Iscoe Mark S, Diniz Hooper Carolina, Levy Deborah R, Buchanan Laurel, Dziura James, Meeker Daniella, Taylor Richard Andrew, D'Onofrio Gail, Oladele Carol, Sarpong Daniel F, Paek Hyung, Wilson Francis P, Heagerty Patrick J, Delgado Mucio Kit, Hoppe Jason, Melnick Edward R
Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.
Department of Biomedical Informatics and Data Sciences, Yale University School of Medicine, New Haven, Connecticut, USA.
BMJ Open. 2025 Feb 20;15(2):e098072. doi: 10.1136/bmjopen-2024-098072.
Despite the current opioid crisis resulting in tens of thousands of deaths every year, buprenorphine, a medication that can reduce opioid-related mortality, withdrawal, drug use and craving, is still underprescribed in the emergency department (ED) for treatment of opioid use disorder (OUD). The EMergency department-initiated BuprenorphinE for opioid use Disorder (EMBED) trial introduced a clinical decision support (CDS) tool that improved the proportion of ED physicians prescribing buprenorphine but did not affect patient-level rates of buprenorphine initiation. The present trial aims to build on these findings by optimising CDS use through iterative improvements, refined interventions and clinician feedback to enhance OUD treatment initiation in EDs.
The Adaptive Decision support for Addiction Treatment (ADAPT) trial employs the Multiphase Optimization Strategy (MOST) framework to refine a multicomponent CDS tool designed to facilitate buprenorphine initiation for OUD in ED settings. Using a pragmatic, learning health system approach in three phases, the trial applies plan-do-study-act cycles for continuous CDS refinement. The CDS will be updated in the preparation phase to reflect new evidence. The optimisation phase will include a 2×2×2 factorial trial, testing the impact of various intervention components, followed by rapid, serial randomised usability testing to reduce user errors and enhance CDS workflow efficiency. In the evaluation phase, the optimised CDS package will be tested in a randomised trial to assess its effectiveness in increasing ED initiation of buprenorphine compared with the original EMBED CDS.
The protocol has received approval from our institution's institutional review board (protocol #2000038624) with a waiver of informed consent for collecting non-identifiable information only. Given the minimal risk involved in implementing established best practices, an independent study monitor will oversee the study instead of a Data Safety Monitoring Board. Findings will be submitted to ClinicalTrials.gov, published in open-access, peer-reviewed journals, presented at national conferences and shared with clinicians at participating sites through email notification.
NCT06799117.
尽管当前的阿片类药物危机每年导致数万人死亡,但丁丙诺啡这种能够降低与阿片类药物相关的死亡率、戒断反应、药物使用及渴望的药物,在急诊科(ED)用于治疗阿片类药物使用障碍(OUD)时,其处方量仍然不足。急诊科启动的丁丙诺啡治疗阿片类药物使用障碍(EMBED)试验引入了一种临床决策支持(CDS)工具,该工具提高了开具丁丙诺啡的急诊科医生比例,但并未影响患者层面的丁丙诺啡起始治疗率。本试验旨在基于这些发现,通过迭代改进、优化干预措施以及临床医生反馈来优化CDS的使用,以提高急诊科对OUD的治疗起始率。
成瘾治疗的适应性决策支持(ADAPT)试验采用多阶段优化策略(MOST)框架来优化一个多组件CDS工具,该工具旨在促进急诊科环境中针对OUD启动丁丙诺啡治疗。该试验分三个阶段采用务实的学习型卫生系统方法,应用计划 - 执行 - 研究 - 行动循环对CDS进行持续优化。CDS将在准备阶段进行更新以反映新证据。优化阶段将包括一项2×2×2析因试验,测试各种干预组件的影响,随后进行快速、连续的随机可用性测试以减少用户错误并提高CDS工作流程效率。在评估阶段,优化后的CDS包将在一项随机试验中进行测试,以评估其与原始EMBED CDS相比在增加急诊科丁丙诺啡起始治疗方面的有效性。
该方案已获得我们机构的机构审查委员会批准(方案编号#2000038624),仅豁免收集不可识别信息时的知情同意。鉴于实施既定最佳实践所涉及的风险极小,将由一名独立研究监测员而非数据安全监测委员会监督该研究。研究结果将提交至ClinicalTrials.gov,发表在开放获取、同行评审的期刊上,在全国性会议上展示,并通过电子邮件通知与参与站点的临床医生分享。
NCT06799117。