Comparative Effectiveness of IIMR Versus CDSMP

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03966872

Collaborator

Patient-Centered Outcomes Research Institute (Other)

600

Enrollment

Locations

Arms

53.9

Anticipated Duration (Months)

300

Patients Per Site

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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. In addition, PCORI is funding an evaluation of a COVID-related intervention that will begin in the Fall 2020.

Condition or Disease	Intervention/Treatment	Phase
Mental Illness Chronic Disease	Behavioral: Integrated Illness Management and Recovery Behavioral: Chronic Disease Self-Management Program	N/A

Detailed Description

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).

Our COVID-related Enhancement will involve enrolling 150 participants from the parent project to an evaluation of an additional I-IMR module compared to usual care during the pandemic. The I-IMR module will be delivered by trained interventionists in 3 calls over 3 weeks to n=75 I-IMR participants. The I-IMR participants and CDSMP participants will continue to receive Usual Care, consisting of generic support calls from clinicians at the study sites. Baseline, and 6, 9, and 12 week assessments will evaluate the effectiveness of the COVID-19 module that will be added to I-IMR.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Sep 2, 2019

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Integrated Illness Management and Recovery (I-IMR): 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 Education and skills training groups on illness management of chronic medical and psychiatric illness. Subsample of 75 will also receive COVID-specific Integrated Illness Management and Recovery module.
Experimental: Stanford Chronic Disease Self-Management Program (CDSMP): 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 Education and skills training groups on illness management of chronic conditions

Arm

Intervention/Treatment

Experimental: Integrated Illness Management and Recovery (I-IMR):

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

Education and skills training groups on illness management of chronic medical and psychiatric illness. Subsample of 75 will also receive COVID-specific Integrated Illness Management and Recovery module.

Experimental: Stanford Chronic Disease Self-Management Program (CDSMP):

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

Education and skills training groups on illness management of chronic conditions

Outcome Measures

Primary Outcome Measures

Change in Knowledge and skills in illness self-management using the Illness Management and Recovery Scale [Change from Baseline to 12 months]
Change in knowledge and skills for illness self-management. Range of scores from 15-75 with higher scores meaning better illness self-management.
Change in Patient Activation on the Patient Activation Measure (PAM) [Change from Baseline to 12 months]
Change in Patient Activation (engagement in health care). Maximum score of 100, higher scores meaning greater activation.
Change in Acute Hospital Events from Electronic Medical Record Review. [Change from Baseline to 12 months]
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.
Knowledge and Behaviors for Preventing Catching and Spreading COVID-19 Scale [Change from Baseline to 12 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.