NCT06441760Recruiting
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
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 420 (estimated)
- First submitted
- 29 May 2024
- Start date
- 10 Jul 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- Boston Medical Center
- NCT number
- NCT06441760
What you commit to
- Study type: Interventional
- Planned participants: 420
- From 10 Jul 2025 to the primary completion date, Dec 2028
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- EMS personnel providing interfacility transport and/or pediatric specialty transport
- Resident physicians-in-training
- Non-physician providers
Who the study is looking for
- 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.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Colorado, University of Colorado Denver Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| BostonMedical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University at Buffalo Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Not yet recruiting |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Active, not recruiting |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Not yet recruiting |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Not yet recruiting |
| Children's National Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.