Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205400
First received: September 13, 2005
Last updated: August 16, 2013
Last verified: August 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00205400     History of Changes
Other Study ID Numbers: M-1999-0280
Study First Received: September 13, 2005
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014