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OpenTrials
Completed

NCT Number: NCT00205400

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.

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Key information

Conditions

Anticoagulation Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medical care delivery model

Procedure

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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
1999
Primary completion
2005
First posted
Sep 20, 2005
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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