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

项目总结 众所周知，经历非致命性阿片类药物过量(OD)的人死亡风险极高。 来自随后的吸毒，但缺乏有效的二级吸毒预防干预措施。大多数人都有过 一名吸毒者被送往急诊科。因此，教育署的访问为接触这些人提供了一个独特的机会 未来吸毒过量死亡的风险最高。作为回应，纽约市(NYC)卫生和心理部门 卫生部(DOHMH)已经实施了Relay，这是一个与个人接触和干预的新计划 在阿片类药物过量后和今后90天内，ED将继续使用阿片类药物，目的是预防随后发生的药物过量事件。这个 接力干预的理论基础是三元影响力理论和动态社会影响理论。 结合了一种激励方法。接力由训练有素的同行领航员进行，他们是DOHMH的工作人员 有使用活物质的经验。建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的合作，以评估Relay在预防 随后发生与阿片类药物相关的不良事件。共有350名符合条件的非致命性阿片类药物过量患者 向4个参与的ED中的一个演示将被登记并随机分配到两个臂中的一个：1)增强往常 CARE(EUC)--药物过量教育和纳洛酮分配(OEND)和阿片类药物治疗计划清单；或2) 接力-同行提供的OD教育和治疗链接，包括90天的同行导航。结果 将通过访谈和行政健康数据进行为期12个月的评估。目标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(任何涉及阿片类药物的OD[致命 或非致命性的]或任何与物质使用有关的急症就诊)，在索引就诊后的12个月内，初级 结果。目标2是评估接力对以下次要结果的影响：启动 阿片类药物使用障碍(MOUD)、服药过量危险行为、下一次阿片类药物相关服药过量的时间，以及 急诊科因任何原因就诊的次数。目标3是确定调解人(例如，OD知识、支持、经验 耻辱、同伴模范)和主持人(例如，物质使用史、年龄、性别、住房状况)的影响 接力赛。目标4是通过评估程序模型的保真度和探索来评估Relay的实施 通过与患者的定性访谈，Relay，阻碍其交付和可持续发展的障碍和促进者 同行导航员和ED提供商。这项拟议的研究意义重大，因为它将提供严格的证据 关于像Relay这样的同行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 制定旨在减少服药过量死亡的计划，即使在没有强有力的证据支持的情况下也是如此。 现在是进行研究的关键时刻，以确定这些新方法中哪些是 有效，以及在什么条件下，这样才能规模化，以改善人口健康。

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.