Abstract Sa1203: Application of a Centralized Media-Based Strategy for Exception from Informed Consent Community Consultation and Public Disclosure in the Pediatric Prehospital Airway Resuscitation Trial

Background: In the United States, enrollment in clinical trials that involve emergency care may require compliance with federal regulations for Exception from Informed Consent (EFIC), including Community Consultation and Public Disclosure (CCPD). The most effective methods for CCPD in studies of emergency care in children are not known. Aim: To describe the results of a centralized media-based CCPD outreach effort for the Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART), a multicenter trial testing paramedic airway management strategies in critically ill and injured children. Methods: During a three-month window, across 10 participating US communities, we deployed social media (SM - Facebook and Instagram) advertisements of the study, targeting users within Emergency Medical Services service regions and zip codes with high anticipated need for pediatric airway management. The SM advertisements hyperlinked to study websites and surveys. We also solicited survey completion using a marketing research platform (Qualtrics Marketing Research Services), targeting the same communities. We determined the extent of SM exposure (impressions), interactions (shares, reactions, saves, comments, likes and clicks), and referrals to study website. For each site, we determined the number of completed surveys and the time required to achieve 200 surveys as required by the Institutional Review Board. We determined the demographics of survey respondents and the percentage with supportive responses. Results: The SM campaign resulted in 23.3M advertisement impressions (range 1.8-2.7M per site) reaching 3.4M unique users (range 239,494-439,360 per site), 13,873 engagements (range 828-1,656 per site) and 10,154 click-throughs to the study website (range 760-1,589 per site). There were 6,771 completed community surveys (range 531-914 per site). Across the sites, time to 200 completed surveys ranged from 5-28 days. Survey respondents were: 54.1% <45 years old, 61.9% female, 27.0% minority race, 14.2% Hispanic ethnicity, and 40.8% household income <$50,000. A total of 6,144 (90.7%; range 88.6-92.6% per site) survey respondents supported trial deployment in their communities. Conclusions: In Pedi-PART a centralized media-based outreach campaign efficiently reached and engaged a vast and diverse population, and yielded key community feedback. This strategy illustrates one robust approach to facilitate CCPD in pediatric emergency care trials.