Recovery Initiation and Management after Overdose (RIMO) Experiment

过量用药后的恢复启动和管理 (RIMO) 实验

• 批准号: 9906195
• 负责人: Christy K Scott
• 金额: $ 58.01万
• 依托单位: CHESTNUT HEALTH SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9906195
• 关键词: Accident and Emergency department; Address; Affordable Care Act; Area; Assertiveness; Chicago; Clinical Trials; Communities; Consent; Control Groups; Data; Dropout; Eligibility Determination; Emergency Medical Technicians; Environmental Risk Factor; Evidence based intervention; Fire - disasters; Focus Groups; Funding; Future; Goals; Grant; Health Benefit; Health Care Costs; Health care facility; Illinois; Individual; Infrastructure; Intervention; Length; Link; Manuals; Medicaid; Mental Health; Methods; Monitor; Naloxone; Opioid; Outcome; Overdose; Paramedical Personnel; Participant; Pharmaceutical Preparations; Phase; Pilot Projects; Play; Police; Procedures; Protocols documentation; Public Health; Randomized; Randomized Controlled Trials; Records; Recovery; Relapse; Reporting; Research; Restaurants; Risk; Role; Services; Standardization; Substance Use Disorder; Symptoms; System; Testing; Time; Training; United States Substance Abuse and Mental Health Services Administration; base; effective therapy; eligible participant; emergency service responder; experimental study; first responder; health care service utilization; heroin use; high risk; medication-assisted treatment; member; opioid epidemic; opioid overdose; opioid use; opioid use disorder; overdose death; phase 2 study; physical conditioning; prescription opioid misuse; prevention service; public health priorities; recruit; residence; response; treatment as usual; treatment effect

Emergency responders, including paramedics, fire fighters, and police, routinely come into contact with individuals who have overdosed and play a critical role in administering naloxone to reverse opioid-related overdose. However, mechanisms to link these individuals to medication-assisted treatment (MAT) following an overdose are lacking. 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 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 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 evidenced-based intervention for treatment linkage, monitoring, and recovery support evaluated in 3 prior clinical trials by the study team. The Phase 1 (R21) Pilot Aim is to: Adapt and pilot test an assertive intervention (RIMO) to link individuals with opioid use disorders (OUD) whose overdose has been reversed by naloxone administered by first responders to MAT. Forty individuals will be recruited from two communities in Chicago with high rates of opioid-related overdose and naloxone administrations and will be randomly assigned to receive either the “referral only” control or “RIMO”. Assessments will be completed at baseline and outcomes collected from treatment records. Recruitment referral methods and RIMO will be refined based on pilot study findings, focus groups with RIMO participants, and input from study partners and advisory board, and the existing intervention procedures manual will be adapted. The Phase 2 (R33) Experiment will use the study recruitment and RIMO procedures refined in Phase 1 to recruit a total of 400 individuals and randomly assign them either to the referral only control or RIMO. All participants will receive standardized assessments at baseline and 1, 3, 6, 9, and 12 months post-randomization. Phase 2 Study Aims are to evaluate RIMO’s: 1. direct effect on linkage to MAT, length of time on medication, dropout, and total days of MAT 2. direct and indirect (via MAT) effects on time to relapse, opioid use, and opioid-related overdose 3. direct and indirect (via MAT and opioid use) effects on opioid-related fatalities, OUD symptoms, physical health, mental health and the cost of health care utilization.

包括护理人员，消防员和警察在内的紧急响应者常规接触 与服用过量并在管理纳洛酮中发挥关键作用的个人 阿片类药物相关的过量。但是，将这些人与药物辅助的机制联系起来 缺乏过量的治疗（MAT）。这项研究针对芝加哥的个人 在过去一周内收到了第一响应者管理的纳洛酮，以扭转用药过量， 但是谁没有进入垫子。研究参与者将通过与 芝加哥消防局（CFD）和警察局（CPD）；急救人员将接受培训 在接收纳洛酮后，征得机敏和定向的个人的同意 研究人员作为纳洛酮标准方案的一部分。那些同意的人将与 在纳洛酮给药的一周内筛选学习资格；合格的参与者将 随机分配给对照组，即像往常一样转介到垫子或恢复启动 和过量用药后的管理，这是一种自信的联系和恢复支持干预措施。 这种干预措施基于基于经验的治疗连接，监测和 研究小组在3项先前的临床试验中评估了恢复支持。 第1阶段（R21）试点的目的是：适应和飞行员测试自信干预（RIMO）以链接 阿片类药物使用障碍（OUD）的人过量用纳洛酮逆转 由急救人员对MAT进行管理。将在两个社区中招募40个人 芝加哥的阿片类药物相关过量和纳洛酮管理率很高，将是随机的 指定接收“仅转介”控件或“ RIMO”。评估将在 从治疗记录中收集的基线和结果。招聘转介方法和Rimo将 根据试点研究结果，与RIMO参与者的焦点小组以及研究的意见进行完善 合作伙伴和顾问委员会以及现有的干预程序手册将得到调整。 第2阶段（R33）实验将使用研究募集和RIMO程序进行完善 阶段1招募了400个人，并将其随机分配给转介 控制或RIMO。所有参与者将在基线和1、3、6、9和 随机后12个月。第二阶段研究的目的是评估Rimo的： 1。直接影响与垫子的连锁，药物治疗的时间长度，辍学和垫子的总天数 2。直接和间接（通过MAT）对继电器，阿片类药物使用和阿片类药物相关的过量效果 3。直接和间接（通过MAT和阿片类药物使用）对阿片类药物有关的死亡，OUD症状，症状的影响 身体健康，心理健康和医疗保健利用的成本。