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Journal of Thrombosis and Thrombolysis

, Volume 26, Issue 1, pp 14–21 | Cite as

Direct-to-patient expert system and home INR monitoring improves control of oral anticoagulation

  • Susan I. O’Shea
  • Murat O. Arcasoy
  • Gregory Samsa
  • Sandra E. Cummings
  • Elizabeth H. Thames
  • Richard S. Surwit
  • Thomas L. OrtelEmail author
Article

Abstract

Background and objective

Internet-based disease management programs have the potential to improve patient care. The objective of this study was to determine whether an interactive, internet-based system enabling supervised, patient self-management of oral anticoagulant therapy provided management comparable to an established anticoagulation clinic.

Patients/methods

Sixty patients receiving chronic oral anticoagulant therapy who had access to the internet and a printer, were enrolled into this prospective, single-group, before-after study from a single clinic and managed between March 2002 and January 2003. Patients learned how to use a home prothrombin time monitor and how to access the system through the internet. Patients used the system for six months, with daily review by the supervising physician. The primary outcome variable was the difference in time in therapeutic range prior to and following introduction of internet-supervised patient self-management.

Results

The mean time in therapeutic range increased from 63% in the anticoagulation clinic (control period) to 74.4% during internet-supervised patient self-management (study period). The mean difference score between control and study periods was 11.4% (P = 0.004, 95% confidence interval 5.5–17.3%). There were no hemorrhagic or thromboembolic complications.

Conclusions

This novel approach of internet-supervised patient self-management improved time in therapeutic range compared to an anticoagulation clinic. This is the first demonstration of an internet-based expert system enabling remote and effective management of patients on oral anticoagulants. Expert systems may be applicable for management of other chronic diseases.

Keywords

Anticoagulation Expert system INR Patient self-management 

Notes

Acknowledgements

The authors wish to thank K. Vokaty, P. A.-C., and K. Baker, R. N., from the Duke Anticoagulation Management Service, for assistance with patient recruitment for the study, and M. Pound, for data entry. Funding for this study was provided by a Small Business and Innovative Research (SBIR) grant (R44 HL 66888) from the NIH to ZyCare®, Inc., Chapel Hill, NC. Home prothrombin time monitors were provided by International Technidyne Corporation, Edison, NJ. Dr. O’Shea was supported in part by a Clinical Scholar Award from the American Society of Hematology, and Dr. Ortel was supported in part by a Midcareer Investigator Award in Patient-Oriented Research (K24 AI0160301) from the NIH.

