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OpenTrials
Enrolling by Invitation

NCT Number: NCT05341986

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical decision support (CDS) tool

Other

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

Primary outcomes

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

    Time frame: through study completion, up to 4 years

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

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Acronym: AF SWCRT-CDS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2022
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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