Journal of Thrombosis and Thrombolysis

, Volume 30, Issue 3, pp 263–275 | Cite as

An evaluation of patient self-testing competency of prothrombin time for managing anticoagulation: pre-randomization results of VA Cooperative Study #481–The Home INR Study (THINRS)

  • Rowena J. Dolor
  • R. Lynne Ruybalid
  • Lauren Uyeda
  • Robert G. Edson
  • Ciaran Phibbs
  • Julia E. Vertrees
  • Mei-Chiung Shih
  • Alan K. Jacobson
  • David B. Matchar
  • for the THINRS Site Investigators
Article

Abstract

Prior studies suggest patient self-testing (PST) of prothrombin time (PT) can improve the quality of anticoagulation (AC) and reduce complications (e.g., bleeding and thromboembolic events). “The Home INR Study” (THINRS) compared AC management with frequent PST using a home monitoring device to high-quality AC management (HQACM) with clinic-based monitoring on major health outcomes. A key clinical and policy question is whether and which patients can successfully use such devices. We report the results of Part 1 of THINRS in which patients and caregivers were evaluated for their ability to perform PST. Study-eligible patients (n = 3643) were trained to use the home monitoring device and evaluated after 2–4 weeks for PST competency. Information about demographics, medical history, warfarin use, medications, plus measures of numeracy, literacy, cognition, dexterity, and satisfaction with AC were collected. Approximately 80% (2931 of 3643) of patients trained on PST demonstrated competency; of these, 8% (238) required caregiver assistance. Testers who were not competent to perform PST had higher numbers of practice attempts, higher cuvette wastage, and were less able to perform a fingerstick or obtain blood for the cuvette in a timely fashion. Factors associated with failure to pass PST training included increased age, previous stroke history, poor cognition, and poor manual dexterity. A majority of patients were able to perform PST. Successful home monitoring of PT with a PST device required adequate levels of cognition and manual dexterity. Training a caregiver modestly increased the proportion of patients who can perform PST.

Keywords

Anticoagulation Patient self-testing Atrial fibrillation Mechanical heart valve 

References

  1. 1.
    Matchar DB, Samsa GP, Cohen SJ, Oddone EZ (2000) Community impact of anticoagulation services: rationale and design of the Managing Anticoagulation Services Trial (MAST). J Thomb Thrombolysis 9(Suppl 1):S7–S11CrossRefGoogle Scholar
  2. 2.
    Beyth RJ, Quinn L, Landefeld CS (2000) A multicomponent intervention to prevent major bleeding complications in older patients receiving warfarin. Ann Intern Med 133:687–695PubMedGoogle Scholar
  3. 3.
    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(5):661–665PubMedGoogle Scholar
  4. 4.
    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 163:2639–2646CrossRefPubMedGoogle Scholar
  5. 5.
    Kortke H, Korfer R (2001) International normalized ratio self-management after mechanical heart valve replacement: is an early start advantageous? Ann Thorac Surg 72:44–48CrossRefPubMedGoogle Scholar
  6. 6.
    Menendez-Jandula 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. Ann Intern Med 142:1–10PubMedGoogle Scholar
  7. 7.
    Heneghan C, Alonso-Coello P, Garcia-Alamino JM, Perera R, Meats E, Glasziou P (2006) Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 367:404–411CrossRefPubMedGoogle Scholar
  8. 8.
    Khan TI, Kamali F, Kesteven P, Avery P, Wynne H (2004) The value of education and self-monitoring in the management of warfarin therapy in older patients with unstable control of anticoagulation. Br J Haematol 126:557–564CrossRefPubMedGoogle Scholar
  9. 9.
    Fitzmaurice DA, Murray ET, McCahon D, Holder R, Raftery JP, Hussain S, Sandhar H, Hobbs FDR (2005) Self management of oral anticoagulation: randomized trial. BMJ 331:1057–1062CrossRefPubMedGoogle Scholar
  10. 10.
    Matchar DB, Jacobson AK, Edson RG et al (2005) The impact of patient self-testing of prothrombin time for managing anticoagulation: rationale and design of VA Cooperative Study #481–The Home INR Study (THINRS). J Thromb Thrombolysis 19:163–172CrossRefPubMedGoogle Scholar
  11. 11.
    Parker R, Baker DW, Williams MV, Nurss JR (1995) The test of functional health literacy in adults: a new instrument for measuring subjects’ literacy skills. J Gen Int Med 10:537–541CrossRefGoogle Scholar
  12. 12.
    Pfeiffer E (1975) A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc 23(10):433–441PubMedGoogle Scholar
  13. 13.
    Penta M, Thonnard J-L, Tesio L (1998) ABILHAND: a Rasch-built measure of manual ability. Arch Phys Med Rehabil 79:1038–1042CrossRefPubMedGoogle Scholar
  14. 14.
    Samsa GP, Matchar DB, Dolor RJ et al (2004) A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation. Health Qual Life Outcomes 2:22. http://www.hqlo.com/content/2/1/22
  15. 15.
    Harrell FE Jr (2001) Regression modeling strategies with applications to linear models, logistic regression, and survival analysis. Springer-Verlag, Inc, New YorkGoogle Scholar
  16. 16.
    Harrell FE, Califf RM, Pryor DB, Lee KL, Rosati RA (1982) Evaluating the yield of a medical test. JAMA 247:2543–2546CrossRefPubMedGoogle Scholar
  17. 17.
    Sawicki PT, for the Working Group for the Study of Patient Self-Management of Oral Anticoagulation (1989) A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled trial. JAMA 281(2):145–150CrossRefGoogle Scholar
  18. 18.
    Cromheecke ME, Levi M, Colly LP, de Mol BJM, Prins MH, Hutten BA, Mak R, Keyzers KCJ, Buller HR (2000) Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomized cross-over comparison. Lancet 356:97–102CrossRefPubMedGoogle Scholar
  19. 19.
    Fitzmaurice DA, Murray ET, Gee KM, Allan TF, Hobbs FDR (2002) A randomized controlled trial of patient self-management of oral anticoagulation treatment compared with primary care management. J Clin Pathol 55:845–849CrossRefPubMedGoogle Scholar
  20. 20.
    Gadisseur APA, Kaptein AA, Breukink-Engbers WGM, van der Meer FJM, Rosendaal FR (2004) Patient self-management of oral anticoagulant care vs. management by specialized anticoagulation clinics: positive effects on quality of life. J Thomb Haemost 2:584–591CrossRefGoogle Scholar
  21. 21.
    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(11):1117–1123PubMedGoogle Scholar
  22. 22.
    Gardiner C, Williams K, Mackie IJ, Machin SJ, Cohen H (2004) Patient self-testing is a reliable and acceptable alternative to laboratory INR monitoring. Br J Haematol 128:242–247CrossRefGoogle Scholar
  23. 23.
    Voeller H, Glatz J, Taborski U, Bernardo A, Dovifat C, Heidinger K (2005) Self-Management of oral Anticoagulation in nonvalvular Atrial Fibrillation (SMAAF study). Z Kardiol 94:182–186CrossRefGoogle Scholar
