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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
September 13, 2005
September 20, 2005
October 27, 2016
August 1999
March 2005   (Final data collection date for primary outcome measure)
Percent time in therapeutic range (TTR) using modified version of Rosendaal method
Same as current
Complete list of historical versions of study NCT00205400 on ClinicalTrials.gov Archive Site
Event rates for thromboembolism, hemorrhages, hospitalizations, urgent care visits, emergency department visits, triage calls, INRs greater than 6.0 and quality of life
Same as current
Not Provided
Not Provided
 
Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Anticoagulation
  • Thromboembolism
Procedure: medical care delivery model
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
192
Not Provided
March 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00205400
M-1999-0280
Not Provided
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Christine Sorkness, Pharm D University of Wisconsin, Madison
University of Wisconsin, Madison
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP