Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
NCT00205400 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192
Last updated 2016-10-27
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.
Conditions
- Anticoagulation
- Thromboembolism
Interventions
- PROCEDURE
-
medical care delivery model
Sponsors & Collaborators
-
University of Wisconsin, Madison
lead OTHER
Principal Investigators
-
Christine Sorkness, Pharm D · University of Wisconsin, Madison
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-08-31
- Primary Completion
- 2005-03-31
Countries
- United States
Study Locations
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