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Detecting and Diagnosing Atrial Fibrillation (D2AF): study protocol for a cluster randomised controlled trial
Steven B Uittenbogaart1, Nicole Verbiest-van Gurp2, Petra M G Erkens3
1Department of General Practice, Amsterdam Medical Center, J2-118, PO Box 22660, 1100 DD, Amsterdam, The Netherlands. s.b.uittenbogaart@amc.uva.nl.
Insights
Early detection of atrial fibrillation (AF) in primary care can prevent strokes. This study compares an enhanced case-finding protocol using pulse palpation, automated devices, and ECGs against usual care to improve AF detection rates and diagnostic accuracy.
Area of Science:
- Cardiology
- Primary Care Medicine
- Medical Diagnostics
Background:
- Atrial fibrillation (AF) is a major risk factor for stroke, significantly increasing morbidity.
- Early detection and treatment of AF, even asymptomatic or paroxysmal cases, can reduce stroke risk by 60% with anticoagulants.
- Current case-finding methods like pulse palpation are effective, but new technologies may enhance AF detection.
Purpose of the Study:
- To determine the yield of an intensive case-finding strategy for atrial fibrillation in primary care.
- To evaluate the diagnostic accuracy of three different case-finding methods for detecting AF.
- To compare an enhanced AF case-finding protocol with usual care in a primary care setting.
Main Methods:
- A multicenter cluster randomized controlled trial involving 96 general practices.
- Inclusion of primary care patients aged 65 years or older without a prior AF diagnosis.
- Intervention group received an enhanced protocol (pulse palpation, automated device, handheld ECG); control group received usual care. Diagnostic accuracy assessed via 12-lead ECG, Holter monitoring, and patient-used handheld ECG.
Main Results:
- The study is currently recruiting practices; primary outcomes are the difference in new AF detection rates and diagnostic accuracy of index tests.
- The 'Detecting and Diagnosing Atrial Fibrillation' (D2AF) study aims to provide data on the effectiveness of the enhanced protocol.
- Results will quantify the yield of intensive case-finding and the accuracy of novel diagnostic tools.
Conclusions:
- An intensive case-finding strategy may improve the detection of atrial fibrillation in primary care.
- The diagnostic accuracy of new methods like automated devices and handheld ECGs needs further evaluation in real-world primary care settings.
- Effective case-finding for atrial fibrillation has the potential to prevent significant morbidity, such as stroke.
Background:
Atrial fibrillation is a common cause of stroke and other morbidity. Adequate treatment with anticoagulants reduces the risk of stroke by 60 %. Early detection and treatment of atrial fibrillation could prevent strokes. Atrial fibrillation is often asymptomatic and/or paroxysmal. Case-finding with pulse palpation is an effective screening method, but new methods for detecting atrial fibrillation have been developed. To detect paroxysmal atrial fibrillation ambulatory rhythm recording is needed. This study aims to determine the yield of case-finding for atrial fibrillation in primary care patients. In addition, it will determine the diagnostic accuracy of three different case-finding methods.
Methods/Design:
In a multicenter cluster randomised controlled trial, we compare an enhanced protocol for case-finding of atrial fibrillation with usual care. We recruit 96 practices. We include primary care patients aged 65 years or older not diagnosed with atrial fibrillation. Within each practice, a cluster of 200 patients is randomly selected and marked. Practices are evenly randomised to intervention or control group. The allocation is not blinded. When a marked patient visits an intervention practice, the case-finding protocol starts, consisting of: pulse palpation, sphygmomanometer with automated atrial fibrillation detection and handheld single-lead electrocardiogram (ECG). All patients with at least 1 positive test and a random sample of patients with negative tests receive a 12-lead ECG. Patients without atrial fibrillation on the 12-lead ECG, undergo additional continuous Holter and use the handheld single-lead ECG at home for 2 weeks. Control practices provide care as usual. The study runs for 1 year in each cluster. The primary outcomes are the difference in detection rate of new AF between intervention and control practices and the accuracy of three index tests to diagnose AF. We are currently recruiting practices. The 'Detecting and Diagnosing Atrial Fibrillation' (D2AF) study will determine the yield of an intensive case-finding strategy and the diagnostic accuracy of three index tests to diagnose atrial fibrillation in a primary care setting.
Trial Registration:
Netherlands Trial Register: NTR4914 , registered on the 25 of November 2014.
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