A structured teaching and self-management program for patients receiving oral anticoagulation - A randomized controlled trial

Context Control 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. Objective To investigate the effects of patients' self-management of oral anticoagulation therapy on accuracy of control and measures of treatment-related quality of life. Design Randomized, single-blind, multicenter trial. Setting and Participants A total of 179 patients receiving long-term oral anticoagulation treatment were enrolled at 5 referral centers in Germany. Intervention Patients were randomized to an oral anticoagulation selfmanagement 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 Measures Deviation of INR values from the individual INR target range (squared) and the 5 categories of treatment-related quality of life. Results Deviation 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. Conclusions An anticoagulation education program that includes selfmanagement 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.