A Hybrid Effectiveness-Implementation Trial of a Wellness Self-Management Program
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mental Illness
- Sponsor
- VA Office of Research and Development
- Enrollment
- 262
- Locations
- 2
- Primary Endpoint
- Short Form-12 (SF-12) General Health (Norm Based)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress Disorder (PTSD) 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 the investigators' own evaluation of an intervention called Living Well), the investigators propose to complete a randomized controlled effectiveness trial of the 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.
Detailed Description
Background: Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress Disorder (PTSD) 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 the investigators' own evaluation of an intervention called Living Well), the investigators propose to complete a randomized controlled effectiveness trial of the 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 the Living Well intervention with 242 Veterans with mental illness and at least one co-occurring chronic medical condition and evaluate the intervention's effects on functional and service related outcomes. The investigators 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. The investigators 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. The 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a diagnosis of schizophrenia/ schizoaffective disorder
- •bipolar disorder
- •major depression with psychotic features
- •post traumatic stress disorder
- •or psychosis not otherwise specified (NOS)
- •age between 18 and 80
- •chart documented presence of at least one of the following chronic medical conditions:
- •a respiratory condition (e.g. asthma, COPD)
- •arthritis
- •cardiovascular condition (e.g. congestive heart failure, hypertension, etc.)
Exclusion Criteria
- •Severe or profound mental retardation
- •Because participants must be able to attend the intervention if assigned to either condition, we will also require potential participants to verify their availability during screening
- •Participation in current ongoing study 'Reducing Internalized Stigma in People with Serious Mental Illness"
Outcomes
Primary Outcomes
Short Form-12 (SF-12) General Health (Norm Based)
Time Frame: Baseline, Post-intervention (3 months after baseline)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.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.
ER Visit Between Baseline and the 6-month Follow-up
Time Frame: Baseline, Follow-up (6-months after baseline)
Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.
Short-Form 12 (SF-12) Physical Scale (Norm Based)
Time Frame: Baseline, Post-intervention (3 months after baseline)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , 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.
Short-Form 12 (SF-12) Mental Scale (Norm Based)
Time Frame: Baseline, Post-intervention (3 months after baseline)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , 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.
Secondary Outcomes
- Measure of Self-Management Behaviors - Physical Activity Subscale(Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline))
- Illness Management Self-Efficacy(Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline))
- Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale(Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline))
- Patient Activation Measure(Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline))
- Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale(Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline))
- Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale(Baseline, Post-Intervention, Follow-up (6 months after baseline))
- Measure of Self-Management Behaviors - Accessing Social Support Subscale(Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline))
- Measure of Self-Management Behaviors - Healthy Eating Subscale(Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline))
- Short-Form 12 (SF-12) Mental Scale (Norm Based)(Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline))
- Short Form-12 (SF-12) General Health (Norm Based)(Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline))
- Short-Form 12 (SF-12) Physical Scale (Norm Based)(Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline))