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

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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.