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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
A. P. A. Gadisseur, MD;
W. G. M. Breukink-Engbers, MD;
F. J. M. van der Meer, MD, PhD;
A. M. H. van den Besselaar, MD, PhD;
A. Sturk, MSc, PhD;
F. R. Rosendaal, MD, PhD
Arch Intern Med. 2003;163:2639-2646.
Background Several studies have demonstrated that patient self-management of oral anticoagulant therapy (OAT) can improve treatment quality. However, most of these studies were not conducted within a specialized anticoagulation care system. The objective of the present study was to determine whether patient self-management of OAT improves the quality of care delivered by anticoagulation clinics.
Methods In this randomized study by 2 Dutch anticoagulation clinics 341 patients aged between 18 and 75 years and receiving long-term OAT were divided into 4 groups: an existing routine care group of patients untrained in self-management; a routine care group of trained patients; a group managed weekly at an anticoagulation clinic where international normalized ratios were measured by trained patients; and weekly patient self-management. A 2-step randomization procedure was followed: first, a Zelen-design randomization was performed to distribute patients (without informing them) to the existing care group or to receive training in self-management; second, trained patients were randomized to the 3 other study groups.
Results Only 25.6% of invited patients agreed to participate in the training program. Patients who remained in the existing care group were within the international normalized ratio target range 63.5% of the time. The type of coumarin taken was a major predicting factor of OAT quality. In all study groups phenprocoumon outperformed acenocoumarol by 11.6% (95% confidence interval [CI], 6.6%-16.5%). Weekly management with phenprocoumon led to a 6.5% improvement (95% CI, 0.0%-13.1%) in time in the international normalized ratio target range when patients were managed at an anticoagulation clinic and to an 8.7% improvement (95% CI, 1.6%-15.9%) when patients were self-managed. Weekly management with acenocoumarol did not improve the quality of OAT.
Conclusion With selected patients, the quality of OAT obtained through patient self-management is at least as high as that delivered by specialized physicians at anticoagulation clinics. Weekly management of OAT with long-acting phenprocoumon has to be preferred at anticoagulation clinics or, where possible, through patient self-management.
From the Departments of Hematology/Hemostasis and Thrombosis Research Center (Drs Gadisseur, van der Meer, van den Besselaar, and Rosendaal) and Clinical Epidemiology (Dr Rosendaal), Leiden University Medical Center, Leiden, the Netherlands; the Leiden Anticoagulation Clinic, Leiden (Drs Gadisseur and van der Meer); the Oost-Gelderland Anticoagulation Clinic, Lichtenvoorde, the Netherlands (Dr Breukink-Engbers); and the Federation of Dutch Anticoagulation Clinics, Voorschoten, the Netherlands (Drs Breukink-Engbers and Sturk).The authors have no relevant financial interest in this article.
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