NCT06441760 Simulation Trial of Telemedical Support for Paramedics
| NCT ID | NCT06441760 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Medical Center |
| Condition | Emergencies |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2025-07-10 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 420 participants in total. It began in 2025-07-10 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * EMS personnel providing interfacility transport and/or pediatric specialty transport * Resident physicians-in-training * Non-physician providers
Contact & Investigator
Tehnaz Boyle, MD PhD
PRINCIPAL INVESTIGATOR
Bosotn Medical Center, Pediatrics Department
Frequently Asked Questions
Who can join the NCT06441760 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Emergencies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06441760 currently recruiting?
Yes, NCT06441760 is actively recruiting participants. Contact the research team at tehnaz.boyle@bmc.org for enrollment information.
Where is the NCT06441760 trial being conducted?
This trial is being conducted at Aurora, United States, New Haven, United States, Boston, United States, Salt Lake City, United States.
Who is sponsoring the NCT06441760 clinical trial?
NCT06441760 is sponsored by Boston Medical Center. The principal investigator is Tehnaz Boyle, MD PhD at Bosotn Medical Center, Pediatrics Department. The trial plans to enroll 420 participants.