Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care

NCT00205400 | Completed

• 1 other identifier: M-1999-0280
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulation; Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Percent time in therapeutic range (TTR) using modified version of Rosendaal method

Secondary Outcomes (1)

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

Interventions

medical care delivery model PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• completion of \>3 months of warfarin
• indefinite warfarin therapy

You may not qualify if:

• patients who currently receive \>25% of INR determinations per year from local labs
• extended absences from VA

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christine Sorkness, Pharm D

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: August 1, 1999
• Primary Completion: March 1, 2005
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

US (1)