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Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care

Primary Purpose

Anticoagulation, Thromboembolism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
medical care delivery model
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anticoagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
October 25, 2016
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00205400
Brief Title
Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
Official Title
Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anticoagulation, Thromboembolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
medical care delivery model
Primary Outcome Measure Information:
Title
Percent time in therapeutic range (TTR) using modified version of Rosendaal method
Secondary Outcome Measure Information:
Title
Event rates for thromboembolism, hemorrhages, hospitalizations, urgent care visits, emergency department visits, triage calls, INRs greater than 6.0 and quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Sorkness, Pharm D
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care

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