NCT06441760

Simulation Trial of Telemedical Support for Paramedics

Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized Control Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

In the United States, the current standard of prehospital (i.e. outside of hospitals) emergency care for children with life-threatening illnesses in the community includes remote physician support for paramedics providing life-saving therapy while transporting the child to the hospital. Most prehospital emergency medical services (EMS) agencies use radio-based (audio only) communication between paramedics and physicians to augment this care. However, this communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment. The purpose of this pilot randomized controlled trial (RCT) is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life threatening illness (respiratory failure). Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. Because real pediatric life-threatening illnesses are rare, high stakes events and involve a vulnerable population (children), this RCT will test the effect of the intervention on paramedic performance in simulated cases of pediatric medical emergencies. The two specific aims for this research are: * Aim 1: To test the intervention efficacy by determining if there is a measurable difference in the frequency of serious safety events between study groups * Aim 2: To compare two safety event detection methods, medical record review, and video review

Conditions

• Emergencies
• Cardiopulmonary Arrest
• Acute Respiratory Failure
• Status Epilepticus

Interventions

Type	Name	Description
OTHER	Video teleconsultation	Each team will participate in 4 video-recorded simulated transports in fully equipped ambulances. Each team will provide resuscitative care in 4 simulated high-risk pediatric transports. EMS personnel will provide care in the ambulance while PEM physicians will provide medical direction remotely using video to communicate with EMS personnel via tablet devices.
OTHER	Audio support	Each team will participate in 4 video-recorded simulated transports in fully equipped ambulances. Each team will provide resuscitative care in 4 simulated high-risk pediatric transports. EMS personnel will provide care in the ambulance while EM physicians will provide medical direction remotely using audio to communicate with EMS personnel via tablet devices.

Timeline

• Start date: 2025-07-10
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2024-06-04
• Last updated: 2025-07-14

Locations

4 sites across 1 country: United States