Hong Heeseung, Wilson Aaron S, Jones Aubrey E, Vazquez Sara R, Gilbert Spencer, Malone Daniel C, Chaiyakunapruk Nathorn, King Jordan B, Barnes Geoffrey D, Sylvester Katelyn W, Dube Gina, Irving Nicole V, Chan Linh, Ragheb Bishoy, Delate Thomas, Witt Daniel M
University of Utah College of Pharmacy, Salt Lake City, Utah.
University of Utah Health Thrombosis Service, Salt Lake City, Utah.
medRxiv. 2025 Aug 21:2025.08.18.25333912. doi: 10.1101/2025.08.18.25333912.
Warfarin 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.
We 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.
We 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.
华法林是一种治疗指数狭窄的药物，需要使用国际标准化比值（INR）进行频繁监测。当前基于诊所的INR监测模式导致华法林管理效果欠佳。与基于诊所的管理相比，华法林患者自我管理（PSM）一直显示出更高的疗效，但在美国医疗系统中几乎未被采用。本研究的目的是在美国医疗系统中实施PSM，采用为克服先前确定的与PSM未充分利用相关的障碍以及潜在的PSM促进因素而制定的策略。
我们旨在通过为解决美国医疗系统特有的PSM障碍而制定的策略，在四个地点对150名成年患者实施PSM。实施策略将以实施研究综合框架和快速循环研究方法支持的质量实施框架为指导。将采用III型混合实施-效果研究设计来评估PSM实施策略的结果，同时收集以RE-AIM框架（覆盖范围、有效性、采用率、实施、维持）的五个要素为中心的PSM临床结果信息。本研究将获得所有参与地点伦理委员会的批准。
我们计划在科学期刊和会议上传播这项研究计划的结果，该计划研究了PSM在美国抗凝管理服务中的可行性，并将PSM实施工具包的内容公开免费提供。
