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Fearon Algorithm in Warfarin Patient Self-Management

CompletedNA

Sponsor: University of Utah

Conditions: Atrial Fibrillation, Venous Thromboses, Heart Valve Diseases

Interventions: Fearon warfarin dosing algorithm, Usual care

Countries: United States

This study aims to explore the feasibility of a novel, patient-specific algorithm for adjusting warfarin doses during chronic anticoagulation therapy. Specifically investigators are interested in determining whether patients can use this algorithm to assume responsibility for managing their own warfarin therapy including making independent decisions about their warfarin dose and when to retest their next international normalized ratio (INR) test based on the result of their current INR result obtained using a point-of-care INR monitor.

Eligibility overview

Sex: ALL

Age: 22 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patients at least 22 years of age treated with warfarin for any indication for at least 18 months prior to enrollment within University of Utah Health system.
* Demonstrates the willingness and ability to test their own INR using a point-of-care INR monitoring device, and willingness to make independent decisions about warfarin dosing based on INR results using a dosing algorithm.
* Willingness to perform INR tests at least once weekly or more frequently as the algorithm dictates.
* Currently have and willing to maintain internet access for the duration of the study in order to complete online case report forms.
* Individual TTR \< 60% over the 12 months prior to study enrollment.

Exclusion Criteria:

* Inherent INR variability \>0.4 (such patients are unlikely to benefit from the Fearon Algorithm).
* Goal INR range less than a full INR point (e.g. 2.0-2.5).
* Known poor compliance to warfarin therapy (e.g., failure to take warfarin as instructed clearly documented in electronic medical record and/or return for INR testing as evidenced by repeated reminder communications documented in electronic medical record).
* More than one interruption of warfarin therapy for invasive procedure(s) lasting more than three days in the 18 months prior to study enrollment.
* Non-English speaking.
* Refusal to provide written informed consent.

Locations (1)

Salt Lake City, Utah, United States