EmergenciesR01NCT06441760
Simulation Trial of Telemedical Support for Paramedics
A study testing Video teleconsultation and Audio support in people with Emergencies and Cardiopulmonary Arrest, run by Boston Medical Center at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Emergencies, Cardiopulmonary Arrest, Acute Respiratory Failure
- What is being tested?
- Video teleconsultation and Audio support
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 9 sitesUnited States
- Study dates
- 10 Jul 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- EMS personnel providing interfacility transport and/or pediatric specialty transport
- Resident physicians-in-training
- Non-physician providers
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 8 recruiting
- Recruiting
Children's Hospital Colorado, University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045
Kathleen Adelgais, MD, 303-724-1055, kathleen.adelgais@childrenscolorado.org
- Recruiting
BostonMedical Center
Boston, Massachusetts, 02118
Tehnaz Boyle, MD PhD, 617-414-3682, tehnaz.boyle@bmc.org
- Recruiting
University at Buffalo
Buffalo, New York, 14203
Kaori Tanaka, MD, 716-888-4888, kaoritan@buffalo.edu
- Not yet recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Sang Lee, MD, 513-636-2745, SangHoon.Lee@cchmc.org
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Marsha Elkunovich, MD, 323-361-2265, melkunovich@chla.usc.edu
- Active, not recruiting
Yale University
New Haven, Connecticut, 06520
- Not yet recruiting
University of Utah
Salt Lake City, Utah, 84112
Bradley Barney, PhD, 801-581-3655, bradley.barney@hsc.utah.edu
- Not yet recruiting
University of Washington
Seattle, Washington, 98105
Michael Sayrre, MD, 206-987-7804, sayrem@uw.edu
- Not yet recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Caleb Ward, MD, 202-555-3748, cward@childrensnational.org
About this study
Official title: 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.
Read more
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
- Being tested
- Video teleconsultation, Audio support
- Keywords
- Prehospital emergency care, Emergency medical services (EMS), Paramedics, Infant simulator mannequins, Telemedical support, Critically ill infants and children, Pediatric emergencies
- Medical subject headings
- Emergencies, Heart Arrest, Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video teleconsultationOther
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.
Audio supportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Audio support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post treatment usually 4 hours
Secondary outcomes (6)
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).
Measured: Post treatment usually 4 hours
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.
Measured: Post treatment usually 4 hours
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.
Measured: Post treatment usually 4 hours
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.
Measured: Post treatment usually 4 hours
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.
Measured: Post treatment usually 4 hours
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.
Measured: Post treatment usually 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start10 Jul 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind, parallel arm, multicenter simulation RCT of prehospital teams from 9 Pediatric Emergency Care Applied Research Network (PECARN) and non-PECARN sites
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Tehnaz Boyle, MD PhD, Principal investigator, Bosotn Medical Center, Pediatrics Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441760
- Sponsor's protocol ID
- H-44972
- Other IDs
- 1R01HD115574-01
- Acronym
- R01
- Status last verified
- Jun 2026
- First submitted
- 29 May 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06441760
- Acronym / sponsor ID
- R01 / H-44972
- Keywords
- Prehospital emergency care, Emergency medical services (EMS), Paramedics, Infant simulator mannequins, Telemedical support, Critically ill infants and children, Pediatric emergencies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blind, parallel arm, multicenter simulation RCT of prehospital teams from 9 Pediatric Emergency Care Applied Research Network (PECARN) and non-PECARN sites
| Arm | Type | Receives |
|---|---|---|
| Teleconsultation video arm with PEM physicians | Experimental | Other: Video teleconsultationEmergency Medical Services (EMS) providers randomized into this arm will receive video teleconsultation with Pediatric Emergency Medicine (PEM) physicians. |
| Audio support arm with EM physicians | Active comparator | Other: Audio supportEMS providers randomized into this arm will receive audio support by usual care Emergency Medicine (EM) physicians. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- EMS personnel providing interfacility transport and/or pediatric specialty transport
- Resident physicians-in-training
- Non-physician providers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video teleconsultationEach 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 | Teleconsultation video arm with PEM physicians |
| Audio supportEach 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. | Other | Audio support arm with EM physicians |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tehnaz Boyle, MD PhD principal investigator
Bosotn Medical Center, Pediatrics Department
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video teleconsultation and Audio support in people with Emergencies and Cardiopulmonary Arrest, run by Boston Medical Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tehnaz Boyle, MD PhD (617-414-3682, tehnaz.boyle@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Serious Safety Events (time frame: Post treatment usually 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.