Recovery Management Checkups for Opioid Use Disorder Experiment
NCT04365920 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 455
Last updated 2025-04-06
Summary
The experiment will be conducted in collaboration with 6 jails representing discrete geographic counties in Illinois and the opioid treatment providers (OTP) that serve them. It will compare a re-entry as usual control group with two experimental groups in terms of their impact on the OUD service cascade, as well as public health and public safety outcomes. Study recruitment sites are six jails that provide treatment with medication for opioid use disorder (MOUD) to inmates with OUD prior to their release. At the time of their release to the community, 750 men and women will be randomly assigned to 1 of 3 groups: a) a re-entry as usual control, b) RMC with monthly checkups for 3 months post-release followed by quarterly checkups up to 2 years, or c) an adaptive version of RMC (RMC-A) that includes a modified checkup schedule based on each individual's pattern of treatment need. All participants will complete research interviews at release and quarterly thereafter up to 2 years post-enrollment.
Conditions
- Opioid-use Disorder
Interventions
- COMBINATION_PRODUCT
-
Recovery Management Checkups (RMC)
The RMC model was designed to improve treatment linkage, engagement, and long-term treatment retention. The conceptual framework was based on the public health theory of chronic disease management, which utilizes ongoing assessment and monitoring through regular face-to-face checkups and early (re)intervention to facilitate detection of relapse, reduce the time to treatment re-entry, and consequently, improve long-term outcomes. The original RMC model includes: 1) a fixed schedule of face-to-face quarterly checkups to assess need for SUD treatment, 2) personalized feedback based on an assessment and motivational interviewing to increase treatment motivation, 3) problem solving around barriers to treatment access and retention, and 4) assistance with scheduling and linkage to treatment. Individuals were deemed to be in "need of treatment" if they reported weekly, or more frequent, substance use since the last checkup, any past-month SUD symptoms, or self-perceived need for treatment.
- COMBINATION_PRODUCT
-
RMC-Adaptive
Participants in the RMC-Adaptive group will receive face-to-face monthly checkups during the first 2 months post-release with additional face-to-face checkups dependent upon the participant's progress. Based on the data presented in the prior section, as long as participants need treatment, they will receive monthly checkups. In addition, for every checkup that a participant does NOT need treatment, the number of months before the next checkup will be increased by 1 month (e.g., after 2 checkups without need, they will receive the next checkup 2 months later, after 3 it will be 3 months, after 4 it will be 4 months, and so on). Based on these decision rules, individuals who have NO treatment need over 24 months will still receive 5 checkups.
Sponsors & Collaborators
-
Chestnut Health Systems
lead OTHER
Principal Investigators
-
Michael L Dennis, PhD · Chestnut Health Systems
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-29
- Primary Completion
- 2025-04-30
- Completion
- 2025-06-30
Countries
- United States
Study Locations
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