Bridging the evidence-to-practice gap: a stepped-wedge cluster randomized controlled trial evaluating practice facilitation as a strategy to accelerate translation of a multi-level adherence intervention into safety net practices.
Bridging the evidence-to-practice gap: a stepped-wedge cluster randomized controlled trial evaluating practice facilitation as a strategy to accelerate translation of a multi-level adherence intervention into safety net practices.
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DOI：
10.1186/s43058-021-00111-2
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发表时间：
2021-02-17
影响因子：
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通讯作者：
Rosal M
中科院分区：
文献类型：
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作者：
Schoenthaler A;De La Calle F;Soto A;Barrett D;Cruz J;Payano L;Rosado M;Adhikari S;Ogedegbe G;Rosal M
与黑人和白色成年人相比，抗高血压药物依从性差是拉丁美洲成年人血压（BP）控制率种族差异的重要原因。虽然多层次的干预措施（例如，那些旨在影响实践、提供者和患者的干预措施）已经有效地改善了未得到充分服务的患有不受控制的高血压的患者的药物依从性，但是将这些干预措施转化为“真实的世界”安全网初级保健环境中的常规实践是不充分和缓慢的。本研究将通过评估实践促进（PF）作为一种实用和定制的策略的有效性来填补这一证据与实践的差距，该策略通过基于团队的护理方法（阿尔塔）来提高拉丁美洲高血压患者的药物依从性，这是一种多层次的方法，旨在改善纽约为拉丁美洲患者服务的10个安全网实践中的药物依从性和BP控制。我们将分两个阶段进行这项研究：（1）实施前阶段，我们将在实施研究综合框架的指导下完善PF战略，以促进阿尔塔在实践中的日常护理中的实施;以及（2）实施阶段，在此期间，我们将在一项逐步楔形分组随机对照试验中评估，PF策略对12个月时阿尔塔实施保真度（主要结局）以及临床结局（次要结局）的影响。将根据普罗克特的《执行成果框架》概述的五个核心层面，采用混合方法评估执行工作的准确性。临床结果指标包括血压控制（定义为BP< 130/80 mmHg）和药物依从性（使用通过药房记录覆盖的天数比例进行评估）。该研究方案采用严格的研究方法来确定PF等实施策略如何加快将循证方法实施到安全网实践的常规护理中的翻译过程，以改善拉丁美洲高血压患者的健康结果，这些患者不成比例地患有血压控制不良。通过审查影响实施的障碍和促进因素，这项研究将有助于提高其调查结果对其他安全网做法的普遍性，并指导全国初级保健做法的有效推广。ClinicalTrials.gov NCT 03713515，注册日期：2018年10月19日。
Poor adherence to antihypertensive medications is a significant contributor to the racial gap in rates of blood pressure (BP) control among Latino adults, as compared to Black and White adults. While multi-level interventions (e.g., those aiming to influence practice, providers, and patients) have been efficacious in improving medication adherence in underserved patients with uncontrolled hypertension, the translation of these interventions into routine practice within “real world” safety-net primary care settings has been inadequate and slow. This study will fill this evidence-to-practice gap by evaluating the effectiveness of practice facilitation (PF) as a practical and tailored strategy for implementing Advancing Medication Adherence for Latinos with Hypertension through a Team-based Care Approach (ALTA), a multi-level approach to improving medication adherence and BP control in 10 safety-net practices in New York that serve Latino patients. We will conduct this study in two phases: (1) a pre-implementation phase where we will refine the PF strategy, informed by the Consolidated Framework for Implementation Research, to facilitate the implementation of ALTA into routine care at the practices; and (2) an implementation phase during which we will evaluate, in a stepped-wedge cluster randomized controlled trial, the effect of the PF strategy on ALTA implementation fidelity (primary outcome), as well as on clinical outcomes (secondary outcomes) at 12 months. Implementation fidelity will be assessed using a mixed methods approach based on the five core dimensions outlined by Proctor’s Implementation Outcomes Framework. Clinical outcome measures include BP control (defined as BP< 130/80 mmHg) and medication adherence (assessed using the proportion of days covered via pharmacy records). The study protocol applies rigorous research methods to identify how implementation strategies such as PF may work to expedite the translation process for implementing evidence-based approaches into routine care at safety-net practices to improve health outcomes in Latino patients with hypertension, who suffer disproportionately from poor BP control. By examining the barriers and facilitators that affect implementation, this study will contribute knowledge that will increase the generalizability of its findings to other safety-net practices and guide effective scale-up across primary care practices nationally. ClinicalTrials.gov NCT03713515, date of registration: October 19, 2018.