Evidence-based Synthesis Program Department of Veterans Affairs

Health Services Research & Development Service

Investigators:

Principal Investigator:

Daniel W. Bradford, MD, MPH

Co-Investigators:

Monica N. Slubicki, MD

Jennifer McDuffie, PhD

Amy Kilbourne, PhD

John W. Williams Jr., MD, MHSc

Research Associate:

Avishek Nagi, MS

Medical Editor:

Liz Wing, MA

Prepared for:

Department of Veterans Affairs

Veterans Health Administration

Health Services Research & Development Service

Washington, DC 20420

Prepared by:

Evidence-based Synthesis Program (ESP) Center 

Durham Veterans Affairs Healthcare System

Durham, NC

John W. Williams Jr., MD, MHSc, Director

Effects of Care Models to Improve 

General Medical Outcomes 

for Individuals With 

Serious Mental Illness

September 2011
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Effects of Care Models to Improve General Medical Outcomes

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This report is based on research conducted by the Evidence-based Synthesis 

Program (ESP) Center located at the Durham VA Medical Center, Durham, NC, 

funded by the Department of Veterans Affairs, Veterans Health Administration, 

Office of Research and Development, Health Services Research and Development. 

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 (e.g., 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.

PREFACE

Health Services Research & Development Service’s (HSR&D’s) Evidence-based Synthesis 

Program (ESP) was established to provide timely and accurate syntheses of targeted healthcare 

topics of particular importance to Veterans Affairs (VA) managers and policymakers, as they 

work to improve the health and healthcare of Veterans. The ESP disseminates these reports 

throughout VA.

HSR&D provides funding for four ESP Centers and each Center has an active VA affiliation. The 

ESP Centers generate evidence syntheses on important clinical practice topics, and these reports 

help:

• develop clinical policies informed by evidence,

• guide the implementation of 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.

In 2009, the ESP Coordinating Center was created to expand the capacity of HSR&D Central 

Office and the four ESP sites by developing and maintaining program processes. In addition, 

the Center established a Steering Committee comprised of HSR&D field-based investigators, 

VA Patient Care Services, Office of Quality and Performance, and Veterans Integrated Service 

Networks (VISN) Clinical Management Officers. The Steering Committee provides program 

oversight, guides strategic planning, coordinates dissemination activities, and develops 

collaborations with VA leadership to identify new ESP topics of importance to Veterans and the 

VA healthcare system.

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

Coordinating Center Program Manager, at nicole.floyd@va.gov.

Recommended citation: Bradford DW, Slubicki MN, McDuffie JR, Kilbourne AM, Nagi A, 

Williams JW Jr. Effects of Care Models to Improve General Medical Outcomes for Individuals 

With Serious Mental Illness. VA-ESP Project #09-010; 2011
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TABLE OF CONTENTS

EXECUTIVE SUMMARY

Background.................................................................................................................................................... 1

Methods......................................................................................................................................................... 1

Data Synthesis............................................................................................................................................... 2

Peer Review................................................................................................................................................... 2

Results ........................................................................................................................................................... 2

Abbreviations Table....................................................................................................................................... 5

INTRODUCTION

Background.................................................................................................................................................... 6

METHODS

Topic Development........................................................................................................................................ 9

Analytic Framework...................................................................................................................................... 9

Search Strategy............................................................................................................................................ 10

Study Selection............................................................................................................................................ 10

Data Abstraction .......................................................................................................................................... 12

Quality Assessment ..................................................................................................................................... 12

Data Synthesis............................................................................................................................................. 12

Rating the Body of Evidence....................................................................................................................... 13

Peer Review................................................................................................................................................. 13

RESULTS

Literature Flow ............................................................................................................................................ 14

Study Characteristics................................................................................................................................... 15

KQ 1. What types of care models have been evaluated prospectively that integrate mental health 

care and primary medical care with the goal of improving general medical outcomes for individuals 

with serious mental illness (SMI)? .............................................................................................................. 17

KQ 2. Do models of integrated care for individuals with SMI improve the process of care for 

preventive services (e.g., colorectal cancer screening) and chronic disease management 

(e.g., annual eye examination in patients with diabetes mellitus [DM])? ................................................... 20

KQ 3. (3a) Do models of integrated care for individuals with SMI improve general functional status 

outcomes (e.g., as measured by SF-36) or disease-specific functional status outcomes (e.g., Seattle 

Angina Questionnaire) related to medical care for chronic medical conditions such as DM, 

hypertension, or heart failure? (3b) Do models of integrated care for individuals with SMI improve 

clinical outcomes related to preventive services (e.g., influenza rates) and chronic medical care 

(e.g., kidney disease, amputations, retinopathy in patients with coexisting DM)? ..................................... 23

KQ 4. What are the gaps in evidence for determining how best to integrate care to improve 

general medical outcomes for individuals with SMI?................................................................................. 25
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SUMMARY AND DISCUSSION

Summary of Evidence by Key Question ..................................................................................................... 29

Limitations................................................................................................................................................... 32

Recommendations for Future Research....................................................................................................... 33

REFERENCES ................................................................................................................................................... 35

APPENDIX A. Search Strategy................................................................................................................. 41

APPENDIX B. Study Selection Form...................................................................................................... 42

APPENDIX C. Criteria Used in Quality Assessment ....................................................................... 44

APPENDIX D. Peer Review Comments/Author Responses ............................................................ 46

APPENDIX E. Excluded Studies................................................................................................................ 52

APPENDIX F. Glossary ................................................................................................................................. 57

FIGURES

Figure 1. Analytic framework for general medical outcomes for SMI ....................................................... 10

Figure 2. Literature flow diagram................................................................................................................ 14

TABLES

Table 1. Summary of inclusion and exclusion criteria ............................................................................. 11

Table 2. Summary of included studies...................................................................................................... 16

Table 3. SMI intervention characteristics informed by Wagner’s Chronic Care Model .......................... 18

Table 4. Process of care outcomes for preventive care (KQ 2)................................................................ 22

Table 5. Process of care outcomes for chronic disease management (KQ 2)........................................... 22

Table 6. Outcome measures...................................................................................................................... 24

Table 7. Outcome summary for KQ 3 ...................................................................................................... 24

Table 8. Summary of gaps in evidence..................................................................................................... 25

Table 9. Ongoing studies evaluating integrated approaches..................................................................... 28

Table 10. Strength of evidence by key question......................................................................................... 29

Table 11. Quality assessment for the four RCTs........................................................................................ 45
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EVIDENCE REPORT

INTRODUCTION

Individuals with serious mental illness (SMI) have shortened life expectancies relative to the 

general population1,2 to an extent that is not explained by unnatural causes such as suicide 

or accidents. Epidemiological studies have estimated the life expectancy of individuals with 

schizophrenia to be 10 to 25 years less than the general population.3-6 Increased morbidity of both 

chronic and acute illnesses in individuals with SMI also reduces quality of life and increases the 

overall burden of disability beyond that of the SMI itself. SMIs have an overwhelming economic 

impact, as measured by direct and indirect costs, including health care costs, disability payments, 

lost productivity, and law enforcement costs. For example, one study estimated annual costs due 

to schizophrenia to be $62.7 billion annually in the U.S.,7

 and patients with bipolar disorder are 

estimated to have the highest total health care costs of any mental illness8,9 with up to 70 percent 

of these costs in non–mental health (e.g., primary care) settings.10,11 Given these issues, methods 

to improve general medical services for individuals with SMI is a pressing priority.

BACKGROUND 

The issues that influence general medical outcomes for individuals with SMI are complex and 

overlapping and likely vary by disease state. Relevant factors can be categorized to include 

population characteristics, contextual and system factors, provider factors, and community 

resources. Interventions aimed at improving general medical outcomes in this population could 

be directed at any one, or several, of these factors. 

The populations of individuals with SMI have consistently shown higher rates of illnesses, such 

as infectious disease,12 diabetes,13-15 respiratory illness,16 and cardiovascular disease,17,18 than the 

general population. Modifiable risk factors for poor health, such as smoking,19 obesity,20,21 alcohol 

and substance abuse,22 and lack of exercise,23 are highly prevalent in individuals with SMI—as 

are obstacles to optimal health care such as poverty,24 homelessness,25 and social isolation.26

Multiple studies show diminished guideline concordance of general medical care provided to 

individuals with SMI , as evidenced by reduced receipt of preventive medical services27,28 and 

lower quality of chronic disease management for illnesses such as diabetes29,30 and cardiovascular 

disease31 as well as acute illnesses such as myocardial infarction.32 In addition, psychiatric 

medications can be risk factors for poor health given the association with some pharmacological 

treatments and medical outcomes such as increased risk of sudden death,33 hyperglycemia,34

hyperlipidemia,35 and weight gain.36

Effectiveness of Health Care Providers

The effectiveness of health care providers in optimizing general medical outcomes in individuals 

with SMI depends on multiple factors, including the type and level of training for working 

with this complex population, attitudes and beliefs about individuals with SMI, and knowledge 

of specific issues affecting individuals with SMI. The range of professionals involved with 

providing psychiatric care to patients with SMI includes disciplines with little or no training in 
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medical issues. Among physician mental health providers (i.e., psychiatrists), general medical 

training is typically limited to less than 6 months of direct service in internal medicine settings. 

Further, general medical providers usually have limited experience working with patients with 

SMI. Although combined training programs, such as those in psychiatry and internal medicine, 

produce physicians who are well trained to address both medical and psychiatric problems, there 

are relatively few of these programs—only 17 in the U.S.37—so graduates of such programs 

represent a small minority of those who provide general medical services along with SMI care. 

Settings of Care

The characteristics of various sites of care where individuals with SMI receive general medical 

services affect the general medical outcomes of this population. Individuals with SMI may 

receive psychiatric and general medical care at sites separated by geography, organization, 

financing, and/or culture.38 While integration of mental health and primary care services has 

been implemented in some settings for depressive and anxiety disorders, general medical 

and psychiatric services typically are received at different sites for individuals with SMI. 

Payment structures may not incentivize collaboration of care among medical and psychiatric 

care providers, making the increased time challenging for this important element of care. 

Even in integrated systems with single payers, medical and psychiatric care systems may be 

held accountable for outcomes that sometimes lead to conflicting medical decisions (e.g., 

psychotropic medication choice may lead to improved psychiatric symptom control while 

worsening metabolic indices). 

Supportive Services

A further impact to general medical outcomes in persons with SMI may be the availability of 

various types of supportive services that facilitate overall well-being and access to care. While 

it has not been systematically studied to this point, the availability of housing, intensive case 

management services, and employment support would be expected to positively influence 

adherence to recommendations and the ability of persons with SMI to access general medical care. 

Integration of Care

In this evidence synthesis, we sought to elucidate the best ways to integrate medical and mental 

health care to improve general medical outcomes in individuals with SMI. We were interested 

in understanding methods of integration of care for those whose psychiatric disability causes the 

greatest barriers to general medical care and for whom the site of greatest interaction with health 

care is the psychiatric setting. The term “serious mental illness” has been defined multiple ways 

and includes groupings of diagnoses and ratings of functional impairment, such as the Global 

Assessment of Functioning. Because the rating of illness severity—particularly those elements 

(e.g., cognitive functioning, communication abilities) that are most likely to have an impact on the 

quality of general medical healthcare received—is rarely reported in studies of general medical care 

in persons with SMI, we used reported psychiatric diagnoses as the best available proxy. 

For this review, we chose to focus on the mental disorders of schizophrenia, schizoaffective 

disorder, and bipolar disorder as representative of the more serious mental illnesses. Lending 

support to this decision are the results of an analysis of a nationally representative survey39
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showing that individuals with psychotic disorders and bipolar disorder, but not major depression, 

were less likely than the general population to have a primary care provider even after 

controlling for demographics, income, and insurance status. Another factor in this choice was 

the large body of literature40,41 and subsequent reviews42,43 that have described efforts to integrate 

primary and mental health care for individuals with unipolar depression and anxiety disorders. 

Throughout health care systems, including the Veterans Health Administration (VHA), there is 

increasing emphasis on the patient-centered medical home (PCMH);44,45 however, the ways this 

model will be implemented in the care of individuals with SMI remain unclear. The organization 

of service delivery for individuals with SMI may be the most modifiable of the many factors 

that impact general medical outcomes in this population. In addition, components may be 

added to the delivery of care to enhance medical outcomes, such as patient self-management 

interventions, decision support, and shared medical records. In this review, we sought to evaluate 

models of care designed to improve general medical outcomes among individuals with SMI. 
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METHODS

TOPIC DEVELOPMENT

This review was commissioned by the Department of Veterans Affairs’ Evidence-based Synthesis 

Program. The topic was selected after a formal topic nomination and prioritization process that 

included representatives from the Office of Mental Health Services, Health Services Research 

and Development, the Mental Health Quality Enhancement Research Initiative (QUERI), and the 

Office of Mental Health and Primary Care Integration. 

The final key questions (KQs) were:

KQ 1. What types of care models have been evaluated prospectively that integrate mental 

health care and primary medical care with the goal of improving general medical outcomes for 

individuals with serious mental illness (SMI)? 

KQ 2. Do models of integrated care for individuals with SMI improve the process of care for 

preventive services (e.g., colorectal cancer screening) and chronic disease management (e.g., 

annual eye examination in patients with diabetes mellitus [DM])? 

KQ 3. (3a) Do models of integrated care for individuals with SMI improve general functional 

status outcomes (e.g., as measured by SF-36) or disease-specific functional status outcomes 

(e.g., Seattle Angina Questionnaire) related to medical care for chronic medical conditions such 

as DM, hypertension, or heart failure? (3b) Do models of integrated care for individuals with 

SMI improve clinical outcomes related to preventive services (e.g., influenza rates) and chronic 

medical care (e.g., kidney disease, amputations, retinopathy in patients with coexisting DM)?

KQ 4. What are the gaps in evidence for determining how best to integrate care to improve 

general medical outcomes for individuals with SMI?

ANALYTIC FRAMEWORK

We developed and followed a standard protocol for all steps of this review. Our approach was 

guided by an analytic framework adapted from a previously developed behavioral model for 

vulnerable populations.46 Figure 1 shows the analytic framework.
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Figure 1. Analytic framework for general medical outcomes for SMI

POPULATION CHARACTERISTICS

Predisposing Enabling Needs

Gender Insurance Comorbid

Age Family medical condition

Employment resources Perceived needs

POPULATION

Schizophrenia

Bipolar disorder

Schizo affective

(KQ1)

(KQ 2)

MODEL OF CARE

Access

Integration

Decision support

Information system

Self-management

Team care 

QUALITY OF CARE 

OUTCOMES

Preventive care 

(e.g., screening, 

immunizations)

Chronic disease care 

(e.g., diabetes eye 

care, lipid measure, 

LDL at goal)

Continuity

Satisfaction

PATIENT 

OUTCOMES

Symptom status

HRQOL

Disease rates

Mortality

(KQ 3)

PROVIDER FACTORS

Experience/training

Attitudes

Knowledge

COMMUNITY RESOURCES

Housing

Supported employment

CONTEXTUAL FACTORS

Financing, practice size, regional 

competition, academic affiliation

SEARCH STRATEGY

We searched for English-language publications in MEDLINE® (via PubMed®), Embase®, 

PsycINFO®, and the Cochrane Library from database inception through March 10, 2011. Search 

terms included terms for schizophrenia and bipolar disorder; a broad set of terms for care models; 

and a set of terms for randomized controlled trials (RCTs) or quasi-experimental studies adapted 

from the Cochrane Effective Practice and Organization of Care Search.47-50 The search strategies 

were developed in consultation with a master librarian. The search terms and MeSH headings for 

the search strategies appear in Appendix A. We supplemented electronic searching by examining the 

bibliographies of the included studies and other review articles. Finally, we searched ClinicalTrials.

gov using the terms “serious mental illness” or “SMI” to assess for evidence of publication bias 

(completed but unpublished studies) and ongoing studies that may fill gaps in evidence.

STUDY SELECTION

Using prespecified inclusion/exclusion criteria (Appendix B), two reviewers assessed the lists of 

titles and abstracts from the databases for further review. Full-text articles of potentially relevant 

abstracts were retrieved for further review. To be included in our evidence report, a study had 

to (1) be a randomized controlled trial (RCT) or quasi-experimental study design, (2) evaluate a 

care model designed to integrate mental and general medical care, (3) include a sample of adult 

patients with SMI (i.e., schizophrenia, bipolar disorder, schizoaffective disorder) or who met 

the definition of SMI based on low functional status (e.g., by Global Assessment of Functioning 

score) and (4) report a relevant outcome. If both preliminary and final reports were published, the 

final data analysis was utilized. The eligibility criteria are described in detail in Table 1. 
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Table 1. Summary of inclusion and exclusion criteria

Study characteristic Inclusion criteria Exclusion criteria

Study design RCT or quasi-experimental study defined as 

nonrandomized cluster controlled trial, controlled before-and-after study, or interrupted 

time series 

Non-English language publication

Cross-sectional and other observational 

designs not listed as included

Population Adults ≥ 18 years of age with schizophrenia, 

schizoaffective disorder, or bipolar disorder

A sample described as persons having SMI 

(based on low functional status and chronicity) and at least 25% are diagnosed with 

schizophrenia, schizoaffective disorder, or 

bipolar disorder

Primary substance abuse

Interventions Interventions with a stated goal to improve 

general medical care or outcomes through 

an integrated model and either one of the 

following:

(1) a system redesign that adds care 

provider(s) to directly address or coordinate 

mental and general medical care

(2) interventions that do not add providers 

but include at least 3 of the following elements: 

• decision support

• information systems

• self-management support

• team care

• enhanced communications between 

mental health providers and general 

medical providers

Interventions designed to be implemented 

primarily in the community (nonmedical 

settings)

Interventions designed to affect only one 

specific outcome or aspect of general 

medical health (e.g., weight loss or smoking cessation, etc.)

Comparators Usual care or other quality improvement 

strategy

None 

Outcomes Process of care measures for preventive 

services (e.g., influenza vaccination rate), 

or chronic disease management (e.g., lipid 

screening or glucose control in a patient with 

diabetes mellitus)

Clinical outcomes (e.g., rate of influenza 

infection)

Physical functioning (SF-36 Physical Component) or disease-specific symptoms (e.g., 

Seattle Angina Questionnaire) measured by 

a validated instrument

Only measures of mental health care 

processes, symptom status, or functional 

status

Setting Outpatient mental health Hospital-based (inpatient) settings

Community-based settings (e.g., senior 

centers, homeless shelters) 
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DATA ABSTRACTION

A trained researcher abstracted data from published articles and reports into a data abstraction 

form; a second reviewer overread the abstracted data. We resolved disagreements by consensus 

among the first and second reviewer or by obtaining a third reviewer’s opinion when consensus 

could not be reached. We abstracted the following data for each included study: 

• study design

• setting

• population characteristics

• subject eligibility and exclusion criteria

• number of subjects and providers

• intervention(s)

• comparison(s)

• length of followup

• outcome(s) 

Intervention characteristics were categorized using the chronic care model and selected elements 

of the patient centered medical home. The chronic care model classifies health care elements 

into six domains: health system, delivery system design, decision support, clinical information 

systems, self-management support, and the community.51 With the exception of health system 

factors (e.g., quality-based incentives), we used these domains along with the following PCMH 

elements: a primary treating clinician, team-based care, and methods to enhance access to care.

We grouped immunizations and cancer screening into the general category of preventive 

services outcomes. For chronic disease care processes, we prioritized those with an established 

link to clinical outcomes (e.g., blood pressure control in patients with diabetes mellitus). Some 

care processes (e.g., cholesterol measurement) could be classified as preventive screening or 

chronic disease management. When these outcomes were reported separately, we grouped them 

according to our analytic framework, but in some cases we could not follow this approach 

because preventive and chronic disease outcomes were reported only in aggregate form. 

QUALITY ASSESSMENT

We assessed the risk of bias pertaining to KQs 2 and 3 using the key quality criteria described in 

the Agency for Healthcare Research and Quality (AHRQ) Methods Guide for Effectiveness and 

Comparative Effectiveness Reviews,

52 adapted for this specific topic (Appendix C). For RCTs, 

we abstracted data on adequacy of randomization and allocation concealment, comparability of 

groups at baseline, blinding, completeness of followup and differential loss to followup, whether 

incomplete data were addressed appropriately, validity of outcome measures and completeness of 

outcomes reporting, and conflict of interest. Using these data elements, we assigned a summary 

quality score of Good, Fair, or Poor to individual RCTs. We assessed studies for applicability to 

U.S. Veterans. 

DATA SYNTHESIS

We constructed summary tables showing the study characteristics and results for all included 

studies, organized by KQ, intervention, or clinical condition, as appropriate. We critically 
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analyzed studies to compare their characteristics, methods, and findings. We compiled a 

summary of findings for each KQ or clinical topic and drew conclusions based on qualitative 

synthesis of the findings. There were not sufficient studies to perform quantitative synthesis 

(meta-analysis). 

RATING THE BODY OF EVIDENCE

We assessed the overall quality of evidence for outcomes using a method developed by the 

Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) Working 

Group,53 which classified the grade of evidence across outcomes according to the following 

criteria:

• High—Further research is very unlikely to change our confidence on the estimate of effect.

• Moderate—Further research is likely to have an important impact on our confidence in the 

estimate of effect and may change the estimate.

• Low—Further research is very likely to have an important impact on our confidence in the 

estimate of effect and is likely to change the estimate.

• Insufficient—Evidence on an outcome is absent or too weak, sparse, or inconsistent to 

estimate an effect.

PEER REVIEW

A draft version of this report was reviewed by technical experts as well as clinical leadership, and 

their comments are provided in Appendix D.
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RESULTS

LITERATURE FLOW

We reviewed 1598 titles and abstracts from the electronic search and an additional 24 from 

reference mining for a total of 1622 references. After applying inclusion/exclusion criteria at 

the abstract level, 1565 references were excluded. We retrieved 57 full-text articles for further 

review, after which another 50 articles were excluded. We identified a total of seven articles 

for inclusion in the current review, representing four RCTs. Four articles contained the main 

outcomes of the RCTs, and three articles, referred to as “companion articles,” contained 

additional data pertinent to the four RCTs. We grouped the studies by KQ. Figure 2 details the 

exclusion criteria at the full-text level and the number of articles related to each of the KQs. 

Additionally, our search of www.clinicaltrials.gov identified 208 potentially relevant trials. Of 

these, four were RCTs and one was a non-RCT of integrated care treatments for individuals with 

SMI. One of these trials was completed, published, and identified in our MEDLINE search.54

The other four studies have yet to be completed. Since we did not identify any registered and 

completed but unpublished trials, there was no evidence in this database of publication bias. The 

identified trial studies, along with one additional observational study identified through contacts 

with experts, are summarized in KQ 4.

Figure 2 illustrates each step of our literature search process. Appendix E provides a complete 

listing of articles excluded at the full-text stage, with reasons for exclusion.

Figure 2. Literature flow diagram

KQ 4

4 studies + 

3 companion articles

Excluded at title/abstract level = 1565 

references

KQ 3 

4 studies + 

3 companion articles

Excluded = 50 references 

Not SMI = 11

Not outpatient = 2

Not RCT = 14

Not integrated care = 15

No medical outcomes = 5

Not peer-reviewed = 2

Not Westernized culture = 1

KQ 2 

4 studies + 

3 companion articles

KQ 1 

4 studies + 

3 companion articles

Search results = 1622 references*

Included 7 articles representing 4 unique 

studies

Pulled for full-text review = 57 references

 *Search results from PubMed (1016), PsychInfo (453), Cochrane (129), and manual (24) were combined.

Abbreviations: KQ = key question; RCT = randomized controlled trial; SMI = serious mental illness
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STUDY CHARACTERISTICS

Basic characteristics of the included studies are summarized in Table 2. Four good-quality RCTs 

(891subjects) met eligibility criteria; no quasi-experimental studies met eligibility criteria. The 

psychiatric diagnoses of interest (schizophrenia, schizoaffective disorder, and bipolar disorder) 

varied in proportion in each study, with two samples55-59 entirely consisting of patients with 

bipolar disorder and another sample60 with 21 to 34 percent carrying the diagnoses of interest. 

Another study54 included 49 percent with the diagnoses of interest. Druss and colleagues (2001)54

reported that 72 to 80 percent of the sample had “severe psychiatric illness” as defined by criteria 

of the National Advisory Mental Health Council.61

Three studies54,57,59,60 tested interventions specifically aimed at improving general medical 

outcomes, while one study55 focused primarily on psychiatric pathology but included an 

emphasis on primary care enrollment and collaboration. Care management or care coordination 

was a common element in the studies; only one study employed co-location of medical and 

psychiatric services. 

Three studies55,57,59,60 were conducted in VA outpatient mental health settings, and one study was 

conducted in an urban community mental health center.54 Samples in VA settings had relatively 

few female participants (ranging from 0.8 to 29%) while almost one-half the sample was female 

in the urban community mental health center study. Participants were, on average, mid-life 

adults; mean ages ranged from 47 to 55 years of age. Followup varied from 24 to 156 weeks. A 

summary of the detailed quality assessment of the studies is found in Appendix C.
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studies

Subjects Setting Intervention summary Followup General medical outcomes Quality

sorder Demographics

Schizophrenia: 21%PTSD: 29%Major affective disorder: 13%Substance use: 28% “Severe psychiatric illness” by NAMHC criteria: 76%

• Gender: 0.8% 

female

• Mean age (yr): 

45.2 +/- 8.2

• Race: 70% white

VA outpatient mental health

Co-located general medical clinic with care provided by a nurse practitioner with supervision from a family practitioner. Care coordination provided by a nurse.

52 wk U.S. Preventive 

Services Task Force indicators; general medical service use

Good

Bipolar disorder type I: 87%Bipolar disorder type II: 13%

• Gender: 28% female• Mean age (yr): 

46.6 +/- 10.1

• Race: 71% “minority”

VA outpatient mental health

Specialty team of psychiatrist and nurse care manager, including self- management support, decision support, emphasis on primary care enrollment and collaboration

156 wk SF-36 Physical 

Health

Good

Bipolar disorder type I: 76%Bipolar disorder type II: 7%Bipolar disorder NOS: 17%

• Gender: 9% female• Mean age (yr): 

55.3+/- 8.4

• Race: 10% African 

American 

VA outpatient mental health

Bipolar disorder medical care model consisting of 4 sessions self-management support, nurse care management, guideline implementation related to cardiovascular risk factors

24 wk SF-12 quality of 

life–physical health; WHO-DAS 

Good

Schizophrenia/ schizoaffective disorder: 36.4%Bipolar disorder: 13.1%PTSD: 5.1%Depression: 45.2%Other: 0.3%Co-occurring substance use disorder: 26%

• Gender: 48.4% 

female

• Mean age (yr): 

46.7 +/- 8.1

• Race: 77.4% African 

American

• Hispanic or Latino: 

1.5% 

• White: 21.1%

Urban community mental health center

Nurse care management with self-management, liaison, and case management components

52 wk RAND Community 

Quality Index; SF36; Framingham Cardiac Index

Good

visory Mental Health Council; PTSD = posttraumatic stress disorder; RCT = randomized controlled trial; SF-36 = Short Form-36; VA = Veterans Affairs; 

on–Disability Assessment Schedule; wk = week/weeks
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KEY QUESTION 1. What types of care models have been evaluated 

prospectively that integrate mental health care and primary medical 

care with the goal of improving general medical outcomes for 

individuals with serious mental illness (SMI)?

Studies of Efficacy 

Our review identified four RCTs that met our inclusion criteria. Classification of the models of 

care used in these studies was informed by Wagner’s Chronic Care model.51,62-64 The models 

of care used in two studies55-59 were explicitly based on Wagner’s model. A third study 54 also 

utilized these principles, while the fourth study60 did not state a clear theoretical model on which 

it was based. 

As required in our inclusion criteria, all the interventions were based primarily in a mental health 

setting, but integration of general medical services varied from services contiguous with the 

mental health clinic60 to care management provided from remote locations.55-59 Three studies54-59

relied on research funds to pay the key staff used for the study intervention, while one study60

was conducted in a setting where the psychiatry service paid the salaries of the staff involved 

in the intervention through clinical funds. The spectrum of clinical disciplines employed in the 

interventions of the four RCTs was relatively narrow and limited to those trained traditionally 

with a primary biomedical orientation (e.g., physicians, nurses, nurse practitioners). All the study 

interventions employed team-based care—at least to the extent of collaboration by multiple 

providers to help patients with their mental health and general medical problems. None of the 

studies used fully integrated teams of mental health and general medical providers working 

closely together with regular team meetings.

In Table 3 and the paragraphs that follow, each intervention is summarized relative to the 

components of Wagner’s Chronic Care Model.
18

e General Medical Outcomes for Individuals With Serious Mental Illness Evidence-based Synthesis Program

racteristics informed by Wagner’s Chronic Care Model

Model elements

Team-based Enhanced 

access

Self-management 

support

Decision 

support

Delivery 

system

Information 

systems

Community 

linkages

Supervising family practitioner and nurse practitioner; liaison with mental health providers

Primary care appointments scheduled to immediately follow mental health appointments when possible

None reported None reported Co-location of 

mental health and primary care services

VA computerized record (both study arms)

None reported

r 

Primary care: emphasis on primary care enrollment and collaboration; otherwise per usual care proceduresPsychiatric care: “specialty team” comprised of a psychiatrist and nurse care coordinator 

Nurse care manager provided same day telephone and next business day clinic appointments

Psychoeducational program (Life Goals Program) primarily addressing bipolar disorder symptoms

Simplified VA Bipolar Clinical Practice Guidelines for providers

Care management; Bipolar Disorders Program

VA computerized record (both study arms)

None reported

e 

l 

Nurse care manager provided liaison between existing providers

None reported Four-session group 

lead by nurse care manager

Continuing medical education and guidelines; pocket cards for medical and mental health providers related to cardiovascular risk factor management

Care management; Bipolar Disorder Medical Care Model

VA computerized record (both study arms)

None reported

: 

Nurse care manager provided liaison between mental health and medical providers

None reported Care manager provided motivational 

interviewing, development of action plans, and coaching 

None reported Care management None reported Public trans- portation and 

child care

 conducted a good-quality RCT evaluating a co-located, integrated medical clinic contiguous with the existing mental 
19

Effects of Care Models to Improve General Medical Outcomes

for Individuals With Serious Mental Illness Evidence-based Synthesis Program

health outpatient clinic versus usual care in a VA medical center. Continuity of primary medical 

care was provided by a team that included a nurse practitioner who was supervised by a family 

practitioner, a nurse case manager, and an administrative assistant. The family practitioner acted 

as a liaison between the physicians in the medical and psychiatry services. Enhanced access was 

provided by reminder calls, followup after missed appointments, and efforts to schedule primary 

care visits immediately following mental health visits. Providers in both the intervention and 

usual care arms of the study had access to the VA’s electronic medical record system including 

records from all care in the VA system. The study intervention did not include additional decision 

support or community linkages. This study intervention was not reported as being designed 

according to an explicitly stated theoretical model. 

Investigators in the VA Cooperative Study55,56,58 conducted a multisite, good-quality RCT to 

evaluate the effectiveness of the Bipolar Collaborative Chronic Care Model versus usual care 

in 11 VA medical centers. The delivery system was a “specialty team” located in the outpatient 

mental health setting and consisted of a psychiatrist who worked in collaboration with the nurse 

care coordinator. The nurse care coordinator provided enhanced access to mental health care 

with same-day telephone visits and next-business-day clinic visits. While focused primarily on 

management of bipolar disorder symptoms, the study intervention also emphasized enrollment in 

primary care and collaboration with medical providers 55 utilizing the nurse care manager. Selfmanagement support, focused on bipolar disorder, was provided through a psychoeducational 

group (Life Goals Program) led by the nurse care coordinator over the first year of the 

intervention. Decision support, again primarily related to bipolar disorder, was implemented 

by providing the psychiatrists a one-page summary and a six-page manual of the VA Bipolar 

Clinical Practice Guidelines. Providers in both the intervention and usual care arms of the study 

had access to the VA’s electronic medical record system. The study intervention did not include 

community linkages. This study intervention was based on Wagner’s Chronic Care Model and 

also drew on elements from the PCMH with a stated patient-centered focus on care for bipolar 

disorder.

Kilbourne and colleagues (2008)57,59 conducted a good-quality RCT that evaluated an 

intervention using existing services for medical and psychiatric care in a VA medical center 

mental health outpatient setting augmented by the bipolar disorder medical care model, 

emphasizing self-management, care management, and guidelines implementation compared to 

usual care. The intervention began with providing four 3-hour sessions aimed at enhancing selfmanagement of bipolar disorder along with general medical issues relevant to cardiovascular 

disease. Upon completion of these sessions, nurse case managers provided continuous care 

management by acting as a liaison among patients and existing medical and psychiatric 

providers. Decision support was implemented through two 1-hour continuing medical education 

sessions for providers of medical and psychiatric care focused on the unique aspects of 

cardiovascular risk factors in individuals with bipolar disorder as well as strategies for managing 

these risk factors based on the American Diabetes Association and American Heart Association 

guidelines. Pocket cards were also provided to reinforce material in these sessions. Providers in 

both the intervention and usual care arms of the study had access to the VA’s electronic medical 

record system including records from all care in the VA system. The study intervention did not 

include elements of enhanced access or community linkages. The study intervention was based 

largely on Wagner’s Chronic Care Model.
20

Effects of Care Models to Improve General Medical Outcomes

for Individuals With Serious Mental Illness Evidence-based Synthesis Program

Druss and colleagues (2010)54 conducted a good-quality RCT evaluating medical care management using a registered nurse care manager in an urban community mental health center setting 

compared to usual care. The nurse care manager functioned not as a member of a team, but rather 

served as a liaison between medical and mental health providers. Patient self-management skills 

were supported through motivational interviewing, development of action plans, and coaching to 

help patients become more active in their own health care. Participants were linked to community resources for child care and public transportation to appointments. The study did not report 

that access to primary care providers was explicitly enhanced, though system level barriers were 

addressed by assisting eligible patients to enroll in entitlement programs. The study intervention 

did not include additional decision support or enhancement of information systems.

