Electronic Clinical Decision Support Tool for Atrial Fibrillation

(AF SWCRT-CDS Trial)

Overseen by Bory Kea, MD, MCR

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Oregon Health and Science University

No Placebo Group

Trial Summary

What is the purpose of this trial?

Atrial fibrillation (AF) is the most common arrhythmia in the world, with significant morbidity and mortality. With appropriate oral anticoagulation, the risk of stroke due to atrial fibrillation decreases by 64%. Although atrial fibrillation is commonly diagnosed and treated in the Emergency Department (ED), oral anticoagulation is significantly underprescribed. Underprescribing has been attributed to a lack of empowerment and deferral of prescribing to longitudinal care clinicians. Using a convergent parallel quantitative-qualitative design (mixed-methods), we propose a stepped-wedge cluster randomized trial design with the implementation of a clinical decision support (CDS) tool in adults with new-onset AF that are OAC-naïve and at significant risk for stroke. In parallel, we will use qualitative approaches to evaluate clinician facilitators and barriers to tool utilization as well as patient satisfaction and engagement with the tool.

Research Team

Bory Kea, MD, MCR

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for adults over 18 with new-onset atrial fibrillation diagnosed in the emergency department, who haven't been prescribed oral anticoagulants recently. It's not for those with severe liver or kidney disease, recent major surgery, certain bleeding conditions, or if they're pregnant.

Inclusion Criteria

I was diagnosed with atrial or paroxysmal fibrillation between 1/11/2022 and 12/31/2025.

I am over 18 years old.

Exclusion Criteria

I have a heart valve problem.

I was hospitalized or had a stroke or death event at my first visit.

I have been prescribed blood thinners in the last 3 months or am managed by a blood thinner clinic.

Treatment Details

Interventions

• Clinical Decision Support (CDS) tool (Behavioural Intervention)

Trial Overview The study tests a Clinical Decision Support tool designed to help doctors decide when to prescribe blood thinners to prevent strokes in patients with atrial fibrillation. The trial randomly assigns periods of time when different EDs will start using the tool.

Participant Groups

Group I: Link-Out Experimental Treatment 1 Intervention

Clinicians will be trained on the web-based portal of the CDS tool and shown where the Link to the tool will be available in the EHR.

Group II: BPA + Link-out Experimental Treatment 1 Intervention

Clinicians will be trained on how a BPA is triggered when a patient is diagnosed with AF. The alert will pop up within the EHR with the Link-out to the web portal.

Group III: BPA + FHIR Experimental Treatment 1 Intervention

Instead of a link to the web-based portal, the BPA will contain a link to the FHIR-integrated CDS tool portal. FHIR will automatically pull EHR data about the patient into the CDS tool portal. Data include demographic information, comorbidities in the active problem list, past medical and surgical history, and social history. Clinicians will also receive training before the implementation of this step.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

John Hunter

Oregon Health and Science University

Chief Medical Officer since 2024

MD, specific details unavailable

Ann Madden Rice

Oregon Health and Science University

Chief Executive Officer

FACHE certification, extensive leadership experience in academic health centers