Clinical trial NCT06441760: Simulation Trial of Telemedical Support for Paramedics
Official title: Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-06-04
Enrollment: 420
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Serious Safety Events
timeFrame: Post treatment usually 4 hours
Secondary outcomes:
measure: Composite team score
timeFrame: Post treatment usually 4 hours
measure: Error in medication choice
timeFrame: Post treatment usually 4 hours
measure: Error in weight-based medication dosing
timeFrame: Post treatment usually 4 hours
measure: Equipment size error
timeFrame: Post treatment usually 4 hours
measure: EMS protocol error
timeFrame: Post treatment usually 4 hours
measure: Equipment Use Error
timeFrame: Post treatment usually 4 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: BostonMedical Center
state: Massachusetts
Study officials:
affiliation: Bosotn Medical Center, Pediatrics Department
name: Tehnaz Boyle, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: