Exemplar Hospital initiation trial to Enhance Treatment Engagement (EXHIT ENTRE): protocol for CTN-0098B a randomized implementation study to support hospitals in caring for patients with opioid use disorder

IF 3.7 2区医学 Q1 SUBSTANCE ABUSE

Addiction Science & Clinical Practice Pub Date : 2024-04-11 DOI:10.1186/s13722-024-00455-9

Gavin Bart, P. Todd Korthuis, Julie M. Donohue, Hildi J. Hagedorn, Dave H. Gustafson, Angela R. Bazzi, Eva Enns, Jennifer McNeely, Udi E. Ghitza, Kara M. Magane, Paulette Baukol, Ashley Vena, Jacklyn Harris, Delia Voronca, Richard Saitz

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引用次数: 0

Abstract

Hospitalizations involving opioid use disorder (OUD) are increasing. Medications for opioid use disorder (MOUD) reduce mortality and acute care utilization. Hospitalization is a reachable moment for initiating MOUD and arranging for ongoing MOUD engagement following hospital discharge. Despite existing quality metrics for MOUD initiation and engagement, few hospitals provide hospital based opioid treatment (HBOT). This protocol describes a cluster-randomized hybrid type-2 implementation study comparing low-intensity and high-intensity implementation support strategies to help community hospitals implement HBOT. Four state implementation hubs with expertise in initiating HBOT programs will provide implementation support to 24 community hospitals (6 hospitals/hub) interested in starting HBOT. Community hospitals will be randomized to 24-months of either a low-intensity intervention (distribution of an HBOT best-practice manual, a lecture series based on the manual, referral to publicly available resources, and on-demand technical assistance) or a high-intensity intervention (the low-intensity intervention plus funding for a hospital HBOT champion and regular practice facilitation sessions with an expert hub). The primary efficacy outcome, adapted from the National Committee on Quality Assurance, is the proportion of patients engaged in MOUD 34-days following hospital discharge. Secondary and exploratory outcomes include acute care utilization, non-fatal overdose, death, MOUD engagement at various time points, hospital length of stay, and discharges against medical advice. Primary, secondary, and exploratory outcomes will be derived from state Medicaid data. Implementation outcomes, barriers, and facilitators are assessed via longitudinal surveys, qualitative interviews, practice facilitation contact logs, and HBOT sustainability metrics. We hypothesize that the proportion of patients receiving care at hospitals randomized to the high-intensity arm will have greater MOUD engagement following hospital discharge. Initiation of MOUD during hospitalization improves MOUD engagement post hospitalization. Few studies, however, have tested different implementation strategies on HBOT uptake, outcome, and sustainability and only one to date has tested implementation of a specific type of HBOT (addiction consultation services). This cluster-randomized study comparing different intensities of HBOT implementation support will inform hospitals and policymakers in identifying effective strategies for promoting HBOT dissemination and adoption in community hospitals. NCT04921787.

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提高治疗参与度的示范医院启动试验（EXHIT ENTRE）：CTN-0098B 的协议，这是一项支持医院护理阿片类药物使用障碍患者的随机实施研究

涉及阿片类药物使用障碍（OUD）的住院病例正在增加。治疗阿片类药物使用障碍（MOUD）可降低死亡率和急症护理使用率。住院是启动 MOUD 和安排出院后持续参与 MOUD 的可行时机。尽管现有 MOUD 启动和参与的质量指标，但很少有医院提供基于医院的阿片类药物治疗（HBOT）。本方案介绍了一项分组随机混合 2 型实施研究，比较了低强度和高强度实施支持策略，以帮助社区医院实施 HBOT。四个州级实施中心拥有启动 HBOT 计划的专业知识，将为 24 家有意启动 HBOT 的社区医院（每中心 6 家医院）提供实施支持。社区医院将随机接受为期 24 个月的低强度干预（分发 HBOT 最佳实践手册、根据手册举办系列讲座、推荐使用公开资源以及按需提供技术援助）或高强度干预（低强度干预外加资助一名医院 HBOT 倡导者并与专家中心定期举行实践促进会议）。主要疗效结果改编自美国国家质量保证委员会（National Committee on Quality Assurance），即出院 34 天后参与 MOUD 的患者比例。次要和探索性结果包括急性病护理利用率、非致命性用药过量、死亡、不同时间点的 MOUD 参与情况、住院时间和违反医嘱出院情况。主要、次要和探索性结果将来自州医疗补助数据。实施结果、障碍和促进因素将通过纵向调查、定性访谈、实践促进联系日志和 HBOT 可持续性指标进行评估。我们假设，在随机分配到高强度组的医院接受治疗的患者中，出院后参与 MOUD 的比例会更高。在住院期间启动 MOUD 可提高住院后 MOUD 的参与度。然而，很少有研究对 HBOT 的使用率、效果和可持续性等方面的不同实施策略进行测试，迄今为止只有一项研究对特定类型的 HBOT（成瘾咨询服务）的实施情况进行了测试。这项分组随机研究比较了不同强度的 HBOT 实施支持，将为医院和政策制定者提供信息，帮助他们确定在社区医院推广和采用 HBOT 的有效策略。NCT04921787。

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来源期刊

Addiction Science & Clinical Practice Psychology-Clinical Psychology

CiteScore

3.90

自引率

10.80%

发文量

审稿时长

28 weeks

期刊介绍： Addiction Science & Clinical Practice provides a forum for clinically relevant research and perspectives that contribute to improving the quality of care for people with unhealthy alcohol, tobacco, or other drug use and addictive behaviours across a spectrum of clinical settings. Addiction Science & Clinical Practice accepts articles of clinical relevance related to the prevention and treatment of unhealthy alcohol, tobacco, and other drug use across the spectrum of clinical settings. Topics of interest address issues related to the following: the spectrum of unhealthy use of alcohol, tobacco, and other drugs among the range of affected persons (e.g., not limited by age, race/ethnicity, gender, or sexual orientation); the array of clinical prevention and treatment practices (from health messages, to identification and early intervention, to more extensive interventions including counseling and pharmacotherapy and other management strategies); and identification and management of medical, psychiatric, social, and other health consequences of substance use. Addiction Science & Clinical Practice is particularly interested in articles that address how to improve the quality of care for people with unhealthy substance use and related conditions as described in the (US) Institute of Medicine report, Improving the Quality of Healthcare for Mental Health and Substance Use Conditions (Washington, DC: National Academies Press, 2006). Such articles address the quality of care and of health services. Although the journal also welcomes submissions that address these conditions in addiction speciality-treatment settings, the journal is particularly interested in including articles that address unhealthy use outside these settings, including experience with novel models of care and outcomes, and outcomes of research-practice collaborations. Although Addiction Science & Clinical Practice is generally not an outlet for basic science research, we will accept basic science research manuscripts that have clearly described potential clinical relevance and are accessible to audiences outside a narrow laboratory research field.