Warfarin Patient Self-management Implementation in the US Healthcare System
Warfarin Patient Self-management Implementation in the US Healthcare System
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.
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