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An International Multicenter Clustered Randomized Controlled Trial to imProveTreatment with AntiCoagulanTs in Patients with Atrial Fibrillation (IMPACT AF)

In 2001, it was estimated that cerebrovascular diseases (stroke) accounted for 5.5 million deaths worldwide with two-thirds occurring in people living in developing countries. Additionally, stroke is the leading cause of disability in adults and each year millions of stroke survivors adapt to a life with restriction in activities of daily living as a consequence of this disease. About one out of five strokes is due to atrial fibrillation and over two thirds of these strokes can be prevented with oral anticoagulation.

Despite the effectiveness of anticoagulation, recent literature reviews and studies have documented that current practice does not follow published guidelines resulting in substantial occurrence of preventable ischemic stroke. Reasons for underuse of anticoagulation are not well understood.  

Few quality improvement interventions have been evaluated to determine impact on patient care and clinical outcomes for patients with atrial fibrillation to reduce stroke rates. Using methods shown to improve adherence (e.g. education of health care providers, improved communication between physicians and patients, patient education and educational outreach visits, and measuring and providing feedback regarding adherence) this study will test an educational intervention to determine impact on patient care and clinical outcomes.

IMPACT AF is a prospective cluster-randomized controlled trial with blinded adjudication of outcomes and intention-to-treat analysis designed to determine if an educational intervention can improve use of oral anticoagulation according to published guidelines in patients with atrial fibrillation at risk for stroke. By completing this important trial, Duke University School of Medicine and all of its collaborating partners hope to better understand reasons for underuse of anticoagulation and address practice gaps to prevent stroke in patients with atrial fibrillation.