title: A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for Advanced Heart Failure: DECIDE-LVAD: Rationale, Design, and Pilot Data.
abstract: Shared decision making is important to ensure that patients receive therapies aligned with their goals and values. Based upon a detailed needs assessment with diverse stakeholders, pamphlet and video decision aids for destination therapy left ventricular assist devices (DT LVAD) were developed to help patients and their caregivers think through, forecast, and deliberate their options. These decision aids are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients and their Caregivers Offered Destination Therapy for End-Stage Heart Failure (DECIDE-LVAD) study, a multicenter, randomized trial aimed at understanding the effectiveness and implementation of a shared decision support intervention for patients considering DT LVAD.
  
  
  
  A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM framework and modeled after an effectiveness-implementation hybrid type II design. Six DT LVAD programs from across the United States will participate. Primary outcomes include knowledge and values-treatment concordance. Patients with advanced heart failure who are being considered for DT LVAD and their caregivers are eligible with a target enrollment of 168 dyads. From August 2014 to January 2015, an acceptability and feasibility pilot study was performed, which clarified opportunities and challenges around decision support for DT LVAD and resulted in significant modifications to the DECIDE-LVAD study.
  
  
  
  Study findings will provide a foundation for implementing decision support interventions, including decision aids, with patients who have chronic progressive illness facing end-of-life decisions involving invasive, preference-sensitive therapy options.
authors.affiliation: Colleen K. McIlvennan, DNP, ANP Assistant Professor of Medicine, Section of Advanced Heart Failure and Transplantation, Division of Cardiology, School of Medicine, University of Colorado, Aurora, and Colorado Cardiovascular Outcomes Research Consortium, Denver. Jocelyn S. Thompson, MA Senior Professional Research Assistant, Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora. Daniel D. Matlock, MD, MPH Associate Professor of Medicine, Adult and Child Center for Health Outcomes Research and Delivery Science and Division of General Internal Medicine, School of Medicine, University of Colorado, Aurora, and Colorado Cardiovascular Outcomes Research Consortium, Denver. Joseph C. Cleveland Jr, MD Professor of Medicine, Division of Cardiothoracic Surgery, Department of Surgery, School of Medicine, University of Colorado, Aurora. Shannon M. Dunlay, MD, MS Associate Professor of Medicine and Health Services Research, Division of Cardiovascular Diseases, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota. Shane J. LaRue, MD, MPHS Assistant Professor of Medicine, Cardiovascular Division, School of Medicine, Washington University, St. Louis, Missouri. Eldrin F. Lewis, MD, MPH Associate Professor of Medicine, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts. Chetan B. Patel, MD Assistant Professor of Medicine, Division of Cardiology, Duke University Medical Center, and Duke Clinical Research Institute, Durham, North Carolina. Mary Norine Walsh, MD Medical Director, Department of Heart Failure and Cardiac Transplantation, St. Vincent Heart Center, Division of Cardiology, Indianapolis, Indiana. Larry A. Allen, MD, MHS Associate Professor of Medicine, Section of Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, and Colorado Cardiovascular Outcomes Research Consortium, Denver.
authors.forename: Colleen K
authors.initials: CK
authors.lastname: McIlvennan
authors.forename: Jocelyn S
authors.initials: JS
authors.lastname: Thompson
authors.forename: Daniel D
authors.initials: DD
authors.lastname: Matlock
authors.forename: Joseph C
authors.initials: JC
authors.lastname: Cleveland
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Dunlay
authors.forename: Shane J
authors.initials: SJ
authors.lastname: LaRue
authors.forename: Eldrin F
authors.initials: EF
authors.lastname: Lewis
authors.forename: Chetan B
authors.initials: CB
authors.lastname: Patel
authors.forename: Mary Norine
authors.initials: MN
authors.lastname: Walsh
authors.forename: Larry A
authors.initials: LA
authors.lastname: Allen
mesh_terms: D017028:Caregivers; D003657:Decision Making; D006333:Heart Failure / Q000451:nursing*; D006353:Heart-Assist Devices; D006801:Humans; D010865:Pilot Projects