P T Sawicki1. 1. Heinrich-Heine University, Department of Metabolic Diseases and Nutrition (Co-Coordinating Center), Düsseldorf, Germany. Sawicki@med.uni-duesseldorf.de
Abstract
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 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 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 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.
RCT Entities:
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 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 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 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.
Authors: J B Segal; R L McNamara; M R Miller; N Kim; S N Goodman; N R Powe; K A Robinson; E B Bass Journal: J Gen Intern Med Date: 2000-01 Impact factor: 5.128
Authors: Daniel M Witt; Robby Nieuwlaat; Nathan P Clark; Jack Ansell; Anne Holbrook; Jane Skov; Nadine Shehab; Juliet Mock; Tarra Myers; Francesco Dentali; Mark A Crowther; Arnav Agarwal; Meha Bhatt; Rasha Khatib; John J Riva; Yuan Zhang; Gordon Guyatt Journal: Blood Adv Date: 2018-11-27