RECRUITING

Simulation Trial of Telemedical Support for Paramedics

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-07
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06441760

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Certified Emergency Medical Technicians (EMTs), Advanced EMTs (AEMTs), and Paramedics (EMT-Ps) who provide direct scene response.
  2. * Board-certified Pediatric Emergency Medicine (PEM) and Emergency Medicine (EM) physicians whose practice includes online medical support for EMS are eligible.
  3. * 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.
  1. * EMS personnel providing interfacility transport and/or pediatric specialty transport
  2. * Resident physicians-in-training
  3. * Non-physician providers

Contacts and Locations

Study Contact

Tehnaz Boyle, MD PhD
CONTACT
617-414-3682
tehnaz.boyle@bmc.org
Divya Gumudavelly, MPH
CONTACT
248-787-0876
divya.gumudavelly@bmc.org

Principal Investigator

Tehnaz Boyle, MD PhD
PRINCIPAL_INVESTIGATOR
Bosotn Medical Center, Pediatrics Department

Study Locations (Sites)

Children's Hospital Colorado, University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Yale University
New Haven, Connecticut, 06520
United States
BostonMedical Center
Boston, Massachusetts, 02118
United States
University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Boston Medical Center

  • Tehnaz Boyle, MD PhD, PRINCIPAL_INVESTIGATOR, Bosotn Medical Center, Pediatrics Department

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-07
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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