Wellness Self-Management

• SF-12 [ Time Frame: baseline ] [ Designated as safety issue: No ]
  The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
  
  

• Illness Management Self-Efficacy [ Time Frame: baseline ] [ Designated as safety issue: No ]
  This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well.
  
  
• Patient Activation Measure [ Time Frame: baseline, end of intervention (3 mo) and 6 mo post baseline ] [ Designated as safety issue: No ]
  This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. The measure has demonstrated reliability and validity.
  
  
• Measure of Self-Management Behaviors [ Time Frame: baseline, end of intervention (3 mo) and 6 mo post baseline ] [ Designated as safety issue: No ]
  This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75.
  
  
• Addiction Severity Index [ Time Frame: baseline, end of intervention (3 mo) and 6 mo post baseline ] [ Designated as safety issue: No ]
  This instrument evaluates frequency and severity of substance use and related psychosocial problems with a high level of psychometric integrity. It is also used to collect self-reported use of alcohol, marijuana, cocaine, alcohol, methamphetamines, opioids, benzodiazepines, and other illicit drugs
  
  
• Morisky Medication Adherence Scale [ Time Frame: baseline, end of intervention (3 mo) and 6 mo post baseline ] [ Designated as safety issue: No ]
  This 8 item self-reported medication adherence scale was developed from a well validated 4-item scale and supplemented with additional items to better capture barriers surrounding adherence behavior. This new scale has demonstrated psychometric properties
  
  
• Colorado Symptom Index [ Time Frame: baseline, end of intervention (3 mo) and 6 mo post baseline ] [ Designated as safety issue: No ]
  The CSI is a 14-item self report measure in which respondents report the frequency with which they experience specific symptoms over the past week, using a 4 point Likert scale that ranges from "not at all" to "at least every day". It is designed to provide a brief self-report index of psychiatric illness severity. The CSI has demonstrated excellent internal consistency, test-retest reliability, and validity indicators
  
  
• Service Utilization Data [ Time Frame: 6 months prior to baseline and 6 months post baseline ] [ Designated as safety issue: No ]
  summaries of somatic and mental health service utilization
  
  
• SF-12 [ Time Frame: end of intervention (3 mo) ] [ Designated as safety issue: No ]
  The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
  
  
• Illness Management Self-Efficacy [ Time Frame: baseline, end of intervention (3 mo) and 6 mo post baseline ] [ Designated as safety issue: No ]
  This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well.
  
  
• SF-12 [ Time Frame: 6 mo post baseline ] [ Designated as safety issue: No ]
  The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
  
  
• Illness Management Self-Efficacy [ Time Frame: 6 mo post baseline ] [ Designated as safety issue: No ]
  This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well.
  
  
• Patient Activation Measure [ Time Frame: 6 mo post baseline ] [ Designated as safety issue: No ]
  This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. The measure has demonstrated reliability and validity.
  
  
• Measure of Self-Management Behaviors [ Time Frame: 6 mo post baseline ] [ Designated as safety issue: No ]
  This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75.
  
  
• Addiction Severity Index [ Time Frame: 6 mo post baseline ] [ Designated as safety issue: No ]
  This instrument evaluates frequency and severity of substance use and related psychosocial problems with a high level of psychometric integrity. It is also used to collect self-reported use of alcohol, marijuana, cocaine, alcohol, methamphetamines, opioids, benzodiazepines, and other illicit drugs
  
  
• Morisky Medication Adherence Scale [ Time Frame: 6 mo post baseline ] [ Designated as safety issue: No ]
  This 8 item self-reported medication adherence scale was developed from a well validated 4-item scale and supplemented with additional items to better capture barriers surrounding adherence behavior. This new scale has demonstrated psychometric properties
  
  
• Colorado Symptom Index [ Time Frame: 6 mo post baseline ] [ Designated as safety issue: No ]
  The CSI is a 14-item self report measure in which respondents report the frequency with which they experience specific symptoms over the past week, using a 4 point Likert scale that ranges from "not at all" to "at least every day". It is designed to provide a brief self-report index of psychiatric illness severity. The CSI has demonstrated excellent internal consistency, test-retest reliability, and validity indicators
  
  

Background:

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 propose to complete a randomized controlled effectiveness trial of our Living Well intervention and simultaneously conduct 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.

Aims:

Primary AIM 1: Complete a randomized controlled effectiveness trial of our Living Well intervention with 234 veterans with SMI and at least one co-occurring chronic medical condition and evaluate the intervention's effects on functional and service related outcomes. We hypothesize 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 evaluate intervention effects on more proximal attitudinal and behavioral outcomes and assess how these factors mediate improvement in the functional and services related outcomes.

Primary AIM 2: Complete 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.

Methods:

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

Impact:

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 are currently no evidence-based peer facilitated medical illness self-management interventions available for dissemination within the VA mental health system. Our proposed study is 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.