Community consultation and public disclosure for the Randomized Trial of Sedative Choice for Intubation

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BACKGROUND: Randomized trials evaluating emergency treatments may be conducted with Exception from Informed Consent (EFIC) when informed consent is infeasible. In EFIC trials, a period of community consultation and public disclosure precedes initiation of enrollment. The Randomized Trial of Sedative Choice for Intubation (RSI) was a 2,365-patient randomized trial conducted with EFIC in 14 emergency departments and intensive care units across the United States. This manuscript reports the approach to community consultation and public disclosure in the RSI trial. METHODS: Community consultation and public disclosure were conducted locally in each region of enrolling sites. The coordinating center provided sites with templates and access to an engagement coordinator to assist with developing and executing site plans. RESULTS: Community consultation and public disclosure occurred at the coordinating center from February 2021-January 2022 and in the regions of the five additional enrolling sites from September 2023-June 2024. Community consultation included in-person surveys with 789 patients or family members in emergency department or intensive care unit waiting rooms and invitation of more than 200 local groups to town halls or Community Engagement Studios. Public disclosure included (i) social media advertisements viewed more than 1.2 million times, (ii) a trial website with more than 16,000 unique visitors, (iii) informational flyers in hospitals and public settings, and (iv) featured information in traditional media. Completing local community consultation and public disclosure required an average of 139 h of research personnel time and approximately $18,822 at each site, in addition to coordinating center effort and costs. CONCLUSIONS: Pre-trial community consultation activities in the RSI trial engaged over 1,000 patients, families, and community members and public disclosure reached over 1.2 million community members. While the total cost and duration of activities at sites were substantially lower than reported in prior EFIC trials, these costs remained significant. TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT05277896; URL: www. CLINICALTRIALS: gov.

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