Recovery Initiation and Management After Overdose (RIMO) Experiment: Phase 2 Main Clinical Trial (R33)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Length of Staying on Medication
研究概览
简要总结
This study targets individuals in Chicago who have received naloxone administered by first responders within the past week to reverse an overdose, but who have not entered into MAT. Study participants will be recruited through partnerships with the Chicago Fire Department (CFD) and/or Police Department (CPD); first responders will be trained to seek consent from individuals who are alert and oriented after receiving naloxone for future contacts by research staff as part of the naloxone standard protocol. Those who consent will be contacted and screened for study eligibility ideally within one week of naloxone administration; eligible participants will be randomly assigned either to the control group, i.e., referral to MAT as usual, or to Recovery Initiation and Management after Overdose (RIMO), an assertive linkage and recovery support intervention. This intervention builds on an evidence-based intervention for treatment linkage, monitoring, and recovery support evaluated in 3 prior clinical trials by the study team.
详细描述
Research staff will work with the Chicago Fire Department's Emergency Medical Services division and the Chicago Police Department to identify people who have just had an opioid overdose reversed with naloxone, recruit them into the trial, randomize them to a passive referral (via a brochure) vs. the RIMO experimental group. Using the study recruitment and RIMO procedures refined in Phase 1, a total of 350 individuals will be recruited and randomly assigned to the "referral to MAT" control or to "RIMO". All participants will receive standardized assessments at baseline and 3, 6, and 9 months post-randomization. The study's aims and their associated hypotheses are:
Aim 1: Evaluate RIMO's direct effect on linkage to MAT, length of time on MAT, dropout, and total days of MAT.
H1: Relative to the control group, RIMO will have a direct effect on: a) initiating MAT sooner, b) staying on medication longer, c) reducing dropout, and d) receiving more total days of MAT.
Aim 2: Evaluate RIMO's direct and indirect (via MAT) effects on time to relapse, opioid use, and opioid-related overdose.
H2: RIMO will have direct and indirect (via days of MAT treatment) effects on: a) time to relapse, b) days of opioid use, and c) number of overdoses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor is blind to the condition of the participant.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •experienced an opioid overdose reversed with naloxone administered by first responders on a participating team within the past week
- •not in treatment during the past 30 days
- •screen positive for an OUD
排除标准
- •under age 18
- •unable to speak and understand English
- •not residing in Chicago
- •cognitively unable to provide informed consent
研究组 & 干预措施
Passive Referral Control
Participants will be given information on recently expanded and publicly-funded MAT treatment in their community.
干预措施: Passive Referral to Treatment Control (Other)
Recovery Initiation and Management after Overdose (RIMO)
Participants assigned to the RIMO arm will meet with Linkage Managers (LM), who will use motivational interviewing (MI) techniques to: 1) identify the need for treatment and barriers to going, 2) discuss with patients the benefits of their decision to go to treatment, including activities they might enjoy as well as things they do not like about their alcohol/substance use, 3) provide personalized feedback to participants about the status of their condition based on responses to the assessment instruments, 4) help participants resolve ambivalence about their use and move them toward a commitment to change by accessing additional care, 5) address existing barriers to treatment (e.g., childcare, transportation), 6) schedule a treatment appointment, and 7) facilitate medication assisted treatment re-entry and engagement.
干预措施: Recovery Initiation and Management after Overdose (RIMO) (Behavioral)
Recovery Initiation and Management after Overdose (RIMO)
Participants assigned to the RIMO arm will meet with Linkage Managers (LM), who will use motivational interviewing (MI) techniques to: 1) identify the need for treatment and barriers to going, 2) discuss with patients the benefits of their decision to go to treatment, including activities they might enjoy as well as things they do not like about their alcohol/substance use, 3) provide personalized feedback to participants about the status of their condition based on responses to the assessment instruments, 4) help participants resolve ambivalence about their use and move them toward a commitment to change by accessing additional care, 5) address existing barriers to treatment (e.g., childcare, transportation), 6) schedule a treatment appointment, and 7) facilitate medication assisted treatment re-entry and engagement.
干预措施: Passive Referral to Treatment Control (Other)
结局指标
主要结局
Length of Staying on Medication
时间窗: 9 months
Days between MAT initiation and discharge, from treatment records.
MAT Days
时间窗: 9 months
Total days of MAT over 9 months from Global Appraisal of Individual Needs Quick (GAIN) and treatment records.
MAT Time to Initiation
时间窗: 9 months
Days from index naloxone administration to the initiation of any kind of MAT, from treatment records.
次要结局
- Opioid Overdose(9 months)
- Opioid Days of Use(9 months)
- Physical Health(9 months)
- Time to Relapse(9 months)
- Opioid-Related Fatality(9 months)
- Opioid Use Disorder symptoms(9 months)
- Mental Health: Internalizing Symptoms(9 months)
- Mental Health: Externalizing Symptoms(9 months)
- Cost of Health Care Utilization(9 months)
研究者
Christine Grella
Senior Research Scientist
Chestnut Health Systems