Smith Shawna N, Greineder Colin F, Errickson Joshua, Burns Jessica, Seagull F Jacob, Kocher Keith E, Kline Jeffrey A, Kullgren Jeffrey T, Lanham Michael S M, Krein Sarah L, Barnes Geoffrey D
Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor, MI, USA.
Michigan Program On Value Enhancement, University of Michigan Medical School, 2800 Plymouth Rd, B14 G214, Ann Arbor, MI, 48109, USA.
Implement Sci Commun. 2025 Apr 2;6(1):33. doi: 10.1186/s43058-025-00720-1.
Home-based care for patients diagnosed in emergency departments (EDs) with low-risk pulmonary embolism (PE) is an evidence-based, guideline-recommended practice that is not widely adopted in the US. Few studies demonstrate how this care pathway can be implemented effectively or test whether implementation strategies can address known barriers. Further, prior studies have lacked diversity in population and health system type and did not integrate theory-informed implementation frameworks. Although essential for establishing the evidence base for safe home management of low-risk acute PE, these studies have thus fallen short of guiding broad dissemination and equitable implementation. To bridge this gap, we are conducting a pragmatic multi-site implementation trial, guided by implementation science theory and frameworks, across twelve diverse hospital settings to assess the effectiveness of new care pathways for patients with low-risk PE presenting to EDs.
METHODS/DESIGN: The study uses a cluster-randomized stepped wedge trial design to investigate a set of implementation strategies to support establishing low-risk PE pathways in 12 EDs. Clusters of three hospitals were randomly assigned to one of four start dates, staggered over a 12-month period. During an initial three-month pre-implementation period, we will work with site champions to identify key site personnel and understand site barriers and facilitators. We will then tailor the care pathway to local needs and capabilities. During the six-month active implementation period, we will provide coaching to help sites implement a multi-component intervention informed by behavioral economics intended to address multi-level (site, provider, patient) barriers and integrate the new care pathway for discharging low-risk PE patients. Sites are then followed for a minimum of 12 months post-implementation. Our primary aim is to assess the change in discharge rates of patients with acute PE pre- and post-implementation. Secondary and exploratory aims will assess change in patient safety outcomes along with other key implementation outcomes guided by the RE-AIM framework.
This study expands upon prior effectiveness research to tailor, implement, and robustly evaluate a multi-component implementation intervention for diverse health systems aiming to increase guideline-based outpatient management of low-risk PE. Broad-scale implementation in the US could avert up to 100,000 hospitalizations annually.
Clinicaltrials.gov (NCT06312332), registered on March 13, 2024.
对于在急诊科被诊断为低风险肺栓塞（PE）的患者，居家护理是一种基于证据且有指南推荐的做法，但在美国并未得到广泛采用。很少有研究表明这种护理途径如何能够有效实施，或者检验实施策略是否能够解决已知的障碍。此外，先前的研究在人群和卫生系统类型方面缺乏多样性，并且没有整合理论指导的实施框架。尽管这些研究对于建立低风险急性肺栓塞安全居家管理的证据基础至关重要，但它们仍不足以指导广泛传播和公平实施。为了弥补这一差距，我们正在实施科学理论和框架的指导下，在十二个不同的医院环境中开展一项务实的多中心实施试验，以评估针对急诊科低风险肺栓塞患者的新护理途径的有效性。
方法/设计：该研究采用整群随机阶梯楔形试验设计，以调查一套实施策略，以支持在12个急诊科建立低风险肺栓塞护理途径。将三家医院组成的群组随机分配到四个开始日期之一，在12个月内错开。在最初为期三个月的实施前期，我们将与现场负责人合作，确定关键的现场人员，并了解现场障碍和促进因素。然后，我们将根据当地需求和能力调整护理途径。在为期六个月的积极实施期内，我们将提供指导，以帮助各地点实施一项基于行为经济学的多成分干预措施，旨在解决多层次（地点、提供者、患者）障碍，并整合用于低风险肺栓塞患者出院的新护理途径。各地点在实施后至少随访12个月。我们的主要目标是评估实施前后急性肺栓塞患者出院率的变化。次要和探索性目标将评估患者安全结果的变化以及由RE-AIM框架指导的其他关键实施结果。
本研究在先前有效性研究的基础上进行扩展，以定制、实施并严格评估一项针对不同卫生系统的多成分实施干预措施，旨在增加基于指南的低风险肺栓塞门诊管理。在美国进行大规模实施每年可避免多达10万次住院治疗。
Clinicaltrials.gov（NCT06312332），于2024年3月13日注册。
