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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Patient makes independent decisions regarding warfarin therapy changes using warfarin dosing tools
Normal care provided by anticoagulation providers
VA Loma Linda Healthcare System
Loma Linda, California, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
COMPLETEDUniversity of Michigan
Ann Arbor, Michigan, United States
COMPLETEDTime in therapeutic INR range (TTR)
Percent time INR in the therapeutic range
Time frame: Change from baseline at 6 months
Percent of patients transitioned to patient self-management
Percent of patients successfully transitioned to warfarin patient self-management
Time frame: 6-months follow up
Episodes of major bleeding
Episodes of bleeding meeting ISTH definition for major bleeding
Time frame: 6-months follow up
Episodes of thromboembolic complications
Objectively diagnosed stroke, venous thrombosis, systemic embolism
Time frame: 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
Time frame: Change from baseline at 6 months
Anticoagulation therapy knowledge scores
Scores measured by the Anticoagulation Knowledge Survey Tool
Time frame: Change from baseline at 6 months
Patient satisfaction survey scores
Patient satisfaction as measured by the Anti-Clot Treatment Scale
Time frame: Change from baseline at 6 months
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University of Utah Thrombosis Center
Salt Lake City, Utah, United States
RECRUITING