Clinical Decision Support for Atrial Fibrillation and Flutter

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

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 Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation and Flutter
• Intervention / Treatment: Other: Comprehensive ED AF management tool

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

Study Locations

• United States
  • California
    • Antioch, California, United States, 94531
      • Kaiser Permanente Antioch Emergency Department
    • Fremont, California, United States, 94538
      • Kaiser Permanente Fremont Emergency Department
    • Manteca, California, United States, 95337
      • Kaiser Permanente Manteca Medical Center
    • Modesto, California, United States, 95356
      • Kaiser Permanente Modesto Medical Center
    • Oakland, California, United States, 94611
      • Kaiser Permanente Oakland Emergency Department
    • Richmond, California, United States, 94801
      • Kaiser Permanente Richmond Emergency Department
    • Roseville, California, United States, 95661
      • Kaiser Permanente Roseville Emergency Department
    • Sacramento, California, United States, 95823
      • Kaiser Permanente South Sacramento Emergency Department
    • Sacramento, California, United States, 95825
      • Kaiser Permanente Sacramento Emergency Department
    • San Francisco, California, United States, 94115
      • Kaiser Permanente San Francisco Emergency Department
    • San Jose, California, United States, 95119
      • Kaiser Permanente San Jose Emergency Department
    • San Leandro, California, United States, 94577
      • Kaiser Permanente San Leandro Emergency Department
    • San Rafael, California, United States, 94903
      • Kaiser Permanente San Rafael Emergency Department
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Santa Clara Emergency Department
    • South San Francisco, California, United States, 94080
      • Kaiser Permanente South San Francisco Emergency Department
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente Walnut Creek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting to KPNC emergency departments with eligibility criteria

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients who were hospitalized	Through emergency department visit, an average of 8 hours
Number of patients who received sustained rate-reduction medications	Through emergency department visit, an average of 8 hours
Number of patients who received stroke prevention interventions	Through emergency department visit, an average of 8 hours

Collaborators and Investigators

• Sponsor: Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): April 30, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter
• Other Study ID Numbers: 1279670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No