Ignite Creation Date:
2024-05-06 @ 2:34 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04365920
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2019-12-19
Brief Title:
Recovery Management Checkups for Opioid Use Disorder Experiment
Sponsor:
Chestnut Health Systems
Organization:
Chestnut Health Systems
Study Overview
Official Title:
Improving Retention Across the OUD Service Cascade Upon Reentry From Jail Using Recovery Management Checkups Experiment
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JCOIN-HUB
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 individuals 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 HEALs 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 RMCs 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 individuals 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 participants 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 behaviorstreatment 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 opiatesmorphine 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 NIHs PhenX common data platform The intervention focuses on improving elements in the OUD service cascade that have historically presented challenges ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None