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IIR 11-276 – HSR Study

IIR 11-276
A Hybrid Effectiveness-Implementation Trial of a Wellness Self-Management Program
Richard W Goldberg, PhD
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, MD
Funding Period: April 2013 - March 2018
Veterans with schizophrenia and other serious mental illnesses (SMI) are at elevated risk for co-occurring chronic medical conditions resulting in increased risk of disability, high health care spending, reduced quality of life and early mortality. Physical wellness is increasingly recognized as a key component of the VA's commitment to developing recovery-oriented and veteran-centered mental health treatment. There is also growing recognition of the value of interventions that promote and improve patient self-management of chronic medical conditions. Building on the established efficacy of consumer facilitated medical illness self-management programming used in the general population and two recent adaptations for use with SMI adults in the public health sector (including our own evaluation of an intervention called Living Well), we completed a randomized controlled effectiveness trial of our Living Well intervention and simultaneously conducted a well specified process evaluation to optimize knowledge accrual regarding important factors that may improve future adoption, implementation and sustainability of the Living Well intervention in the VA system of care.


Primary AIM 1: Completed a randomized controlled effectiveness trial of our Living Well intervention with 242 veterans with SMI and at least one co-occurring chronic medical condition and evaluated the intervention's effects on functional and service related outcomes. We hypothesized that those randomized to the Living Well intervention will, in comparison to those randomized to a medical illness education and support group, demonstrate improved general health functioning including physical and emotional functioning as well as reduced rates of medical emergency room visits for management of a chronic medical condition. We will also evaluated intervention effects on more proximal attitudinal and behavioral outcomes and will assess how these factors mediate improvement in the functional and services related outcomes.

Primary AIM 2: Completed a well specified process evaluation based on the RE-AIM evaluation framework to better understand contextual factors that can improve the Reach, Effectiveness, Adoption, Implementation and Maintenance which together determine the potential public health impact of the Living Well intervention.


A mix of temporally overlapping quantitative and qualitative methods was used to maximize integration and synthesis of data streams across the two aims to optimize knowledge accrual.

Primary AIM 1: Using an intent-to-treat framework, we collected data from every participant at the time of enrollment, randomization (1-3 after enrollment), post-treatment (3 months post randomization), and again 3 months later (9 months from baseline). Services data regarding use of the ER and other medical services including outpatient appointments with primary and specialty care medical providers within the VA were collected at the follow-up assessment (6 months from randomization) as this allowed for a more realistic timeframe for assessing effects on service utilization. To inform related analyses we also collected retrospective service utilization data for a full six months before baseline. We recruited participants from outpatient programs with the VAMHCS (Baltimore and Perry Point) and from the DCVA.

Primary AIM 2: Methods primarily included qualitative data collection, including pre-trial series of qualitative focus groups with a range of key stakeholders to: 1) Identify obstacles and barriers that might impede the proposed trial, and; 2) collect contextual information that will inform future dissemination and sustainability of the Living Well intervention in the broader VA context. We completed focus groups with local clinicians and administrators working in each of the three implementation sites (one group for each site). Queries also focused on clinician/administrator perceptions of how well they think Living Well fits with existing clinic services for Veterans with co-occurring medical conditions (REACH), and their perceptions of potential barriers and facilitators associated with adopting the Living Well intervention for use in their programs/clinics (ADOPTION / IMPLEMENTATION). The groups also discussed how to best secure buy-in from program administrators, clinicians and service recipients to support Living Well during the trial (ADOPTION / IMPLEMENTATION) and anticipated challenges to securing the resources needed to support and sustain Living Well beyond the trial (MAINTENANCE). Also, after completing the effectiveness trial (AIM 1) we conducted focus group or in-depth individual interviews with Veteran study participants, Veterans who served as peer co-facilitators in the Living Well condition, and various stakeholders involved in the pre-trail evaluation to: 1) extend and enhance our understanding of intervention outcome and processes, and; 2) inform the development of an implementation toolkit to support future dissemination efforts. Finally, we are now completing a cost analysis that will include assessment of the average cost of a Living Well program, including implementation and operating costs, and complete an initial analysis of VA health care cost consequences of Living Well to assess whether participation in Living Well results in any savings (i.e., "cost offsets") to the VA healthcare system. The analysis will apply the opportunity cost approach from the perspective of the VA health care system (i.e., the "payer perspective"). The analyses will focus on both direct and indirect costs.

The RCT included 242 Veterans. In the Living Well condition, compared with an active control group, there were greater improvements in the following at 3 months: mental health related quality of life (t=2.15, df=619, p=.032), self-management self-efficacy (t=4.10, df=622, p<.0001), patient activation (t=2.08, df=622, p=.038), internal health locus of control (t=2.01, df=622, p=.045), behavioral/cognitive symptom management (t=2.77, df=620, p=.006), and overall psychiatric symptoms (t=-2.02, df=603, p=.044). There were no group or time effects on emergency room use (t=0.47, df=480, p=.640). The control group exhibited greater increases in physical health related quality of life at 3 months (t=-2.23, df=619, p=.026). Only the significant group difference in self-management self-efficacy was maintained at 6 months (t=2.86, df=622, 0.004).

Analyses of study specified qualitative and cost data are on-going. Interim findings from the qualitative data are being used to inform a developing draft of an implementation and training manual that can be used for future dissemination and implementation efforts.

Despite the growing recognition that self-management strategies hold enormous promise for improving quality and outcomes of care for chronic medical illnesses, and the fact that self-management is gaining prominence as a mental health recovery oriented treatment focus, there is limited research on peer facilitated medical illness self-management interventions available for dissemination within the VA mental health system. Our proposed study was designed to both generate evidence supporting the effectiveness of a peer co-facilitated intervention and to help speed throughput to public health impact by collecting important contextual information about factors that may improve future dissemination and implementation efforts.

Another project impact will be the creation of an implementation toolkit that will be made available to support dissemination.

External Links for this Project

NIH Reporter

Grant Number: I01HX000844-01A1

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None at this time.

DRA: Mental, Cognitive and Behavioral Disorders
DRE: Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: none
MeSH Terms: none

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