Evaluation of a Telemedicine-Based Service for the Follow-Up and Monitoring of Patients Treated With Oral Anticoagulant Therapy

The authors have designed and developed a telemedicine-based service for the follow-up and monitoring of patients on oral anticoagulant therapy (OAT) that consists of two phases; the first involving self-testing and the second involving guided self-management. To evaluate the first phase of the protocol, a project was conducted with 108 patients, with a mean age of 72.7 years and a mean treatment time at the start of the study of 55.2 months, divided into two groups: telemedicine and control (conventional procedure). The degree of anticoagulation control was similar in the two groups: individual in-range international normalized ratios (59.2% vs 61.1%; p = 0.55) and individual time within target range (65.7% vs 66.4%; p = 0.85) showed no significant differences. The incidence of adverse events--death (5.5% vs 5.5%; p = 1.0), major hemorrhagic complications (0% vs 1.8%; p = 1.0), minor hemorrhagic complications (7.4% vs 3.7%; p = 0.67), and thromboembolism (1.8% vs 3.7%; p = 1.0)--was also similar, with no significant differences. Acceptability of the change, measured in terms of quality of life (SF-12 and Sawicki questionnaires) and anxiety (state-trait anxiety inventory questionnaire) at the beginning and end of the study period was higher in the telemedicine group, with statistically significant improvements in mental component summary (3.6 vs -6.2; p = 0.02), dissatisfaction (-0.8 vs 0.2; p = 0.001), stress (-0.3 vs 0.05; p = 0.03), limitations (-0.2 vs 0.3; p = 0.005), social problems (-0.1 vs 0.3; p = 0.03), and state anxiety (-2.5 vs 2.3; p = 0.04). Parameters related to costs, such as the mean number per patient of office visits due to OAT (1.7 vs 13.8; p < 0.001) and other office visits (10.1 vs 11.5; p = 0.028), were also more favorable in the telemedicine group, as were additional parameters that enabled an exhaustive evaluation of the service. The positive results obtained indicate that the second phase of the trial can be initiated.

[1]  Catherine Pence,et al.  Anticoagulation self-monitoring. , 2005, The American journal of nursing.

[2]  N H Holford,et al.  Clinical pharmacokinetics and pharmacodynamics of warfarin. Understanding the dose-effect relationship. , 1986, Clinical pharmacokinetics.

[3]  H. Völler,et al.  Guidelines for implementation of patient self-testing and patient self-management of oral anticoagulation. International consensus guidelines prepared by International Self-Monitoring Association for Oral Anticoagulation. , 2005, International journal of cardiology.

[4]  J. Hambleton Home Monitoring of Anticoagulation , 2003, Journal of Thrombosis and Thrombolysis.

[5]  Adolfo Muñoz Carrero,et al.  Model Formulation: Proof-of-concept Design and Development of an EN13606-based Electronic Health Care Record Service , 2007, J. Am. Medical Informatics Assoc..

[6]  A modified method of prothrombin time/International Normalised Ratio determination in capillary blood and monitoring oral anticoagulant therapy , 2006, Clinical chemistry and laboratory medicine.

[7]  V. Vats,et al.  Outcomes of oral anticoagulant therapy managed by telephone vs in-office visits in an anticoagulation clinic setting. , 2006, Chest.

[8]  D. Fitzmaurice,et al.  A primary care evaluation of three near patient coagulometers. , 1999, Journal of clinical pathology.

[9]  Roberts T. Jones,et al.  INRstar: computerised decision support software for anticoagulation management in primary care. , 2005, Informatics in primary care.

[10]  F. Kamali,et al.  The value of education and self‐monitoring in the management of warfarin therapy in older patients with unstable control of anticoagulation , 2004, British journal of haematology.

[11]  A. Forster,et al.  Effect of study setting on anticoagulation control: a systematic review and metaregression. , 2006, Chest.

[12]  G. Rodgers,et al.  Home prothrombin time monitoring: A literature analysis , 2004, American journal of hematology.

[13]  A. Tagliaferri,et al.  Computer Assisted Anticoagulant Therapy , 2003, Pathophysiology of Haemostasis and Thrombosis.

[14]  Gaietà Permanyer-Miralda,et al.  El Cuestionario de Salud SF-36 español: una década de experiencia y nuevos desarrollos , 2005 .

[15]  X. Bonfill,et al.  Comparing Self-Management of Oral Anticoagulant Therapy with Clinic Management , 2005, Annals of Internal Medicine.

[16]  C. Sorkness,et al.  Comparison of outcomes using 2 delivery models of anticoagulation care. , 2006, Archives of internal medicine.

