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Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Completed

Conditions

Thromboembolism
Anticoagulation

Treatments

Procedure: medical care delivery model

Study type

Interventional

Funder types

Other

Identifiers

NCT00205400
M-1999-0280

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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