A randomized, parallel group, pragmatic comparative-effectiveness trial comparing medication-assisted treatment induction methods in primary care practices: The HOMER study protocol.
A randomized, parallel group, pragmatic comparative-effectiveness trial comparing medication-assisted treatment induction methods in primary care practices: The HOMER study protocol.
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DOI：
10.1371/journal.pone.0290388
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发表时间：
2023
期刊：
影响因子：
3.7
通讯作者：
中科院分区：
文献类型：
--
作者：
阿片类药物使用障碍（OUD）代表了美国的公共卫生危机。在初级保健中使用丁丙诺啡治疗阿片类药物使用障碍（MOUD）是一种经过验证的OUD治疗策略。MOUD诱导是患者开始戒断并接受第一剂丁丙诺啡。诱导方法之间的差异可能会影响短期稳定，长期维持和生活质量。本文描述了一项研究的方案，该研究旨在：（1）比较接受办公室、家庭或远程医疗诱导的患者在MOUD中的短期稳定和长期维持治疗，（2）确定与成功长期治疗相关的临床相关实践和患者特征。该研究设计是一个随机，平行组，务实的比较有效性试验的三种护理模式的MOUD诱导在100个初级保健的做法在美国。符合条件的患者至少16岁，已被临床医生确定为阿片类药物依赖，并将从MOUD中获益。患者将被随机分配至三种诱导对照药物之一：办公室、家庭或远程医疗诱导。主要结局是诱导后30、90和270天的丁丙诺啡用药和非法阿片类药物使用。次要结局包括生活质量和维持治疗的潜在介质（意向、计划、自动性）。潜在的调节因素包括健康的社会决定因素、物质使用史和吸引力以及执行功能。意向治疗分析将使用一般/广义线性混合模型评估干预措施对长期治疗的影响，对协变量进行调整，用于结局分析。分析包括分层/纵向数据的实践和患者水平的随机效应。没有大规模的随机比较有效性研究比较了家庭诱导与办公室或远程医疗MOUD诱导对初级保健环境中OUD患者的长期结局。本研究的结果将为初级保健提供者提供证据和指导，为特定患者选择最有益的诱导方法。
Opioid use disorder (OUD) represents a public health crisis in the United States. Medication for opioid use disorder (MOUD) with buprenorphine in primary care is a proven OUD treatment strategy. MOUD induction is when patients begin withdrawal and receive the first doses of buprenorphine. Differences between induction methods might influence short-term stabilization, long-term maintenance, and quality of life. This paper describes the protocol for a study designed to: (1) compare short-term stabilization and long-term maintenance treatment engagement in MOUD in patients receiving office, home, or telehealth induction and (2) identify clinically-relevant practice and patient characteristics associated with successful long-term treatment. The study design is a randomized, parallel group, pragmatic comparative effectiveness trial of three care models of MOUD induction in 100 primary care practices in the United States. Eligible patients are at least 16 years old, have been identified by their clinician as having opioid dependence and would benefit from MOUD. Patients will be randomized to one of three induction comparators: office, home, or telehealth induction. Primary outcomes are buprenorphine medication-taking and illicit opioid use at 30, 90, and 270 days post-induction. Secondary outcomes include quality of life and potential mediators of treatment maintenance (intentions, planning, automaticity). Potential moderators include social determinants of health, substance use history and appeal, and executive function. An intent to treat analysis will assess effects of the interventions on long-term treatment, using general/generalized linear mixed models, adjusted for covariates, for the outcomes analysis. Analysis includes practice- and patient-level random effects for hierarchical/longitudinal data. No large-scale, randomized comparative effectiveness research has compared home induction to office or telehealth MOUD induction on long-term outcomes for patients with OUD seen in primary care settings. The results of this study will offer primary care providers evidence and guidance in selecting the most beneficial induction method(s) for specific patients.
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影响因子：
5
作者：
COHEN, S;KAMARCK, T;MERMELSTEIN, R
通讯作者：
MERMELSTEIN, R
丁丙诺啡诱导策略的比较：以患者为中心的家庭归纳与护理标准的基于办公室的归纳。
影响因子：
3.9
作者：
Cunningham CO;Giovanniello A;Li X;Kunins HV;Roose RJ;Sohler NL
通讯作者：
Sohler NL
影响因子：
105.7
作者：
Campbell, MK;Elbourne, DR;Altman, DG
通讯作者：
Altman, DG
影响因子：
3.9
作者：
Hagen, Egon;Erga, Aleksander H.;Walderhaug, Espen
通讯作者：
Walderhaug, Espen
影响因子：
2.7
作者：
HANDELSMAN, L;COCHRANE, KJ;KANOF, PD
通讯作者：
KANOF, PD