Clinical decision support to Optimize Care of patients with Atrial Fibrillation or flutter in the Emergency department: protocol of a stepped-wedge cluster randomized pragmatic trial (O'CAFÉ trial)

Trials. 2023 Mar 31;24(1):246. doi: 10.1186/s13063-023-07230-2.

Abstract

Background: Management of adults with atrial fibrillation (AF) or atrial flutter in the emergency department (ED) includes rate reduction, cardioversion, and stroke prevention. Different approaches to these components of care may lead to variation in frequency of hospitalization and stroke prevention actions, with significant implications for patient experience, cost of care, and risk of complications. Standardization using evidence-based recommendations could reduce variation in management, preventable hospitalizations, and stroke risk.

Methods: We describe the rationale for our ED-based AF treatment recommendations. We also describe the development of an electronic clinical decision support system (CDSS) to deliver these recommendations to emergency physicians at the point of care. We implemented the CDSS at three pilot sites to assess feasibility and solicit user feedback. We will evaluate the impact of the CDSS on hospitalization and stroke prevention actions using a stepped-wedge cluster randomized pragmatic clinical trial across 13 community EDs in Northern California.

Discussion: We hypothesize that the CDSS intervention will reduce hospitalization of adults with isolated AF or atrial flutter presenting to the ED and increase anticoagulation prescription in eligible patients at the time of ED discharge and within 30 days. If our hypotheses are confirmed, the treatment protocol and CDSS could be recommended to other EDs to improve management of adults with AF or atrial flutter.

Trial registration: ClinicalTrials.gov NCT05009225 . Registered on 17 August 2021.

Keywords: Anticoagulants; Atrial fibrillation; Atrial flutter; Cardioversion; Emergency medicine; Patient admission; Randomized trial.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Anticoagulants / therapeutic use
  • Atrial Fibrillation* / complications
  • Atrial Fibrillation* / diagnosis
  • Atrial Fibrillation* / therapy
  • Atrial Flutter* / complications
  • Atrial Flutter* / diagnosis
  • Atrial Flutter* / therapy
  • Decision Support Systems, Clinical*
  • Emergency Service, Hospital
  • Humans
  • Pragmatic Clinical Trials as Topic
  • Randomized Controlled Trials as Topic
  • Stroke* / diagnosis
  • Stroke* / prevention & control

Substances

  • Anticoagulants

Associated data

  • ClinicalTrials.gov/NCT05009225