References

  1. 1.
    Heit JA (2002) Venous thromboembolism epidemiology: implications for prevention and management. Semin Thromb Hemost 28(Suppl 2):3–13PubMedCrossRefGoogle Scholar
  2. 2.
    Ridker PM, Goldhaber SZ, Danielson E, Rosenberg Y, Eby CS, Deitcher SR, Cushman M, Moll S, Kessler CM, Elliott CG, Paulson R, Wong T, Bauer KA, Schwartz BA, Miletich JP, Bounameaux H, Glynn RJ, (2003) PREVENT I. Long-term, low-intensity warfarin therapy for the prevention of recurrent venous thromboembolism. N Engl J Med 348:1425–1434PubMedCrossRefGoogle Scholar
  3. 3.
    Kearon C, Ginsberg JS, Kovacs MJ, Anderson DR, Wells P, Julian JA, MacKinnon B, Weitz JI, Crowther MA, Dolan S, Turpie AG, Geerts W, Solymoss S, van Nguyen P, Demers C, Kahn SR, Kassis J, Rodger M, Hambleton J, Gent M (2003) comparison of low-intensity warfarin therapy with conventional-intensity warfarin therapy for long-term prevention of recurrent venous thromboembolism. N Engl J Med 349:631–639PubMedCrossRefGoogle Scholar
  4. 4.
    McBride R (1996) For the Stroke Prevention in Atrial Fibrillation Investigators. Adjusted-dose warfarin versus low-intensity, fixed-dose warfarin plus aspirin for high-risk patients with atrial fibrillation: Stroke Prevention in Atrial Fibrillation III randomised clinical trial. Lancet 348:633–638CrossRefGoogle Scholar
  5. 5.
    Mok CK, Boey J, Wang R, Chan TK, Cheung KL, Lee PK, Chow J, Ng RP, Tse TF (1985) Warfarin versus dipyridamole-aspirin and pentoxifylline-aspirin for the prevention of prosthetic heart valve thromboembolism: a prospective randomized clinical trial. Circulation 72:1059–1063PubMedGoogle Scholar
  6. 6.
    Beyth RJ, Quinn L, Landefeld CS (2000) A multicomponent intervention to prevent major bleeding complications in older patients receiving warfarin. A randomized, controlled trial. Ann Intern Med 133:687–695PubMedGoogle Scholar
  7. 7.
    Fihn SD, Callahan CM, Martin DC, McDonell MB, Henikoff JG, White RH (1996) The risk for and severity of bleeding complications in elderly patients treated with warfarin. The National Consortium of Anticoagulation Clinics. Ann Intern Med 124:970–979PubMedGoogle Scholar
  8. 8.
    Gitter MJ, Jaeger TM, Petterson TM, Gersh BJ, Silverstein MD (1995) Bleeding and thromboembolism during anticoagulant therapy: a population-based study in Rochester, Minnesota. Mayo Clin Proc 70:725–733PubMedGoogle Scholar
  9. 9.
    Chiquette E, Amato MG, Bussey HI (1998) Comparison of an anticoagulation clinic with usual medical care. Anticoagulation control, patient outcomes, and health care costs. Arch Intern Med 158:1641–1647PubMedCrossRefGoogle Scholar
  10. 10.
    Horstkotte D, Piper C, Wiemer M (1998) Optimal frequency of patient monitoring and intensity of oral anticoagulation therapy in valvular heart disease. J Thrombos Thrombolys 5:S19–S24CrossRefGoogle Scholar
  11. 11.
    Samsa GP, Matchar DB (2000) Relationship between test frequency and outcomes of anticoagulation: a literature review and commentary with implications for the design of randomized trials of patient self-management. J Thrombos Thrombolys 9:283–292CrossRefGoogle Scholar
  12. 12.
    Sawicki PT (1999) 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. JAMA 281:145–150PubMedCrossRefGoogle Scholar
  13. 13.
    Koertke H, Minami K, Bairaktaris A, Wagner O, Koerfer R (2000) INR self-management following mechanical heart valve replacement. J Thrombos Thrombolys 9(Suppl 1):S41–S45CrossRefGoogle Scholar
  14. 14.
    Ansell JE, Patel N, Ostrovsky D, Nozzolillo E, Peterson AM, Fish L (1995) Long-term patient self-management of oral anticoagulation. Arch Intern Med 155:2185–2189PubMedCrossRefGoogle Scholar
  15. 15.
    Menéndez-Jándula B, Souto JC, Oliver A, Montserrat I, Quintana M, Gich I, Bonfill X, Fontcuberta J (2005) Comparing self-management of oral anticoagulant therapy with clinic management. A randomized trial. Ann Intern Med 142:1–10PubMedGoogle Scholar
  16. 16.
    DeLoughery TG (2001) Oral anticoagulants. In: Goodnight SH, Hathaway WE (eds) Disorders of hemostasis & thrombosis. McGraw-Hill, New York, pp 543–552Google Scholar
  17. 17.
    Rosendaal FR, Cannegieter SC, van der Meer FJ, Briet E (1993) A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 69:236–239PubMedGoogle Scholar
  18. 18.
    Loeliger EA (1985) Laboratory control, optimal therapeutic ranges and therapeutic quality control in oral anticoagulation. Acta Haematol 74:125–131PubMedGoogle Scholar
  19. 19.
    van den Besselaar AMHP (1990) Recommended method for reporting therapeutic control of oral anticoagulant therapy. Thromb Haemost 63:316–317PubMedGoogle Scholar
  20. 20.
