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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• Certified Emergency Medical Technicians (EMTs), Advanced EMTs (AEMTs), and Paramedics (EMT-Ps) who provide direct scene response.

• Board-certified Pediatric Emergency Medicine (PEM) and Emergency Medicine (EM) physicians whose practice includes online medical support for EMS are eligible.

• The control arm will include physicians who provide radio/telephone support in usual care at each site. In the intervention arm, experts will be PEM with/without EMS board-certification as they have relevant pediatric training and experience.

Locations
United States
Colorado
Children's Hospital Colorado, University of Colorado Denver Anschutz Medical Campus
NOT_YET_RECRUITING
Aurora
Connecticut
Yale University
RECRUITING
New Haven
Massachusetts
BostonMedical Center
RECRUITING
Boston
Utah
University of Utah
NOT_YET_RECRUITING
Salt Lake City
Contact Information
Primary
Tehnaz Boyle, MD PhD
tehnaz.boyle@bmc.org
617-414-3682
Backup
Divya Gumudavelly, MPH
divya.gumudavelly@bmc.org
248-787-0876
Time Frame
Start Date: 2025-07-10
Estimated Completion Date: 2028-12
Participants
Target number of participants: 420
Treatments
Experimental: Teleconsultation video arm with PEM physicians
Emergency Medical Services (EMS) providers randomized into this arm will receive video teleconsultation with Pediatric Emergency Medicine (PEM) physicians.
Active_comparator: Audio support arm with EM physicians
EMS providers randomized into this arm will receive audio support by usual care Emergency Medicine (EM) physicians.
Sponsors
Leads: Boston Medical Center
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov