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)
| Autor: | Maedean Brown, Marlene Santos, Y. Li, Karen E. A. Burns, Rosane Nisenbaum, Doris Y Leung, M. Hammond Mobilio, Azra Premji, L. Gotlib-Conn, Sangeeta Mehta, Leena Rizvi, Y. Lee, J. Lee, Melissa J Parker, M. Wang, Orla Smith |
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| Rok vydání: | 2014 |
| Předmět: |
Research design
Male medicine.medical_specialty Critical Illness Decision Making MEDLINE Pilot Projects Critical Care and Intensive Care Medicine law.invention Randomized controlled trial law Informed consent Anesthesiology Surveys and Questionnaires medicine Humans Physician's Role Randomized Controlled Trials as Topic Ontario Research ethics Informed Consent business.industry Middle Aged Intensive care unit Research Personnel Intensive Care Units Research Design Family medicine Female business Qualitative research |
| Zdroj: | Intensive care medicine. 41(1) |
| ISSN: | 1432-1238 |
| Popis: | 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. A pilot mixed methods study of first encounters with SDMs. 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. 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. |
| Databáze: | OpenAIRE |
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