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Fearon Algorithm in Warfarin Patient Self-Management

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ClinicalTrials.gov Identifier: NCT03911661
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Roche Diagnostics
Information provided by (Responsible Party):
Daniel Witt, University of Utah

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Venous Thromboses Heart Valve Diseases Other: Fearon warfarin dosing algorithm Other: Usual care Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of the Fearon Algorithm in Warfarin Patient Self-Management
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Management
The standard management phase will be historical and consist of warfarin management during the 12-months prior to signing informed consent.
 Other: Usual care
Historical management of warfarin by patient's usual care providers
Experimental: Fearon Algorithm (FA) Anticoagulation Management Service
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
Blood test drawn by patient using a point of care INR monitor
Other Name: Point of care INR test
Experimental: Fearon Algorithm (FA) Patient Self Management
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
Blood test drawn by patient using a point of care INR monitor
Other Name: Point of care INR test


Outcome Measures
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Primary Outcome Measures :
  1. Participant time spent in therapeutic INR range [ Time Frame: 6-12 months ]
    Estimated time patient's INR is within their specified target range

  2. Participant percent of INRs in the therapeutic INR range [ Time Frame: 6-12 months ]
    Actual proportion of measured INR within participant's specified target range

  3. Number of participant's INR results resulting in a warfarin dose change [ Time Frame: 6-12 months ]
    Proportion of participant's measured INRs that result in warfarin dose being changed


Secondary Outcome Measures :
  1. The number of participants experiencing major bleeding [ Time Frame: 6-12 months ]
    Bleeding events meeting the criteria for major bleeding

  2. The number of participants experiencing clinically relevant non-major bleeding [ Time Frame: 6-12 months ]
    Bleeding events meeting the criteria for clinically relevant non-major bleeding

  3. The number of participants experiencing thromboembolic events [ Time Frame: 6-12 months ]
    Thromboembolic events meeting study definition


Other Outcome Measures:
  1. The proportion of participants successfully transitioned to patient self management [ Time Frame: Assessed at month 6 of study period ]
    Proportion of patients successfully able to assume responsibility for managing their own warfarin therapy


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911661


Contacts
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Contact: Daniel M Witt, PharmD 801-581-8851 dan.witt@pharm.utah.edu
Contact: Sara Vazquez, PharmD 801-581-3449 sara.vazquez@hsc.utah.edu

Locations
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United States, Utah
University of Utah Thrombosis Center Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Sara Vazquez, PharmD    801-581-3449    sara.vazquez@hsc.utah.edu   
Contact: Daniel M Witt, PharmD    801-581-8851    dan.witt@pharm.utah.edu   
Sponsors and Collaborators
University of Utah
Roche Diagnostics
Investigators
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Principal Investigator: Daniel M Witt, PharmD University of Utah
More Information
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Responsible Party: Daniel Witt, Professor and Chair, Department of Pharmacotherapy, University of Utah
ClinicalTrials.gov Identifier: NCT03911661     History of Changes
Other Study ID Numbers: 00115634
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Thrombosis
Venous Thrombosis
Heart Valve Diseases
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Warfarin
Anticoagulants