Developing an Implementation Strategy to Improve Peri-procedural Anticoagulation Management for Patients with Atrial Fibrillation

摘要： 候选人：杰弗里·巴恩斯，医学博士，理学硕士，心脏病专家和初级临床研究员，专注于使用 卫生系统重组，以改善抗凝相关护理。巴恩斯博士的长期职业目标是 结合健康系统工程原则(例如，精益和六西格玛工作流程模型开发和 优化)以及实施科学方法，以提高 心血管护理，特别是房颤患者的抗凝治疗。建议的K01指导 职业发展奖包括一项为期5年的培训和研究活动计划，该计划将为Dr。 巴恩斯拥有成为一名成功的独立调查员所需的必要技能和经验。 研究背景：每年超过50万名长期服用华法林(口服)的患者 抗凝剂)，以防止与房颤相关的中风，需要暂时中断其 用于外科手术或程序的抗凝剂方案。通常，这些房颤患者接受较短的- 在手术前后使用“桥接”抗凝剂(如肝素)，以帮助预防中风。然而， 强有力的证据表明，这些短效桥接抗凝剂不会造成任何中风。 预防有益，但确实会导致危及生命的出血。抗凝诊所配备有专业护士。 和药剂师，以确保安全和有效的管理慢性华法林抗凝。然而，由于 由于大多数医疗中心内部缺乏协调和沟通，抗凝诊所经常 不参与有关抗凝药物的围手术期管理决策。有很棒的 需要一种战略来确保安全、循证的围术期抗凝护理，方法是重新组织 外科团队与其他提供者之间的协调(例如，心脏科、初级保健和抗凝 诊所)。这项提议的短期目标是获得卫生系统工程方面的必要技能， 实施科学和组织变革领导力，以制定和实施程序周围的 抗凝系统重组，强调加强协调和沟通 从业者。 具体目标：1)在六个不同的领域内建立围手术期抗凝护理的重组模式 使用健康系统工程方法的医疗保健中心；2)制定重新- 不同类型房颤患者围手术期抗凝管理的组织模式 医疗中心集团；以及3)进行单中心试点研究，以实施重新组织的周边地区 程序性抗凝交付模式强调改善组织内提供者的协调和 沟通。 研究计划：为了实现这些目标，巴恩斯博士将进行直接观察和半结构化 与关键利益相关者面谈，以开发并优化循证周到的工作流程模型。 程序性抗凝治疗。然后，他将使用利益相关者半结构化访谈来制定 重组围术期抗凝管理的实施策略。最后，他将表演 实施重组抗凝策略以评估可行性的单中心先导研究， 可接受性和有效性。这项研究将为未来的多中心实施研究提供参考。 职业发展计划：巴恩斯博士将发展健康系统工程方面的专业知识 方法，包括精益和六西格玛工作流程模型开发和优化，以及 在多组成部分(或复杂)干预措施实施方法方面的专业知识。巴恩斯博士的职业生涯 发展目标将通过跨学科团队的密切指导来支持；指导来自 专家咨询小组；高级教学课程；出席专业会议和研讨会； 参加定期研讨会；指导手稿准备和赠款提案的制定；以及 实施他的研究活动。这项培训将直接帮助巴恩斯博士实现预防 通过改善提供者的协调和沟通，准备好不良抗凝药物事件 他随后提交了一份成功的R01申请。 环境：巴恩斯博士的独特资源包括一支专注且成就卓著的指导团队， 一支强大的临床实验室和研究人员，位于6 抗凝诊所和保健中心(MAQI2)；以及 密歇根大学和医疗政策与创新研究所在 支持初级调查员发展为独立调查员。

Abstract: CANDIDATE: Geoffrey Barnes, MD, MSc is a cardiologist and junior clinical investigator focused on using health system re-organization to improve anticoagulation-related care. Dr. Barnes' long-term career objective is to combine health systems engineering principles (e.g. Lean and Six Sigma work flow model development and optimization) along with implementation science approaches to improve the safety and coordination of cardiovascular care, especially for anticoagulated patients with atrial fibrillation. The proposed K01 mentored career development award includes a 5-year plan for training and research activities that will provide Dr. Barnes with the necessary skills and experience needed to become a successful independent investigator. RESEARCH CONTEXT: Over 500,000 patients each year who are chronically taking warfarin (an oral anticoagulant) to prevent strokes related to atrial fibrillation require a temporary interruption of their anticoagulant regimen for a surgery or procedure. Commonly, these atrial fibrillation patients receive shorter- acting “bridging” anticoagulants (e.g. heparin) around the time of surgery to help prevent strokes. However, robust evidence indicates that these shorter-acting bridging anticoagulants do not provide any stroke prevention benefit, but do cause life-threatening bleeding. Anticoagulation clinics are staffed by expert nurses and pharmacists to ensure safe and effective management of chronic warfarin anticoagulation. However, due to a lack of coordination and communication within most healthcare centers, anticoagulation clinics are often not involved in the peri-procedural management decisions about anticoagulant medications. There is great need for a strategy to ensure safe, evidence-based peri-procedural anticoagulation care by re-organizing the coordination between the surgical team and other providers (e.g. cardiology, primary care, and anticoagulation clinic). The short-term goal of this proposal is to acquire the requisite skills in health systems engineering, implementation science and organizational change leadership to develop and implement a peri-procedural anticoagulation system re-organization that emphasized improved coordination and communication between practitioners. SPECIFIC AIMS: 1) Develop a re-organized model of peri-procedural anticoagulation care within six diverse healthcare centers using health systems engineering methods; 2) Develop an implementation strategy for a re- organized model of peri-procedural anticoagulation management of atrial fibrillation patients within a diverse group of healthcare centers; and 3) Perform a single-center pilot study of implementing a re-organized peri- procedural anticoagulation delivery model emphasizing improved intra-organizational provider coordination and communication. RESEARCH PLAN: To accomplish these aims, Dr. Barnes will perform direct observations and semi-structured interviews with key stakeholders to develop and then optimize a work flow model for evidence-based peri- procedural anticoagulation management. He will then use stakeholder semi-structured interviews to develop an implementation strategy for re-organizing per-procedural anticoagulation management. Finally, he will perform a single center pilot study where the re-organized anticoagulation strategy is implemented to assess feasibility, acceptability and efficacy. This study will inform a future multi-center implementation study. CAREER DEVELOPMENT PLAN: Dr. Barnes will develop expertise in health systems engineering approaches, including Lean and Six Sigma work flow model development and optimization, along with expertise in implementation methods for multi-component (or complex) interventions. Dr. Barnes' career development goals will be supported through close mentorship from an interdisciplinary team; guidance from an expert advisory panel; advanced didactic coursework; attendance at professional meetings and workshops; participation in regular seminars; guidance in manuscript preparation and grant proposal development; and implementing his research activities. This training will directly contribute to Dr. Barnes' goal of preventing adverse anticoagulant drug events through improved provider coordination and communication and prepare him to subsequently submit a successful R01 application. ENVIRONMENT: Dr. Barnes' unique resources include a dedicated and accomplished mentorship team with whom he has previously collaborated; a robust clinical laboratory and research personnel located at six anticoagulation clinics and healthcare centers (MAQI2); and the outstanding research infrastructure at the University of Michigan and Institute for Healthcare Policy and Innovation with demonstrated success in supporting junior investigators as they develop into independent investigators.