Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Karen EA Burns
St. Michael’s Hospital,
30 Bond Street, Office 4-045 Donnelly Wing, Toronto, Ontario
Canada
Perspective
The Approach Trial: A Mixed Methods Pilot RCT Comparing Alternative Strategies for Approaching Substitute Decision Makers for Proxy Consent
for Research Participation
Author(s): Karen EA Burns, Leena Rizvi, Orla M Smith and Mehta S
Karen EA Burns, Leena Rizvi, Orla M Smith and Mehta S
Background: Most critically ill patients are unable to comprehend or communicate and Substitute Decision Makers (SDMs) typically provide proxy consent for research. Ontario legislation requires individuals within the ‘circle of care’ to introduce research personnel to SDMs with some Research Ethics Boards (REBs) mandating physician involvement. We aim to conduct mixed methods, pilot Randomized Controlled Trial (RCT) comparing two strategies for introducing research to SDMs and a fully nested qualitative study evaluating SDM’s experience in being approached for consent.
Methods/Design: A multicentre, pilot, mixed methods RCT comparing different strategies [physician (MD) introduction vs. non-physician (non-MD) introduction] for initially introducing research personnel and research participation to SDMs (target n=150) of critically ill adults. In the interventio.. View More»
DOI:
10.4172/2167-0870.1000164