Study protocol for "Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET)": a pragmatic trial comparing implementation strategies.
Study protocol for "Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET)": a pragmatic trial comparing implementation strategies.
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DOI：
10.1186/s13012-015-0333-y
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发表时间：
2015-10-16
期刊：
影响因子：
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通讯作者：
Smith D
中科院分区：
文献类型：
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作者：
Gold R;Hollombe C;Bunce A;Nelson C;Davis JV;Cowburn S;Perrin N;DeVoe J;Mossman N;Boles B;Horberg M;Dearing JW;Jaworski V;Cohen D;Smith D
很少有研究直接比较在任何情况下实施战略的有效性，我们也不知道以前没有直接比较不同战略组合如何有效地支持社区卫生中心实施的试验。本文概述了在安全网(扩散网)中支持实施和适应的实践研究的方案，该试验旨在比较几种支持干预实施的常见策略的有效性，并探索在社区卫生中心环境中影响这些策略有效性的背景因素。这项整群随机试验比较了三种日益实践的实施战略如何支持在由12个医疗保健组织管理的29个社区卫生中心采用基于证据的糖尿病质量改善干预措施。战略如下：(ARM 1)以纸质和电子形式介绍的工具包，其中包括一次培训网络研讨会；(ARM 2)工具包加上面对面培训，重点是实践变革和变革管理战略；(ARM 3)工具包，面对面培训，以及通过现场访问促进实践。我们使用混合方法收集和分析数据：(I)关于研究临床特征的基线调查，以探索这些特征如何影响诊所实施工具的能力和每个实施战略的有效性；(Ii)关于符合指南的处方变化率的量化数据；以及(Iii)关于量化结果背后的“如何”和“为什么”的定性数据。感兴趣的结果是临床水平的结果，使用REACH、Efficiency、Adption、Implementation、Maintenance(RE-AIM)框架进行分类，采用分段回归模型进行中断的时间序列设计。这项务实的试验将比较每种实施策略在“现实世界”实践中的效果。通过比较在社区卫生中心实施临床创新的实用、可推广的方法，更好地了解不同的战略如何支持实施工作可以对实施科学领域产生积极影响。弥补文献中的这一差距是朝着有效传播和实施有效干预措施进入社区卫生中心这一国家长期目标迈出的关键一步。临床试验.gov，NCT02325531
Little research has directly compared the effectiveness of implementation strategies in any setting, and we know of no prior trials directly comparing how effectively different combinations of strategies support implementation in community health centers. This paper outlines the protocol of the Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET), a trial designed to compare the effectiveness of several common strategies for supporting implementation of an intervention and explore contextual factors that impact the strategies’ effectiveness in the community health center setting. This cluster-randomized trial compares how three increasingly hands-on implementation strategies support adoption of an evidence-based diabetes quality improvement intervention in 29 community health centers, managed by 12 healthcare organizations. The strategies are as follows: (arm 1) a toolkit, presented in paper and electronic form, which includes a training webinar; (arm 2) toolkit plus in-person training with a focus on practice change and change management strategies; and (arm 3) toolkit, in-person training, plus practice facilitation with on-site visits. We use a mixed methods approach to data collection and analysis: (i) baseline surveys on study clinic characteristics, to explore how these characteristics impact the clinics’ ability to implement the tools and the effectiveness of each implementation strategy; (ii) quantitative data on change in rates of guideline-concordant prescribing; and (iii) qualitative data on the “how” and “why” underlying the quantitative results. The outcomes of interest are clinic-level results, categorized using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, within an interrupted time-series design with segmented regression models. This pragmatic trial will compare how well each implementation strategy works in “real-world” practices. Having a better understanding of how different strategies support implementation efforts could positively impact the field of implementation science, by comparing practical, generalizable methods for implementing clinical innovations in community health centers. Bridging this gap in the literature is a critical step towards the national long-term goal of effectively disseminating and implementing effective interventions into community health centers. ClinicalTrials.gov, NCT02325531