Simulation Trial of Telemedical Support for Paramedics (NCT06441760)
Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized Control Trial
๐ฉบ Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Children's Hospital Los Angeles โ Los Angeles, California
Age range: 21 Years
๐งช Interventions in This Study
- Video teleconsultation (OTHER)
- Audio support (OTHER)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (9 Sites)
- Children's Hospital Los Angeles โ Los Angeles, California
- Children's Hospital Colorado, University of Colorado Denver Anschutz Medical Campus โ Aurora, Colorado
- Yale University โ New Haven, Connecticut
- Children's National Medical Center โ Washington D.C., District of Columbia
- BostonMedical Center โ Boston, Massachusetts
- University at Buffalo โ Buffalo, New York
- Cincinnati Children's Hospital Medical Center โ Cincinnati, Ohio
- University of Utah โ Salt Lake City, Utah
- University of Washington โ Seattle, Washington
๐ Contact the Study Coordinator
Phone: (617) 414-3682
Email: tehnaz.boyle@bmc.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.