Simulation Trial of Telemedical Support for Paramedics

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Boston Medical Center
Study ID
NCT06441760
Status
Recruiting
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Conditions

  • Acute Respiratory Failure
  • Cardiopulmonary Arrest
  • Emergencies
  • Status Epilepticus

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Video teleconsultation — OTHER
    Each team will participate in 4 video-recorded simulated transports in fully equipped ambulances. Each team will provide resuscitative care in 4 simulated high-risk pediatric transports. EMS personnel will provide care in the ambulance while PEM physicians will provide medical direction remotely using video to communicate with EMS personnel via tablet devices.
  • Audio support — OTHER
    Each team will participate in 4 video-recorded simulated transports in fully equipped ambulances. Each team will provide resuscitative care in 4 simulated high-risk pediatric transports. EMS personnel will provide care in the ambulance while EM physicians will provide medical direction remotely using audio to communicate with EMS personnel via tablet devices.

Study Details

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

Key Dates

Start date
Jul 10, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Teleconsultation video arm with PEM physicians
    Emergency Medical Services (EMS) providers randomized into this arm will receive video teleconsultation with Pediatric Emergency Medicine (PEM) physicians.
  • Active Comparator: Audio support arm with EM physicians
    EMS providers randomized into this arm will receive audio support by usual care Emergency Medicine (EM) physicians.

Primary Outcome Measure

Number of Serious Safety Events [ Time Frame: Post treatment usually 4 hours ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Children's Hospital Colorado, University of Colorado Denver Anschutz Medical CampusAuroraColorado80045
Kathleen Adelgais, MD
[email protected]
303-724-1055
Yale UniversityNew HavenConnecticut06520
Marc Auerbach, MD
[email protected]
203-785-4688
BostonMedical CenterBostonMassachusetts02118
Tehnaz Boyle, MD PhD
[email protected]
617-414-3682
University of UtahSalt Lake CityUtah84112
Bradley Barney, PhD
[email protected]
801-581-3655

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado, University of Colorado Denver Anschutz Medical Campus· Aurora, COYale University· New Haven, CTBostonMedical Center· Boston, MAUniversity of Utah· Salt Lake City, UT

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