The Belgian Improvement Study on Oral Anticoagulation Therapy: a randomized clinical trial

Abstract

Aims: In Belgium, general practitioners (GPs) mainly manage oral anticoagulation therapy. To improve the quality of oral anticoagulation management by GPs and to compare different models and interventions, a randomized clinical trial was performed.

Methods and results: Stratified randomization divided 66 GP-practices into four groups. A 6-month retrospective analysis assessed the baseline quality. In the prospective study, each group received education on oral anticoagulation, anticoagulation files, and patient information booklets (groups A, B, C, and D). Group B additionally received feedback every 2 months on their anticoagulation performance; group C determined the international normalized ratio (INR) with a CoaguChek device in the doctor's office or at the patient's home; and group D received Dawn AC computer assisted advice for adapting oral anticoagulation. For the different groups, the time spent in target INR range (Rosendaal's method) and adverse events related to anticoagulation were determined and compared with the same quality indicators at baseline. There was a significant increase in per cent of time within 0.5 INR from target, from 49.5% at baseline to 60% after implementing the different interventions. However, neither the per cent in target range nor the event rates differed among the four groups.

Conclusion: The interventions significantly improved the quality of management of oral anticoagulation by Belgian GPs, mainly as a result of an education and support programme.