- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04925427
Reducing Opioid Mortality in Illinois (ROMI)
Justice Community Opioid Innovation Network (JCOIN): Reducing Opioid Mortality in Illinois
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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)
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Harold Pollack, PhD
- Phone Number: 773-834-4292
- Email: haroldp@uchicago.edu
Study Contact Backup
- Name: Mai Pho, MD
- Phone Number: 773-834-3689
- Email: mpho@bsd.uchicago.edu
Study Locations
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Illinois
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Chicago, Illinois, United States, 60608
- Not yet recruiting
- Cook County Department of Corrections
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Contact:
- Marianne Kelly, PhD
- Phone Number: 773-674-7100
- Email: Marianne.Kelly@cookcountyil.gov
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Murphysboro, Illinois, United States, 62966
- Not yet recruiting
- Jackson County Jail
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Contact:
- Jeff Whitbeck
- Phone Number: 618-687-2292
- Email: Jeff.Whitbeck@jacksoncounty-il.gov
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Ottawa, Illinois, United States, 61350
- Recruiting
- LaSalle County Jail
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Contact:
- Jason Edgcomb
- Phone Number: 815-434-8383
- Email: jedgcomb@lasallecounty.org
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Springfield, Illinois, United States, 62794
- Not yet recruiting
- Illinois Department of Corrections
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Contact:
- Steve Meeks, MD
- Phone Number: 312-814-3017
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Waukegan, Illinois, United States, 60085
- Not yet recruiting
- Lake County Sheriff's Office Corrections Division
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Contact:
- Anthony Vega
- Email: AVega@lakecountyil.gov
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must be at least 18 years old
- Reside in designated research site county or zip code
- Satisfy criteria for likely OUD based upon nonmedical use of prescription opioids, heroin, or synthetic opioids.
Exclusion Criteria:
- Participants experiencing cognitive impairments that preclude informed consent.
- Reside out of the service area.
- Prior enrollment in a parallel JCOIN study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Case Management and Peer Recovery
Participants in the CM/PRC + OEND arm will receive one year of service delivery.
During the initial intake interview the CM will identify primary, secondary, and tertiary barriers to treatment initiation and completion, then create an action plan tailored to each client.
PRCs with lived SUD or incarceration experience will address recovery barriers, while CMs will focus on service barriers.
Where beneficial and desired by the clients, PRCs will accompany clients to provider and select service appointments to promote engagement and retention.
CM/PRC teams will provide OEND upon community re-entry.
The teams will provide follow-up phone calls and home visits to facilitate service linkages.
Contact frequency will depend on clients' individual barriers (e.g., transportation, homelessness), but will include at least weekly in-person or telephone check-ins for first six months, reduced to monthly check-ins after that.
|
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.
|
Placebo Comparator: Naloxone-Only
Participants randomized to the Usual care + OEND condition will be trained on naloxone administration by research staff at the time of randomization.
Upon community re-entry,they will be given a naloxone kit and information on local resources for harm reduction, SUD treatment, and additional supportive services.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Addiction treatment engagement
Time Frame: 12 months
|
Number (%) of participants with two or more addiction treatment provider encounters within three months of study enrollment
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of participants enrolled in Medicaid or private insurance
Time Frame: 12 months
|
Defined as Medicaid or private insurance enrollment during the intervention period.
|
12 months
|
Percent of participant utilizing mental health services
Time Frame: 90 days
|
Defined as any mental health utilization within 90 days conditional on CAT-MH diagnostic.
|
90 days
|
Days of Opioid Use
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.
|
12 months
|
Patient Reported Outcomes Measurement Information System
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.
|
12 months
|
Health services costs
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.
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12 months
|
Re-arrest and Re-incarceration
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.
|
12 months
|
Self-reported rate of illegal activity
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.
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12 months
|
Social cost of self reported crime
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.
|
12 months
|
Social cost of re-arrest and associated offenses
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).
|
12 months
|
Days of stimulant Use
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.
|
12 months
|
Opioid Use Disorder (OUD) Symptoms
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.
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12 months
|
Stimulant Use Disorder Symptoms
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.
|
12 months
|
All-cause mortality
Time Frame: 12 months
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Mortality from any cause
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mai Pho, MD, University of Chicago
- Principal Investigator: Harold Pollack, PhD, University of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB19-1775
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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