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Clinical Trials/NCT06441760
NCT06441760
Recruiting
Not Applicable

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

Boston Medical Center4 sites in 1 country420 target enrollmentJuly 10, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emergencies
Sponsor
Boston Medical Center
Enrollment
420
Locations
4
Primary Endpoint
Number of Serious Safety Events
Status
Recruiting
Last Updated
9 months ago

Overview

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
Registry
clinicaltrials.gov
Start Date
July 10, 2025
End Date
December 1, 2028
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Number of Serious Safety Events

Time Frame: Post treatment usually 4 hours

Serious safety events are defined as clinical care actions that reach the patient and have the potential to cause moderate-to-severe harm or death. An investigator developed predefined serious safety event checklist developed for each simulated transport scenario will be used to record serious safety events. Serious safety events will be scored as: present, absent, or not observable.

Secondary Outcomes

  • Error in medication choice(Post treatment usually 4 hours)
  • EMS protocol error(Post treatment usually 4 hours)
  • Composite team score(Post treatment usually 4 hours)
  • Error in weight-based medication dosing(Post treatment usually 4 hours)
  • Equipment Use Error(Post treatment usually 4 hours)
  • Equipment size error(Post treatment usually 4 hours)

Study Sites (4)

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