  24. 24.
    Christensen TD, Maegaard M, Sorensen HT, Hjortdal VE, Hasenkam JM (2007) Self-versus conventional management of oral anticoagulant therapy. Am J Cardiovasc Drugs 7(3):191–197CrossRefPubMedGoogle Scholar
  25. 25.
    Christensen TD, Maegaard M, Sorensen HT, Hjortdal VE, Hasenkam JM (2006) Self-management versus conventional management of oral anticoagulant therapy: a randomized, controlled trial. Eur J Int Med 17:260–266CrossRefGoogle Scholar
  26. 26.
    Gardiner C, Williams K, Longair I, Mackie IJ, Machin SJ, Cohen H (2005) A randomized control trial of patient self-management of oral anticoagulation compared with patient self-testing. Br J Haematol 132:598–603CrossRefGoogle Scholar
  27. 27.
    Dauphin C, Legault B, Jaffeaux P, Motreff P, Azarnoush K, Joly H, Geoffroy E, Abulet-Cuvelier B, Camillieri L, Lusson JR, Cassagnes J, de Riberolles C (2008) Comparison of INR stability between self-monitoring and standard laboratory method: preliminary results of a prospective study in 67 mechanical heart valve patients. Arch Cardiovasc Dis 101:753–761PubMedGoogle Scholar
  28. 28.
    Horstkotte D, Piper C, Wiemer M (1998) Optimal frequency of patient monitoring and intensity of oral anticoagulation therapy in valvular heart disease. J Thromb Thombolysis 5:S19–S24CrossRefGoogle Scholar
  29. 29.
    Koertke H, Zitterman A, Wagner O, Koerfer R (2007) Self-management of oral anticoagulation therapy improves long-term survival in patients with mechanical heart valve replacement. Ann Thorac Surg 83:24–29CrossRefPubMedGoogle Scholar
  30. 30.
    Sidhu P, O’Kane HO (2001) Self-managed anticoagulation: results from a two-year prospective randomized trial with heart valve patients. Ann Thorac Surg 72:1523–1527CrossRefPubMedGoogle Scholar
  31. 31.
    Jowett S, Bryan S, Murray E et al (2006) Patient self-management of anticoagulation therapy: a trial-based cost-effectiveness analysis. Br J Haematol 134(6):632–639CrossRefPubMedGoogle Scholar
  32. 32.
    Siebenhofer A, Rakovac I, Kleespies C, Piso B, Didjurgeit U, for the SPOG 60+ Study Group (2008) Self-management of oral anticoagulation reduces major outcomes in the elderly. A randomized controlled trial. Thromb Haemost 100:1089–1098PubMedGoogle Scholar
  33. 33.
    Siebenhofer A, Rakovac I, Kleespies C, Piso B, Didjurgeit U (2007) Self-management of oral anticoagulation in the elderly: rationale, design, baselines and oral anticoagulation control after one year of follow-up. Thromb Haemost 97:408–416PubMedGoogle Scholar
  34. 34.
    Eitz T, Schenk S, Fritzsche D, Bairaktaris A, Wagner O, Koertke H, Koerfer R (2008) International normalized ratio self-management lowers the risk of thromboembolic events after prosthetic heart valve replacement. Ann Thorac Surg 85:949–955CrossRefPubMedGoogle Scholar
  35. 35.
    Garcia-Alamino JM, Ward AM, Alonso-Coello P, Perera R, Bankhead C, Fitzmaurice D, Heneghan CJ (2010). Self-monitoring and self-management of oral anticoagulation (review). The Cochrane Library, Issue 4, Wiley LtdGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Rowena J. Dolor
    • 1
    • 2
    • 11
  • R. Lynne Ruybalid
    • 3
  • Lauren Uyeda
    • 4
  • Robert G. Edson
    • 4
  • Ciaran Phibbs
    • 5
    • 6
  • Julia E. Vertrees
    • 7
  • Mei-Chiung Shih
    • 4
    • 8
  • Alan K. Jacobson
    • 3
    • 9
  • David B. Matchar
    • 1
    • 2
    • 10
  • for the THINRS Site Investigators
  1. 1.Center for Health Services Research in Primary CareVA Medical CenterDurhamUSA
  2. 2.Division of General Internal Medicine, Department of Medicine, and Center for Clinical Health Policy ResearchDuke University Medical CenterDurhamUSA
  3. 3.Research and Development Service (151)Jerry L. Pettis VA Medical CenterLoma LindaUSA
  4. 4.Cooperative Studies Program Coordinating Center (151K)VA Palo Alto Health Care SystemPalo AltoUSA
  5. 5.Health Economics Resource CenterVA Palo Alto Health Care SystemPalo AltoUSA
  6. 6.Department of Pediatrics and Center for Primary Care and Outcomes ResearchStanford University School of MedicineStanfordUSA
  7. 7.VA Cooperative Studies Program Clinical Research Pharmacy Coordinating CenterAlbuquerqueUSA
  8. 8.Division of Biostatistics, Department of Health Research and PolicyStanford UniversityStanfordUSA
  9. 9.Department of Internal MedicineLoma Linda UniversityLoma LindaUSA
  10. 10.Program in Health Services and Systems ResearchDuke-National University of Singapore Graduate Medical SchoolSingaporeSingapore
  11. 11.Duke Clinical Research InstituteDurhamUSA

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