Overcoming Barriers to Warfarin Patient Self-Management (PSM) in the US Healthcare System: Implementation Trial Study Protocol

IntroductionWarfarin is a narrow therapeutic index drug that requires frequent monitoring using the international normalized ratio (INR). Current clinic-based INR monitoring models lead to suboptimal warfarin management. Warfarin patient self-management (PSM) has consistently demonstrated superior efficacy compared to clinic-based management but is virtually unused in the US healthcare system. The objective of this study is to implement PSM in the US healthcare system using strategies developed to overcome previously identified barriers associated with PSM underutilization as well as potential PSM facilitators. Methods and analysisWe aim to implement PSM with 150 adult patients at four sites using strategies developed to address barriers to PSM specific to the US healthcare system. Implementation strategies will be guided by the Consolidated Framework for Implementation Research and the Quality Implementation Framework supported by Rapid Cycle Research Methodology. A type III hybrid implementation-effectiveness study design will be used to assess PSM implementation strategy outcomes while also gathering information on PSM clinical outcomes centered on the five elements of the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). This study will be approved by the ethics boards at all participating sites. DiscussionWe plan to disseminate the results of this research program examining the feasibility of PSM in US anticoagulation management services in scientific journals and conferences, as well as making elements of the PSM implementation toolkit publicly and freely available. Trial Registration: ClinicalTrials.gov Identifier: NCT04766216