A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled trial. Working Group for the Study of Patient Self-Management of Oral Anticoagulation.

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.

[1]  S. Kumar,et al.  Poor Compliance Is a Major Factor in Unstable Outpatient Control of Anticoagulant Therapy , 1989, Thrombosis and Haemostasis.

[2]  J. Parker-Williams,et al.  Multicenter evaluation of a new capillary blood prothrombin time monitoring system , 1995, Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis.

[3]  L. Goldman,et al.  The bleeding severity index: validation and comparison to other methods for classifying bleeding complications of medical therapy. , 1989, Journal of clinical epidemiology.

[4]  L Goldman,et al.  Major bleeding in outpatients treated with warfarin: incidence and prediction by factors known at the start of outpatient therapy. , 1989, The American journal of medicine.

[5]  G G Koch,et al.  A general methodology for the analysis of experiments with repeated measurement of categorical data. , 1977, Biometrics.

[6]  A. Gallus,et al.  Trial of different intensities of anticoagulation in patients with prosthetic heart valves. , 1990, The New England journal of medicine.

[7]  J. Hirsh.  Oral anticoagulant drugs. , 1991, The New England journal of medicine.

[8]  J. Ansell,et al.  Patient self-management of oral anticoagulation guided by capillary (fingerstick) whole blood prothrombin times. , 1989, Archives of internal medicine.

[9]  H. Kwaan,et al.  Current concepts of warfarin therapy. , 1986, Archives of internal medicine.

[10]  V. J. Redding,et al.  Drug interactions with coumarin derivative anticoagulants. , 1982, British medical journal.

[11]  E. Loeliger.  ICSH/ICTH recommendations for reporting prothrombin time in oral anticoagulant control. , 1985, Haematologica.

[12]  S. Schulman.  Quality of oral anticoagulant control and treatment in Sweden , 1994, Journal of internal medicine.

[13]  B M Duxbury,et al.  Therapeutic control of anticoagulant treatment. , 1982, British medical journal.

[14]  J. Hirsh,et al.  Evaluation of a portable prothrombin time monitor for home use by patients who require long-term oral anticoagulant therapy. , 1993, Archives of internal medicine.

[15]  A. Harries,et al.  ANTICOAGULANT CONTROL , 1981, The Lancet.

[16]  L. Fish,et al.  Long-term patient self-management of oral anticoagulation. , 1995, Archives of internal medicine.

[17]  F. Rosendaal.  The Scylla and Charybdis of oral anticoagulant treatment. , 1996, The New England journal of medicine.

[18]  I. Mühlhauser,et al.  Intensified antihypertensive therapy is associated with improved survival in type 1 diabetic patients with nephropathy , 1995, Journal of hypertension.

[19]  S. Kitchen,et al.  Thromboplastin Related Differences in the Determination of International Normalised Ratio: A Cause for Concern? , 1994, Thrombosis and Haemostasis.

[20]  I. Mühlhauser,et al.  Diabetes education and insulin therapy: when will they ever learn? , 1993, Journal of internal medicine.

[21]  S A McCurdy,et al.  Home prothrombin time monitoring after the initiation of warfarin therapy. A randomized, prospective study. , 1989, Annals of internal medicine.

[22]  V. Marzinotto,et al.  Home monitoring of warfarin therapy in children with a whole blood prothrombin time monitor. , 1995, The Journal of pediatrics.

[23]  R. Hall,et al.  Guidelines for prevention of thromboembolic events in valvular heart disease. Ad Hoc Committee of the Working Group on Valvular Heart Disease, European Society of Cardiology. , 1993, The Journal of heart valve disease.

[24]  R. Hall,et al.  Guidelines for prevention of thromboembolic events in valvular heart disease. Study Group of the Working Group on Valvular Heart Disease of the European Society of Cardiology. , 1995, European heart journal.