

Nonfatal CV 

events

1% (3/261)

Nonfatal CV 

events

Usual care

<1% (2/258)

Home/web 

only

1.5% (4/259)

(Green 2008)

Hunt 200872

IG=230

CG=233

NR NR NR NR NR NR 12 monthsa

33%

12 monthsa

31%

(P=.77)

NR NR

Vivian 200268

IG=27

CG=29

NR NR NR NR NR NR >90% of patients in both 

groups stated they took their 

drugs as directed by their 

health care professional and 

did not take more than 

prescribed (P=1.00)

-Forgot to take drug ≥1x/wk 

IG: 68% CG: 48% (P=.252)

NR NR

Okamoto 

200175

IG=164

CG=166

NR NR NR NR NR NR NR NR None 

Reported

Cardiac 

problems

2 patients

Headache

1 patient

Dizziness

1 patient
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study 

Intervention 

(n) 

Control (n)

Inappropriate 

dosage/prescription or 

omission % (n/N)

Ineffectiveness% (n/N)

Drug-drug or drug-disease

interaction (describe) % 

(n/N)

Non-adherence to 

prescribed regimen

% (n/N)

Clinical/adverse events % 

(n/N)

Pharmacy 

Component Control Pharmacy Component Control Pharmacy Component Control Pharmacy Component Control Pharmacy Component Control

Solomon 1998

Gourley 1998c 

23,24

IG=63

CG=70

Drug needed not 

prescribed 1.6% 

(4/255 problems 

identified by 

pharmacists)

Drug not needed 

but prescribed

0.4% (1/255)

Dose problem

3.5% (9/255)

NR NR NR Risk of 

interaction

12.2% 

(31/255 

problems 

identified by 

pharmacists)

NR Patient 

compliance

0.23d 

Patient 

compliance

0.61d

(P<.05) 

NR by group NR by group

*All p-values versus control unless indicated. ARQ = Adverse reaction questionnaire; BP = blood pressure; CG = control group; CV = cardiovascular; IG = intervention group; MI 

= myocardial infarction; MPR = medication possession ratio; TIA = transient ischemic attacks a Values reported are the inverse of adherence to hypertension medication

b Adverse reaction questionnaire included 47 questions of typical medication adverse effects; patient could rate the potential reaction as follows: 0 (not at all), 1 (a little bit), 2 

(somewhat), 3 (quite a bit), or 4 (very much). The responses for each patient were summed (potential range, 0–188). c Drug problems or needs identified by pharmacist were reported but there were no comparator data

d Mean sum score (1 point for every “yes” non-compliance item) based on a 4-item scale self-reported adherence measure
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 33. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – Hypertension Studies

Study;

Intervention (n) 

Control (n)

All-cause mortality

% (n/N)

Health-related quality of life 

(describe) Access to care (describe) Patient satisfaction with care (describe)

Pharmacy 

component Control Pharmacy component Control Pharmacy component Control Pharmacy component Control

Hirsch 201469

IG=75

CG=91

NR NR NR NR NR NR Mean (SD) (0-

100 scale with 

higher # = higher 

satisfaction)

6 months

92.4 (10.9); n=49

9 months

92.7 (11.0); n=44

NR

Magid 201370

IG=175

CG=173

NR NR NR NR NR NR % very or 

completely 

satisfied with 

HTN care

58% 

(102/175)

42%

(73/173)

P<.001a 
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study;

Intervention (n) 

Control (n)

All-cause mortality

% (n/N)

Health-related quality of life 

(describe) Access to care (describe) Patient satisfaction with care (describe)

Pharmacy 

component Control Pharmacy component Control Pharmacy component Control Pharmacy component Control

Margolis 201362

IG=228

CG=222

NR NR SF-12 Physical

0-100

mean (95% CI)

Baseline

48.0

Change

6 monthsb

-0.50 (-1.56, 0.56)

12 monthsb

-0.84 (-2.0, 0.32)

18 monthsb

-0.54 (-1.77, 0.69)

SF-12 Mental

Baseline

52.2

6 monthsb

0.25 (-0.88, 1.38)

12 monthsb

-0.05 (-1.83, 0.78)

18 monthsb

1.51 (-0.18, 2.40)

SF-12 Physical

0-100, mean

(95% CI)

Baseline

47.3

Change

6 monthsb

-1.17 (-2.26, 0.07)

12 monthsb

-0.72 (-1.90, 0.45)

18 monthsb

-0.82 (-2.09, 0.45)

SF-12 Mental

Baseline

51.2

6 monthsb

0.09 (-1.08, 1.26)

12 monthsb

-0.78 (-2.11, 0.55)

18 monthsb

0.50 (-0.83, 1.84)

Can 

communicate 

with healthcare 

team:

mean (95% CI)

Baseline:

4.4 (4.2-4.5)

Change

6m:

0.08 (-0.02, 0.18)

12m:

-0.02 (-0.13, 0.1)

18m:

0.11 (-0.01, 0.21)

Had problems 

getting needed 

care:

Mean (95% CI)

Baseline:

1.7 (1.5, 1.9)

Change

6m

0.15 (-0.09, 0.39)

12m

0.15 (-0.15,0 .45)

18m

0.07 (-0.22, 0.35)

Can 

communicate 

with healthcare 

team:

Mean (95% CI)

Baseline:

4.4 (4.2-4.5)

Change

6m:

-0.06 (-0.16-

0.04)

12m:

0.07 (-0.04-0.18)

18m:

0.09 (-0.01-0.2)

Had problems 

getting needed 

care:

Mean (95% CI)

Baseline:

1.9 (1.6, 2.1)

Change

6m

0.18 (-0.07, 0.43)

12m

0.04 (-0.26, 0.35)

18m

0.05 (-0.24, 0.34)

CAHPS 0-5c

Overall rating of 

health care

Baseline 4.3 (4.2, 

4.4

Change

6 monthsb

0.27 (0.16, 0.39)

12 monthsb

0.22 (0.08, 0.35)

18 monthsb

0.26 (0.13, 0.38)

Baseline 4.3 (4.1, 

4.4

Change

6 monthsb

0.11 (-0.01, 0.23)

12 monthsb

0.18 (0.14, 0.32)

18 monthsb

0.15 (0.03, 0.28)
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Study;

Intervention (n) 

Control (n)

All-cause mortality

% (n/N)

Health-related quality of life 

(describe) Access to care (describe) Patient satisfaction with care (describe)

Pharmacy 

component Control Pharmacy component Control Pharmacy component Control Pharmacy component Control

Green 200871

IG=261

Home BP and Web 

only CG=259

Usual care CG=258

Ralston 201474

IG=186

CG=197 (Home BP 

and Web)

<1% (1/261)

Cardiac 

arrest 

Usual care

(0/258)

Home/web 

only

<1% 

(2/259)

cancer

SF-12 measures

0-100, 100 

highest

SF-12 General 

health

Baseline

67.1 (SD 20.4)

12 months

66.6 (22.2)

SF-12 Physical

Baseline

80.6 (SD 27)

12 months

81.0 (26.5)

SF-12 Emotional

Baseline

71.6 (SD 16.8)

12 months

71.7 (19.7)

SF-12 Gen. health

Baseline

67.1 (SD 20.4)

12 months

Usual care

66.7 (20.4)

Home/web only

66.6 (20.9)

SF-12 Physical

Baseline

80.6 (SD 27)

12 months

Usual care

78.1 (27.7)

Home/web only

77.7 (30.3)

SF-12 Emotional

Baseline

71.6 (SD 16.8)

12 months

Usual care

71.5 (17.7)

Home/web only

72.1 (16.8)

NR NR CAHPS 0-10c

Baseline

7.9 (SD 1.5)

12 months

8.3 (1.4)

PACIC Overall 

Mean (SD)

3.3 (0.8)

Baseline

7.9 (SD 1.5)

12 months

Usual care

8.1 (1.5)

Home/web only

8.1 (1.5)

(Green 2008)

2.5 (0.9)

(P<.001)

(Ralston 2014)

Hunt 200872

IG=230

CG=233

NR NR MOS SF-36

Physical

41

Mental

45

General Health

44

Physical

42 (P=.12)

Mental

44 (P=.16)

General Health

42 (P=.01)

NR NR Overall 

satisfaction

8.6

8.5 (P=.75)

Vivian 200268

IG=27

CG=29

NR NR SF-36

No statistically significant differences 

were noted between the 2 groups from 

baseline to end of study

NR NR Very satisfied 

with

pharmacy 

services

88% (23/26)

68% (18/27)

(P=.098)
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Study;

Intervention (n) 

Control (n)

All-cause mortality

% (n/N)

Health-related quality of life 

(describe) Access to care (describe) Patient satisfaction with care (describe)

Pharmacy 

component Control Pharmacy component Control Pharmacy component Control Pharmacy component Control

Okamoto 200175

IG=164

CG=166

NR NR SF-36

Only statistically significant difference at 

end of study was found in the rolephysical domain. Scores were 

significantly higher (P=0.03) in the 

Intervention group (78.5 vs. 70.7). No 

differences between groups for any 

other scores

NR NR NR NR

Solomon 1998

Gourley 199823,24

IG=63

CG=70

NR NR No statistically significant differences 

were noted between the 2 groups on 

QoL items

NR NR Greater satisfaction in the intervention 

group. Intervention group provided 

more positive responses (significant 

differences in 8/10 items from the 

Pharmaceutical Care Questionnaire) 

about their pharmacists compared with 

controls

Erickson 199765

IG=40

CG=40

NR NR Groups similar for SF-36 Health Survey 

scores 

NR NR NR NR

CAHPS = Consumer Assessment of Healthcare Providers and Systems survey; CG = control group; IG = intervention group; PACIC = Patient Assessment of Chronic Illness Care; 

QoL = quality of life; SF-36 = Short-Form 36 a All p-values versus control unless indicated

b Change from baseline (95% CI)

c 0 worst, 5 best
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Table 34. Healthcare Utilization and Cost Outcomes – Hypertension Studies 

Study; 

Intervention 

(n) 

Control (n)

Office visits (means (SD) 

unless otherwise 

indicated)

Urgent care or / 

Emergency room (ER) 

(means (SD) unless 

otherwise indicated)

Hospitalization

(means (SD) unless 

otherwise indicated)

Medications

(means (SD) unless otherwise 

indicated)

Costs or Other (describe)

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Carter 201561

IG=194 

(Brief) 

IG=207 

(Sustained)

CG=224

NR NR NR NR NR NR Dose increases 

or med additions

First 9 months

Brief: 3.1 (3.2)

Sustained:

2.7 (3.1)

At 12 months

Sustained: 

0.3 (0.8)

At 18 months

Sustained:

0.4 (1.2)

At 24 months

Sustained:

0.3 (0.9)

0.7 (1.0) 

(P<.001)

0.1 (0.5)

(P=.25) 

0.3 (0.7)

(P=.31) 

0.2 (0.5)

(P=.21) 

NR NR

Zillich 201566

IG=465

CG=1,268

NR NR NR NR NR NR Medication 

Changes during 

12 month followup:

4 types of BP 

meds had more 

changes (P<.01) 

in case group; 3 

types of med 

plus “others” 

were nonsignificant

NR NR NR

Hirsch 201469

IG=75

CG=91

PCP visits

Mean (SD)

1.8 (1.5)

PC and 

pharmacy

4.4 (1.9)

PCP visits

Mean (SD)

4.2 (1.0)

(P<.001)a 

PC and 

pharmacy

4.2 (1.0)

(P=.38)

NR NR NR NR NR NR NR NR
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Study; 

Intervention 

(n) 

Control (n)

Office visits (means (SD) 

unless otherwise 

indicated)

Urgent care or / 

Emergency room (ER) 

(means (SD) unless 

otherwise indicated)

Hospitalization

(means (SD) unless 

otherwise indicated)

Medications

(means (SD) unless otherwise 

indicated)

Costs or Other (describe)

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Magid 201370

IG=175

CG=173

Mean (SD) 

3.3 (2.5);

n=162

3.1 (2.3);

n=164

(P=.16) 

Mean(SD) 

0.04 (0.19)

n=162

0.05 

(0.23)

n=164

(P=.44) 

Mean (SD) 

0.03 (0.17) 

n=162

0.04 

(0.20);

n=164

(P=.57) 

No medication

4% (6/162)

≥1 dose increase

43% (69/162)

≥1 medications 

added

70% (113/162)

No medication

9% (15/164)

(P=.05) 

≥1 dose increase

12% (20/164)

(P<.001)

≥1 medications 

added

25% (41/164)

(P<.001)

NR NR

Margolis 

201362

IG=228

CG=222

Pharmacist 

visits: 11.4 

(SD 3.9)

NR NR NR non-CV 

hospitalizations

noted as 

most 

common 

adverse 

event out of 

n=49 events

non-CV 

hospitalizations 

noted as 

most 

common 

adverse 

event out 

of n=60 

events

Prescribed any 

HTN medication

Baseline 77%

Change

6 monthsb

17% (13, 20)

12 monthsb

18% (13, 21)

18 monthsb

18% (14, 21);

At months 6, 12, 

18 

95% were on 

HTN medication

Baseline 73%

Change

6 monthsb

6% (-2, 13)

(P<.01) 

12 monthsb

7% (-0.8, 14)

(P<.01) 

18 monthsb

8% (-0.3, 14)

(P<.05) 

At months 6, 12, 

18

79-81% were on 

HTN medication

Direct 

program 

costs

$1045 over 

the 12-month 

period

NR

Magid 201167

IG=174

CG=164

NR NR NR NR NR NR # HTN med. 

classes

Baseline 2.1 

Change

6 monthsb

0.3 

Intensity of HTN 

med. regimenc

Baseline 3.2 

6 monthsb

0.6 (P=.008)

# HTN med. 

classes

Baseline 2.1 

Change

6 monthsa

0.1 (P=.05)

Intensity of HTN 

med. regimenc

Baseline 3.3 

6 monthsb

0.2 (P=.008)

NR NR
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study; 

Intervention 

(n) 

Control (n)

Office visits (means (SD) 

unless otherwise 

indicated)

Urgent care or / 

Emergency room (ER) 

(means (SD) unless 

otherwise indicated)

Hospitalization

(means (SD) unless 

otherwise indicated)

Medications

(means (SD) unless otherwise 

indicated)

Costs or Other (describe)

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Carter 200963

IG=192

CG=210

NR NR NR NR NR NR Mean increase in 

# HTN meds.

from baseline

1.1 

# of HTN meds.

Baseline 1.3

6 months

2.4 (1.1) 

Mean increase in 

# HTN meds.

from baseline

0.3 (P<.001)

# of HTN meds.

Baseline 1.9

6 months

2.2 (1.1) (P=.22)

NR NR

Carter 200864

IG=101

CG=78

NR NR NR NR NR NR # HTN meds.

Baseline 1.5

9 months

2.4 (0.9)

# HTN meds.

Baseline 1.4

9 months

1.9 (1.0)

(P=.003)

NR NR

Green 200871

IG=261

Home BP 

and Web only 

CG=259

Usual care 

CG=258

PC visits

3.2

between 

groups

Modest 

significant 

decrease in 

% of 

patients with 

office visits 

to specialist 

in the 

intervention 

group 

(P=.04) vs. 

other groups

PC visits

Usual care

3.2

Home/web 

only

3.0

P=NS

NS

between groups

NS

between groups

# HTN med. 

classes

Baseline 1.64

12 months

2.16 (0.93)

(P<.001)

compared to all 

controls

Aspirin use

Baseline 49%

12 months

67% (149/222)

# HTN med. 

classes

Baseline 1.64

12 months

Usual care 

1.69 (0.85);

Home/web only 

1.94 (0.91)

Aspirin use

Baseline 49%

12 months

Usual care 

53% (124/234)

Home/web only 

56% (131/234)

NR NR
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Study; 

Intervention 

(n) 

Control (n)

Office visits (means (SD) 

unless otherwise 

indicated)

Urgent care or / 

Emergency room (ER) 

(means (SD) unless 

otherwise indicated)

Hospitalization

(means (SD) unless 

otherwise indicated)

Medications

(means (SD) unless otherwise 

indicated)

Costs or Other (describe)

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Hunt 200872

IG=230

CG=233

PCP

3.2 (2.7); 

n=142

Total

7.2 (3.3)

PC-HTN

1.8 (1.7)

Total-HTN

5.8 (2.6)

PCP

4.7 (3.1); 

n=130

(P<.0001)

Total

4.9 (3.3)

(P<.0001)

PC-HTN

2.9 (2.2)

(P<.0001)

Total-HTN

3.1 (2.4)

(P<.0001)

NR NR NR NR # HTN meds.

Mean (SD)

12 months

2.7 (1.2); n=142

# HTN meds.

12 months

2.4 (1.1); n=130

(P=.02) 

Use of 

generic antiHTN agent

51%

Use of 

generic 

anti-HTN 

agent

40%

(P=.008)

Borenstein 

200373

IG=98

CG=99

PC visits

3.4

Provider and 

pharmacy

8.0

PC visits

6.0 (P<.01)

Provider and 

pharmacy

6.6 (P=.06)

NR NR NR NR Patients

receiving at least 

one first-line antiHTN agent

Baseline

68%

12 months 

80% (78/98)

Change (P=.02)

Patients 

receiving at least 

one first-line antiHTN agent

Baseline

60%

12 months 

70% (69/99)

Change (P=.02)

Average 

provider visit 

costs/patient

$160

Increase in

drug costs 

from baseline

$11.31

Average 

provider 

visit 

costs/pati

ent

$195 

(P=.04) 

Increase 

in

drug costs 

from 

baseline

$4.25 

(P=.12)

Vivian 200268

IG=27

CG=29

77% (20/27) 

had ≥1 

appointment 

with 

physician 

63% (17/29) 

had 

appointment 

with PCP 

(P=0.372).

NR NR NR NR ACEI

69 (18/26)

NS for all other 

HTN meds

ACEI

96 (26/27)

(P=.052)

NS for all other 

HTN meds

NR NR
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Study; 

Intervention 

(n) 

Control (n)

Office visits (means (SD) 

unless otherwise 

indicated)

Urgent care or / 

Emergency room (ER) 

(means (SD) unless 

otherwise indicated)

Hospitalization

(means (SD) unless 

otherwise indicated)

Medications

(means (SD) unless otherwise 

indicated)

Costs or Other (describe)

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Pharmacy 

component Control

Okamoto 

200175

IG=164

CG=166

Clinic visits

5.25

Clinic visits

1.41

(P<.001)

None 4 patients No patient hospitalized 

during the study for

reasons related to BP

# HTN meds.

Baseline

2.18

6 months

2.12

# HTN meds.

Baseline

2.06 (P=.33)

6 months

2.2 (P=.67)

Drug costs/pt

$112 ($153) 

Clinic visit 

costs

$131 ($59)

Total cost/pt

$243 ($169)

Drug 

costs/pt

$149 

($230) 

(P=.08) 

Clinic visit 

costs

$74 ($89)

(P<.001)

Total 

cost/pt

$233 

($267)

(P=.71)

Erickson 

199765

IG=40

CG=40

Clinic visits

4.1

Clinic visits

3.5 (P=.06)

NR NR NR NR Number of antihypertensive therapies 

prescribed per person similar 

between groups

NR NR

ACEI = Angiotensin-converting enzyme inhibitor; CG = control group; CV cardiovascular; IG = intervention group; PC = primary care; PCP = primary care physician; pt = 

patient; SD = standard deviation a All p-values versus control unless indicated

b Change from baseline (95% CI) c Intensity of hypertension medication regimen was based on patient report of medication regimen (specific medication and dosage) with confirmation by reviewing the pharmacy 

list available through the site’s electronic medical record or the pill bottles that patients brought to the visits. For each patient, an average intensity score was derived based on the 

sum of the medication intensity score divided by the number of antihypertensive medications prescribed.
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 35. Goal Attainment Outcomes – Hypertension Studies

Study;

Intervention (n) 

Control (n)

Patient Goal Attainment definition

Percentage of patients attaining goal % (n/N) 

Pharmacy component Control

Carter 201561

IG=194 (Brief)

IG=207 (Sustained)

CG=224

BP <140/90 mmHg or <130/80 mmHg for 

patients with DM or CKD

9 months: 43% in intervention groups 9 months: 34%

OR 1.57 (0.99, 2.50) (P=.059)

Zillich 201566

IG=465

CG=1,268

BP <130/80 mmHg (DM or CKD)

BP <140/90 mmHg (Other)

Baseline: 35%

6m: 57%

12m: 64%

Baseline: 49% (P<.0001)

6month: 57% OR 1.1 (0.9-1.3) (P=.28)

12month: 60% OR 1.3 (1.1-1.6) (P=<.01)

Hirsch 201469

IG=75

CG=91

BP goal <140/<90 mm Hg;

<130/<80 mm 41Hg with comorbid diabetes

Baseline 53% (40/75)

6 months 81% (60/74) 

9 months 70% (50/71) 

Baseline 46% (41/89)

6 months 44% (40/91) (P<.001)

9 months 52% (47/91) (P<.02)

Magid 201370

IG=175

CG=173

BP goal <140/<90 mm Hg; <

130/<80 mm Hg with comorbid diabetes or 

CKD

Overall: 6 m 54% (95/175)

DM/CKD: 6 m 52% (42/81)

6 months, Overall 35% (61/173)

6 months, DM/CKD 22% (19/88)

(P<.05)

Margolis 201362

IG=228

CG=222

BP goal <140/<90 mm Hg;

<130/<80 mm Hg with comorbid diabetes or 

CKD

6 months 72% (148/206)

12 months 71% (141/198) 

18 months 72% (135/188) 

51% for patients attending all clinic visits 

at 6, 12,and 18 months

Differential change from baseline for 

patients attending all clinic visits (95% CI)

29.6 (13.1, 46.0)

6 months 45% (89/197) (P<.001)

12 months 53% (102/193) (P=.005)

18 months 57% (104/182) (P=.003)

