Abstract Sat902: Surrogate-Researcher Dyad Consent Experience for Participation in a Cardiac Arrest Clinical Trial: A Multicenter Qualitative Study

Abstract

Introduction/background: Surrogate informed consent for emergency research poses unique challenges which are not well defined. Research question/hypothesis: We explored experiences of surrogate decision makers (SDMs) and researchers during consent for the Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP) trial. Goals/Aim: Identify aspects of the consenting process experienced by researchers and SDMs and their decision-making. Methods/Approach: This multicenter, qualitative study involved separate interviews of SDMs and corresponding researchers involved in consent for ICECAP, including both SDMs who declined and consented. Three qualitative researchers thematically coded interviews using inductive and deducting coding. Results/Data: We recruited 20 researcher-SDM dyads from 4 centers, including 14 consents and 6 declines; 4 remote consents. The research team’s process for enrolling patients and the clinical team structure of caring for post-arrest patients differed by site. These environmental norms and the researcher’s role influenced researchers’ views more than SDMs’. Instead, SDM-researcher relationship (i.e. trust/rapport) impacted SDMs’ experiences. For example, some centers had a team member give clinical updates and then a separate researcher approach for consent. Researchers felt this was beneficial but SDMs had less of an opinion about this structure. Although researchers felt SDMs understood the trial, majority of corresponding SDMs could not explain the trial purpose (n=15). Almost all SDMs reported the emergency nature of consent made the experience overwhelming (n=19) and impeded their understanding. Both preferred in-person consent compared to remote, but remote did not influence SDMs’ decisions. SDMs considered risks and benefits of the trial when deciding to participate and described other influential facilitators and barriers (Table 1). SDMs and researchers felt that the process could be improved by enhancing communication (n=6 and 4). SDMs suggestions for improving the consent process included assessing emotions (n=4), better written material (n=3), and early prognostication (n=2). Whereas, researchers focused more on the consent structure (using exception for informed consent (n=5) and extending time to consent (n=8)). Conclusion: Stakeholder engagement allows for the identification of modifiable barriers and facilitators which can improve the consent process after cardiac arrest.