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Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
This study is ongoing, but not recruiting participants.
Sponsored by: University of Wisconsin, Madison
Information provided by: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205400
  Purpose

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.


Condition Intervention
Anticoagulation
Thromboembolism
Procedure: medical care delivery model

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Percent time in therapeutic range (TTR) using modified version of Rosendaal method

Secondary Outcome Measures:
  • Event rates for thromboembolism, hemorrhages, hospitalizations, urgent care visits, emergency department visits, triage calls, INRs greater than 6.0 and quality of life

Estimated Enrollment: 192
Study Start Date: August 1999
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205400

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Christine Sorkness, Pharm D University of Wisconsin, Madison
  More Information

Study ID Numbers: M-1999-0280
Study First Received: September 13, 2005
Last Updated: September 13, 2005
ClinicalTrials.gov Identifier: NCT00205400  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Embolism and Thrombosis
Embolism
Vascular Diseases
Thrombosis
Thromboembolism

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009