21% for patients attending all clinic visits 

at 6, 12,and 18 months

Magid 201167

IG=174

CG=164

BP goal <140/<90 mm Hg; <130/<80 mmHg 

with comorbid diabetes or CKD

6 months

36% (49/136) 

6 months

35% (51/145) (P=.89)

Carter 200963

IG=192

CG=210

BP control was <140/90 mm Hg;

<130/ 80 mm Hg with comorbid diabetes or 

CKD

6 months 64% (122/191) 

6 months, non-diabetics 69% 

6 months, diabetics 46% 

6 months 30% (63/210) (P<.001)

6 months, non-diabetics 32% (P<.001)

6 months, diabetics 26% (P=.003)

Carter 200864

IG=101

CG=78

BP control was <140/90 mm Hg;

<130/ 80 mm Hg with comorbid diabetes or 

CKD

9 months, Overall

89% (90/101);

9 months, non-diabetics 91% 

9 months, diabetics 82% 

9 months, Overall

53% (41/78);

9 months, non-diabetics 63%

9 months, diabetics 24%

(P<.001)
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Study;

Intervention (n) 

Control (n)

Patient Goal Attainment definition

Percentage of patients attaining goal % (n/N) 

Pharmacy component Control

Green 200871

IG=261

Home BP and Web 

only CG=259

Usual care CG=258

BP goal <140/<90 mm Hg 12 months 

56% (133/237) (95% CI 49, 62%)

P<.01 

Patients With Systolic BP

at Baseline ≥160 mm Hg

54% (28/52) (95% CI 40, 67%)

P<.01 

12 months 

Usual care 31% (77/247) (95% CI 25, 

37%)

Home/web only 36% (89/246) (95% CI 30, 

42%)

Patients With Systolic BP

at Baseline ≥160 mm Hg

Usual care 20% (10/51) (95% CI 11, 33%)

Home/web only 26% (12/47) (95% CI 15, 

40%)

Hunt 200872

IG=230

CG=233

Target BP was <140/90 mm Hg 12 months, last study visit

62% (88/142)

12 months, last study visit

44% (57/130)

(P=.003)

Borenstein 200373

IG=98

CG=99

BP goal was <140/90 mm Hg for patients < 

65 years of age; <160/90 mm Hg for 

patients ≥65 years of age

12 months 60% (59/98) 12 months 43% (42/98)

(P=.02) 

Vivian 200268

IG=27

CG=29

BP below140/90 mm Hg 6 months 81% (21/26) 6 months 30% (8/27)

(P=.001)

Erickson 199765

IG=40

CG=40

BP goal ≤140/≤90 mm Hg 5 months 45% (18/40) 5 months 30% (12/40) (P=.17)

CG = control group; IG = intervention group; DM = diabetes mellitus; CKD = chronic kidney disease; NR=not reported; OR = odds ratio
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

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Table 36. Study and Intervention Characteristics – Polypharmacy/High Risk Studies

Author, 

year

Study 

design

Type of 

Clinic

Target Population 

Duration of study/

follow-up

Inclusion/ 

Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Lee 200677

FAME

Cohort 

(phase 1) 

followed by 

RCT 

(phase 2)

Outpatient 

general 

medicine 

service and 

Armed 

Forces 

Retirement 

Home (both 

Walter 

Reed Army 

Medical 

Center)

Older patients 

taking multiple 

medications

14 months 

3 phases:

-run-in phase: 

(n=200) 2 month 

run-in with no 

intervention; 

baseline 

adherence, BP, 

LDL determined

-phase 1: (n=174) 

6 month cohort, all 

patients received 

comprehensive 

program

-Phase 2: (n=159) 

6 month RCT 

(continuation of 

program or usual 

care)

Inclusion:

-age 65 or older

-taking at least 4 

chronic medications 

per day

Exclusion:

-did not live 

independently (ie, 

nursing home or 

assisted living 

excluded)

-serious medical

conditions such that 

1-year survival was 

unlikely

For RCT –

determine 

maintenance of 

medication 

adherence after 

withdrawal of 

intervention

Primary 

outcome: 

persistence of 

medication 

adherence

Clinical 

pharmacists

N=83 for RCT

-Individualized medication 

education

-Dispensing of medications in 

blister pack adherence aid

-Follow-up every 2 months

Mode/Frequency:

-Run-in phase: initial visit

-First phase: regular follow-up 

with clinical pharmacists every 2 

months

N=76 for RCT

Pre-study 

medication 

provision (no 

education, no 

blister packs)

Not reported
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Author, 

year

Study 

design

Type of 

Clinic

Target Population 

Duration of study/

follow-up

Inclusion/ 

Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Taylor, 

200378

RCT

Community

-based 

primary 

care 

(Family 

medicine) 

clinics 

affiliated 

with 

academic 

center 

(rural, highpoverty) 

Adults at high risk 

for medicationrelated adverse 

events

12 months

Inclusion:

-age ≥18 yrs

-receive care at 

participating clinics

-3 or more of these 

risk factors:

a. 5 or more meds

b. 12 or more 

doses/day

c. 4 or more med 

changes past year

d. 3 or more 

concurrent diseases

e. history of 

medication noncompliance, 

f. drugs requiring 

therapeutic 

monitoring

Exclusion:

-cognitive 

impairment

-history of missed 

office visits

-scheduling conflicts

-life expectancy < 1 

year

Determine effect 

of 

pharmaceutical 

care on 

prevention, 

detection, and 

resolution of 

drug-related 

problems in highrisk patients in a 

rural community

Primary outcome 

not specified

Clinical 

pharmacist

N=33

Usual medical care plus:

-20-minute meeting with 

pharmacist before PCP visit

-Evaluate therapy indication, 

effectiveness, dosage; 

correct/give practical directions; 

assess drug interactions, 

therapeutic duplication, duration 

of treatment, untreated 

indications, and expense

-Review medical record for medrelated problems

-Chart review - ensure drugs and 

allergies documented

-History to determine 

compliance; check for 

complications of therapies

-Comprehensive individualized 

patient education (review of 

disease, importance of lifestyle 

modifications, drug info)

-Monitor patients’ responses to 

drugs

-Attempt to improve compliance 

through simplified dosing, 

teaching techniques like peak 

flow meter use, inhaler use, 

glucometer use, pill boxes

Mode/Frequency:

-20-minute meeting with 

pharmacist

-Saw patients during follow-up 

visits

N=36

Usual medical 

care (no 

pharmacist 

intervention) 

Therapeutic 

recommendations 

communicated to 

physicians orally or 

written notes
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Author, 

year

Study 

design

Type of 

Clinic

Target Population 

Duration of study/

follow-up

Inclusion/ 

Exclusion Criteria

Goal of 

Intervention

Primary 

Outcome

Type of 

pharmacist Pharmacist Intervention Comparator 

intervention Collaboration

Malone et 

al, 2000 

and 

200179,80

RCT

VA Medical 

Center 

primary 

care clinics

Adult ambulatory 

care patients at 

high risk for drugrelated problems

12 months

Inclusion:

-VAMC patient for 

≥12 months, 

ongoing 

-3 or more of:

a. 5 or more meds

b. 12 or more 

doses/day

c. 4 or more med 

changes past yr

d. 3 or more 

concurrent diseases

e. h/o med noncompliance

f. drugs requiring 

therapeutic 

monitoring

Exclusion:

-participated in 

pharmacistmanaged clinics 

past year

-life expectancy <12 

mo

-psychiatry care

-non-English 

speaker

-visually impaired

“determine if 

clinical 

pharmacists 

could affect 

economic 

resource use 

and humanistic 

outcomes in a 

population of 

veterans

identified to be at 

high risk to 

experience a 

medicationrelated problem”

-economic

Costs

-HRQOL

-patient 

satisfaction

Clinical 

pharmacist

N=523

-Pharmacists practiced within 

scope of practice of respective 

VAMC

-Medical records reviewed and 

patients interviewed to optimize 

medication therapy

-Assess appropriateness of 

medication therapy

-Physical assessments, (eg, BP)

-Establish goals of medication 

therapy

-Assess medication compliance

-Conduct in-office laboratory 

tests (eg, finger stick blood 

glucose)

-Identify non-treated disease 

states that may benefit from 

pharmacological therapy

-Check for drug interactions

-Monitor meds for therapeutic 

effect and toxicity by requesting 

laboratory tests

-Patient education

-Refer patients to primary care 

physicians, specialists, and other 

health care providers

-Depending on site and scope of 

practice, start, stop, or change 

medication therapy

Mode/Frequency:

-At least 3 visits with clinical 

pharmacist (most face-to-face, 

few telephone)

N=531

Primary care with 

physician; no 

pharmacist 

contact

“clinical 

pharmacists 

worked with 

physicians and 

other health care 

providers”

BP = blood pressure; ER = emergency room; h/o=history of; HRQOL = health related quality of life; LDL = low density lipoprotein cholesterol; MAI = medication 

appropriateness index; PCP = primary care provider; RCT = randomized controlled trial; VAMC = Veterans Affairs Medical Center
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Table 37. Drug-related Problems Outcomes – Polypharmacy/High Risk Studies

Study 

Intervention 

(n) 

Control (n)

Inappropriate 

dosage/prescription 

or omission 

% (n/N)

Ineffectiveness% (n/N) Drug-drug or drug-disease

interaction (describe) % (n/N)

Non-adherence to 

prescribed regimen

% (n/N)

Clinical/adverse events 

% (n/N)

Pharmacy 

component Control Pharmacy component Control Pharmacy component Control

Pharmacy 

componen

t

Control Pharmacy 

component Control

Lee 200677

IG=83

CG=73

NR NR NR NR NR NR Mean (SD) 

adherence 

at end of 

RCT

95.5% 

(7.7%)

69.1% 

(16.4%)

(P<.001)

NR NR

Taylor 200378

IG=33

CG=36

Percent of 

prescriptions 

that were 

inappropriate 

Inappropriate 

dosage:

Baseline:

63.3%

(133/210 

prescriptions)

12 months:

12.9% 

(20/155 

prescriptions)

Inappropriate 

indication: 

Baseline: 

33.3% 

(70/210 

prescriptions)

12 months 

16.2% 

(25/155 

prescriptions)

Inappropriate 

dosage:

Baseline: 

62.3% 

(129/207)

12 months:

63.8% 

(143/224) 

(P=NR)

Inappropriate 

indication:

Baseline:

46.8% 

(97/207)

12 months:

48.2% 

(108/224)

(P=NR)

Baseline:

29.1% 

(61/210 

prescriptions

12 months: 

13.6% 

(21/155)

Baseline:

44.9% 

(93/207 

prescriptions)

12 months: 

44.6% 

(100/224) 

(P=NR)

Drug-drug

Baseline:

22.9% 

(48/210 

prescriptions)

12 months:

5.8% (9/155)

Drug-disease

Baseline:

18.6% 

(39/210)

12 months:

9.0% 

(14/155)

Drug-drug

Baseline:

17.9% (37/207 

prescriptions)

12 months:

22.8% 

(51/224)

(P=NR)

Drug-disease

Baseline: 

21.3% 

(44/207) 