[17]  Adolfo Muñoz Carrero,et al.  Airmed-cardio: a GSM and Internet services-based system for out-of-hospital follow-up of cardiac patients , 2005, IEEE Transactions on Information Technology in Biomedicine.

[18]  Joseph Finkelstein,et al.  Feasibility and Patients' Acceptance of Home Automated Telemanagement of Oral Anticoagulation Therapy , 2003, AMIA.

[19]  R. Perera,et al.  Self-monitoring of oral anticoagulation: a systematic review and meta-analysis , 2006, The Lancet.

[20]  D. Fitzmaurice,et al.  Patient self‐management of anticoagulation therapy: a trial‐based cost‐effectiveness analysis , 2006, British journal of haematology.

[21]  M. Wurster,et al.  Anticoagulation management: a new approach. , 2006, Disease management : DM.

[22]  S J Machin,et al.  Can oral anticoagulation be managed using telemedicine and patient self-testing? A pilot study. , 2006, Clinical and laboratory haematology.

[23]  P. Sawicki,et al.  Self‐management of oral anticoagulation: long‐term results , 2003, Journal of internal medicine.

[24]  J. L. Peña,et al.  Metodología de introducción de servicios de e-salud para el seguimiento y control de pacientes crónicos , 2004 .

[25]  L B Sheiner,et al.  Computer-aided long-term anticoagulation therapy. , 1969, Computers and biomedical research, an international journal.

[26]  L. Lynd,et al.  Cost-effectiveness of self-managed versus physician-managed oral anticoagulation therapy , 2006, Canadian Medical Association Journal.

[27]  David G. Covell,et al.  Systems and Microcomputer Approach to Anticoagulant Therapy , 1980, IEEE Transactions on Biomedical Engineering.

[28]  S. Testa,et al.  Reorganisation of an anticoagulation clinic using a telemedicine system: description of the model and preliminary results , 2006, Internal and emergency medicine.

[29]  E. E. van der Wall,et al.  Risks of oral anticoagulant therapy with increasing age. , 2005, Archives of internal medicine.

[30]  W T Sawyer,et al.  Digital computer-assisted warfarin therapy: comparison of two models. , 1979, Computers and biomedical research, an international journal.

[31]  D. Singer,et al.  Antithrombotic therapy in atrial fibrillation: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. , 2004, Chest.

[32]  Paul E. Milligan,et al.  Patient and physician satisfaction with a telephone-based anticoagulation service , 2001, Journal of General Internal Medicine.

[33]  Chris Gardiner,et al.  Patient self‐testing is a reliable and acceptable alternative to laboratory INR monitoring , 2005, British journal of haematology.

[34]  J. A. Sacristán,et al.  Los medicamentos en la Unin Europea: el tndem comercio-salud , 2005 .

[35]  F. Rosendaal,et al.  A model‐based algorithm for the monitoring of long‐term anticoagulation therapy , 2005, Journal of thrombosis and haemostasis : JTH.

[36]  P. Sawicki,et al.  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. , 1999, JAMA.

[37]  D. Hughes WHO Expert Committee On Biological Standardization - 31st Report , 1983 .

[38]  D. Fitzmaurice,et al.  A systematic review of outcome measures reported for the therapeutic effectiveness of oral anticoagulation , 2003, Journal of clinical pathology.

[39]  H. Cohen,et al.  A randomised controlled trial of patient self management of oral anticoagulation compared with patient self-testing. , 2005 .

[40]  Anders Odén,et al.  Oral anticoagulation and risk of death: a medical record linkage study , 2002, BMJ : British Medical Journal.

[41]  David A Fitzmaurice,et al.  Anticoagulation in hospitals and general practice , 2003, BMJ : British Medical Journal.

[42]  Aida Ribera,et al.  [The Spanish version of the Short Form 36 Health Survey: a decade of experience and new developments]. , 2005, Gaceta sanitaria.

[43]  R. Beyth,et al.  A Multicomponent Intervention To Prevent Major Bleeding Complications in Older Patients Receiving Warfarin , 2000, Annals of Internal Medicine.

[44]  Fitzmaurice,et al.  Review of computerized decision support systems for oral anticoagulation management , 1998, British journal of haematology.

[45]  M. Prins,et al.  Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomised cross-over comparison , 2000, The Lancet.

[46]  P. Jenks,et al.  “Meteorobiology” may have a role in sudden infant death , 1996, BMJ.

[47]  E. Linares,et al.  Adaptación transcultural de un cuestionario para medir la calidad de vida de los pacientes con anticoagulación oral , 2004 .