Clinical trial NCT04925427: Reducing Opioid Mortality in Illinois
Official title: Justice Community Opioid Innovation Network (JCOIN): Reducing Opioid Mortality in Illinois
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use
Opioid-use Disorder
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Community Outreach Intervention Projects
name: Cook County Sheriff Office
name: Cook County Health & Hospitals System
name: Lake County Sheriff Office
name: LaSalle County Jail
name: Perfectly Flawed Foundation
name: Jackson County Sheriff Office
name: Illinois Department of Corrections
First posted: 2021-06-14
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Addiction treatment engagement
timeFrame: 12 months
Secondary outcomes:
measure: Percent of participants enrolled in Medicaid or private insurance
timeFrame: 12 months
measure: Percent of participant utilizing mental health services
timeFrame: 90 days
measure: Days of Opioid Use
timeFrame: 12 months
measure: Days of stimulant Use
timeFrame: 12 months
measure: Opioid Use Disorder (OUD) Symptoms
timeFrame: 12 months
measure: Stimulant Use Disorder Symptoms
timeFrame: 12 months
measure: Patient Reported Outcomes Measurement Information System
timeFrame: 12 months
measure: Health services costs
timeFrame: 12 months
measure: Re-arrest and Re-incarceration
timeFrame: 12 months
measure: Self-reported rate of illegal activity
timeFrame: 12 months
measure: Social cost of self reported crime
timeFrame: 12 months
measure: Social cost of re-arrest and associated offenses
timeFrame: 12 months
measure: All-cause mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Cook County Department of Corrections
state: Illinois
city: Murphysboro
country: United States
facility: Jackson County Jail
state: Illinois
city: Ottawa
country: United States
facility: LaSalle County Jail
state: Illinois
city: Springfield
country: United States
facility: Illinois Department of Corrections
state: Illinois
city: Waukegan
country: United States
facility: Lake County Sheriff's Office Corrections Division
state: Illinois
Study officials:
affiliation: University of Chicago
name: Harold Pollack, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Mai Pho, MD
role: PRINCIPAL_INVESTIGATOR
References: