Optimizing Stroke Prophylaxis of Acute Atrial Fibrillation With an Electronic Clinical Decision Support Tool

NCT05341986 | Enrolling By Invitation

• 1 other identifier: STUDY00022471
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of patients appropriately prescribed OACs after CDS tool implementation.

  The primary outcome is the number of patients appropriately prescribed OACs after CDS tool implementation.

  through study completion, up to 4 years

Secondary Outcomes (1)

• Clinician and patient feedback on acceptability and identification of barriers and facilitators to use of the tool.

  through study completion, up to 4 years

Study Arms (3)

Link-Out

OTHER

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.

Other: Clinical Decision Support (CDS) tool

BPA + Link-out

OTHER

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.

Other: Clinical Decision Support (CDS) tool

BPA + FHIR

OTHER

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.

Other: Clinical Decision Support (CDS) tool

Interventions

Clinical Decision Support (CDS) tool OTHER

Implementation of an EHR-based CDS tool for providers to use.

BPA + FHIR; BPA + Link-out; Link-Out

Eligibility Criteria

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

You may qualify if:

• A diagnosis of atrial fibrillation or paroxysmal atrial fibrillation (ICD-10 I48.0, I48.1, I48.9) during an ED visit with start dates between 1/11/2022 and 12/31/2025 within the patient's age \>18 years.

You may not qualify if:

• Valvular disease, pregnancy, large esophageal varices, thrombocytopenia, severe or uncontrolled bleeding, severe liver or kidney disease, major surgery within 72 hours; OR
• Recent brain, eye or spinal cord injury or surgery; OR
• ED stroke, death or hospitalization at index visit; OR
• Patient transferred from another hospital (to ensure availability of index ED visit data); OR
• Left against medical advice; OR
• Evidence of non-OAC naïve patient:
• OAC prescribed in the prior 3mo to index ED visit; OR
• Being managed by an anticoagulation clinic (ACC);

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Compact Disks; Equipment and Supplies

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Videodisc Recording; Optical Storage Devices; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Bory Kea, MD, MCR

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Using a convergent parallel quantitative-qualitative design (mixed-methods), we propose a stepped-wedge cluster randomized trial design with the implementation of an electronic health record (EHR) clinical decision support (CDS) tool in adults with new-onset AF that are OAC-naïve and at significant risk for stroke, in three ED settings with different practice patterns and culture, patient populations, and organizational readiness. 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.

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 22, 2022
• Study Start: January 11, 2022
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)