Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
- Conditions
- AnticoagulationThromboembolism
- Registration Number
- NCT00205400
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
Hypothesis: Does the time spent within the target INR range differ when patients are managed by AMD or IT models of anticoagulation care?
Experimental Design: The 36-month trial enrolled 192 eligible patients currently receiving chronic warfarin therapy at the William S. Middleton Memorial VA Hospital. Consenting patients are enrolled and randomized to 1 of 2 groups: usual clinic care with face-to-face visits every 4 weeks (AMS model) or clinic visits every 3 months with interim laboratory visits and telephone follow-up every 4 weeks (IT model). At study conclusion, the amount of time the INR is within target range will be compared between the two groups. Thromboembolic and bleeding event rates, patient knowledge, quality of life and healthcare utilization will also be analyzed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
- completion of >3 months of warfarin
- indefinite warfarin therapy
- patients who currently receive >25% of INR determinations per year from local labs
- extended absences from VA
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent time in therapeutic range (TTR) using modified version of Rosendaal method
- Secondary Outcome Measures
Name Time Method Event rates for thromboembolism, hemorrhages, hospitalizations, urgent care visits, emergency department visits, triage calls, INRs greater than 6.0 and quality of life
Trial Locations
- Locations (1)
University of Wisconsin
🇺🇸Madison, Wisconsin, United States