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临床试验/NCT04925427
NCT04925427招募中不适用

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

University of Chicago10 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,500
试验地点
10
主要终点
Addiction treatment engagement

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Addiction treatment engagement

时间窗: 12 months

Number (%) of participants with two or more addiction treatment provider encounters within three months of study enrollment

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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