Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
This trial is active, not recruiting.
|Treatment||medical care delivery model|
|Sponsor||University of Wisconsin, Madison|
|Start date||August 1999|
|End date||March 2005|
|Trial size||192 participants|
|Trial identifier||NCT00205400, M-1999-0280|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Percent time in therapeutic range (TTR) using modified version of Rosendaal method
Event rates for thromboembolism, hemorrhages, hospitalizations, urgent care visits, emergency department visits, triage calls, INRs greater than 6.0 and quality of life
Male or female participants at least 18 years old.
Inclusion Criteria: - completion of >3 months of warfarin - indefinite warfarin therapy Exclusion Criteria: - patients who currently receive >25% of INR determinations per year from local labs - extended absences from VA
|Official title||Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care|
|Principal investigator||Christine Sorkness, Pharm D|
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