A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial

Summary Background Oral anticoagulationis underused in patients with atrial fibrillation. We assessed the impact of a multifaceted educational intervention, versus usual care, on oral anticoagulantuse in patients with atrial fibrillation. Methods This study was a two-arm, prospective, international, cluster-randomised, controlled trial. Patients were included who had atrial fibrillationand an indication for oral anticoagulation. Clusters were randomised (1:1) to receive a quality improvement educational intervention (intervention group) or usual care (control group). Randomisation was carried out centrally, using the eClinicalOS electronic data capturesystem. The intervention involved education of providers and patients, with regular monitoring and feedback. The primary outcome was the change in the proportion of patients treated with oral anticoagulantsfrom baseline assessment to evaluation at 1 year. The trial is registered at ClinicalTrials.gov, number NCT02082548. Findings 2281 patients from five countries (Argentina, n=343; Brazil, n=360; China, n=586; India, n=493; and Romania, n=499) were enrolled from 48 clusters between June 11, 2014, and Nov 13, 2016. Follow-up was at a median of 12·0 months (IQR 11·8–12·2). Oral anticoagulantuse increased in the intervention group from 68% (804 of 1184 patients) at baseline to 80% (943 of 1184 patients) at 1 year (difference 12%), whereas in the control group it increased from 64% (703 of 1092 patients) at baseline to 67% (732 of 1092 patients) at 1 year (difference 3%). Absolute differencein the change between groups was 9·1% (95% CI 3·8–14·4); odds ratio of change in the use of oral anticoagulationbetween groups was 3·28 (95% CI 1·67–6·44; adjusted p value=0·0002). Kaplan-Meier estimatesshowed a reduction in the secondary outcome of stroke in the intervention versus control groups (HR 0·48, 95% CI 0·23–0·99; log-rank p value=0·0434). Interpretation A multifaceted and multilevel educational intervention, aimed to improve use of oral anticoagulationin patients with atrial fibrillationand at risk for stroke, resulted in a significant increase in the proportion of patients treated with oral anticoagulants. Such an intervention has the potential to improve stroke prevention around the world for patients with atrial fibrillation. Funding Bayer, Boehringer Ingelheim, Bristol-MyersSquibb, Daiichi Sankyo, and Pfizer.