12 months: 

19.6% 

(44/224)

(P=NR)

Mean 

compliance

12 months

100%

Mean 

compliance 

(SD) 

88.9 (6.3%)

(P=.115)

Patients with 

at least one 

“medication 

misadventure”

12 months: 

2.8% (4/33) 3.0% 

(3/36) 

(P=.73) 

CG = comparison group; IG = intervention group; NR = not reported; SD = standard deviation
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Table 38. Mortality, Quality of Life, Access, and Patient Satisfaction Outcomes – Polypharmacy/High Risk Studies

Study; 

Intervention (n) 

Control (n)

All-cause mortality

% (n/N)

Health-related quality of life 

(describe) Access to care (describe) Patient satisfaction with care (describe)

Pharmacy 

component Control Pharmacy component Control Pharmacy component Control Pharmacy component Control

Taylor 200378

IG=33

CG=36

NR NR SF-36, groups similar (P values 

not reported)

NR NR Pharmacy 

related 

satisfaction 

(reporting 

unclear)

81.9 (4.8)

89 (6.2) (P=.000)

Malone 2000, 

Malone 200179,80

IG=523

CG=531 

randomized; 447 

and 484 completed

NR NR SF-36, No clinically meaningful 

effect on HRQOL but evidence to 

suggest a dose-response 

relationship.

NR NR There was no difference in patient 

satisfaction between groups at 

baseline or over time.

CG = comparison group; HRQOL = health-related quality of life; IG = intervention group; NR = not reported; SD = standard deviation; SF-36 = Short-form 36
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Table 39. Healthcare Utilization and Cost Outcomes – Polypharmacy/High Risk Studies

Study; 

Intervention (n) 

Control (n)

Office visits

Urgent care visits/ 

Emergency room (ER) 

visits

Hospitalizations Medications Costs or Other (describe)

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

componen

t Control

Pharmacy 

component Control

Lee 200677

IG=83

CG=73

NR NR NR NR NR NR Mean 

number of 

antihypertensives 

used

2.6 (1.23)

2.61 (1.14)

(P=.93) 

NR NR

Taylor 200378

IG=33

CG=36

NR NR 4/33 (total)

Change 

from 

previous 12 

months: -12

6/36 (total)

Change 

from 

previous 12 

months: 0

(P=.044)

2/33 (total)

Change in 

hospitalizations from 

previous 12 

months: -22

11/36 (total)

Change in 

hospitalizations from 

previous 12 

months: 0

(P=.003)

Number of 

prescribed 

medications

mean (SD) 

at 12 

months: 

4.7 (2.0) 

Number of 

prescribed 

medications

mean (SD) 

at 12 

months: 

6.2 (2.0)

(P=.002)

Drug is not 

least 

expensive of 

options

Baseline: 

50% 

(105/210 

prescriptions)

12 months: 

38.7% 

(60/155) 

Baseline:

62.3% 

(129/207)

12 months: 

60.3% 

(135/224)

(P=NR)

Malone 2000, 

Malone 200179,80

IG=523

CG=531 

randomized; 447 

and 484 completed

Before: 

mean (SD) 

21.7 (21.0)

After: 26.3 

(20.8)

Mean 

increase 

4.8

Before: 

mean 20.6 

(17.2) 

After: 23.4 

(20.5)

Mean 

increase 

2.8

(P=.003)

NR NR Before: 

0.34 (0.78)

After: 

0.53 (0.98)

Mean 

increase 

0.13

Before:

0.36 (0.81)

After: 

0.57 (1.20)

Mean 

increase 

0.19

(P=.29) 

Before: 

Drug fills: 

56.9 (40.0)

Mean 

increase 

5.6

Before 

Drug fills: 

53.2 (34.5)

Mean 

increase 

4.0

(P=.12) 

Mean cost 

(all costs: 

clinic visits, 

drug, lab, 

and 

hospitalizations) 

baseline: 

$4,927

After: $5,947

Mean 

increase 

$1,020

Mean cost 

baseline 

$4,419

After 

$5,732

Mean 

increase 

$1,313

(P=.06) 

CG = comparison group; IG = intervention group; NR = not reported; SD = standard deviation
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Table 40. Goal Attainment Outcomes – Polypharmacy/High Risk Studies

Study;

Intervention (n) 

Control (n)

Patient Goal Attainment definition

Percentage of patients attaining goal (n/N) 

Pharmacy component Control

Lee 200677

IG=83

CG=73

Medication adherence > 80% at end of RCT 97% (75/77) 22% (15/69) 

(P<.001)

Taylor 200378

IG=33

CG=36

Hypertension (goal ≤ 140/90 mmHg, or ≤135/80mmHg 

if diabetic)

Diabetes (HbA1c ≤7.5%)

Dyslipidemia (ATP III guidelines)

Anticoagulation (INR 2-3)

91.7% (22/24)

100% (13/13)

77.8% (14/19)

100% (4/4)

27.6% (8/29)

(P<.005)

26.7% (5/16)

(P<.005)

5.9% (1/19)

(P<.005)

16.7% (1/6) 

(P=NS)

ATP III = Adult Treatment Panel III; CG = comparison group; IG = intervention group; INR = International Normalized Ratio; NR = not reported; NS = not statistically 

significant; RCT = randomized controlled trial
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APPENDIX D. RISK OF BIAS TABLES

Table 1. Risk of Bias for Cardiovascular Disease, Dyslipidemia, Chronic Obstructive Pulmonary Disease, and Chronic Kidney Disease 

Studies 

Author, Year Randomized? Sequence 

Generation

Allocation 

Concealment

Risk of Bias from 

Confounding (nonrandomized)