Summary of Findings

The four studies represented in our review were similar in many ways, showing a relatively 

limited variety of approaches to improving general medical care. All studies used nurse care 

or case managers to some extent to augment or facilitate care provided by physicians or nurse 

practitioners. Notably, disciplines such as psychologists, with expertise in facilitating behavior 

change, and nutritionists were not incorporated into the models tested. As described above, three 

of the four studies had substantial basis in the Chronic Care Model, but elements of PCMH, such 

as having a primary treating provider, team-based care, and enhanced access, were not robustly 

employed. Three of the four studies were set in the VA system, while one was a non-VA study. 

KEY QUESTION 2. Do models of integrated care for individuals with 

SMI improve the process of care for preventive services 

(e.g., colorectal cancer screening) and chronic disease management 

(e.g., annual eye examination in patients with diabetes mellitus [DM]?

Studies of Efficacy 

Two good-quality trials54,60 provided data relevant to KQ 2. Process of care outcomes are 

summarized for preventive services (Table 4) and chronic disease management (Table 5). At 

baseline, the quality of general medical care was low, leaving ample room for intervention 

effects. In both studies, a high proportion (52 to 54%) of medical diagnoses were not 

documented previously in the medical record, and in one study,60 only about 20 percent of 

recommended preventive services had been provided prior to study start.54

In both studies, the intervention improved preventive care as measured by receipt of 

immunizations and screening tests. Druss and colleagues (2001)60 reported higher influenza 

vaccination rates in the intervention versus usual care group (32.2% versus 11.5%, p = 0.006), 

while more subjects in usual care versus intervention received the pneumococcal vaccination 

(32.8% versus 11.9%, p = 0.006). This latter difference was not statistically significant in the 

subgroup with an indication for pneumococcal vaccination.

Selected screening tests were also more likely to be performed in the intervention group 

than in the usual care group: digital rectal examination (69.5% versus 44.3%, p = 0.005) and 

flexible sigmoidoscopy (33.9% versus 14.8%, p = 0.01).60 The investigators also reported a 

nonsignificant difference favoring the intervention for hemoccult testing (49.2% versus 44.3%, 
21

Effects of Care Models to Improve General Medical Outcomes

for Individuals With Serious Mental Illness Evidence-based Synthesis Program

p = 0.10). In the more recent study,54 a broader set of general medical process measures were 

evaluated. Immunization outcomes were reported as the proportion of recommended services 

received (influenza; hepatitis B; measles, mumps, and rubella; pneumococcal; tetanus-diphtheria; 

and varicella). The intervention group was more likely to receive indicated vaccinations than 

the usual care group (24.6% versus 3.8%, p < 0.001). In addition, other recommended screening 

services (cholesterol, fecal occult blood, HIV, sigmoidoscopy, and tuberculosis testing) were 

completed more frequently in the intervention than usual care group (50.4% versus 21.6%, p < 

0.001).54

The effects of the intervention on chronic disease management focused on process outcomes 

relevant to cardiovascular disease risk. Druss and colleagues (2001)60 reported significantly 

higher rates in the intervention group for weight measurement, diabetes screening, cholesterol 

screening, and smoking education. In the intervention group, these services were provided to 

71.2 to 84.7% percent of the subjects by study end compared to 45.9 to 63.9 percent in the usual 

care group. In the later study, 54Druss and colleagues found higher rates of indicated services 

for cardiovascular disease (34.9 versus 27.7%, p = 0.03) in the intervention group in an analysis 

established a priori of a subset of 202 subjects who had one or more cardiometabolic conditions 

(diabetes, hypertension, hypercholesterolemia, or coronary artery disease). In the subset 

with blood tests available, the Framingham Cardiac Index (a measure of the 10-year risk of 

myocardial infarction or coronary-related death) was also significantly lower in the intervention 

group at study end (6.9 versus 9.8%, p = 0.03), with the intervention group’s index improving 

and the usual care group’s index worsening during the course of the study. However, an analysis 

that adjusted for baseline cardiovascular risk did not show a statistically significant change in 

risk between groups.
22

e General Medical Outcomes for Individuals With Serious Mental Illness Evidence-based Synthesis Program

mes for preventive care (KQ 2)

Intervention summary Preventive care

Immunizations Screening procedures

Co-located general medical clinic with care provided by a nurse practitioner with supervision from a family practitioner. Care coordination provided by a nurse.

Intervention• Flu: 32.2%• Pneumovax: 11.9% 

Control

• Flu:11.5%• Pneumovax: 

32.8%

Intervention

• Hemoccult: 49.2%• Digital rectal 

exam: 65.9%

• Flexible sigmoidoscopy: 33.9%

Control

• Hemoccult: 44.3%• Digital rectal exam: 

44.3%

• Flexible sigmoidoscopy: 14.8%

Nurse care management with 

self-management, liaison, and case management components.

Intervention24.7%a

Control3.8%a

Intervention 50.4%b

Control 21.6%b

ended immunizations performed (influenza; hepatitis B; measles, mumps, and rubella; pneumococcal bacterial infection; tetanus-diphtheria; 

ended screening tests performed (cholesterol, fecal blood, HIV, sigmoid, and tuberculosis).

olled trial

mes for chronic disease management (KQ 2)

Intervention summary Chronic disease management

Intervention Control

Co-located general medical clinic with care provided by a nurse practitioner with supervision from a family practitioner. Care coordination provided by a nurse.

• (At 12 mo) Diabetes screening: 71.2%• Cholesterol screening: 79.7%• Weight measured?: 84.7%• Smoking education 84.7%

• Diabetes screening: 45.9%• Cholesterol screening: 57.4%• Weight measured: 59.0%• Smoking education: 63.9%

Nurse care management with self-management, liaison, and case management components.

• Proportion of indicated services received for 

cardiovascular disease: 34.9%a

• Framingham Cardiac Index: 6.9%

• Proportion of indicated services 

received for cardiovascular disease: 27.7%

• Framingham Cardiac Index: 9.8%

d of services received for cardiovascular disease among the subset with at least one cardiometabolic condition (diabetes, hypertension, 

y disease).

olled trial
23

Effects of Care Models to Improve General Medical Outcomes

for Individuals With Serious Mental Illness Evidence-based Synthesis Program

Summary of Findings

Only two of the four studies identified for this review reported on measures relevant to KQ 2. 

Generally, the study interventions improved process measures for preventive services, and 

cardiovascular disease management. However, some measures represented a “low bar,” such as 

measuring weight rather than evaluating the quality of care for weight control. Other measures 

of relevant care processes (e.g., physical activity counseling) were not reported. Although rates 

of recommended services were improved by the intervention, they remained suboptimal in all 

groups at study end.

KEY QUESTION 3. (3a) Do models of integrated care for individuals 

with SMI improve general functional status outcomes (e.g., as 

measured by SF-36) or disease-specific functional status outcomes 

(e.g., Seattle Angina Questionnaire) related to medical care for chronic 

medical conditions such as DM, hypertension, or heart failure? (3b) 

Do models of integrated care for individuals with SMI improve clinical 

outcomes related to preventive services (e.g., influenza rates) and 

chronic medical care (e.g., kidney disease, amputations, retinopathy 

in patients with coexisting DM)? 

Studies of Efficacy 

Four good-quality studies met our criteria for KQ 3a. All studies measured general functional 

status outcomes, described in Table 6. Of these, three used the SF-36 item Short-Form Survey65-67

and one used the SF-12 item Short-Form Survey.68 Neither disease-specific symptom scales nor 

disease-specific functional status scales were reported in any of the studies. In addition, none of 

the four trials met our criteria for KQ3b by reporting clinical outcomes related to preventative 

services (e.g., incidence of influenza illness) or chronic medical care (e.g., diabetic retinopathy). 

Brief descriptions of relevant outcomes for each study are described below. Table 7 summarizes 

outcomes.

Druss and colleagues (2001)60 reported scores at 52-week followup on the physical health 

component of the SF-36 Short-Form Survey. Mean scores were higher for the intervention than 

for usual care group (50.9 [SD 7.1] versus 45.3 [SD 9.7], p = NR). The difference in change 

between the two groups was significant (t170 = 3.7, P<0.001), with subjects in the integrated 

care clinic scoring 4.7 points higher than baseline in the physical component summary score 

compared to a 0.3 point decline from baseline in the score of subjects in the general medicine 

clinic. Higher scores indicated better functional status, and a five-point difference is generally 

considered a clinically important difference. 

Kilbourne and colleagues (2008)57,59 used the physical health component of the SF-12 ShortForm Survey to report functional outcomes after 24 weeks of the bipolar disorder medical care 

model versus usual care. The bipolar disorder medical care intervention did not address general 

medical problems directly but emphasized enrollment in and collaboration with primary care. 

Change in SF-12 scores from baseline to 24-week follow up differed significantly between 

intervention and control groups (intervention change in score = 0.8 [SD 6.7] versus control 
24

Effects of Care Models to Improve General Medical Outcomes

for Individuals With Serious Mental Illness Evidence-based Synthesis Program

change in score -0.6 [SD 6.6]; p = 0.04). 

Investigators in the VA Cooperative Study55,56,58 as well as Druss and colleagues (2010)54

also reported on functional outcomes using the SF-36 questionnaire. In the VA Cooperative 

Study, there was no statistically significant difference at 3-year followup between the Bipolar 

Collaborative Chronic Care Model and usual care groups on the SF-36 physical health 

component (mean = 43.4, 95% confidence interval [CI], 42.4 to 44.4 versus mean = 42.9, 

95% CI, 41.9 to 43.9). Similarly, Druss and colleagues (2010)54 did not report a statistically 

significant difference between the mean scores of intervention versus usual care group on the 

SF-36 physical health component, although their findings exhibited a trend toward significance. 

At 1-year followup, SF-36 physical component scores were 37.1 (SD 11.5) and 34.7 (SD 11.9) 

for the medical care management and usual care groups respectively (p = 0.08). They also noted 

that the difference in change between the two group scores was not statistically significant 

(intervention group +1.9% versus usual care group -2.8%). This Druss study was the only one of 

the four reviewed that focused on an urban community mental health center and did not include 

veterans.

Table 6. Outcome measures

Measure General class Items measured Scoring range; 

population mean 

(SD)

Direction for better 

outcomes

SF-36 36-item Short 

Form Health 

Survey

Physical functioning, role 

limitations due to physical health 

problems, bodily pain, general 

health

0 to 100; 50 (10) Higher scores indicate 

better outcomes

SF-12 12-item Short 

Form Health 

Survey

Physical functioning, role 

limitations due to physical health 

problems, bodily pain, general 

health

0 to 100; 50 (10) Higher scores indicate 

better outcomes

Table 7. Outcome summary for KQ 3

Study Followup Intervention versus control outcome

Druss et al., 200160 52 weeks SF-36 physical component: mean 50.9 (SD 7.1) vs. 45.3 (SD 9.7); p <0.001 

for difference in change scores using baseline, 6-month and 12-month assessments

Bauer et al., 200655,56

Kilbourne et al., 200958

(VA Cooperative 

Study)

156 weeks SF-36 physical component: mean 43.4 (95% CI, 42.4 to 44.4) vs. 42.9 

(95% CI, 41.9 to 43.9)

Kilbourne et al., 

200857,59

12 weeks

24 weeks

SF-12 physical component: mean 38.5 (SD 8.4) vs. 33.9 (SD 8.6), p = NR

SF-12 physical component: mean 37.0 (SD 7.3) vs. 35.1 (SD 7.7) , p = NR; 

difference in change scores using baseline, 3 month and 6 month assessments: 2.5, 95% CI, 0.5 to 4.9

Druss et al., 201054 52 weeks SF-36 physical component: mean 37.1 (SD 11.5) versus 34.7 (SD 11.9); 

p < 0.08; difference in change scores: “not significant,” p value not reported

Abbreviation: CI = confidence interval; NR = not reported; p = probability; SD = standard deviation; SF = Short Form
25

Effects of Care Models to Improve General Medical Outcomes

for Individuals With Serious Mental Illness Evidence-based Synthesis Program

Summary of Findings

In summary, the findings from two good-quality RCTs provided support for small improvements 

in general functional outcomes at followup periods ranging up to 52 weeks. Two other RCTs 

did not find statistically significant differences using similar health outcome survey measures 

when comparing integrated care to usual care. Thus, effects on physical function appear small 

and inconsistent. However, interventions varied in their focus on care processes that could 

be expected to improve physical function. Followup periods ranged from 24 to 156 weeks, 

and interventions that focus primarily on preventive care could be expected to require long 

followup periods to show positive effects on physical functioning. Three of the four studies 

were conducted in the VA system, with two of three VA studies demonstrating improvements in 

general functional outcomes. Given the range of medical services generally offered on site at VA 

health care locations, integration and collocation approaches may be easier to implement, and VA 

interventions generalize more easily to VA settings.

We did not identify published trials or quasi-experimental studies examining clinical outcomes 

relating to preventative services.

KEY QUESTION 4. What are the gaps in evidence for determining 

how best to integrate care to improve general medical outcomes for 

individuals with SMI? 

Only four trials, comprising 891 individuals, were identified by this review. The relatively 

small number of trials and limited range of outcomes reported make definitive conclusions 

difficult. Further, the small number of trials makes it difficult to identify the key elements of the 

interventions. We summarize the gaps in evidence in Table 8 and then discuss these gaps further.

Table 8. Summary of gaps in evidence

The key intervention components are uncertain.

There is greater uncertainty about intervention effects for individuals with SMIs other than bipolar disorder.

Effects on clinical outcomes have not been studied.

Sustainability of intervention effects is uncertain.

Effects of interventions (effectiveness) are uncertain when part of routine care rather than part of an 

RCT.

Effects of current VA delivery models are uncertain, including primary care services co-located in the 

mental health setting and assertive community treatment. 

There is uncertainty about effects of current VA programs to improve mental health outcomes of veterans with SMI (e.g., assertive community treatment) that theoretically may have beneficial effects on 

general medical outcomes.

Abbreviation: RCT = randomized controlled trial; SMI = serious mental illness; VA = Veterans Affairs
26

Effects of Care Models to Improve General Medical Outcomes

for Individuals With Serious Mental Illness Evidence-based Synthesis Program

The four RCTs included in our review, as reported in KQ 1, offered interventions with multiple 

components—with all components offered to those receiving the intervention. These study 

designs did not permit disaggregation of intervention effects for each intervention component.

Because two studies focused entirely on individuals with bipolar disorder, the proportion of 

studies with other SMIs was relatively few, with just 19 percent of the overall samples identified 

as having schizophrenia or schizoaffective disorder. The two studies that included individuals 

with SMI other than bipolar disorder did not provide subgroup analyses by diagnosis, so possible 

differences in the efficacy of the study interventions between diagnostic groups is unknown. 

Global Assessment of Functioning was reported in only one trial and only by study assignment 

group, so it was not possible to determine the overall number of individuals who met our study 

criteria based on level of functioning. 

None of the four trials provided information on general medical outcomes, such as rates of 

diabetic neuropathy, influenza, or myocardial infarction, that occurred in study populations either 

during the delivery of the study intervention or in follow-up. While many measures selected for 

process of preventive care and quality of chronic disease management are known to be correlated 

with clinical outcomes, absence of this information is a substantial gap in the evidence. It may be 

possible, particularly for the three studies conducted in VA settings, to obtain additional followup data on general medical outcomes on study subjects.

Three of the four studies54,57,60 evaluated interventions implemented at only one site. Only one 

study60 explicitly stated that existing staff or resources were used in the study intervention, with 

the other trials delivering interventions with staff funded with research grants. Therefore, the 

RCTs reviewed primarily provided evidence regarding efficacy of the study interventions under 

ideal and closely controlled conditions. Information about the effectiveness of these interventions 

when implemented in existing programs was lacking.

All of the studies included in this review were RCTs with randomization at the patient level. 

No studies were identified using other designs stated in our inclusion criteria, such as cluster 

randomized trials, nonrandomized cluster controlled trials, controlled before-and-after studies, or 

interrupted time series designs. These additional designs can yield different types of information 

from the patient-level RCT, given that they are most often conducted in natural environments, 

thus producing fewer threats to external validity. For example, three of the four RCTs were 

conducted in single sites where motivation of the researchers and clinicians was likely to be high. 

Multisite designs might provide broader information on the effectiveness of the interventions in 

more naturalistic settings.

Two models of delivery of care that have already been implemented in the VA are relevant to 

our study questions: programs with co-located mental health and primary care and assertive 

community treatment programs. Mental health–primary care programs, which serve veterans 

with SMI in a clinic organized under the mental health service and are often co-located with 

mental health clinics, have been implemented in 10 out of 107 VA medical centers, based on 

a national survey of mental health leaders. After adjustment for organizational and patientlevel factors, analyses of data from these programs showed that patients from co-located 

clinics received better quality of care compared with those without co-location on four of nine 

indicators. The study showed a need for additional chronic disease management strategies in 
27

Effects of Care Models to Improve General Medical Outcomes

for Individuals With Serious Mental Illness Evidence-based Synthesis Program

these co-located clinics, given that HgA1c was actually less well controlled in these clinics 

compared to those without co-location. Another study using VA data in these co-located clinics, 

compared to those without co-location, showed a significant reduction in hospitalizations 

for ambulatory care–sensitive conditions.69,70 Additional evaluation of these programs, even 

retrospectively, has the potential to provide valuable information relevant to our study questions, 

including filling some of the gaps in evidence identified here (e.g., lack of quasi-experimental 

designs, broader diversity of included subjects based on diagnosis, and reporting of general 

medical outcomes).

