Clinical Decision Support for Atrial Fibrillation and Flutter

NCT05009225 | Active Not Recruiting

• 1 other identifier: 1279670
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 16

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.

Conditions

Atrial Fibrillation and Flutter

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Comprehensive ED AF management tool OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting to KPNC emergency departments with eligibility criteria

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (16)

Kaiser Permanente Antioch Emergency Department

Antioch, California, 94531, United States

Location

Kaiser Permanente Fremont Emergency Department

Fremont, California, 94538, United States

Location

Kaiser Permanente Manteca Medical Center

Manteca, California, 95337, United States

Location

Kaiser Permanente Modesto Medical Center

Modesto, California, 95356, United States

Location

Kaiser Permanente Oakland Emergency Department

Oakland, California, 94611, United States

Location

Kaiser Permanente Richmond Emergency Department

Richmond, California, 94801, United States

Location

Kaiser Permanente Roseville Emergency Department

Roseville, California, 95661, United States

Location

Kaiser Permanente South Sacramento Emergency Department

Sacramento, California, 95823, United States

Location

Kaiser Permanente Sacramento Emergency Department

Sacramento, California, 95825, United States

Location

Kaiser Permanente San Francisco Emergency Department

San Francisco, California, 94115, United States

Location

Kaiser Permanente San Jose Emergency Department

San Jose, California, 95119, United States

Location

Kaiser Permanente San Leandro Emergency Department

San Leandro, California, 94577, United States

Location

Kaiser Permanente San Rafael Emergency Department

San Rafael, California, 94903, United States

Location

Kaiser Permanente Santa Clara Emergency Department

Santa Clara, California, 95051, United States

Location

Kaiser Permanente South San Francisco Emergency Department

South San Francisco, California, 94080, United States

Location

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California, 94596, United States

Location

Related Publications (2)

• Vinson DR, Warton EM, Durant EJ, Mark DG, Ballard DW, Hofmann ER, Sax DR, Kene MV, Lin JS, Poth LS, Ghiya MS, Ganapathy A, Whiteley PM, Bouvet SC, Rauchwerger AS, Zhang JY, Shan J, DiLena DD, Kea B, Pai AP, Loyles JB, Solomon MD, Go AS, Reed ME. Decision Support Intervention and Anticoagulation for Emergency Department Atrial Fibrillation: The O'CAFE Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2443097. doi: 10.1001/jamanetworkopen.2024.43097.

  PMID: 39504024 DERIVED

• Vinson DR, Rauchwerger AS, Karadi CA, Shan J, Warton EM, Zhang JY, Ballard DW, Mark DG, Hofmann ER, Cotton DM, Durant EJ, Lin JS, Sax DR, Poth LS, Gamboa SH, Ghiya MS, Kene MV, Ganapathy A, Whiteley PM, Bouvet SC, Babakhanian L, Kwok EW, Solomon MD, Go AS, Reed ME; Kaiser Permanente CREST Network. 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'CAFE trial). Trials. 2023 Mar 31;24(1):246. doi: 10.1186/s13063-023-07230-2.

  PMID: 37004068 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 17, 2021
• Study Start: October 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)