Clinical trial NCT04766216: Warfarin Patient Self-management Implementation in the US Healthcare System
Official title: Overcoming Barriers to Warfarin Patient Self-management Implementation in the US Healthcare System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Venous Thromboembolism
Heart Valve Diseases
Keywords: Warfarin
Self-management
Implementation science
Anticoagulants
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: University of Michigan
name: VA Loma Linda Health Care System
name: Kaiser Foundation Research Institute
First posted: 2021-02-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time in therapeutic INR range (TTR)
timeFrame: Change from baseline at 6 months
measure: Percent of patients transitioned to patient self-management
timeFrame: 6-months follow up
Secondary outcomes:
measure: Episodes of major bleeding
timeFrame: 6-months follow up
measure: Episodes of thromboembolic complications
timeFrame: 6-months follow
measure: Mental and physical health-related quality of life scores
timeFrame: Change from baseline at 6 months
measure: Anticoagulation therapy knowledge scores
timeFrame: Change from baseline at 6 months
measure: Patient satisfaction survey scores
timeFrame: Change from baseline at 6 months
Other outcomes:
measure: Patient self-management cost effectiveness
timeFrame: 3-month cycles
Locations:
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Salt Lake City
country: United States
facility: University of Utah Thrombosis Center
state: Utah
Study officials:
References: