Motivational Interviewing to Support Oral AntiCoagulation adherence in patients with non-valvular Atrial Fibrillation (MISOAC-AF): a randomized clinical trial
- 9 April 2020
- journal article
- research article
- Published by Oxford University Press (OUP) in European Heart Journal - Cardiovascular Pharmacotherapy
- Vol. 7 (FI1), f63-f71
- https://doi.org/10.1093/ehjcvp/pvaa039
Abstract
Aims We aimed to assess the impact of an educational, motivational intervention on the adherence to oral anticoagulation (OAC) in patients with non-valvular atrial fibrillation (AF). Methods and results Hospitalized patients with non-valvular AF who received OAC were randomly assigned to usual medical care or a proactive intervention, comprising motivational interviewing, and tailored counselling on medication adherence. The primary study outcome was adherence to OAC at 1 year, which was evaluated according to proportion of days covered (PDC) by OAC regimens and was assessed through nationwide registers of prescription claims. Secondary outcomes included the rate of persistence to OAC, gaps in treatment, and clinical events. A total of 1009 patients were randomized, 500 in the intervention group and 509 in the control group. At 1-year follow-up, 77.2% (386/500) of patients in the intervention group were adherent (PDC > 80%), compared with 55% (280/509) in the control group [adjusted odds ratio (aOR) 2.84, 95% confidence interval (CI) 2.14–3.75; P < 0.001]. Mean PDC ± standard deviation was 0.85 ± 0.26 and 0.75 ± 0.31, respectively (P < 0.001). Patients that received the intervention were more likely to persist in their OAC therapy at 1 year (aOR 2.42, 95% CI 1.71–3.41; P < 0.001). Usual medical care was associated with more major (≥3 months) treatment gaps (aOR 2.39, 95% CI 1.76–3.26; P < 0.001). Clinical events over a median follow-up period of 2 years did not differ among treatment groups. Conclusion In patients receiving OAC therapy for non-valvular AF, a multilevel motivational intervention significantly improved medication adherence and rate of therapy persistence, and reduced major gaps in treatment. No significant impact on clinical outcomes was observed. Trial registration number NCT02941978.Keywords
This publication has 37 references indexed in Scilit:
- Worldwide Epidemiology of Atrial FibrillationCirculation, 2014
- Educational Intervention Improves Anticoagulation Control in Atrial Fibrillation Patients: The TREAT Randomised TrialPLOS ONE, 2013
- Incidence and prevalence of atrial fibrillation: an analysis based on 8.3 million patientsEP Europace, 2012
- Withdrawal of Antithrombotic Agents and Its Impact on Ischemic Stroke OccurrenceStroke, 2011
- Underuse of Oral Anticoagulants in Atrial Fibrillation: A Systematic ReviewThe American Journal of Medicine, 2010
- Apixaban for Reduction In Stroke and Other ThromboemboLic Events in Atrial Fibrillation (ARISTOTLE) trial: Design and rationaleAmerican Heart Journal, 2010
- Good and poor adherence: optimal cut-point for adherence measures using administrative claims dataCurrent Medical Research and Opinion, 2009
- Meta-analysis: Antithrombotic Therapy to Prevent Stroke in Patients Who Have Nonvalvular Atrial FibrillationAnnals of Internal Medicine, 2007
- Newly Detected Atrial Fibrillation and Compliance With Antithrombotic GuidelinesArchives of Internal Medicine, 2007
- Atrial fibrillation as an independent risk factor for stroke: the Framingham Study.Stroke, 1991