title: Is there a role for physician involvement in introducing research to surrogate decision makers in the intensive care unit? (The Approach trial: a pilot mixed methods study).
abstract: OBJECTIVE
  To assess the feasibility of conducting a randomized trial comparing two strategies [physician (MD) vs. non-physician (non-MD)] for approaching substitute decision makers (SDMs) for research and to evaluate SDMs' experiences in being approached for consent.
  
  
  METHODS
  A pilot mixed methods study of first encounters with SDMs.
  
  
  RESULTS
  Of 137 SDMs (162 eligibility events), 67 and 70 were randomized to MD and non-MD introductions, respectively. Eighty SDMs (98 events) provided consent and 21 SDMs (24 events) declined consent for studies, including 2 SDMs who provided and declined consent. We identified few missed introductions [4/52 (7.7 %)] and protocol violations [6/117 (5.1 %)], high comfort, satisfaction and acceptance scores and similar consent rates in both arms. SDMs provided consent significantly more often when a patient update was provided in the MD arm. Most SDMs (85.7 %) felt that physician involvement was inconsequential and preferred physician time to be dedicated to patient care; however, SDM experiences were closely related to their recall of being approached and recall was poor. SDMs highlighted 7 themes of importance to them in research surrogate decision-making.
  
  
  CONCLUSIONS
  SDMs prioritized the personal attributes of the person approaching them over professional designation and preferred physician time to be dedicated to patient care. A mixed methods design evaluated intervention fidelity and provided the rationale for not proceeding to a larger trial, despite achieving all feasibility metrics in the pilot trial.
  
  
  BACKGROUND
  NCT01232621.
authors.affiliation: Interdepartmental Division of Critical Care, University of Toronto, Toronto, Canada, burnsk@smh.ca.
authors.forename: K E A
authors.initials: KE
authors.lastname: Burns
authors.forename: L
authors.initials: L
authors.lastname: Rizvi
authors.forename: O M
authors.initials: OM
authors.lastname: Smith
authors.forename: Y
authors.initials: Y
authors.lastname: Lee
authors.forename: J
authors.initials: J
authors.lastname: Lee
authors.forename: M
authors.initials: M
authors.lastname: Wang
authors.forename: M
authors.initials: M
authors.lastname: Brown
authors.forename: M
authors.initials: M
authors.lastname: Parker
authors.forename: A
authors.initials: A
authors.lastname: Premji
authors.forename: D
authors.initials: D
authors.lastname: Leung
authors.forename: M
authors.initials: M
authors.lastname: Hammond Mobilio
authors.forename: L
authors.initials: L
authors.lastname: Gotlib-Conn
authors.forename: R
authors.initials: R
authors.lastname: Nisenbaum
authors.forename: M
authors.initials: M
authors.lastname: Santos
authors.forename: Y
authors.initials: Y
authors.lastname: Li
authors.forename: S
authors.initials: S
authors.lastname: Mehta
mesh_terms: D016638:Critical Illness; D003657:Decision Making; D005260:Female; D006801:Humans; D007258:Informed Consent; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D009864:Ontario; D010819:Physician's Role; D010865:Pilot Projects; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012108:Research Personnel; D011795:Surveys and Questionnaires