Warfarin Patient Self-management Implementation in the US Healthcare System

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04766216
• Other study ID #: IRB_00141141
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: Daniel M Witt, PharmD
• Phone: 801-581-8851
• Email: dan.witt[@]pharm.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 30, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Valve Diseases
• Thromboembolism
• Venous Thromboembolism

Intervention

Other:
• Patient self-management
Patient makes independent decisions regarding warfarin therapy changes using warfarin dosing tools
• Usual care provided by anticoagulation providers
Normal care provided by anticoagulation providers

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	VA Loma Linda Healthcare System	Loma Linda	California
United States	University of Utah Thrombosis Center	Salt Lake City	Utah

Sponsors (5)

Lead Sponsor	Collaborator
University of Utah	Brigham and Women's Hospital, Kaiser Foundation Research Institute, University of Michigan, VA Loma Linda Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient self-management cost effectiveness	Cohort simulation Markov model compared to usual care	3-month cycles
Primary	Time in therapeutic INR range (TTR)	Percent time INR in the therapeutic range	Change from baseline at 6 months
Primary	Percent of patients transitioned to patient self-management	Percent of patients successfully transitioned to warfarin patient self-management	6-months follow up
Secondary	Episodes of major bleeding	Episodes of bleeding meeting ISTH definition for major bleeding	6-months follow up
Secondary	Episodes of thromboembolic complications	Objectively diagnosed stroke, venous thrombosis, systemic embolism	6-months follow
Secondary	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
Secondary	Anticoagulation therapy knowledge scores	Scores measured by the Anticoagulation Knowledge Survey Tool	Change from baseline at 6 months
Secondary	Patient satisfaction survey scores	Patient satisfaction as measured by the Anti-Clot Treatment Scale	Change from baseline at 6 months