Simulation Trial of Telemedical Support for Paramedics

Official title

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

Overview

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

Interventions

• Other Video teleconsultation
  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.
• Other Audio support
  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.

Primary outcome measures

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

Secondary outcome measures (6)

• Harm score [Time frame: Post treatment usually 4 hours]
• Error in medication choice [Time frame: Post treatment usually 4 hours]
• Error in weight-based medication dosing [Time frame: Post treatment usually 4 hours]
• Equipment size error [Time frame: Post treatment usually 4 hours]
• EMS protocol error [Time frame: Post treatment usually 4 hours]
• Equipment Use Error [Time frame: Post treatment usually 4 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 9 centers

• Children's Hospital Los Angeles — Los Angeles
• Children's Hospital Colorado, University of Colorado Denver Anschutz Medical Campus — Aurora
• Yale University — New Haven
• Children's National Medical Center — Washington D.C.
• BostonMedical Center — Boston
• University at Buffalo — Buffalo
• Cincinnati Children's Hospital Medical Center — Cincinnati
• University of Utah — Salt Lake City
• … and 1 more center

Identifiers

NCT: NCT06441760 · H-44972 · 1R01HD115574-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