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Electronic health record-embedded decision support to reduce stroke risk in patients with atrial fibrillation - Study
Mark H Eckman1, Ruth Wise1, Carol Knochelmann1
1Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.
Insights
This study evaluated an Atrial Fibrillation Decision Support Tool (AFDST) with a best practice advisory (BPA) to improve stroke prevention in primary care. The tool aims to increase appropriate anticoagulation therapy for atrial fibrillation patients.
Area of Science:
- Cardiology
- Health Informatics
- Implementation Science
Background:
- Atrial fibrillation (AF) is a common arrhythmia and a major stroke risk factor.
- Anticoagulation therapy effectively reduces stroke risk in AF patients.
- Underutilization of anticoagulation therapy in AF presents a significant clinical challenge.
Purpose of the Study:
- To evaluate the effectiveness of an Atrial Fibrillation Decision Support Tool (AFDST) integrated into electronic health records.
- To assess if a best practice advisory (BPA) enhances the AFDST's impact on appropriate anticoagulation.
- To reduce the gap in stroke prevention for AF patients within a health system.
Main Methods:
- A prospective, randomized trial enrolling 800 primary care patients with AF receiving suboptimal anticoagulation.
- Patients randomized to usual care with AFDST access or usual care plus a BPA notification.
- Intervention focused on provider-facing decision support in an ambulatory setting.
Main Results:
- Primary outcome: change to appropriate thromboprophylaxis at 3 months post-randomization.
- Secondary outcomes: Reach and Adoption metrics from the RE-AIM framework.
- Sample size calculation based on achieving ≥10% appropriate anticoagulation in the experimental arm versus 4% in the usual care arm.
Conclusions:
- The study aims to determine if adding a BPA to an AFDST improves appropriate thromboprophylaxis in primary care for AF patients.
- Durability of treatment changes will be assessed at 3 months and end-of-study.
- Patient enrollment was expected to conclude by June 2022.
Background:
Atrial fibrillation (AF) is the most common significant cardiac rhythm disorder and is a powerful common risk factor for stroke. Randomized trials have demonstrated that anticoagulation can reduce the risk of stroke in patients with AF. Yet, there continues to be widespread underutilization of this therapy. To address this practice gap locally and improve efforts to reduce the risk of stroke for patients with AF in our health system, we have designed a study to implement and evaluate the effectiveness of an Atrial Fibrillation Decision Support Tool (AFDST) embedded within our electronic health record.
Methods:
Our intervention is provider-facing and focused on decision support. The clinical setting is ambulatory patients being seen by primary care physicians. Patients include those with both incident and prevalent AF. This randomized, prospective trial will enroll 800 patients in our University of Cincinnati Health System who are currently receiving less than optimal anticoagulation therapy as determined by the AFDST. Patients will be randomized to one of two arms - 1) usual care, in which the AFDST is available for use; 2) addition of a best practice advisory (BPA) to the AFDST notifying the clinician that their patient stands to gain a significant benefit from a change in their current thromboprophylactic therapy.
Results:
The primary outcome is effectiveness of the BPA measured by change to "appropriate thromboprophylaxis" based on the AFDST recommendation at 3 months post randomization. Secondary endpoints include Reach and Adoption, from the RE-AIM framework for implementation studies. Sample size is based upon an improvement from inappropriate to appropriate anticoagulation therapy estimated at 4% in the usual care arm and ≥10% in the experimental arm.
Conclusion:
Our goal is to examine whether addition of a BPA to an AFDST focused on primary care physicians in an ambulatory care setting will improve "appropriate thromboprophylaxis" compared with usual care. Results will be examined at 3 months post randomization and at the end of the study to evaluate durability of changes. We expect to complete patient enrollment by the end of June 2022.
Trial Registration:
Clinicaltrials.gov NCT04099485.
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