Simulation Trial of Telemedical Support for Paramedics

NCT06441760 | Recruiting

• 2 other identifiers: H-449721R01HD115574-01
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 4

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

Conditions

Emergencies; Cardiopulmonary Arrest; Acute Respiratory Failure; Status Epilepticus

Keywords

Prehospital emergency care; Emergency medical services (EMS); Paramedics; Infant simulator mannequins; Telemedical support; Critically ill infants and children; Pediatric emergencies

Outcome Measures

Primary Outcomes (1)

• Number of Serious Safety Events

  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.

  Post treatment usually 4 hours

Secondary Outcomes (6)

• Composite team score

  Post treatment usually 4 hours

• Error in medication choice

  Post treatment usually 4 hours

• Error in weight-based medication dosing

  Post treatment usually 4 hours

• Equipment size error

  Post treatment usually 4 hours

• EMS protocol error

  Post treatment usually 4 hours

Study Arms (2)

Teleconsultation video arm with PEM physicians

EXPERIMENTAL

Emergency Medical Services (EMS) providers randomized into this arm will receive video teleconsultation with Pediatric Emergency Medicine (PEM) physicians.

Other: Video teleconsultation

Audio support arm with EM physicians

ACTIVE COMPARATOR

EMS providers randomized into this arm will receive audio support by usual care Emergency Medicine (EM) physicians.

Other: Audio support

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.

Teleconsultation video arm with PEM physicians

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.

Audio support arm with EM physicians

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• EMS personnel providing interfacility transport and/or pediatric specialty transport
• Resident physicians-in-training
• Non-physician providers

Sponsors & Collaborators

• Boston Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

Children's Hospital Colorado, University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

BostonMedical Center

Boston, Massachusetts, 02118, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Emergencies; Heart Arrest; Status Epilepticus

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Tehnaz Boyle, MD PhD

  Bosotn Medical Center, Pediatrics Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tehnaz Boyle, MD PhD

CONTACT

617-414-3682; tehnaz.boyle@bmc.org

Divya Gumudavelly, MPH

CONTACT

248-787-0876; divya.gumudavelly@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All participants will be blinded to the simulated transport scenarios.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blind, parallel arm, multicenter simulation RCT of prehospital teams from 9 Pediatric Emergency Care Applied Research Network (PECARN) and non-PECARN sites

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: July 10, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)