Blinding Incomplete 

Outcome

Reporting

Selective 

Reporting

Overall

Cardiovascular Disease or Risk Factors for Cardiovascular Disease

Taveira 201411 Y unclear unclear unclear low low Medium

Irons 201212 N high high unclear low low High

Coronary Artery Disease

Spence 201413 N high high unclear low low High

Olson 200914 Y low unclear unclear unclear low Medium

Congestive Heart Failure

Gattis 199915 Y low unclear low low low Low

Murray 200716 Y low unclear low unclear low Medium

Dyslipidemia

Smith 201354 N high low unclear low low Medium

Miller 200855 N high high unclear unclear low High

Mazzolini 200556 N high high unclear low low High

Straka 200557 N high high unclear low low High

Ellis 200058 Y high low low high low Medium

Bogden 199759 Y unclear unclear unclear low low Medium

Konzem 199760 N low high unclear low high High

Chronic Obstructive Pulmonary Disease

Cooney 201520 Y low low low unclear low Low

Aspinall 

2012/201321,22 N unclear high unclear low low Medium

Solomon 199823

Gourley 199824 Y low unclear high unclear low Medium

Chronic Kidney Disease

Pai 2009 (2 

articles18)

17 Y (pilot) low low unclear high high Medium

Bucaloiu 200719 N low high unclear low low Medium
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Table 2. Risk of Bias for Depression Studies

Author, Year Randomized? Sequence 

Generation

Allocation 

Concealment

Risk of Bias from 

Confounding (nonrandomized)

Blinding Incomplete 

Outcome 

Reporting

Selective 

Reporting

Overall

Adler 200425 Y low low low high low Low

Capoccia 200426 Y unclear unclear unclear low low Medium

Finley 200328 Y unclear low low high low Medium

Finley 200229 N high high low high low High

Table 3. Risk of Bias for Diabetes Studies

Author, Year Randomized? Sequence 

Generation

Allocation 

Concealment

Risk of Bias from 

confounding (nonrandomized)

Blinding Incomplete 

Outcome 

Reporting

Selective 

Reporting

Overall

McAdam-Marx 

201553 N low unclear unclear low low Medium

Rothman, 200539 Y low low low low low Low

Skinner 201535 N low low unclear low low Low

Chung, 201450 N high low unclear low low Medium

Spence, 201413 N high low high low low Medium

Brummel, 201346 N high high unclear low low High

Ip, 201343 N unclear low unclear low low Medium

Jacobs, 201238 Y low low unclear low low Low

Salvo, 201249 N high unclear high low low Medium

Cohen, 201132 Y unclear unclear unclear low low Medium

Padiyara, 201145 N high low unclear low unclear Medium

Pape, 201148 Y unclear unclear unclear high low Medium

Taveira, 201130 Y low low unclear low low Low

Heisler, 

2010/201233,34 Y low low unclear low low Low

Jameson, 201036 Y low low unclear low low High

Johnson, 201042 N high high unclear low low High

Taveira, 201031 Y unclear unclear low low low Medium

Fox, 200947 N high low unclear low low Medium

Scott, 200640 Y low unclear unclear unclear low Medium

Kelly, 200044 N high unclear unclear high low Medium

Odegard, 200551 Y unclear unclear low high unclear Medium

ShaneMcWhorter, 

200541 N unclear high unclear low low High
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Author, Year Randomized? Sequence 

Generation

Allocation 

Concealment

Risk of Bias from 

confounding (nonrandomized)

Blinding Incomplete 

Outcome 

Reporting

Selective 

Reporting

Overall

Stroup, 200352 Y unclear unclear high low low Medium

Jaber, 199637 Y unclear unclear high low low Medium

Table 4. Risk of Bias for Hypertension Studies

Author, Year Randomized? Sequence 

Generation

Allocation 

Concealment

Risk of Bias from 

confounding (nonrandomized)

Blinding Incomplete 

Outcome 

Reporting

Selective 

Reporting

Overall

Carter 201561 Y unclear unclear unclear low low Medium

Zillich 201566 N low low unclear low Low Low

Hirsch, 201469 Y low unclear NA uncleara low low Medium

Magid 201370 Y low unclear NA low low low Medium

Margolis 201362 Y cluster unclear unclear NA high low low Medium

Magid 201167 Y low unclear NA low low low Medium

Carter 200963 Y cluster unclear unclear NA unclear low low Medium

Carter 200864 Y cluster unclear unclear NA low low low Medium

Green 200871 Y low low NA low low low Low

Hunt 200872 Y low unclear NA low highb low Medium

Borenstein 

200373 Y unclear unclear NA unclear low low Medium

Vivian 200268 Y unclear unclear NA high low low Medium

Okamoto 200175 Y unclear unclear NA unclear low low Medium

Solomon 199823

Gourley 199824 Y low unclear NA high unclear low Medium

Erickson 199765 N high high unclear high low High a Potentially not blinded. Chart reviews were conducted by 2 clinical coordinators, one of whom was the study coordinator for this study. 

b Very high attrition
Pharmacist-led Chronic Disease Management Evidence-based Synthesis Program

165

Table 5. Risk of Bias for Polypharmacy Studies

Author, Year Randomized? Sequence 

Generation

Allocation 

Concealment

Risk of Bias from 

Confounding (nonrandomized)

Blinding Incomplete 

Outcome 

Reporting

Selective 

Reporting

Overall

Polypharmacy/High Risk

Lee 200677 Y (Phase 2) low low high low low Low

Taylor 200378 Y unclear unclear unclear high low Medium

Malone 2000 and 

200179,80 Y low unclear low high low Medium