The Approach Trial: A Mixed Methods Pilot RCT Comparing Alternative Strategies for Approaching Substitute Decision Makers for Proxy Consent for Research Participation
|Karen EA Burns1,2,3*, Leena Rizvi1, Orla M Smith1,2,4 and Mehta S2,3,5|
|1Division of Critical Care, St Michael’s Hospital, Toronto, Canada|
|2Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, Canada|
|3Faculty of Medicine and Dentistry, University of Toronto, Toronto, Canada|
|4Bloomberg School of Nursing, University of Toronto, Toronto, Canada|
|5Division of Critical Care Medicine, Mount Sinai Hospital, Toronto, Canada|
|Corresponding Author :||Karen EA Burns MD, FRCPC, MSc
Divisions of Respirology and Critical Care Medicine
St. Michael’s Hospital, 30 Bond Street
Office 4-045 Donnelly Wing, Toronto, Ontario, Canada
Tel: 416-864-6060 X3567
E-mail: [email protected]
|Received March 31, 2014; Accepted April 25, 2014; Published April 27, 2014|
|Citation: Burns KEA, Rizvi L, Smith OM, Mehta S (2014) The Approach Trial: A Mixed Methods Pilot RCT Comparing Alternative Strategies for Approaching Substitute Decision Makers for Proxy Consent for Research Participation. J Clin Trials 4:164. doi:10.4172/2167-0870.1000164|
|Copyright: © 2014 Burns KEA, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.|
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 intervention arm, physicians will introduce research coordinators (RCs) and study participation to SDMs using a standardized script. In the control arm, RCs will introduce themselves or be introduced by a non-MD member of the ICU team. We will consider the trial feasible if (i) ≤ 15% of physician introductions are missed due to lack of
physician availability (MD introduction arm) and (ii) cross-overs (from one arm to the other) occur in ≤15% of encounters. We expect that ≤20% of introductions will be missed due to inability to contact an SDM and moderate to high SDM questionnaire completion rates. In the qualitative study, we will interview 12 SDMs (6 MD and 6 non-MD introductions) to describe their experience in being approached.
Discussion: The Approach Trial will evaluate how to best approach SDMs to make encounters more comfortable, credible, informed, and less burdensome for them. Prior to engaging in a large RCT, we will first demonstrate that it is feasible to implement an RCT evaluating a time-sensitive intervention that cannot be objectively measured and which is applied in a complex setting.