title: Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial.
abstract: BACKGROUND
  Patients, identified to be at risk for but who have never experienced a potentially lethal cardiac arrhythmia, have the option of receiving an implantable cardioverter defibrillator (ICD) as prophylaxis against sudden cardiac death - a primary prevention indication. In Canada, there is no clear framework to support patients' decision-making for these devices. Decision support, using a decision aid, could moderate treatment-related uncertainty and prepare patients to make well-informed decisions. Patient decision aids provide information on treatment options, risks, and benefits, to help patients clarify their values for outcomes of treatment options. The objectives of this research are: 1) develop a decision aid, 2) evaluate the decision aid, and 3) determine the feasibility of conducting a trial.
  
  
  METHODS
  A development panel comprised of the core investigative team, health service researchers, decision science experts, cardiovascular healthcare practitioners, and ICD patient representatives will collaborate to provide input on the content and format of the aid. To generate probabilities to include in the aid, we will synthesize primary prevention ICD evidence. To obtain anonymous input about the facts and content, we will employ a modified Delphi process. To evaluate the draft decision aid will invite ICD patients and their families (n = 30) to rate its acceptability. After we evaluate the aid, to determine the feasibility, we will conduct a feasibility pilot randomized controlled trial (RCT) in new ICD candidates (n = 80). Participants will be randomized to receive a decision aid prior to specialist consultation versus usual care. Results from the pilot RCT will determine the feasibility of research processes; inform sample size calculation, measure decision quality (knowledge, values, decision conflict) and the influence of health related quality of life on decision-making.
  
  
  CONCLUSIONS
  Our study seeks to develop a decision aid, for patients offered their first ICD for prophylaxis against sudden cardiac death. This paper outlines the background and methods of a pilot randomized trial which will inform a larger multicenter trial. Ultimately, decision support prior to specialist consultation could enhance the decision-making process between patients, physicians, and families, associated with life-prolonging medical devices like the ICD.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01876173.
authors.affiliation: School of Nursing, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada. carroll@mcmaster.ca.
authors.forename: Sandra L
authors.initials: SL
authors.lastname: Carroll
authors.forename: Michael
authors.initials: M
authors.lastname: McGillion
authors.forename: Dawn
authors.initials: D
authors.lastname: Stacey
authors.forename: Jeff S
authors.initials: JS
authors.lastname: Healey
authors.forename: Gina
authors.initials: G
authors.lastname: Browne
authors.forename: Heather M
authors.initials: HM
authors.lastname: Arthur
authors.forename: Lehana
authors.initials: L
authors.lastname: Thabane
mesh_terms: D001145:Arrhythmias, Cardiac / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D002985:Clinical Protocols; D016757:Death, Sudden, Cardiac / Q000209:etiology / Q000517:prevention & control*; D003661:Decision Support Techniques; D017147:Defibrillators, Implantable; D003697:Delphi Technique; D004554:Electric Countershock / Q000295:instrumentation*; D005240:Feasibility Studies; D006801:Humans; D009864:Ontario; D010358:Patient Participation; D018579:Patient Selection; D010817:Physician-Patient Relations; D010865:Pilot Projects; D011237:Predictive Value of Tests; D011322:Primary Prevention / Q000295:instrumentation*; D011368:Professional-Family Relations; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors