Comparative Effectiveness of IIMR Versus CDSMP

Study Overview
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Brief Summary
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The study will enroll 600 people with serious mental illness who receive services at Centerstone in KY or TN and will compare two different evidence-based self-management interventions: Integrated Illness Management and Recovery (I-IMR), a program developed by the study team at Dartmouth that trains people with serious mental illness on physical and mental health self-management, and the Stanford Chronic Disease Self-Management Program (CDSMP), a program largely focused on physical health self-management that has been used widely in the general population.

Detailed Description
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The proposed study will be the first to compare two commonly used but substantially different, evidence-based self-management interventions. Integrated Illness Management and Recovery (I-IMR), is an individually-tailored, 16-session, integrated program combining both physical and mental health self-management specifically developed for people with SMI. In contrast, the Stanford Chronic Disease Self-Management Program (CDSMP) is a group-based, 6-session, chronic disease self-management program largely focused on physical health self-management alone. I-IMR is delivered by community mental health providers or by community outreach workers, while CDSMP is co-delivered by two peers or by a health professional and a peer. Both programs have been widely recommended, disseminated, and used. The proposed parent study will randomize people with serious mental illness to I-IMR (n=300) and CDSMP (n=300).

Official Title
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Comparative Effectiveness of Integrated Illness Management and Recovery Versus the Chronic Disease Self-Management Program

Conditions
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Mental Illness, Chronic Disease

Intervention / Treatment
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* Behavioral: Integrated Illness Management and Recovery
* Behavioral: Chronic Disease Self-Management Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Serious Mental Illness (diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or chronic depression with moderate impairment in functioning) receiving services at Centerstone(KY and TN) Diagnosis of a chronic medical condition increasing risk of early mortality from cardiovascular or respiratory disease (e.g., diabetes, hyperlipidemia, hypertension, COPD, heart failure, tobacco dependence, obesity), and at least 1 ER visit or hospitalization within the past year or judgment by the treatment team of substantial need for illness self-management training. Exclusion Criteria: Consumers who do not speak English Consumers with either no, or a well-controlled medical condition will not be included Individuals residing in a nursing home or other institution Evidence of significant cognitive impairment as indicated by a Mini Mental Status Examination score <24, will be excluded Eligibility for the COVID -related substudy is dependent on enrollment and participation in the parent project.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Illness Management and Recovery (I-IMR):<br>Participants assigned to I-IMR will receive 2 individual sessions to discuss principles of recovery and set personally meaningful goals, with the remainder of the 14 I-IMR sessions delivered in groups of 8-10 (to enable individual tailoring) | Behavioral: Integrated Illness Management and Recovery<br>* Education and skills training groups on illness management of chronic medical and psychiatric illness.<br>|
| Experimental: Stanford Chronic Disease Self-Management Program (CDSMP):<br>Participants randomly assigned get a 6-session group-based educational program co-delivered by two peers (lay people who have successfully managed a chronic illness) or a peer and a professional | Behavioral: Chronic Disease Self-Management Program<br>* Education and skills training groups on illness management of chronic conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knowledge and skills in illness self-management using the Illness Management and Recovery Scale | Change in knowledge and skills for illness self-management. Range of scores from 15-75 with higher scores meaning better illness self-management. | Change from Baseline to 12 months | 
| Change in Patient Activation on the Patient Activation Measure (PAM) | Change in Patient Activation (engagement in health care). Maximum score of 100, higher scores meaning greater activation. | Change from Baseline to 12 months | 
| Change in Acute Hospital Events from Electronic Medical Record Review. | Change in the number of acute hospital events. At each assessment a combination of participant report and verified information from mental health clinics will be used to validate the number acute hospital events. | Change from Baseline to 12 months | 
| Knowledge and Behaviors for Preventing Catching and Spreading COVID-19 Scale | Change in score on this measure, which was developed as part of the study plan because no suitable scale existed to assess knowledge and safety behaviors for COVID-19. Scores range from 0-100%, with higher scores indicating greater knowledge and enactment of safety behaviors. | Change from Baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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integrated health, mental health, illness management, cardiovascular disease, physical health