Damschroder Laura J, Sussman Jeremy B, Pfeiffer Paul N, Kurlander Jacob E, Freitag Michelle B, Robinson Claire H, Spoutz Patrick, Christopher Melissa L D, Battar Saraswathy, Dickerson Kimberly, Sedgwick Christopher, Wallace-Lacey Ashleigh G, Barnes Geoffrey D, Linsky Amy M, Ulmer Christi S, Lowery Julie C
Center for Clinical Management Research, VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA.
Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Implement Sci Commun. 2022 May 14;3(1):53. doi: 10.1186/s43058-022-00297-z.
The adoption and sustainment of evidence-based practices (EBPs) is a challenge within many healthcare systems, especially in settings that have already strived but failed to achieve longer-term goals. The Veterans Affairs (VA) Maintaining Implementation through Dynamic Adaptations (MIDAS) Quality Enhancement Research Initiative (QUERI) program was funded as a series of trials to test multi-component implementation strategies to sustain optimal use of three EBPs: (1) a deprescribing approach intended to reduce potentially inappropriate polypharmacy; (2) appropriate dosing and drug selection of direct oral anticoagulants (DOACs); and (3) use of cognitive behavioral therapy as first-line treatment for insomnia before pharmacologic treatment. We describe the design and methods for a harmonized series of cluster-randomized control trials comparing two implementation strategies.
For each trial, we will recruit 8-12 clinics (24-36 total). All will have access to relevant clinical data to identify patients who may benefit from the target EBP at that clinic and provider. For each trial, clinics will be randomized to one of two implementation strategies to improve the use of the EBPs: (1) individual-level academic detailing (AD) or (2) AD plus the team-based Learn. Engage. Act.
(LEAP) quality improvement (QI) learning program. The primary outcomes will be operationalized across the three trials as a patient-level dichotomous response (yes/no) indicating patients with potentially inappropriate medications (PIMs) among those who may benefit from the EBP. This outcome will be computed using month-by-month administrative data. Primary comparison between the two implementation strategies will be analyzed using generalized estimating equations (GEE) with clinic-level monthly (13 to 36 months) percent of PIMs as the dependent variable. Primary comparative endpoint will be at 18 months post-baseline. Each trial will also be analyzed independently.
MIDAS QUERI trials will focus on fostering sustained use of EBPs that previously had targeted but incomplete implementation. Our implementation approaches are designed to engage frontline clinicians in a dynamic optimization process that integrates the use of actional clinical data and making incremental changes, designed to be feasible within busy clinical settings.
ClinicalTrials.gov: NCT05065502 . Registered October 4, 2021-retrospectively registered.
在许多医疗系统中，采用并维持循证实践（EBP）是一项挑战，尤其是在那些已经努力但未能实现长期目标的环境中。退伍军人事务部（VA）通过动态适应维持实施（MIDAS）质量提升研究计划（QUERI）项目获得资助，作为一系列试验，以测试多组件实施策略，以维持三种循证实践的最佳使用：（1）一种旨在减少潜在不适当多药治疗的减药方法；（2）直接口服抗凝剂（DOAC）的适当剂量和药物选择；（3）在药物治疗之前使用认知行为疗法作为失眠的一线治疗方法。我们描述了一系列比较两种实施策略的整群随机对照试验的设计和方法。
对于每项试验，我们将招募8 - 12家诊所（总共24 - 36家）。所有诊所都将能够获取相关临床数据，以识别该诊所和提供者处可能从目标循证实践中受益的患者。对于每项试验，诊所将被随机分配到两种实施策略之一，以改善循证实践的使用：（1）个体层面的学术详细指导（AD）或（2）AD加上基于团队的“学习。参与。行动”（LEAP）质量改进（QI）学习计划。主要结局将在三项试验中作为患者层面的二分反应（是/否）进行操作化，表明在可能从循证实践中受益的患者中存在潜在不适当药物（PIM）的患者。该结局将使用逐月管理数据进行计算。两种实施策略之间的主要比较将使用广义估计方程（GEE）进行分析，以诊所层面每月（13至36个月）的PIM百分比作为因变量。主要比较终点将在基线后18个月。每项试验也将独立进行分析。
MIDAS QUERI试验将专注于促进对以前有目标但实施不完整的循证实践的持续使用。我们的实施方法旨在使一线临床医生参与一个动态优化过程，该过程整合了实际临床数据的使用并进行渐进式改变，旨在在繁忙的临床环境中可行。
ClinicalTrials.gov：NCT05065502。2021年10月4日注册——追溯注册。
