Vinereanu D, et al. - An international, cluster-randomised trial is done to evaluate the effect of a multifaceted educational intervention, versus usual care, on oral anticoagulant use in patients with atrial fibrillation. A multifaceted and multilevel educational intervention aimed to improve the utilization of oral anticoagulation in patients with atrial fibrillation and 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.

Methods

• For this study, they designed a two-arm, prospective, international, cluster-randomised, controlled trial.
• Patients who had atrial fibrillation and an indication for oral anticoagulation were included in this study.
• Clusters were randomised (1:1) to receive a quality improvement educational intervention (intervention group) or usual care (control group).
• Randomisation was carried out centrally, utilizing the eClinicalOS electronic data capture system.
• 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 anticoagulants from baseline assessment to evaluation at 1 year.

Results

• Between June 11, 2014, and Nov 13, 2016, total 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.
• Follow-up was at a median of 12·0 months (IQR 11·8-12·2).
• Oral anticoagulant use 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 difference in the change between groups was 9·1% (95% CI 3·8-14·4); odds ratio of change in the use of oral anticoagulation between groups was 3·28 (95% CI 1·67-6·44; adjusted p value=0·0002).
• Kaplan-Meier estimates demonstrated 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).