Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized Control Trial - ABSTRACT The Emergency Medical Services (EMS) 2050 Agenda for Future Systems envisions that telehealth tools could make prehospital care safer and more effective, but few EMS systems use video technology. Teleconsultation with pediatric experts reduces in-hospital errors in children, but whether it prevents prehospital harm—a national priority—is unknown. To guide EMS systems, we need prehospital trials demonstrating patient safety benefits for critically ill infants and children, a high risk group for prehospital error. Video use could also help EMS systems track and measure intervention effects as the most common method, chart review, underestimates safety event (care could/did cause harm) prevalence and may lack sensitivity to measure changes in care safety and quality with real-world use. The R01 objective is to test the efficacy of teleconsultation to reduce harm in a controlled prehospital setting using in situ simulation, an innovative technique to test early stage intervention effects on clinical processes with real multidisciplinary teams in actual prehospital environments. In prior KL2/K23 awards, we designed a prototype platform using scalable low-cost technology, validated a simulation model and tool-kit to study safety events in critical pediatric transports, and demonstrated intervention acceptability and feasibility in a pilot simulation randomized controlled trial (RCT). Now, we will test intervention efficacy (Aim 1) and compare safety surveillance methods (Aim 2) to target two critical gaps. In Aim 1, we will test the efficacy of teleconsultation with pediatric emergency physicians using video (intervention) versus usual care physicians using audio (control) communication with EMS teams to reduce serious safety events (cause moderate-severe harm/death, primary outcome) in the simulation model. In Aim 2, we will compare the frequency, type, and reasons for differences in serious safety event detection (primary outcome) when using video review versus chart review methods. We will conduct a multicenter, single-blind, parallel-arm, simulation RCT in the Pediatric Emergency Care Applied Research Network (PECARN) and its EMS affiliates to enroll a diverse cohort and leverage EMS collaborations and research infrastructure for high-quality generalizable results. We will randomize real-world EMS-physician teams to teleconsultation or control arms. Each team will complete 4 standardized, video-recorded, simulated transports in real ambulances. EMS providers will document care in a simulated EMS medical record to create a unique dataset of paired video and chart records. In Aim 1, we will measure between group differences after blinded raters use video review to score serious safety events on the simulation tool-kit checklist. In Aim 2, raters will use an EMS chart review tool to identify serious safety events in paired video and chart records using both review methods in a randomized crossover design. This R01 will generate the first efficacy evidence for teleconsultation as an innovative prehospital intervention for children by demonstrating reduced harm in high- risk prehospital settings and illuminating patient safety blind spots in surveillance methods. We will advance the field by providing the scientific basis for EMS systems to adopt new models of care to achieve EMS 2050 goals.