    Ortel TL (2005) Clinical implications for patients on antithrombotic therapy while taking supplements. Thromb Res 117:75–80PubMedCrossRefGoogle Scholar
  21. 21.
    Cannegieter SC, Rosendaal FR, Wintzen AR, van der Meer FJ, Vandenbroucke JP, Briet E (1995) Optimal oral anticoagulant therapy in patients with mechanical heart valves. N Engl J Med 333:11–17PubMedCrossRefGoogle Scholar
  22. 22.
    Kulinna W, Ney D, Wenzel T, Heene DL, Harenberg J (1999) The effect of self-monitoring the INR on quality of anticoagulation and quality of life. Semin Thromb Hemost 25:123–126PubMedGoogle Scholar
  23. 23.
    Watzke HH, Forberg E, Svolba G, Jimenez-Boj E, Krinninger B (2000) A prospective controlled trial comparing weekly self-testing and self-dosing with the standard management of patients on stable oral anticoagulation. Thromb Haemost 83:661–665PubMedGoogle Scholar
  24. 24.
    Taborski U, Muller-Berghaus G (1999) State-of-the-art patient self-management for control of oral anticoagulation. Semin Thromb Hemost 25:43–47PubMedCrossRefGoogle Scholar
  25. 25.
    Lafata JE, Martin SA, Kaatz S, Ward RE (2000) Anticoagulation clinics and patient self-testing for patients on chronic warfarin therapy: a cost-effectiveness analysis. J Thrombos Thrombolys 9(Suppl 1):S13–S19CrossRefGoogle Scholar
  26. 26.
    Cromheecke ME, Levi M, Colly LP, de Mol BJ, Prins MH, Hutten BA, Mak R, Keyzers KC, Buller HR (2000) Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomised cross-over comparison. Lancet 356:97–102PubMedCrossRefGoogle Scholar
  27. 27.
    Gadisseur APA, Breukink-Engbers WGM, Van der Meer FJM, van den Besselaar AMH, Sturk A, Rosendaal FR (2003) Comparison of the quality of oral anticoagulant therapy through patient self-management and management by specialized anticoagulation clinics in the Netherlands. A randomized clinical trial. Arch Intern Med 163:2639–2646PubMedCrossRefGoogle Scholar
  28. 28.
    Sunderji R, Gin K, Shalansky K, Carter C, Chambers K, Davies C, Schwartz L, Fung A (2004) A randomized trial of patient self-managed versus physician-managed oral anticoagulation. Can J Cardiol 20:1117–1123PubMedGoogle Scholar
  29. 29.
    Fitzmaurice DA, Murray ET, McCahon D, Holder R, Raftery JP, Hussain S, Sandhar H, Hobbs FD (2005) Self-management of oral anticoagulation: randomized trial. BMJ doi:10.1136/bmj.38618.580903.AE Google Scholar
  30. 30.
    Heneghan P, Alonso-Coello JM, Perera R, Meats E, Glasziou P (2006) Self-monitoring or oral anticoagulation: a systematic review and meta-analysis. Lancet 367:404–411PubMedCrossRefGoogle Scholar
  31. 31.
    Reiger DA, Sunderji R, Lynd L, Gin K, Marra CA (2006) Cost-effectiveness of self-managed versus physician managed oral anticoagulation therapy. CMJA 174:1847–1852Google Scholar
  32. 32.
    Baglin TP, Cousins D, Keeling DM, Perry DJ, Watson HG (2006) Recommendations from the British Committee for Standards in Haematolgoy and National Patient Safety Agency. Br J Haematol 136:26–29PubMedCrossRefGoogle Scholar
  33. 33.
    Ansell J, Hirsh J, Dalen J, Bussey H, Anderson D, Poller L, Jacobson A, Deykin D, Matchar D (2001) Managing oral anticoagulant therapy. Chest 119:22S–38SPubMedCrossRefGoogle Scholar
  34. 34.
    Murray E, Fitzmaurice D, McCahon D, Fuller C, Sandhur H (2004) Training for patients in a randomized controlled trial of self management of warfarin treatment. BMJ 328:437–438PubMedCrossRefGoogle Scholar
  35. 35.
    Bodenheimer T, Grumbach K (2003) Electronic technology. A spark to revitalize primary care? JAMA 290:259–264PubMedCrossRefGoogle Scholar
  36. 36.
    Terry K (2001) Monitor patients online? Med Econ 78:67–70PubMedGoogle Scholar
  37. 37.
    Gomez EJ, Hernando ME, Garcia A, Del Pozo F, Cermeno J, Corcoy R, Brugues E, De Leiva A (2002) Telemedicine as a tool for intensive management of diabetes: the DIABTel experience. Comput Methods Progr Biomed 69:163–177CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Susan I. O’Shea
    • 1
    • 6
  • Murat O. Arcasoy
    • 1
  • Gregory Samsa
    • 2
  • Sandra E. Cummings
    • 3
  • Elizabeth H. Thames
    • 1
  • Richard S. Surwit
    • 3
    • 4
  • Thomas L. Ortel
    • 1
    • 5
    Email author
  1. 1.Division of Hematology, Department of MedicineDuke University Medical CenterDurhamUSA
  2. 2.Center for Clinical Health Policy ResearchDuke University Medical CenterDurhamUSA
  3. 3.ZyCare, IncChapel HillUSA
  4. 4.Department of Psychiatry and Behavioral SciencesDuke University Medical CenterDurhamUSA
  5. 5.Departments of Medicine & Pathology, Hemostasis and Thrombosis CenterDuke University Medical CenterDurhamUSA
  6. 6.Department of HaematologyCork University HospitalCorkIreland

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