NCT Number: NCT04925427
Reducing Opioid Mortality in Illinois (ROMI) is 5-year research study led by the University of Chicago in partnership with the University of Illinois at Chicago's (UIC) Community Outreach Intervention Projects (COIP), the Illinois Criminal Justice Information Authority (ICJIA) and the American Institutes for Research (AIR). ROMI aims to understand and test strategies for linking individuals with a history of opioid use disorder who are released from Illinois jails and prisons to substance use treatment. ROMI is one of twelve grants awarded by the National Institutes of Health (NIH) as part of the Justice Community Opioid Innovation Network (JCOIN) to support research on quality addiction treatment for opioid use disorder in criminal justice settings nationwide.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Cook County Department of Corrections, Chicago, Illinois, United States
This NIDA-funded multi-site randomized control trial (RCT) examines the effectiveness of an established, intensive case management model for study participants who are awaiting release from four jails and two prisons across Illinois. The investigators seek to demonstrate that a unified case management approach can improve treatment engagement and retention among individuals who face high risks of opioid use disorders, overdose, and related harms. The investigators will examine the impact of case management and peer recovery coaching on participants' engagement with treatment and harm reduction interventions. The investigators will also study secondary outcomes including insurance enrollment, re-arrest, use of mental health services, and more.
ROMI will enroll at least 300 individuals with opioid disorders in the CMPR group, and at least 300 participants in the naloxone-only across five geographically distinct sites of care. All participants will receive harm reduction resources. The investigators hypothesize that the treatment group will display declines in opioid use, re-arrest, self-reported syringe sharing, and overdose risk behaviors relative to the control groups. The investigators will also examine differences between urban - rural and rural differences in treatment engagement and retention engagement, retention, and downstream outcomes across treatment arms. Aside from demonstrating these treatment impacts, the investigators will guide, document and evaluate ROMI's implementation efforts to ensure consistency across sites across sites and to inform future replication of the model in different settings or for different populations. (Edited 11/27/23 to reflect changes in recruitment from 500 in each treatment arm to 300)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A blend between a Critical Time Intervention (CTI) case management model and a peer recovery coaching approach. CORI will employ peer-based case management/recovery coaching and other transitional services (e.g., peer navigation) to provide support and service linkages to medication-assisted treatment (MAT) and harm reduction interventions to reduce subsequent opioid use and related harms.
Participants will be trained on naloxone administration, and upon re-entry, they will be given a naloxone kit and information on local resources for harm reduction, SUD treatment, and additional supportive services.
Time frame: 12 months
Number (%) of participants with two or more addiction treatment provider encounters within three months of study enrollment
Time frame: 12 months
Defined as Medicaid or private insurance enrollment during the intervention period.
Time frame: 90 days
Defined as any mental health utilization within 90 days conditional on CAT-MH diagnostic.
Time frame: 12 months
A self-reported count 0 to 90 days of using any kind of opioids each quarter, as indicated by the Global Appraisal of Individual Needs (GAIN)assessment tool.
Time frame: 12 months
A self-reported count 0 to 90 days of using any kind of stimulants each quarter, as indicated by the Global Appraisal of Individual Needs (GAIN)assessment tool.
Time frame: 12 months
A self-reported count of Opioid Use Disorder (OUD) symptoms, again as captured by the GAIN instrument, measuring past month, past 90 days, year, and lifetime. SUD/MH symptoms as captured by the CAT-MH/SUD.
Time frame: 12 months
A self-reported count of Stimulant Use Disorder symptoms, again as captured by the GAIN instrument, measuring past month, past 90 days, year, and lifetime. SUD/MH symptoms as captured by the CAT-MH/SUD.
Time frame: 12 months
This scale of person-centered measures includes eight domains (physical function, ability to participate in social roles and activities, anxiety, depression, fatigue, sleep disturbance, cognitive function ability, pain interference, and pain intensity). These are elicited in a five point likert scale (from 1= never to 5 = always) with higher scores equaling more of the concept being measured, which may be better or worse based on the domain measured.
Time frame: 12 months
This cost measure is based on the self-reported frequency of all healthcare services use. Measured using published Medicare reimbursement rates for all pertinent medical care services. Addiction services cost as measured by DATCAP methodology.
Time frame: 12 months
Arrest or re-incarceration based on any charge using data from Illinois Criminal Justice Information Authority (ICJIA). The investigators will examine the binary outcomes of re-arrest and reincarceration, and also count data models of the number of arrests post-enrollment during days of non-incarceration.
Time frame: 12 months
This is a self-reported count of 19 items across different types of illegal activities following the JCOIN core measures instrument.
Time frame: 12 months
Total social cost of self-reported illegal activity, using estimates for offense-specific economic valuations of social cost per offense and a self-reported count of 19 items across different types of illegal activities.
Time frame: 12 months
Total social cost of crime, using estimates for offense-specific economic valuations of social cost per offense and any charge using data from Illinois Criminal Justice Information Authority (ICJIA).
Time frame: 12 months
Mortality from any cause
Contact information is provided by the study sponsor or research team.
Harold Pollack, PhD
CONTACT
Mai Pho, MD
CONTACT
University of Chicago
Other
Justice Community Opioid Innovation Network (JCOIN): Reducing Opioid Mortality in Illinois
Acronym: ROMI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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