This trial is active, not recruiting.

Conditions anticoagulation, thromboembolism
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Percent time in therapeutic range (TTR) using modified version of Rosendaal method
time frame:

Secondary Outcomes

Event rates for thromboembolism, hemorrhages, hospitalizations, urgent care visits, emergency department visits, triage calls, INRs greater than 6.0 and quality of life
time frame:

Eligibility Criteria

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

Additional Information

Official title Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
Principal investigator Christine Sorkness, Pharm D
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.