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Clinical Trials/NCT05009225
NCT05009225Active, not recruitingNot Applicable

Reducing Variation in Hospitalization and Processes of Care in Emergency Department Patients With Atrial Fibrillation: A Stepped Wedge Cluster Randomized Trial

Kaiser Permanente16 sites in 1 country4,000 target enrollmentStarted: October 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
4,000
Locations
16
Primary Endpoint
Number of patients who received sustained rate-reduction medications

Study Overview

Brief Summary

Atrial fibrillation (AF) is a major public health problem: it impairs quality of life and independently heightens the risks of ischemic stroke, heart failure and all-cause mortality. AF is a common reason for presenting to emergency departments (ED) in Kaiser Permanente Northern California (KPNC) and is associated with frequent hospitalization. Additionally, inter-facility hospitalization rates for AF vary across KPNC. Improvements in modifiable components of ED AF care could potentially reduce low-yield hospitalizations and the associated costs, patient inconveniences, and complications that can ensue. Real-time clinical decision support systems (CDSS) can transform entrenched physician practices and improve patient outcomes. The investigators will conduct a stepped-wedge cluster randomized trial of a CDSS intervention across 13 KPNC EDs for the comprehensive management of acute AF with the following three aims: 1) To evaluate the impact of the CDSS intervention on index hospitalization rates; 2) To evaluate the impact of the CDSS intervention on ED AF rate and rhythm control process-of-care metrics; and 3) To evaluate the impact of the CDSS intervention on AF stroke prevention actions for eligible participants at the time of ED discharge. The investigators hypothesize that the CDSS intervention will safely reduce index hospitalization rates, improve rate and rhythm control process-of-care metrics, and increase stroke prevention actions for eligible participants at ED discharge and within 30 days.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult (≥18y) KPNC members presenting to the ED with a primary ED diagnosis of atrial fibrillation/flutter (AF/FL). Subjects who meet criteria will be identified electronically within the CDSS tool in the electronic health record.

Exclusion Criteria

  • Children (<18y).
  • Non-members of KPNC.
  • Patients who were prisoners, pregnant, receiving hospice or palliative care, or who left against medical advice at the index encounter for AF/FL.

Outcomes

Primary Outcomes

Number of patients who received sustained rate-reduction medications

Time Frame: Through emergency department visit, an average of 8 hours

Number of patients who were hospitalized

Time Frame: Through emergency department visit, an average of 8 hours

Number of patients who received stroke prevention interventions

Time Frame: Through emergency department visit, an average of 8 hours

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (16)

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