CClinicalTrials.gg
RecruitingNCT06441760R01Updated Jun 30, 2026

Simulation Trial of Telemedical Support for Paramedics

An interventional study of Video teleconsultation and Audio support in Emergencies, Cardiopulmonary Arrest and Acute Respiratory Failure, sponsored by Boston Medical Center. Recruiting at 9 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Boston Medical Center · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
420
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • 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
03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's planned enrollment of 420 is above the median of 145 across 931 interventional studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

Boston Medical Center is the lead sponsor of 314 studies on the registry; 34 are open to participants now.

Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • EMS personnel providing interfacility transport and/or pediatric specialty transport
  • Resident physicians-in-training
  • Non-physician providers
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
420 participants (estimated)

Study 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.

    Other: Video teleconsultation

  • 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

Interventions

  • OtherVideo 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.

  • OtherAudio 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.

06

What researchers measure

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.

    Time frame: Post treatment usually 4 hours

Secondary outcomes

  1. Harm score

    The harm score is calculated from the serious safety event checklist for each scenario type. The harm score is the percentage of observable serious safety events that are present among all possible observable serious safety events possible in the checklist. The denominator includes the total number of items measuring observable serious safety events that could occur independently; items scored as non-observable are excluded. For serious safety events that depend on the ABSENCE of a "parent" error (e.g., CPR indicated, but not done"), the denominator for the Harm Score percentage is the total number of observable "child" events (e.g., "Use of compression-only CPR" or "Delayed compressions \>1 minute in unresponsive patient with no pulse"). This is to avoid deflating the harm score for teams where parent SSEs occur, and so child SSEs cannot occur (i.e., are not possible).

    Time frame: Post treatment usually 4 hours

  2. Error in medication choice

    Errors in medication choice are measured by specific items within the serious safety event checklist. 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 that measure medication choice that were scored as the error being present over all possible items related to medication choice.

    Time frame: Post treatment usually 4 hours

  3. Error in weight-based medication dosing

    These are measured by specific items within the serious safety event checklist. 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 present over all possible items related to weight-based medication dosing.

    Time frame: Post treatment usually 4 hours

  4. Equipment size error

    These are measured by specific items within the serious safety event checklist. 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 present over all possible items related to equipment sizing.

    Time frame: Post treatment usually 4 hours

  5. EMS protocol error

    These are measured by specific items within the serious safety event checklist. These will be any error, omission 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 present over all possible items related to selection of appropriate EMS protocols.

    Time frame: Post treatment usually 4 hours

  6. Equipment Use Error

    These are measured by specific items within the serious safety event checklist. These will be any error in equipment usage during each case. This will be reported as the proportion or percentage of items scored as present over all possible items related to equipment use.

    Time frame: Post treatment usually 4 hours

07

Study locations

4 of 9 sites recruiting
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
    Recruiting
  • Children's Hospital Colorado, University of Colorado Denver Anschutz Medical Campus
    Aurora, Colorado 80045, United States
    Recruiting
  • Yale University
    New Haven, Connecticut 06520, United States
    Active, not recruiting
  • Children's National Medical Center
    Washington D.C., District of Columbia 20010, United States
    Not yet recruiting
  • BostonMedical Center
    Boston, Massachusetts 02118, United States
    Recruiting
  • University at Buffalo
    Buffalo, New York 14203, United States
    Recruiting
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
    Not yet recruiting
  • University of Utah
    Salt Lake City, Utah 84112, United States
    Not yet recruiting
  • University of Washington
    Seattle, Washington 98105, United States
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06441760
Lead sponsor
Boston Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Jun 4, 2024
Start date
Jul 10, 2025
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jun 30, 2026

Study contacts

Tehnaz Boyle, MD PhD
Contact
tehnaz.boyle@bmc.org
617-414-3682
Robert Seitter, MS
Contact
Robert.seitter@bmc.org
781 571 2664
Tehnaz Boyle, MD PhD
principal investigator · Bosotn Medical Center, Pediatrics Department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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