A Structured Teaching and Self-management Program for Patients Receiving Oral AnticoagulationA Randomized Controlled Trial

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Abstract
Research from JAMA — A Structured Teaching and Self-management Program for Patients Receiving Oral Anticoagulation — A Randomized Controlled Trial — ContextControl of oral anticoagulation therapy has been reported to often be inadequate. Previous retrospective investigations suggest that patients' self-adjustment of oral anticoagulants may lead to improved control.ObjectiveTo investigate the effects of patients' self-management of oral anticoagulation therapy on accuracy of control and measures of treatment-related quality of life.DesignRandomized, single-blind, multicenter trial.Setting and ParticipantsA total of 179 patients receiving long-term oral anticoagulation treatment were enrolled at 5 referral centers in Germany.InterventionPatients were randomized to an oral anticoagulation self-management group based on a structured treatment and teaching program and international normalized ratio (INR) self-monitoring. The control group received conventional care as provided by family physicians, including referral to specialists if necessary.Main Outcome MeasuresDeviation of INR values from the individual INR target range (squared) and the 5 categories of treatment-related quality of life.ResultsDeviation of INR value from the mean of the INR target range was significantly lower in the intervention group at 3-month (squared INR deviation, 0.59 vs 0.95; P<.001) and 6-month follow-up (0.65 vs 0.83; P=.03) compared with the control group. Also, the intervention group had INR values within the target range more often (repeated measurement analysis for categorical data, P=.006). The results were mainly due to less frequent suboptimal INR values in the intervention group (32.8% vs 50.0% [P=.03] at 3-month, and 33.7% vs 48.2% [P=.08] at 6-month follow-up). Treatment-related quality-of-life measures, especially treatment satisfaction scores, were significantly higher in the intervention group compared with controls.ConclusionsAn anticoagulation education program that includes self-management of anticoagulation therapy results in improved accuracy of anticoagulation control and in treatment-related quality-of-life measures. Further studies are needed to describe whether the program will reduce risk of bleeding or thromboembolism.