Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00205400
• Collaborator: (none)
• Enrollment: 192
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anticoagulation; Thromboembolism	Procedure: medical care delivery model	N/A

Study Design

• Study Type: Interventional
• 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
• Study Start Date: Aug 1, 1999
• Actual Primary Completion Date: Mar 1, 2005

Outcome Measures

Primary Outcome Measures

1. Percent time in therapeutic range (TTR) using modified version of Rosendaal method []

Secondary Outcome Measures

1. Event rates for thromboembolism, hemorrhages, hospitalizations, urgent care visits, emergency department visits, triage calls, INRs greater than 6.0 and quality of life []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00205400
• Other Study ID Numbers: M-1999-0280
• First Posted: Sep 20, 2005
• Last Update Posted: Oct 27, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Thromboembolism

Study Results

No Results Posted as of Oct 27, 2016