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: 10022294
• 负责人: Kelly Doran
• 金额: $ 76.74万
• 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 2021-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10022294
• 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.

项目概要 已知经历非致命性阿片类药物过量 (OD) 的个体死亡风险极高 但大多数患有 OD 的人缺乏有效的二级预防干预措施。 OD 被带到急诊科 (ED)，因此提供了接触这些患者的独特机会。 纽约市 (NYC) 健康和精神部对此做出回应。 卫生局 (DOHMH) 实施了 Relay，这是一项新颖的计划，可以让个人参与并进行干预 在使用阿片类药物 OD 后以及接下来的 90 天内，急诊室将进行急诊室检查，目的是预防后续的 OD 事件。 接力干预以三元影响力理论和动态社会影响力理论为基础， Relay 采用激励方法，由经过培训的同伴导航员（DOHMH 工作人员）提供。 拟议的随机对照试验代表了一项合作。 学术、公共卫生和医疗服务合作伙伴之间合作评估 Relay 对预防疾病的影响 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性阿片类药物 OD 患者。 向 4 个参与的 ED 之一进行介绍的患者将被登记并随机分配到两个组之一：1) 增强型常规 护理 (EUC) — OD 教育和纳洛酮分配 (OEND) 以及阿片类药物治疗计划清单；或 2) 接力——同伴提供的 OD 教育和治疗联系，包括 90 天的同伴导航结果。 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发生频率的有效性（任何与阿片类药物相关的 OD [致命 或非致命]或任何与物质使用相关的急诊室就诊），在初次就诊后的 12 个月内，主要 结果 2 是评估接力对以下次要结果的影响：启动。 治疗阿片类药物使用障碍 (MOUD) 的药物、OD 风险行为、下次阿片类药物相关 OD 的时间，以及 目标 3 是确定调解者（例如 OD 知识、支持、经验）。 耻辱、同伴模范）和调节因素（例如药物使用史、年龄、性别、住房状况） Relay 的目标 4 是通过评估程序模型的保真度并探索来评估 Relay 的实现。 通过对患者进行定性访谈，Relay 来了解其实施和可持续性的障碍和促进因素 同行导航者和 ED 提供者拟议的研究很重要，因为它将提供严格的证据。 关于像 Relay 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 在阿片类药物危机没有减弱的迹象的情况下，卫生当局正在采取行动。 制定旨在减少 OD 死亡的计划，即使没有强有力的证据支持。 现在是进行研究以确定哪些新方法是最重要的时刻 有效以及在什么条件下有效，以便能够扩大规模以改善人口健康。