Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care

Thromboembolism Clinical Trial

Official title:

Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205400
• Other study ID #: M-1999-0280
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: October 25, 2016
• Start date: August 1999

Study information

• Verified date: October 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anticoagulation
• Thromboembolism

Intervention

Procedure:
• medical care delivery model

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent time in therapeutic range (TTR) using modified version of Rosendaal method
Secondary	Event rates for thromboembolism, hemorrhages, hospitalizations, urgent care visits, emergency department visits, triage calls, INRs greater than 6.0 and quality of life