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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Other: Clinical Decision Support (CDS) tool

• Registration Number: NCT05341986
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

OBJECTIVES:

AIM 1: Compare the magnitude of change of appropriate OAC prescribing over time at each ED with EHR-Based CDS tool implementation.

H1a. A CDS tool will increase the prescribing of OACs at ED discharge in patients with new AF.

H1b. The highly-integrated EHR-based CDS tool with a trigger will have a greater impact on the volume of prescribing compared to a less integrated web-based portal.

AIM 2: Evaluate clinician experiences with factors that influence the CDS tool implementation through a qualitative approach.

H2a. Clinicians will have high acceptability of the tool and be open to additional CDS tools.

H2b. Health system resources, such as the ability to refer patients to an anticoagulation clinic or primary care, will facilitate ED tool utilization.

AIM 3 (Exploratory): Determine patient satisfaction and engagement with ED visits across the three steps of CDS tool implementation and explore patient-clinician stories as mini-case studies (dyads) related to the recall of their experiences.

AIM 1 addresses whether a CDS tool can increase clinician prescribing-thereby improving long-term outcomes for patients. AIM 2 will address clinician facilitators and barriers to the CDS tool. AIM 3 (exploratory) will allow the exploration of a patient-centered approach for the future development of a scalable and generalizable strategy for large-scale dissemination. Through a convergent parallel quantitative-qualitative study, we will capitalize on a missed opportunity to change the trajectory of care and outcomes of newly ED-diagnosed AF patients.

Study Timeline

• Study Start: 2022-01-11
• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-03-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BPA + Link-out	Clinical Decision Support (CDS) tool	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.
BPA + FHIR	Clinical Decision Support (CDS) tool	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.
Link-Out	Clinical Decision Support (CDS) tool	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.

Primary Outcome Measures

Name	Time	Method
Number of patients appropriately prescribed OACs after CDS tool implementation.	through study completion, up to 4 years	The primary outcome is the number of patients appropriately prescribed OACs after CDS tool implementation.

Secondary Outcome Measures

Name	Time	Method
Clinician and patient feedback on acceptability and identification of barriers and facilitators to use of the tool.	through study completion, up to 4 years	Secondary outcomes include the clinician and patient feedback on acceptability and identification of barriers and facilitators to use of the tool.

Trial Locations

Locations (1)

Oregon Health & Science University (OHSU); 🇺🇸 Portland, Oregon, United States