title: Pilot study of a novel patient self-management program for warfarin therapy using venipuncture-acquired international normalized ratio monitoring.
abstract: OBJECTIVE
  To compare clinical and safety outcomes of warfarin therapy before and after implementation of a novel patient self-management (PSM) program in which patients received their venipuncture-derived international normalized ratio (INR) results through a secure online messaging system and adjusted their warfarin dosages and follow-up visits according to provided support tools.
  
  
  METHODS
  Prospective, open-label, 3-month, pilot study.
  
  
  METHODS
  Centralized clinical pharmacy anticoagulation service.
  
  
  METHODS
  Forty-four patients with atrial fibrillation who were receiving warfarin for more than 6 months were enrolled in the trial between January 1, 2011, and February 28, 2011; 39 patients completed the trial. Patients acted as their own controls.
  
  
  METHODS
  Patients received dosing decision support tools during a 2-hour live PSM training class. Those who then demonstrated proficiency in PSM assumed responsibility for their warfarin therapy management.
  
  
  RESULTS
  Outcomes of warfarin therapy were measured in each patient before and after implementation of the PSM program. Study variables included time in the therapeutic INR range (TTR), numbers of INR tests performed, and episodes of major bleeding or thrombosis. No significant difference in TTR occurred between the 90 days before PSM program participation and the 90 days of PSM (82.9% vs 81.2%, p=0.65). The mean number of INR tests performed for each patient increased from 2.97 before PSM program participation to 4.38 during PSM (p<0.01). No bleeding or thrombotic events occurred during the PSM phase.
  
  
  CONCLUSIONS
  Patients were trained to engage in PSM using support tools and venipuncture-derived INR results received by an online messaging system to adjust warfarin dosage and frequency of INR testing. No significant difference in TTR occurred in these patients before and during the PSM. This novel PSM model appears to be a feasible method of managing warfarin therapy in carefully selected patients; however, a larger, randomized controlled trial is needed to evaluate the safety and efficacy of the model and its effect on anticoagulation service workload.
authors.affiliation: Clinical Pharmacy Anticoagulation Service, Aurora, Colorado 80011, USA. brandon.x.simmons@kp.org
authors.forename: Brandon J
authors.initials: BJ
authors.lastname: Simmons
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Jenner
authors.forename: Thomas
authors.initials: T
authors.lastname: Delate
authors.forename: Nathan P
authors.initials: NP
authors.lastname: Clark
authors.forename: Deanna
authors.initials: D
authors.lastname: Kurz
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Witt
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy*; D003661:Decision Support Techniques; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019934:International Normalized Ratio; D020407:Internet; D008297:Male; D008875:Middle Aged; D018962:Phlebotomy / Q000379:methods; D010865:Pilot Projects; D011446:Prospective Studies; D012648:Self Care; D013997:Time Factors; D014859:Warfarin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D014859:Warfarin