Clinical trial NCT04365920: Recovery Management Checkups for Opioid Use Disorder Experiment
Official title: Improving Retention Across the OUD Service Cascade Upon Reentry From Jail Using Recovery Management Checkups Experiment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Opioid-use Disorder
Lead sponsor: Chestnut Health Systems
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Re-Entry as Usual; Recovery Management Checkups (RMC); RMC-Adaptive
Primary purpose: TREATMENT

Brief 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.

Detailed description: This project aims to complement HEAL's Justice Community Opioid Innovation Network (JCOIN) initiative by focusing on post-release recovery in six county jails in Illinois with the goal of increasing linkage to and retention in community-based treatment with medication for opioid use disorder (MOUD) and reducing both opioid use disorder (OUD) relapse and criminal recidivism over two years. The study builds upon the platform of prior research demonstrating the effectiveness of the Recovery Management Checkups (RMC) intervention. To date, three randomized controlled trials conducted by the study investigators have demonstrated RMC's effectiveness by increasing treatment engagement and retention, re-linking recovering patients to treatment when indicated, and improving their health, psychosocial functioning, and other outcomes. Across these studies, relative to controls, participants in the RMC condition reported more treatment initiation, more days of treatment received, fewer days of substance use, and fewer health symptoms. In the proposed study, an adapted version of the RMC (RMC-A) will build upon the core components of the RMC by tailoring the checkup frequency to the individual's assessed need for treatment over time. The goal of the proposed experiment is to compare linkage and retention rates as well as public health and public safety outcomes of 750 male and female offenders who will be randomly assigned to 1 of 3 groups upon their release from jail: a) re-entry as usual (control), b) the original RMC, and c) a RMC-Adaptive version in which the frequency and content of checkups will be based upon the participant's ongoing progress as assessed by a set of indicators of treatment need. The study will be conducted in collaboration with 6 county jails in Illinois, and their local OTPs that currently provide pre-release MOUD to offenders with OUD. Pre-release participants will be screened for history of OUD and eligibility for MOUD following usual procedures. All participants will receive quarterly research follow-up assessments. Data sources include interviews with standardized measures, urine tests, treatment records to verify treatment received, recidivism, death records, and cost accounting. Research staff will administer the 25-minute Global Appraisal of Individual Needs - Quick (GAIN-Q3) and several supplemental scales at study enrollment, and again quarterly over 24 months post-study enrollment. The GAIN-Q3 includes 8 primary domains: 1) background, 2) school problems, 3) work problems, 4) physical health, 5) sources of stress, 6) HIV risk behaviors, 7) substance use, and 8) crime and violence. The response set captures the recency of these symptoms (life time, past year, past 90 days, past month) and treatment involvement, then the frequency (days) of behaviors/treatment utilization in the past 90 days. The GAIN-Q3 includes a behavioral health screener, health care utilization measures, measures of days of methadone treatment, heroin and other opioid use, days of other types of treatment, and other substance use. The GAIN-Q3 will be supplemented with the Quality of Life measure from the Patient Reported Outcomes Measurement Information System (PROMIS) - R. Data will be collected via a cloud-based computer program that controls ranges and skip-outs and identifies major inconsistencies for interviewers. All interviewers will receive extensive training and monitoring to ensure data quality. At the time of each in-person research assessment, on-site urine screens will be conducted with DrugCheck cups and fentanyl test strips using an immunoassay for rapid qualitative results based on SAMHSA-standard cutoffs for methadone and opiates/morphine in general, as well as specific tests for fentanyl, Oxycodone, and other substances. Research staff will be trained on a protocol that minimizes false negatives consistent with NIH's PhenX common data platform. The intervention focuses on improving elements in the OUD service cascade that have historically presented challenges, i.e., successful treatment linkage, engagement, and retention in community-based treatment post-release. With its emphasis on adapting an existing evidence-based intervention (RMC) to reduce high drop-out and increase retention in treatment with MOUD, it places individuals with OUD at lower risk for relapse, overdose, and death. The RMC model also proactively addresses the well-documented chronic cyclical nature of addiction, whereby individuals transition between being in treatment, in the community using, incarcerated, and in recovery. Findings from the study may help to target resources to those with demonstrated need, and reduce the intervention burden on those with lower need, thus resulting in an improved overall effectiveness and cost-effectiveness of RMC checkups.

Eligibility criteria: Inclusion Criteria:

* meets DSM-5 opioid use disorder criteria in the past year
* reports heroin or other opioid use in the 90 days prior to entering jail
* is released from 1 of the participating jails.

Exclusion Criteria:

* is under age 18
* has cognitive impairment that precludes ability to give informed consent
* resides outside the service area.

Primary outcomes:
measure: Months of treatment with medication for opioid use disorder (MOUD)
timeFrame: 24 months
Secondary outcomes:
measure: Opioid Use Disorder (OUD) service cascade
timeFrame: 24 months
measure: Days of Opioid Use
timeFrame: 90 days
measure: Opioid Use Disorder (OUD) Symptoms
timeFrame: 90 days
measure: Quality of Life (QoL): self-reported frequency of problems and strengths
timeFrame: 7 days
measure: Costs-of-Healthcare-Utilization
timeFrame: 90 days
measure: Illegal Activity
timeFrame: 24 months
measure: Re-arrest and Re-incarceration
timeFrame: 24 months
measure: Costs-of-Crime
timeFrame: 90 days
measure: Quality Adjusted Life Years (QALYs)
timeFrame: 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chestnut Health Systems-Lighthouse Institute
state: Illinois
Study officials:
affiliation: Chestnut Health Systems
name: Michael L Dennis, PhD
role: PRINCIPAL_INVESTIGATOR
References: