The Approach Trial: A Mixed Methods Pilot RCT Comparing Alternative Strategies for Approaching Substitute Decision Makers for Proxy Consentfor Research Participation

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.