University of Colorado Department of Family Medicine, Aurora, Colorado
University of Colorado Department of Family Medicine, Aurora, Colorado.
Ann Fam Med. 2024 Sep-Oct;22(5):444-450. doi: 10.1370/afm.3149.
The usual challenges of conducting primary care research, including randomized trials, have been exacerbated, and new ones identified, during the COVID-19 pandemic. HOMER (Home versus Office for Medication Enhanced Recovery; subsequently, Comparing Home, Office, and Telehealth Induction for Medication Enhanced Recovery) is a pragmatic, comparative-effectiveness research trial that aims to answer a key question from patients and clinicians: What is the best setting in which to start treatment with buprenorphine for opioid use disorder for this patient at this time? In this article, we describe the difficult journey to find the answer. The HOMER study began as a randomized trial comparing treatment outcomes in patients starting treatment with buprenorphine via induction at home (unobserved) vs in the office (observed, synchronous). The study aimed to enroll 1,000 participants from 100 diverse primary care practices associated with the State Networks of Colorado Ambulatory Practices and Partners and the American Academy of Family Physicians National Research Network. The research team faced unexpected challenges related to the COVID-19 pandemic and dramatic changes in the opioid epidemic. These challenges required changes to the study design, protocol, recruitment intensity, and funding conversations, as well as patience. As this is a participatory research study, we sought, documented, and responded to practice and patient requests for adaptations. Changes included adding a third study arm using telehealth induction (observed via telephone or video, synchronous) and switching to a comprehensive cohort design to answer meaningful patient-centered research questions. Using a narrative approach based on the Greek myth of Homer, we describe here the challenges and adaptations that have provided the opportunity for HOMER to thrive and find the way home. These clinical trial strategies may apply to other studies faced with similar cultural and extreme circumstances.
在 COVID-19 大流行期间，开展初级保健研究（包括随机试验）所面临的常见挑战更加严峻，并且又出现了一些新的挑战。HOMER（家庭与办公室药物强化康复；随后，比较家庭、办公室和远程医疗诱导药物强化康复）是一项实用的、比较有效性研究试验，旨在回答患者和临床医生的一个关键问题：对于这名患者，在此时此地，开始使用丁丙诺啡治疗阿片类药物使用障碍，最佳治疗地点在哪里？本文介绍了寻找答案的艰难历程。HOMER 研究最初是一项随机试验，比较在家（未观察到）和在办公室（观察到，同步）开始接受丁丙诺啡治疗的患者的治疗结果。该研究旨在从与科罗拉多州门诊实践州网络和合作伙伴以及美国家庭医生学会国家研究网络相关的 100 个不同的初级保健实践中招募 1000 名参与者。研究团队面临着与 COVID-19 大流行相关的和阿片类药物流行的戏剧性变化带来的意想不到的挑战。这些挑战需要改变研究设计、方案、招募强度和资金讨论，同时还需要耐心。由于这是一项参与式研究，我们寻求、记录并回应了实践和患者对适应的要求。这些变化包括增加了第三个研究组，使用远程医疗诱导（通过电话或视频观察，同步），并切换到综合队列设计，以回答有意义的以患者为中心的研究问题。基于希腊神话荷马的叙述方法，我们在这里描述了挑战和适应，这些挑战和适应为 HOMER 的蓬勃发展和找到回家的路提供了机会。这些临床试验策略可能适用于其他面临类似文化和极端情况的研究。
