Thromboembolism Clinical Trial
Official title:
Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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