Optimizing Stroke Prophylaxis of Acute Atrial Fibrillation with an Electronic Clinical Decision Support Tool (AF SWCRT-CDS)

Optimizing Stroke Prophylaxis of Acute Atrial Fibrillation with an Electronic Clinical Decision Support Tool: a Stepped-Wedge Cluster Randomized Trial Design

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Clinical Decision Support (CDS) 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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University (OHSU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria (Patients):

• 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.

Exclusion Criteria (Patients):

• 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);

Inclusion/Exclusion Criteria (Clinicians): All ED clinicians (board certified or eligible) interfacing with patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Link-Out; 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; Implementation of an EHR-based CDS tool for providers to use.
Other: BPA + Link-out; 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; Implementation of an EHR-based CDS tool for providers to use.
Other: BPA + FHIR; 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; Implementation of an EHR-based CDS tool for providers to use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Bory Kea, MD, MCR, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: STUDY00022471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No