Abstract
BACKGROUND: Emergency care trials may require compliance with federal Exception from Informed Consent (EFIC) regulations, including community consultation (CC) and public disclosure (PD). The reach of traditional CC and PD modalities is limited. We describe the application of novel digital engagement tools to enrich CC and PD in a pediatric emergency care trial. METHODS: In support of EFIC CC and PD efforts for the Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART), a multicenter trial of paramedic airway management in critically ill children, we deployed two digital engagement tools: 1) social media advertisements, and 2) marketing research panels. We disseminated social media advertisements (Facebook and Instagram) describing the study to targeted users in 10 communities. We determined social media advertisement impressions and engagements (shares, reactions, saves, comments, likes and clicks). We also disseminated community surveys using a marketing research panel (Qualtrics Marketing Research Services), determining the number of completed surveys, time to achieve 200 surveys, demographics of survey respondents and percentage with supportive responses. RESULTS: There were 23.3 million social media advertisement impressions (range 1.8-2.7 million per community) reaching 3.4 million unique users (range 239,494-439,360 per community) and resulting in 13,873 engagements (range 828-1,656 per community). Distribution of the community survey through the marketing research panel resulted in 6,771 completed surveys (range 531-914 per community). Across communities, time to 200 completed surveys ranged from 5-28 days. Survey respondents were 61.9% female, 27.0% minority race and 40.8% household income <$50,000. Most survey respondents (90.7%) supported the trial. CONCLUSIONS: Digital engagement tools efficiently reached a large and diverse population and yielded key community feedback to inform research trial deployment. Digital engagement tools offer valuable techniques to enrich EFIC CC and PD efforts.