Simulation Trial of Telemedical Support for Paramedics (R01)

July 11, 2025 updated by: Boston Medical Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Children's Hospital Colorado, University of Colorado Denver Anschutz Medical Campus
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • BostonMedical Center
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post treatment usually 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite team score
Time Frame: Post treatment usually 4 hours
The composite team performance score is calculated from the modified Lammer's simulation checklist tool as the percentage of completed actions that can be observed during the simulation by either video review or in person observation. This checklist tool contains 171 items across 3 simulated transport scenarios that represent critical actions expected for optimal care performance.
Post treatment usually 4 hours
Error in medication choice
Time Frame: Post treatment usually 4 hours
Errors in medication choice are measured by specific items within the modified Lammer's simulation checklist tool. These will be any incorrect type of medication used by a team during simulation, including unanticipated medication choices which raters feel was not indicated or potentially harmful by consensus opinion. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to medication choice.
Post treatment usually 4 hours
Error in weight-based medication dosing
Time Frame: Post treatment usually 4 hours
These are measured by specific items within modified Lammer's simulation checklist tool. These will be any error in pediatric weight-based dose calculation, including error in volume of administered drug. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to weight-based medication dosing.
Post treatment usually 4 hours
Equipment size error
Time Frame: Post treatment usually 4 hours
These are measured by specific items within the modified Lammer's simulation checklist tool. These will be any error in size of equipment used during each case. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to equipment sizing
Post treatment usually 4 hours
EMS protocol error
Time Frame: Post treatment usually 4 hours
These are measured by specific items within the modified Lammer's simulation checklist tool. These will be any error observed omission, error, or deviation in offline and online EMS treatment protocols that could result in patient harm. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to selection of appropriate EMS protocols.
Post treatment usually 4 hours
Equipment Use Error
Time Frame: Post treatment usually 4 hours
These are measured by specific items within the modified Lammer's simulation checklist tool. These will be any error in equipment usage during each case. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to equipment use.
Post treatment usually 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Tehnaz Boyle, MD PhD, 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 Major Dates

Study Start (Actual)

July 10, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

May 29, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 11, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-44972
  • 1R01HD115574-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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