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

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.

[1]  M. Aguilar,et al.  Oral anticoagulants for preventing stroke in patients with non-valvular atrial fibrillation and no previous history of stroke or transient ischemic attacks. , 2005, The Cochrane database of systematic reviews.

[2]  J. Vermylen,et al.  Quality assessment of oral anticoagulation in Belgium, as practiced by a group of general practitioners , 2005, Acta cardiologica.

[3]  James Douketis,et al.  Clinical Impact of Bleeding in Patients Taking Oral Anticoagulant Therapy for Venous Thromboembolism , 2003, Annals of Internal Medicine.

[4]  F. Rosendaal,et al.  Comparison of the quality of oral anticoagulant therapy through patient self-management and management by specialized anticoagulation clinics in the Netherlands: a randomized clinical trial. , 2003, Archives of internal medicine.

[5]  M. Ruivard,et al.  Physician compliance with outpatient oral anticoagulant guidelines in Auvergne, France , 2003, Journal of General Internal Medicine.

[6]  S. Schulman Care of Patients Receiving Long-Term Anticoagulant Therapy , 2003 .

[7]  J. Ansell Optimizing the Efficacy and Safety of Oral Anticoagulant Therapy: High-Quality Dose Management, Anticoagulation Clinics, and Patient Self-Management , 2003, Seminars in vascular medicine.

[8]  Leon Poller,et al.  European Concerted Action on Anticoagulation , 2002, Thrombosis and Haemostasis.

[9]  Kenneth F Schulz,et al.  Generation of allocation sequences in randomised trials: chance, not choice , 2002, The Lancet.

[10]  J. Hippisley-Cox,et al.  Do single handed practices offer poorer care? Cross sectional survey of processes and outcomes , 2001, BMJ : British Medical Journal.

[11]  L. Kalra,et al.  Are the results of randomized controlled trials on anticoagulation in patients with atrial fibrillation generalizable to clinical practice? , 2001, Archives of internal medicine.

[12]  F D Hobbs,et al.  Oral anticoagulation management in primary care with the use of computerized decision support and near-patient testing: a randomized, controlled trial. , 2000, Archives of internal medicine.

[13]  P. Sawicki,et al.  A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled trial. Working Group for the Study of Patient Self-Management of Oral Anticoagulation. , 1999, JAMA.

[14]  J. Jespersen,et al.  Multicentre randomised study of computerised anticoagulant dosage , 1998, The Lancet.

[15]  J. Douketis,et al.  Accuracy of a portable International Normalization Ratio monitor in outpatients receiving long-term oral anticoagulant therapy: comparison with a laboratory reference standard using clinically relevant criteria for agreement. , 1998, Thrombosis research.

[16]  P. Rose,et al.  New approaches to the delivery of anticoagulant services. , 1998, Blood reviews.

[17]  Guidelines on oral anticoagulation: third edition , 1998 .

[18]  M. Moia,et al.  Thrombotic Events during Oral Anticoagulant Treatment: Results of the Inception-cohort, Prospective, Collaborative ISCOAT Study , 1997, Thrombosis and Haemostasis.

[19]  J. Parker-Williams,et al.  Multicenter evaluation of a new capillary blood prothrombin time monitoring system , 1995, Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis.

[20]  J. Vandenbroucke,et al.  Optimal oral anticoagulant therapy in patients with mechanical heart valves. , 1995, The New England journal of medicine.

[21]  P. Koudstaal Optimal oral anticoagulant therapy in patients with nonrheumatic atrial fibrillation and recent cerebral ischemia. , 1995, The New England journal of medicine.

[22]  J A Knottnerus,et al.  Does feedback improve the quality of cervical smears? A randomized controlled trial. , 1993, The British journal of general practice : the journal of the Royal College of General Practitioners.

[23]  B. Mciver,et al.  Comparison of anticoagulant control among patients attending general practice and a hospital anticoagulant clinic. , 1993, The British journal of general practice : the journal of the Royal College of General Practitioners.

[24]  F R Rosendaal,et al.  A Method to Determine the Optimal Intensity of Oral Anticoagulant Therapy , 1993, Thrombosis and Haemostasis.

[25]  J. Vermylen,et al.  Ervaringen tijdens de "Belgian Improvement Study on Oral Anticoagulation Therapy" (BISOAT) , 2005 .

[26]  J. Ansell,et al.  Anticoagulation Management as a Risk Factor for Adverse Events: Grounds for Improvement , 2004, Journal of Thrombosis and Thrombolysis.

[27]  S. Schulman Clinical practice. Care of patients receiving long-term anticoagulant therapy. , 2003, The New England journal of medicine.

[28]  R. Grol,et al.  Implementatie : effectieve verandering in de patiëntenzorg , 2001 .

[29]  N. Freemantle,et al.  Audit and feedback: effects on professional practice and health care outcomes. , 2000, The Cochrane database of systematic reviews.

[30]  K. Haustein Pharmacokinetic and Pharmacodynamic Properties of Oral Anticoagulants, Especially Phenprocoumon , 1999, Seminars in thrombosis and hemostasis.

[31]  W. G. Breukink-Engbers Monitoring therapy with anticoagulants in The Netherlands. , 1999, Seminars in thrombosis and hemostasis.

[32]  G. Leipnitz,et al.  Improved Therapeutic Safety of Oral Anticoagulant Therapy in Germany: The Saarland Model , 1999, Seminars in thrombosis and hemostasis.

[33]  R. Linhardt,et al.  Production and chemical processing of low molecular weight heparins. , 1999, Seminars in thrombosis and hemostasis.

[34]  J Jespersen,et al.  Multicentre randomised study of computerised anticoagulant dosage. European Concerted Action on Anticoagulation. , 1998, Lancet.

[35]  J. Vandenbroucke,et al.  Bleeding complications in oral anticoagulant therapy. An analysis of risk factors. , 1993, Archives of internal medicine.