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Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00205400
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 27, 2016
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment Phase
Anticoagulation Thromboembolism Procedure: medical care delivery model Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
Study Start Date : August 1999
Actual Primary Completion Date : March 2005

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00205400

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

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Responsible Party: University of Wisconsin, Madison Identifier: NCT00205400    
Other Study ID Numbers: M-1999-0280
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases