Warfarin Patient Self-management Implementation in the US Healthcare System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Atrial Fibrillation, Venous Thromboembolism, Heart Valve Diseases

Intervention / Treatment
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* Other: Patient self-management
* Other: Usual care provided by anticoagulation providers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Warfarin, Self-management, Implementation science, Anticoagulants