Warfarin Patient Self-management Implementation in the US Healthcare System

Sponsor

University of Utah (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04766216

Collaborator

Brigham and Women's Hospital (Other), University of Michigan (Other), Tennessee Valley Health Systems Veterans Affairs Medical Center (Other), VA Loma Linda Health Care System (U.S. Fed), Kaiser Foundation Research Institute (Other)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Venous Thromboembolism Heart Valve Diseases	Other: Patient self-management Other: Usual care provided by anticoagulation providers	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Patient self-management cost effectiveness [3-month cycles]
Cohort simulation Markov model compared to usual care

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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