Overcoming barriers to warfarin patient self-management implementation in the US healthcare system

项目摘要 在美国，接受华法林治疗的患者很少被允许进行患者自我管理（PSM） 这比标准的临床医生指导的华法林管理更少负担、更便宜和更安全。 国家和国际循证指南小组强烈建议PSM优于其他华法林 因为它可以改善INR控制，降低血栓形成的风险， 在不增加出血风险的情况下将死亡率降低一半，并提高患者满意度和生活质量。的 美国环境中PSM利用不足的原因尚未得到系统评估和验证。我们 将解决这一知识差距，并提供基本信息，以提高PSM在 美国医疗保健系统。我们的目标1将评估和验证PSM的障碍和促进因素，并评估其 适用于美国医疗保健系统;目标2将在美国制定和测试PSM实施策略 采用快速循环研究方法建立流动护理站点;目标3将评估实施情况 （可行性、保真度、采用）、临床（有效性、安全性、公平性、以患者为中心）和最终用户 （满意度）结果。我们应用的长期目标是提高门诊的安全性， 通过增加PSM实施华法林治疗。我们的应用程序支持的使命 AHRQ通过提高药物的安全性和改善整体健康，并侧重于一个特定的 关注领域，即实施措施、指标、工具和/或实践的干预措施（PSM）， 确保对在门诊护理环境中接受高风险治疗的个人进行适当监测， 作为抗凝治疗。我们的研究建议是由一个实施科学逻辑模型， 纳入了众所周知的实施科学框架，以支持具体目标。定性数据 目标1的收集和分析工作将利用《综合实施框架》组织进行 研究（CFIR）是一个决定性框架，确定了影响执行的五个领域： 干预，内部设置，外部设置，个人和实施过程。在每一个 域提供了关于确定和衡量潜在实施障碍或促进因素的因素的指导。 目标2中的方案支助和管理实施活动将以质量实施框架为指导， 确定了关键的实施过程步骤以及与这些步骤相关的具体行动， 用于实现高质量的PSM实施。执行战略将得到快速周期的支持 AHRQ基于实践的研究网络开发的研究框架。执行成果 目标3将使用众所周知的覆盖、有效性、采用、实施、维护（RE- AIM）框架。我们将利用第三类混合研究设计来测试PSM实施策略， 观察/收集PSM相关临床和经济结局的信息。

Project 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 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 application supports the mission of the AHRQ by improving the safety of medication and improvement in overall health and focuses on a specified area of interest, namely an intervention (PSM) that implements a measure, metric, tool, and/or practice to ensure appropriate monitoring for individuals receiving high risk treatments in the ambulatory care setting such as anticoagulation therapy. 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.