Fearon Algorithm in Warfarin Patient Self-Management

NCT03911661 | Completed

• 1 other identifier: 00115634
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Venous Thromboses; Heart Valve Diseases

Outcome Measures

Primary Outcomes (3)

• Participant time spent in therapeutic INR range

  Estimated time patient's INR is within their specified target range

  6-12 months

• Participant percent of INRs in the therapeutic INR range

  Actual proportion of measured INR within participant's specified target range

  6-12 months

• Number of participant's INR results resulting in a warfarin dose change

  Proportion of participant's measured INRs that result in warfarin dose being changed

  6-12 months

Secondary Outcomes (3)

• The number of participants experiencing major bleeding

  6-12 months

• The number of participants experiencing clinically relevant non-major bleeding

  6-12 months

• The number of participants experiencing thromboembolic events

  6-12 months

Other Outcomes (1)

• The proportion of participants successfully transitioned to patient self management

  Assessed at month 6 of study period

Study Arms (3)

Standard Management

ACTIVE COMPARATOR

The standard management phase will be historical and consist of warfarin management during the 12-months prior to signing informed consent.

Other: Usual care

Fearon Algorithm (FA) Anticoagulation Management Service

EXPERIMENTAL

Once study patients have received an approved FA report, the FA AMS phase of the study will commence. An investigator will communicate the new warfarin tablet size, if necessary, and use the FA report to determine warfarin doses for the patient.

Other: Fearon warfarin dosing algorithm

Fearon Algorithm (FA) Patient Self Management

EXPERIMENTAL

At the conclusion of the six-month FA anticoagulation management service phase, patients will be trained to use the FA for patient self management (PSM) and after successfully demonstrating the ability to engage in PSM the FA PSM phase of the study will commence.

Other: Fearon warfarin dosing algorithm

Interventions

Fearon warfarin dosing algorithm OTHER

Blood test drawn by patient using a point of care INR monitor

Also known as: Point of care INR test

Fearon Algorithm (FA) Anticoagulation Management Service; Fearon Algorithm (FA) Patient Self Management

Usual care OTHER

Historical management of warfarin by patient's usual care providers

Standard Management

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

University of Utah Thrombosis Center

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thrombosis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thrombosis; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Daniel M Witt, PharmD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Pharmacotherapy

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: November 20, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 31, 2021
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)