Clinical Decision Support for Atrial Fibrillation and Flutter

Atrial Fibrillation and Flutter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05009225
• Other study ID #: 1279670
• Status: Active, not recruiting
• Start date: October 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4000
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation and Flutter
• Atrial Flutter

Intervention

Other:
• Comprehensive ED AF management tool
Managing atrial fibrillation (AF) patients in the emergency department (ED) is complex, often requiring many separate decisions: How to best reduce the heart rate? Should emergency physicians attempt cardioversion? If so, how? Does this patient need stroke prevention? The investigators' CDSS provides emergency physicians with a one-stop, evidence-based resource that addresses all aspects of ED AF management.

Locations

Country	Name	City	State
United States	Kaiser Permanente Antioch Emergency Department	Antioch	California
United States	Kaiser Permanente Fremont Emergency Department	Fremont	California
United States	Kaiser Permanente Manteca Medical Center	Manteca	California
United States	Kaiser Permanente Modesto Medical Center	Modesto	California
United States	Kaiser Permanente Oakland Emergency Department	Oakland	California
United States	Kaiser Permanente Richmond Emergency Department	Richmond	California
United States	Kaiser Permanente Roseville Emergency Department	Roseville	California
United States	Kaiser Permanente Sacramento Emergency Department	Sacramento	California
United States	Kaiser Permanente South Sacramento Emergency Department	Sacramento	California
United States	Kaiser Permanente San Francisco Emergency Department	San Francisco	California
United States	Kaiser Permanente San Jose Emergency Department	San Jose	California
United States	Kaiser Permanente San Leandro Emergency Department	San Leandro	California
United States	Kaiser Permanente San Rafael Emergency Department	San Rafael	California
United States	Kaiser Permanente Santa Clara Emergency Department	Santa Clara	California
United States	Kaiser Permanente South San Francisco Emergency Department	South San Francisco	California
United States	Kaiser Permanente Walnut Creek Medical Center	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who were hospitalized		Through emergency department visit, an average of 8 hours
Primary	Number of patients who received sustained rate-reduction medications		Through emergency department visit, an average of 8 hours
Primary	Number of patients who received stroke prevention interventions		Through emergency department visit, an average of 8 hours