A stepped wedge cluster randomized implementation trial to increase outpatient management of low-risk pulmonary embolism from the emergency department - the MEDIC ALERT PE study.

Background: 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.

Discussion: 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.

Trial registration: Clinicaltrials.gov (NCT06312332), registered on March 13, 2024.