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.

紧急救援人员，包括护理人员，消防队员和警察，经常接触 与服用过量并在服用纳洛酮以逆转 阿片类药物过量然而，将这些人与药物辅助联系起来的机制 治疗（MAT）后，过量缺乏。这项研究的目标是芝加哥的个人， 在过去一周内接受了第一反应者给予的纳洛酮以逆转过量， 但没有进入MAT的人。研究参与者将通过与 芝加哥消防局（CFD）和警察局（CPD）;第一反应人员将接受培训， 接受纳洛酮后警觉和定向的个人同意未来接触， 作为纳洛酮标准方案的一部分。同意的人将被联系， 在纳洛酮给药后一周内筛选研究合格性;合格受试者将 随机分配到对照组，即，像往常一样转诊至MAT，或转诊至恢复启动 和过量后的管理（RIMO），一个自信的联系和恢复支持干预。 该干预措施建立在循证干预措施的基础上，用于治疗联系、监测和 研究团队在3项既往临床试验中评价了恢复支持。 第1阶段（R21）试点目标是：调整和试点测试一种肯定的干预措施（RIMO）， 阿片类药物使用障碍（OUD）患者，其药物过量已被纳洛酮逆转 由MAT的第一反应者施用。将从两个社区招募40人， 芝加哥，阿片类药物相关过量和纳洛酮给药率较高，将随机 被分配接收“仅转诊”控制或“RIMO”。评估将于 从治疗记录中收集的基线和结果。招聘推荐方法和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投入进行完善 将对合作伙伴和咨询委员会以及现有干预程序手册进行调整。 II期（R33）实验将使用在 第一阶段招募400人，随机分配至仅转诊组 控制或RIMO。所有参与者将在基线和第1、3、6、9和10天接受标准化评估。 随机化后12个月。II期研究的目的是评价RIMO： 1.对MAT关联的直接影响、用药时间长度、脱落和MAT总天数 2.对至复发时间、阿片类药物使用和阿片类药物相关过量的直接和间接（通过MAT）影响 3.直接和间接（通过MAT和阿片类药物使用）对阿片类药物相关死亡，OUD症状， 身体健康、心理健康和卫生保健利用成本。