Department of Emergency Medicine, NYU School of Medicine, 227 East 30(th) Street, New York, NY 10016, United States; Department of Population Health, NYU School of Medicine, 180 Madison Avenue, New York, NY 10016, United States.
Bureau of Alcohol and Drug Use Prevention, Care, and Treatment, Division of Mental Hygiene, New York City Department of Health and Mental Hygiene, 42-09 28(th) Street, Queens, Long Island City, NY 11101, United States.
Contemp Clin Trials. 2023 Mar;126:107111. doi: 10.1016/j.cct.2023.107111. Epub 2023 Feb 4.
Patients presenting to emergency departments (EDs) after a nonfatal opioid-involved overdose are at high risk for future overdose and death. Responding to this risk, the New York City (NYC) Department of Health and Mental Hygiene operates the Relay initiative, which dispatches trained peer "Wellness Advocates" to meet patients in the ED after a suspected opioid-involved overdose and follow them for up to 90 days to provide support, education, referrals to treatment, and other resources using a harm reduction framework.
In this article, we describe the protocol for a multisite randomized controlled trial of Relay. Study participants are recruited from four NYC EDs and are randomized to receive the Relay intervention or site-directed care (the control arm). Outcomes are assessed through survey questionnaires conducted at 1-, 3-, and 6-months after the baseline visit, as well as through administrative health data. The primary outcome is the number of opioid-related adverse events, including any opioid-involved overdose or any other substance use-related ED visit, in the 12 months post-baseline. Secondary and exploratory outcomes will also be analyzed, as well as hypothesized mediators and moderators of Relay program effectiveness.
We present the protocol for a multisite randomized controlled trial of a peer-delivered OD prevention intervention in EDs. We describe how the study was designed to minimize disruption to routine ED operations, and how the study was implemented and adapted during the COVID-19 pandemic. This trial is registered with ClinicalTrials.gov [NCT04317053].
在非致命性阿片类药物过量后到急诊科就诊的患者有很高的再次过量和死亡风险。为了应对这一风险，纽约市（NYC）卫生和心理卫生局运营了 Relay 计划，该计划派遣经过培训的同伴“健康倡导者”在疑似阿片类药物过量后到急诊科与患者会面，并在 90 天内为他们提供支持、教育、治疗转介和其他资源，采用减少伤害的框架。
在本文中，我们描述了一项针对 Relay 的多地点随机对照试验的方案。研究参与者从纽约市的四家急诊科招募，并随机分配到接受 Relay 干预或现场定向护理（对照组）。通过基线访问后 1、3 和 6 个月进行的调查问卷调查，以及通过行政健康数据评估结果。主要结果是在基线后 12 个月内与阿片类药物相关的不良事件的数量，包括任何阿片类药物过量或任何其他与物质使用相关的急诊科就诊。还将分析次要和探索性结果，以及 Relay 计划有效性的假设中介和调节因素。
我们提出了一项多地点随机对照试验的方案，该试验评估了在急诊科由同伴提供的 OD 预防干预措施。我们描述了如何设计研究以最小化对常规急诊科运作的干扰，以及如何在 COVID-19 大流行期间实施和调整研究。这项试验在 ClinicalTrials.gov 上注册[NCT04317053]。
