Stepped implementation-to-target: a study protocol of an adaptive trial to expand access to addiction medications.
Stepped implementation-to-target: a study protocol of an adaptive trial to expand access to addiction medications.
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DOI：
10.1186/s13012-022-01239-y
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发表时间：
2022-09-29
影响因子：
7.2
通讯作者：
McGovern, Mark P.
中科院分区：
文献类型：
--
作者：
Ford, James H.;Cheng, Hannah;Gassman, Michele;Fontaine, Harrison;Garneau, Helene Chokron;Keith, Ryan;Michael, Edward;McGovern, Mark P.
关键词：
为了应对美国阿片类药物流行病，已经发起了重要的全国性运动，以扩大“阿片类药物使用障碍”（MOUD）的治疗范围。虽然普通医疗机构的采用率有所增加，但专业成瘾项目在覆盖范围和采用率方面都落后。为了提高实施战略的质量，研究需要更精确的方法来定制战略，而不是一刀切的方法，记录参与者的参与和对战略交付的忠诚度，并进行经济分析，为决策和政策提供信息。研究还没有将所有这三个建议，以解决在专业成瘾项目中实施和维持MOUD的挑战。该项目旨在与华盛顿州卫生保健管理局合作招募72个专业成瘾项目，并在适应性试验设计中采用基于测量的逐步实现目标的方法。计划将暴露于一系列强度和成本不断增加的实施策略：（1）加强监测和反馈（EMF），（2）为期2天的研讨会，然后，如果未实现成果目标，则随机分配到内部促进或外部促进。这项研究有三个目标：（1）评估实施战略对目标结果的顺序影响，（2）检查响应战略的结果的背景调节者和中介者，以及（3）每个实施战略的文档和模型成本。目标成果由RE-AIM框架和成瘾护理级联组织。该实施项目包括序贯多分配随机试验（SMART）设计和基于标准的设计的要素。作为一种创新和有效的方法，参与方案只收到实现目标成果所需的实施战略。研究结果有可能为实施研究提供信息，并为关键决策者提供如何在系统层面解决阿片类药物流行病的证据。本试验于2022年4月25日在ClinicalTrials.gov（NCT 05343793）上注册。在线版本包含补充材料，可通过10.1186/s13012-022-01239-y获得。
In response to the US opioid epidemic, significant national campaigns have been launched to expand access to `opioid use disorder (MOUD). While adoption has increased in general medical care settings, specialty addiction programs have lagged in both reach and adoption. Elevating the quality of implementation strategy, research requires more precise methods in tailoring strategies rather than a one-size-fits-all-approach, documenting participant engagement and fidelity to the delivery of the strategy, and conducting an economic analysis to inform decision making and policy. Research has yet to incorporate all three of these recommendations to address the challenges of implementing and sustaining MOUD in specialty addiction programs. This project seeks to recruit 72 specialty addiction programs in partnership with the Washington State Health Care Authority and employs a measurement-based stepped implementation-to-target approach within an adaptive trial design. Programs will be exposed to a sequence of implementation strategies of increasing intensity and cost: (1) enhanced monitoring and feedback (EMF), (2) 2-day workshop, and then, if outcome targets are not achieved, randomization to either internal facilitation or external facilitation. The study has three aims: (1) evaluate the sequential impact of implementation strategies on target outcomes, (2) examine contextual moderators and mediators of outcomes in response to the strategies, and (3) document and model costs per implementation strategy. Target outcomes are organized by the RE-AIM framework and the Addiction Care Cascade. This implementation project includes elements of a sequential multiple assignment randomized trial (SMART) design and a criterion-based design. An innovative and efficient approach, participating programs only receive the implementation strategies they need to achieve target outcomes. Findings have the potential to inform implementation research and provide key decision-makers with evidence on how to address the opioid epidemic at a systems level. This trial was registered at ClinicalTrials.gov (NCT05343793) on April 25, 2022. The online version contains supplementary material available at 10.1186/s13012-022-01239-y.
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影响因子：
12.7
作者：
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通讯作者：
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DOI：
10.1186/1748-5908-4-50
发表时间：
2009-08-07
期刊：
Implementation science : IS
影响因子：
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DOI：
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期刊：
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DOI：
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发表时间：
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期刊：
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影响因子：
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通讯作者：
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