Patient self-management of oral anticoagulant care vs. management by specialized anticoagulation clinics: positive effects on quality of life.

BACKGROUND: Oral anticoagulant therapy (OAT) implies frequent blood checks and dose changes to prevent thromboembolic or hemorrhagic complications. This may interfere with patients' social and working circumstances in addition to the possible stress caused by the condition necessitating this treatment. We studied whether patient self-management could be a way to improve quality of life in these patients. METHODS: Within a multicenter randomized study performed by two Dutch anticoagulation clinics, designed to study the effect on treatment quality (time within target range) of different modalities of patient self-management, we looked at the effect of increased patient education (n = 28), self-monitoring of the International Normalized Ratio (INR) (n = 47) and full patient self-management (INR monitoring and dosing of the OAT) (n = 41) on the quality of life of the patients. This was done with the aid of a written questionnaire (32 questions, minimum score = 1, maximum score = 6) at baseline (n = 163), and after 26 weeks (n = 118). We compared the results after 26 weeks with those at baseline, as well as between groups. RESULTS: General treatment satisfaction was already high under routine care (5.11 on a scale of 1-6) and increased further through self-monitoring of the INR (+0.19) and full self-management (+0.32). Distress (-0.44), perceived daily hassles (-0.31) and strain on the social network (-0.21) were reduced through full self-management. Improved patient education was associated with increased distress (+0.33) and perceived daily hassles (+0.23). Comparison at 26 weeks between groups showed similar improvements on these outcomes for self-monitoring and self-management vs. routine care after education.

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.

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.

Oral anticoagulant monitoring by laboratory or near-patient testing: what a clinician should be aware of.

Prothrombin time (PT) is the primary laboratory test for monitoring oral anticoagulant treatment but is influenced by preanalytical conditions and analytical variables, that is, thromboplastin reagents and instrumentation. Standardization and normalization of test results is mandatory. PT results should be transformed to International Normalized Ratio (INR) by calibration of the reagent/instrument system with International Reference standards according to World Health Organization guidelines. However, there is still uncertainty in the INR that is caused in part by calibration errors and in part by interaction between the PT reagent and various factors in the patient's specimen. These problems are highlighted in INR measurements performed with whole blood coagulation monitors. Each center should maintain an appropriate scheme of internal and external quality control for the laboratory INR measurement as well as the individual point-of-care coagulation monitors used by the center and patients for self-testing.