Warfarin Patient Self-management Implementation in the US Healthcare System

Overcoming Barriers to Warfarin Patient Self-management Implementation in the US Healthcare System

In the US, patients receiving warfarin therapy are rarely allowed to engage in patient self-management (PSM) which is less burdensome, less expensive, and safer than standard clinic-directed warfarin management. The long-term objective of our application is to improve the safety of ambulatory warfarin therapy through increasing the implementation of PSM.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Heart Valve Diseases; Venous Thromboembolism
• Intervention / Treatment: Other: Patient self-management; Other: Usual care provided by anticoagulation providers

Detailed Description

In the US, patients receiving warfarin therapy are rarely allowed to engage in patient self-management (PSM) which is less burdensome, less expensive, and safer than standard clinician-directed warfarin management. National and international evidence-based guideline panels strongly recommend PSM over other warfarin management methods for appropriate patients because it improves INR control, cuts risk of thrombosis and death by half without increasing bleeding risk, and increases patient satisfaction and quality of life. The reasons behind PSM underutilization in US settings have not been systematically assessed and validated. We will address this knowledge gap and provide foundational information for increasing PSM utilization within the US healthcare system. Our Aim 1 will assess and validate barriers and facilitators to PSM and evaluate their applicability to the US healthcare system; Aim 2 will develop and test PSM implementation strategies in US ambulatory care sites using rapid-cycle research methodology; and Aim 3 will assess implementation (feasibility, fidelity, adoption), clinical (effectiveness, safety, equity, patient-centeredness), and end-user (satisfaction) outcomes. The long-term objective of our application is to improve the safety of ambulatory warfarin therapy through increasing the implementation of PSM. Our research proposal is guided by an implementation science logic model that incorporates well-known implementation science frameworks to support the specific aims. Qualitative data collection and analysis for Aim 1 will be organized using the Consolidated Framework for Implementation Research (CFIR) a determinant framework that identifies five domains influencing implementation: Intervention, Inner Setting, Outer Setting, Individuals, and the Implementation Process. Constructs within each domain provide guidance on factors to identify and measure as potential implementation barriers or facilitators. PSM implementation activities in Aim 2 will be guided by the Quality Implementation Framework (QIF), which identifies the critical implementation process steps and specific actions related to these steps that can be utilized to achieve quality PSM implementation. Implementation strategies will be supported by the rapid-cycle research framework developed by the AHRQ Practice Based Research Network. Implementation outcomes in Aim 3 will be structured using the well-known Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM) framework. We will utilize a type III hybrid research design to test PSM implementation strategies while observing/gathering information on PSM-related clinical and economic outcomes.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel M Witt, PharmD; Phone Number: 801-581-8851; Email: dan.witt@pharm.utah.edu

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92357
      • Not yet recruiting
      • VA Loma Linda Healthcare System
      • Contact: Linh Chan, PharmD; Phone Number: 909-894-7996; Email: Linh.Chan@va.gov
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Katelyn Sylvester, PharmD; Phone Number: 617-264-5856; Email: ksylvester3@bwh.harvard.edu
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Geoffrey Barnes, MD; Phone Number: 734-763-0047; Email: gbarnes@med.umich.edu
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah Thrombosis Center
      • Contact: Daniel M Witt, PharmD; Phone Number: 801-581-8851; Email: dan.witt@pharm.utah.edu
      • Contact: Sara Vazquez, PharmD; Phone Number: 801-581-3449; Email: sara.vazquez@hsc.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 18 years of age treated with warfarin for any indication for at least 9 months prior to enrollment
• Demonstrate the willingness and ability to test their own INR using a home INR monitoring device or have same-day access to clinic-derived INR results (e.g., via electronic medical record secure messaging)
• Willing to make independent decisions about warfarin dosing based on INR results
• Able to perform INR tests at least every 2 weeks
• Currently have and willing to maintain internet access for the duration of the study in order to complete online data collection forms
• Have an anticipated duration of warfarin therapy of at least 6 months

Exclusion Criteria:

• Goal INR range other than 2.0-3.0 or 2.5-3.5
• Known poor adherence to warfarin therapy
• Non-English speaking
• Inability or refusal to provide written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Warfarin Patient Self-Management; Patients managing decisions relating to warfarin dose and next INR test based on the results of current INR test	Other: Patient self-management; Patient makes independent decisions regarding warfarin therapy changes using warfarin dosing tools
Active Comparator: Historical Control; Patients managed by anticoagulation providers prior to transitioning to warfarin patient self-management	Other: Usual care provided by anticoagulation providers; Normal care provided by anticoagulation providers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in therapeutic INR range (TTR)	Percent time INR in the therapeutic range	Change from baseline at 6 months
Percent of patients transitioned to patient self-management	Percent of patients successfully transitioned to warfarin patient self-management	6-months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodes of major bleeding	Episodes of bleeding meeting ISTH definition for major bleeding	6-months follow up
Episodes of thromboembolic complications	Objectively diagnosed stroke, venous thrombosis, systemic embolism	6-months follow
Mental and physical health-related quality of life scores	Mental and physical domains of quality of life as measured by the SF-12 survey	Change from baseline at 6 months
Anticoagulation therapy knowledge scores	Scores measured by the Anticoagulation Knowledge Survey Tool	Change from baseline at 6 months
Patient satisfaction survey scores	Patient satisfaction as measured by the Anti-Clot Treatment Scale	Change from baseline at 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient self-management cost effectiveness	Cohort simulation Markov model compared to usual care	3-month cycles

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: University of Michigan; Brigham and Women's Hospital; Kaiser Foundation Research Institute; VA Loma Linda Health Care System; Tennessee Valley Health Systems Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Warfarin; Self-management; Anticoagulants; Implementation science
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Atrial Fibrillation; Thromboembolism; Venous Thromboembolism; Heart Valve Diseases
• Other Study ID Numbers: IRB_00141141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No