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Simulation Trial of Telemedical Support for Paramedics
NCT06441760 · Boston Medical Center
In plain English
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Official title
Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized Control Trial
About this study
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
Study design
Enrollment target: 420 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-07-10
Estimated completion: 2028-12
Last updated: 2025-07-14
Interventions
Other: Video teleconsultationOther: Audio support
Primary outcomes
- • Number of Serious Safety Events (Post treatment usually 4 hours)
Sponsor
Boston Medical Center · other
With: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contacts & investigators
ContactTehnaz Boyle, MD PhD · contact · tehnaz.boyle@bmc.org · 617-414-3682
ContactDivya Gumudavelly, MPH · contact · divya.gumudavelly@bmc.org · 248-787-0876
InvestigatorTehnaz Boyle, MD PhD · principal_investigator, Bosotn Medical Center, Pediatrics Department
All locations (4)
Children's Hospital Colorado, University of Colorado Denver Anschutz Medical CampusNot Yet Recruiting
Aurora, Colorado, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
BostonMedical CenterRecruiting
Boston, Massachusetts, United States
University of UtahNot Yet Recruiting
Salt Lake City, Utah, United States