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Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205400
First Posted: September 20, 2005
Last Update Posted: October 27, 2016
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.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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

Study Type: Interventional
Study Design: 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

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
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205400     History of Changes
Other Study ID Numbers: M-1999-0280
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: October 27, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases