Reducing Opioid Mortality in Illinois

Официальное название

Justice Community Opioid Innovation Network (JCOIN): Reducing Opioid Mortality in Illinois

Обзор

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.

Подробное описание

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)

Вмешательства

• Поведенческое Case Management and Peer Recovery
  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.
• Поведенческое Naloxone-Only
  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.

Первичные конечные точки

• Addiction treatment engagement [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Percent of participants enrolled in Medicaid or private insurance [Срок оценки: 12 months]
• Percent of participant utilizing mental health services [Срок оценки: 90 days]
• Days of Opioid Use [Срок оценки: 12 months]
• Days of stimulant Use [Срок оценки: 12 months]
• Opioid Use Disorder (OUD) Symptoms [Срок оценки: 12 months]
• Stimulant Use Disorder Symptoms [Срок оценки: 12 months]
• Patient Reported Outcomes Measurement Information System [Срок оценки: 12 months]
• Health services costs [Срок оценки: 12 months]
• Re-arrest and Re-incarceration [Срок оценки: 12 months]
• Self-reported rate of illegal activity [Срок оценки: 12 months]
• Social cost of self reported crime [Срок оценки: 12 months]
• Social cost of re-arrest and associated offenses [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Participants experiencing cognitive impairments that preclude informed consent.
• Reside out of the service area.
• Prior enrollment in a parallel JCOIN study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 5 центров

• Cook County Department of Corrections — Chicago
• Jackson County Jail — Murphysboro
• LaSalle County Jail — Ottawa
• Illinois Department of Corrections — Springfield
• Lake County Sheriff's Office Corrections Division — Waukegan

Публикации

• Pho MT, Bouris A, Carreon ED, Stinnette M, Kaufmann M, Shuman V, Watson DP, Jimenez AD, Powell B, Kaplan C, Zawacki S, Morris S, Garcia J, Hafertepe A, Hafertepe K, Pollack HA, Schneider JA, Boodram B. Implementation strategies to support recovery support workers serving criminal legal involved people who use drugs. J Subst Use Addict Treat. 2025 Feb;169:209583. doi: 10.1016/j.josat.2024.209583. E PMID 39586354

Идентификаторы

NCT: NCT04925427 · IRB19-1775

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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