Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program

Relay 的随机对照试验 - 纽约市非致命药物过量反应计划

• 批准号: 9907365
• 负责人: Kelly Doran
• 金额: $ 76.88万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2022-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9907365
• 关键词: Randomized; Controlled; Trial; Relay; NYC

PROJECT SUMMARY Individuals who experience a nonfatal opioid overdose (OD) are known to be at exceedingly high risk of dying from a subsequent OD, but effective secondary OD prevention interventions are lacking. Most people who have an OD are brought to an emergency department (ED). ED visits thus offer a unique opportunity to reach those at highest risk for future OD death. In response, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) has implemented Relay, a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. The Relay intervention is grounded in the theory of triadic influence and dynamic social impact theory, and it incorporates a motivational approach. Relay is delivered by trained peer navigators, who are DOHMH staff with lived substance use experience. The proposed randomized controlled trial represents a collaboration between academic, public health, and medical service partners to evaluate the impact of Relay on preventing subsequent opioid-related adverse events. A total of 350 eligible individuals with nonfatal opioid OD presenting to one of 4 participating EDs will be enrolled and randomized to one of two arms: 1) enhanced usual care (EUC)—OD education and naloxone distribution (OEND) and list of opioid treatment programs; or 2) Relay—peer-delivered OD education and treatment linkage, including 90 days of peer navigation. Outcomes will be measured for 12 months through interviews and administrative health data. Aim 1 is to evaluate the effectiveness of Relay to reduce the frequency of opioid-related adverse events (any opioid-involved OD [fatal or nonfatal] or any substance use-related ED visit), in the 12 months following the index visit, the primary outcome. Aim 2 is to evaluate the impact of Relay on the following secondary outcomes: initiation of medication for opioid use disorder (MOUD), OD risk behaviors, time to next opioid-involved OD, and frequency of ED visits for any cause. Aim 3 is to identify mediators (e.g., OD knowledge, support, experience of stigma, peer modeling) and moderators (e.g., substance use history, age, sex, housing status) of the effect of Relay. Aim 4 is to evaluate Relay’s implementation by assessing fidelity to the program model and exploring barriers and facilitators to its delivery and sustainability through qualitative interviews with patients, Relay peer navigators, and ED providers. The proposed study is significant because it will provide rigorous evidence about whether peer interventions like Relay can meaningfully impact the opioid crisis by reducing opioid- related adverse events. In the midst of an opioid crisis that shows no signs of abating, health authorities are developing programs aimed at reducing OD deaths, even in the absence of strong evidence to support them. This is a critically important time to conduct research that identifies which of these new approaches are effective, and under what conditions, so they can be brought to scale to improve population health.

项目摘要 已知经历非致命阿片类药物过量（OD）的个人死亡风险极高 但缺乏有效的二级OD预防干预措施。大多数人谁有 OD被带到急诊科（艾德）。因此，艾德访问提供了一个独特的机会， 是未来过量死亡的最高风险作为回应，纽约市（NYC）卫生和精神卫生部 卫生部（DOHMH）实施了接力，这是一个新颖的计划， 阿片类药物OD后的艾德和接下来的90天，目的是预防随后的OD事件。的 接力干预的理论基础是三元影响理论和动态社会影响理论， 包含了一种激励方法。接力是由训练有素的同行导航员，谁是DOHMH工作人员提供 有吸毒经历的人拟议的随机对照试验代表了一种合作 学术界，公共卫生和医疗服务合作伙伴之间，以评估接力对预防的影响， 随后的阿片类药物相关不良事件。共有350名符合条件的非致命阿片类药物过量患者 将入组4名参与ED之一的患者，并随机分配至两组之一：1）增强常规 护理（EUC）-OD教育和纳洛酮分配（OEND）以及阿片类药物治疗计划列表;或2） 中继-同伴提供的OD教育和治疗联系，包括90天的同伴导航。成果 将通过访谈和行政健康数据进行为期12个月的测量。目的1是评估 Relay降低阿片类药物相关不良事件频率的有效性（任何阿片类药物相关OD [致死性 或非致死性]或任何物质使用相关的艾德访视），在索引访视后12个月内， 结果。目的2是评价Relay对以下次要结局的影响： 阿片类药物使用障碍（MOUD）的药物治疗，OD风险行为，至下一次阿片类药物相关OD的时间，以及 任何原因的艾德访视频率。目标3是确定介体（例如，OD知识、支持、经验 耻辱，同伴建模）和主持人（例如，物质使用史、年龄、性别、住房状况）的影响 继电器.目标4是通过评估对程序模型的保真度和探索 障碍和促进其交付和可持续性，通过定性访谈患者，中继 对等导航器和艾德提供者。这项拟议中的研究意义重大，因为它将提供严格的证据， 关于像中继这样的同伴干预是否可以通过减少阿片类药物来有意义地影响阿片类药物危机， 相关不良事件。在阿片类药物危机没有减弱迹象的情况下，卫生当局 制定旨在减少OD死亡的计划，即使没有强有力的证据支持他们。 这是一个至关重要的时间进行研究，以确定这些新方法中的哪些是 有效，以及在什么条件下，以便它们可以大规模地改善人口健康。