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)

K. E.A. Burns, L. Rizvi, O. M. Smith, Y. Lee, J. Lee, M. Wang, M. Brown, M. Parker, A. Premji, Doris Y Leung, M. Hammond Mobilio, L. Gotlib-Conn, R. Nisenbaum, M. Santos, Y. Li, S. Mehta

Research output: Journal article publicationJournal articleAcademic researchpeer-review

10 Citations (Scopus)

Abstract

Purpose: 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.Conclusion: 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. Trial Registration Number: NCT01232621.
Original languageEnglish
Pages (from-to)58-67
Number of pages10
JournalIntensive Care Medicine
Volume41
Issue number1
DOIs
Publication statusPublished - 1 Jan 2015
Externally publishedYes

Keywords

  • Consent
  • Critical care
  • Qualitative research
  • Randomized trial
  • Research ethics
  • Substitute decision makers

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine

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