Assertive community treatment—implemented in the VA as Mental Health Intensive Case 

Management (MHICM)—has been shown to be effective in reducing symptom severity 

and inpatient psychiatric utilization among individuals with SMI; client-reported housing, 

quality of life, satisfaction with services are improved.71 Though these programs, and their 

evaluation, to date have been focused on mental health outcomes, case managers do facilitate 

receipt of primary care services to varying degrees—yet general medical outcomes of patients 

receiving MHICM and other assertive community treatment implementations have been largely 

unreported.

It is notable that the collaborative care models for bipolar disorder employed in two of the 

studies 55,57 have gained sufficient evidence to be included in the recommendations of two recent 

clinical treatment guidelines.72,73 Still, the impact of these models on general medical outcomes 

remains an area where additional study is needed.

Our search of www.clinicaltrials.gov identified three RCTs and one observational study 

evaluating integrated approaches to addressing the general medical needs of individuals with 

SMI. One of these studies is being conducted in VHA. These studies are summarized in Table 9.
28

e General Medical Outcomes for Individuals With Serious Mental Illness Evidence-based Synthesis Program

ating integrated approaches

VA/DOD 

population?

Intervention Comparator Sponsor and

ClinicalTrials.gov ID 

number

Funding 

start and 

stop date

Status

th 

Y Behavioral: life goals 

collaborative care

Usual care Department of 

Veterans AffairsNCT01244854

October 2010 to December 2011

Enrolling by invitation

n a 

N IMBED: active 

comparator—a primary care providerLiaison: Active comparator—a medical case manager 

Treatment as usual; no intervention

The University of Texas Health Science Center at San AntonioNCT01115114

January 2009 to September 2012

Recruiting

N Care team No intervention; 

referral only

National Institute of Mental Health NCT01228032

April 2010 to January 2015

Recruiting

n 

)

N Nurse-administered 

lifestyle counseling

None Consorci Hospitalari 

de VicNCT01182012

August 2010 to December 2012

Recruiting

o

al 

rious 

Y Enrollment in a colocated, integrated 

primary care clinic in the mental health outpatient unit

Subject is own comparator; timeseries design

Systems Outcomes and Quality in Chronic Disease and Rehabilitation; ProvidenceVA Medical Center

Unfunded Completed; 

manuscript in press

rolled trial
29

Effects of Care Models to Improve General Medical Outcomes

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SUMMARY AND DISCUSSION

A key observation that emerges from this review is that integration of care for the purpose of 

improving general medical outcomes in individuals with SMI is an understudied area, with only 

four RCTs meeting our study criteria. Further, these studies tested a limited range of approaches 

to integrating care. Despite these limitations, these four studies provided useful findings for 

several of our key questions. These findings and the overall strength of evidence are summarized 

and discussed by key question.

SUMMARY OF EVIDENCE BY KEY QUESTION

Table 10. Strength of evidence by key question

Key question Strength of 

evidence Summary

KQ 1. What types of care models 

have been evaluated prospectively 

that integrate mental health care 

and primary medical care with the 

goal of improving general medical 

outcomes for individuals with serious mental illness (SMI)? 

Not relevant to 

KQ 1

4 good-quality studies

Conclusions: 

• The degree of integration of care ranged from limited 

to moderate.

• The range of integrated care models tested was relatively limited. Many PCMH elements were not included 

in tested models.

• A broader range of disciplines should be included in 

future evaluations of integrated care models. 

KQ 2. Do models of integrated care 

for individuals with SMI improve 

the process of care for preventive 

services (e.g., colorectal cancer 

screening) and chronic disease 

management (e.g., annual eye examination in patients with diabetes 

mellitus [DM])? 

Moderate 2 good-quality studies

Conclusions:

• Studies showed generally positive effects on immunization rates, cancer screening, and selected screening 

for cardiovascular disease.

• Important cancer-screening practices (e.g., mammography, pap smears) and chronic disease care unrelated to cardiovascular disease were not studied.

KQ 3. (3a) Do models of integrated care for individuals with SMI 

improve general functional status 

outcomes (e.g., as measured by 

SF-36) or disease-specific functional 

status outcomes (e.g., Seattle Angina Questionnaire) related to medical 

care for chronic medical conditions 

such as DM, hypertension, or heart 

failure? 

(3b) Do models of integrated care 

for individuals with SMI improve clinical outcomes related to preventive 

services (e.g., influenza rates) and 

chronic medical care (e.g., kidney 

disease, amputations, retinopathy in 

patients with coexisting DM)?

Moderate for 

KQ 3a

Insufficient for 

KQ 3b

4 good-quality studies for KQ 3a; no studies reported data 

relevant to KQ 3b 

Conclusions:

• Studies reported inconsistent effects on physical 

functional status. Two studies showed small, positive 

effects, and two showed no statistically or clinically 

significant benefit. 

• No study reported effects on disease-specific functional status or clinical outcomes. 
30

Effects of Care Models to Improve General Medical Outcomes

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Key question Strength of 

evidence Summary

KQ 4. What are the gaps in evidence for determining how best to 

integrate care to improve general 

medical outcomes for individuals 

with SMI?

Not relevant to 

KQ 4

4 good-quality studies

Conclusions:

• There was little diversity in the types of models tested, 

with most models based on Wagner’s Chronic Care 

Model.

• Elements of PCMH, other than those that overlap with 

the chronic care model, were not generally evaluated. 

• Other than cardiovascular disease, greater variety of 

chronic disease outcomes is missing in the literature.

• There was relatively little evidence regarding individuals with schizophrenia and related psychotic disorders.

Abbreviation: DM = diabetes mellitus; KQ = key question; PCMH = patient-centered medical home; SF = Short Form; SMI = 

serious mental illness

KQ 1

For KQ 1, four RCTs (represented by seven articles) evaluated approaches to integrated care and 

most commonly were theoretically based on the chronic care model. All integrated care models 

were set in mental health specialty settings, had additional personnel, and used care management 

or care coordination as a key strategy. Only one study used co-located mental health and general 

medical services. Self-management support was a component in three of the four studies, but 

only one study used decision support for general medical care. 

Within VHA, general medical and psychiatric services are most often provided in settings that 

are organizationally and geographically distinct. Integrating these services for patients with 

SMI has the potential to improve outcomes. At the simplest level, the integration of mental and 

physical health care takes place when specialty mental health and general medical providers 

collaborate to address the mental and physical health needs of their patients. Broadly speaking, 

integration can occur in two ways: specialty mental health care being introduced into general 

medical settings or general medical care being introduced into specialty mental health settings. 

A robust literature shows that integrating mental health services into primary care improves 

mental health outcomes. In contrast, few trials have tested approaches to integrating care to 

improve general medical outcomes for patients with SMI. On the spectrum of limited integration 

(e.g., communication between providers) to fully integrated (e.g., shared development and 

implementation of the treatment plan), the interventions tested range from limited55,56,58 to 

moderately integrated.60

Although these interventions have been informed by the chronic care model, elements such as 

decision support, shared decisionmaking, self-management support related to chronic medical 

conditions, and community linkages have not been commonly included. If the conceptual model 

were broadened to include elements of PCMH, then additional elements such as designated 

care teams, shared medical appointments, home telemonitoring, test and referral tracking, and 

performance monitoring might be tested. Implementing the PCMH in VHA—known as the 

Patient Aligned Care Team (PACT)—provides a potential opportunity to test these models for 

individuals with SMI. The locus of care for such a model for individuals with SMI is yet to 

be determined. The studies identified maintained mental health settings as the central point of 
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for Individuals With Serious Mental Illness Evidence-based Synthesis Program

care with services either augmented in these settings by co-located general medical services, or 

by placing care managers in the mental health setting to facilitate care in the general medical 

setting. Given the intensity of psychiatric services often required and provided in this population, 

this may be a logical approach; however, studies where psychiatric services were provided 

to augment general medical services in the general medical setting were not identified. It is 

possible that the general medical and mental health needs of some individuals with SMI can be 

adequately provided within the context of PACT, but this model of care has not yet been formally 

evaluated. Finally, by emphasizing the team-care approach essential to PACT, these models 

could test multidisciplinary teams that include nutritionists and psychologists or health educators 

to address needed behavior changes. Consistent with the transformation of VA mental health 

services towards a recovery orientation, peer support interventions may also be useful, with one 

pilot study showing benefit for patient activation and number of primary care visits in a study of 

veterans with SMI.74

Another potential strategy that does not appear to have been studied is the training of mental 

health professionals to directly manage some common general medical illnesses. It is possible 

that this strategy could improve general medical outcomes in individuals with SMI without 

increasing the burden on primary care services. However, interventions that attempt to improve 

mental health care through training primary care providers have been largely ineffective. 

KQ 2

Two good-quality trials involving 527 patients reported outcomes relevant to KQ 2. These 

studies showed generally positive effects on immunization rates, cancer screening, and selected 

screening for cardiovascular disease. We rated the strength of evidence for these outcomes as 

moderate. However, important cancer-screening practices (e.g., mammography, pap smears) and 

chronic disease care unrelated to cardiovascular disease were not studied.

When examined in detail, these studies showed important differences in intervention design, 

with Druss and colleagues (2001)60 co-locating primary care services in the mental health setting 

in a VA medical center and Druss and colleagues (2010)54 providing care management in an 

urban community mental health center to facilitate care with various primary care providers in 

the community. In the later study, primary care providers were organizationally and physically 

separate from the community mental health center. These studies provide evidence that integrated 

care models can improve preventive services and chronic disease management as compared with 

usual care—one in an integrated system and one in a nonintegrated system. Both studies included 

a broad range of individuals with SMI. Given the theoretical reasons, as shown in our analytic 

framework, for differential effects by specific mental illnesses, social support systems, and 

severity of chronic medical illnesses, larger studies in multiple sites would be helpful to further 

understand the impact of integrated care models on these outcomes for individuals with SMI.

KQ 3

For KQ 3, four good-quality trials reported inconsistent effects on physical components of 

functional status. Two studies showed small, positive effects, and two showed no statistically 

or clinically significant benefit. We rated the strength of evidence for the finding of no to small 
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for Individuals With Serious Mental Illness Evidence-based Synthesis Program

positive effects on physical functioning as “moderate.” No study reported disease-specific 

functional status or clinical outcomes. We rated the strength of evidence “insufficient” for these 

outcomes. 

Integrated care models, ranging from limited to moderate levels of integration, had inconsistent 

effects on the physical component of functional status for individuals with SMI. Additional 

studies may help to clarify these mixed results. Interventions that are more tailored to specific 

disease states, or utilize greater levels of integration and organizational support may be required 

to produce more robust effects on functional status. That there were no studies providing data 

on clinical outcomes, such as disease-specific or all-cause mortality rates, is a significant gap 

in the literature. However, numerous studies among the general population have demonstrated 

strong links between process measures for prevention and chronic disease management and 

improvement in clinical outcomes. Given the size and duration of studies required to demonstrate 

differences in ultimate clinical outcomes for these issues, studies that assess well-established 

intermediate outcomes may be adequate, particularly given potentially higher priority gaps in the 

literature. In addition, there is not a strong reason to believe that process outcome linkages would 

differ for the general and SMI populations. However, incorporation of disease-specific symptom 

and physical function measures would be feasible and should be strongly considered in future 

trials. 

KQ 4

Among the four studies reviewed, there was relatively little diversity in the types of models 

tested, with most models based on Wagner’s Chronic Care Model. Elements of PCMH, other 

than those that overlap with the chronic care model, were not generally evaluated. Other models, 

including community-based care approaches may hold promise but were not evaluated in this 

review. At this early stage in the development of interventions to improve general medical 

outcomes, researchers and policymakers should remain open to alternative models.

With cardiovascular disease being a main source of morbidity and mortality in the general 

population and particularly in individuals with SMI, the focus on this category of disease is 

important. However, a greater variety of chronic disease outcomes is missing in the literature. 

Finally, there was relatively little evidence regarding individuals with schizophrenia and related 

psychotic disorders.

Important gaps in the literature were identified in our review. These gaps are further discussed in 

the Recommendations for Future Research section below. 

LIMITATIONS

The term “serious mental illness” varies in definition—an issue that makes it challenging to 

study this population through systematic reviews. Serious mental illness is not a MeSH search 

term, making searches of electronic databases challenging. Although we used broad and sensitive 

search strategies across multiple databases and augmented the searches by reviewing the 

bibliographies of selected articles, our search strategy may still have missed relevant articles. 

Three of the four studies were conducted in VA settings, possibly limiting applicability outside of 

nonintegrated health care systems.
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In addition to the above limitations, our methodological approach had important strengths. 

First, limiting our review to evidence gleaned from clinical trials and quasi-experimental studies 

allowed us to focus on quality over quantity when examining this relatively undeveloped body 

of research. In addition, our evidence synthesis was guided by a carefully designed standardized 

protocol, including a systematic search of research databases and relevant bibliographies, double 

data abstraction, and use of validated criteria to assess the quality of identified studies. Further, 

we searched for evidence of publication bias in ClinicalTrials.gov. In sum, this was a highly 

structured and systematic review of the extant evidence. 

RECOMMENDATIONS FOR FUTURE RESEARCH

The combination of the known gaps in the quality of general medical care and subsequent 

outcomes in this population, together with the few relevant studies identified, confirms the 

importance of future research in this area. Proven interventions that close gaps in quality and can 

be implemented widely are needed. The ultimate goal is to improve general medical outcomes 

for individuals with serious mental illnesses; however none of the studies identified reports distal 

clinical outcomes, such as disease-specific symptom measures or disease-specific or all-cause 

mortality rates. Future research should include longer-term follow up and patient important 

clinical outcomes, particularly in the absence of a strong process – outcome association for 

intermediate outcomes.

SMIs encompass a wide variety of psychopathologies. Individuals with various psychiatric 

diagnoses within this broad group may, by virtue of the nature of their psychiatric symptoms, 

have differences in their experience of general medical care, leading to disparate outcomes 

among these subgroups. Individuals with bipolar disorder comprised two of the four studies 

identified here. A considerable amount of research has been conducted in the VHA and elsewhere 

that demonstrates significant disparities in outcomes and quality measures for individuals with 

other disorders, including and perhaps especially, schizophrenia and related disorders. Yet, 

studies here included a relatively small number of individuals with these disorders identified, 

with no analyses conducted by subgroup. While some methods to improve integration of care for 

individuals with SMI may be generalized among these diagnostic entities, some may need to be 

more specific to the psychiatric diagnostic group. Future research could focus on integration of 

psychiatric and general medical care for individuals with schizophrenia and related disorders as 

well as other diagnostic subgroups.

With the exception of the study by Bauer and colleagues (2006),55,56,58 all of the identified studies 

were conducted in one site, and all of the studies identified used clinical staff funded through 

research studies. Larger studies in more naturalistic, real-world settings are needed to evaluate 

the effectiveness, as opposed to efficacy, of the strategies tested. The models used in the studies 

in this review could be described broadly as: 

1. Co-location of primary care services in the mental health setting.60

2. Optimization of treatment for psychiatric illness through collaborative care in the mental 

health setting with enhanced enrollment in and collaboration with primary care.55,56,58

3. Modification of the collaborative care model for psychiatric illness to specifically address 

common general medical issues seen in individuals with SMI.57,59
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4. Nurse care management, focused on general medical issues, provided in the mental health 

setting to increase information exchange, access to primary care, and collaboration with 

primary care providers.54

The VA Cooperative Studies Program provides an valuable infrastructure for testing the 

effectiveness of larger scale implementation of these models, perhaps using RCTs with 

randomization at the site level. A large multicenter study might also allow for disaggregation of 

effects of various model components.

While our systematic review intentionally excluded interventions delivered in the community, 

the mental health outcomes associated with assertive community treatment emphasize the 

effectiveness of community-based interventions in this population. Assertive community 

treatment, implemented in the VA as Mental Health Intensive Case Management, operates under 

multiple principles, including that most services are provided within the team as opposed to 

being brokered out to other providers. The inclusion of a primary care provider, integrated into 

the workings of an assertive community treatment team, has not been studied as a platform for 

delivery of primary care services to this population. The model used in Druss and colleagues 

(2010)54 could be applied to the assertive community treatment model, with case managers 

having increased emphasis on coordination of services for general medical illnesses and disease 

registries implemented to assure preventive services are delivered. While we limited studies in 

this review to those conducted in traditional mental health outpatient settings, services delivered 

in the community may also be important to improving general medical care in this population.

Additional sites of delivery of mental health services focusing on individuals with SMI could 

potentially be targets for studying the addition of services oriented toward general physical 

health. For example, in the VA, Psychosocial Rehabilitation and Recovery Centers (PRRCs) 

provide treatment and rehabilitation services to Veterans with SMI. The addition of primary care 

services and the impact of wellness-oriented activities could be studied in PRRCs. Also, some 

VA Community Based Outpatient Centers (CBOCs) have developed integrated care programs. 

There may be a ready opportunity to conduct a high-quality observational study comparing these 

centers to CBOCs without integrated care programs.

By design, our review did not address disparities in quality of care received by individuals with 

SMI in general medical inpatient settings. Gaps in quality of care may also exist in inpatient care 

received by individuals with SMI, as has been shown for myocardial infarction32 and in receipt of 

and outcomes after nonemergency surgical procedures.75 These issues were beyond the scope of 

the current review but may be important topics for future systematic reviews.
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