Simulation Trial of Telemedical Support for Paramedics (R01)

Boston Medical Center (BMC)

Status: Enrolling

Conditions: Status Epilepticus; Emergencies; Cardiopulmonary Arrest; Acute Respiratory Failure

Treatments: Other: Video teleconsultation; Other: Audio support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06441760

H-44972

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

Details and patient eligibility

About

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

Enrollment: 420 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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420 participants in 2 patient groups

Teleconsultation video arm with PEM physicians

Experimental group

Description:

Emergency Medical Services (EMS) providers randomized into this arm will receive video teleconsultation with Pediatric Emergency Medicine (PEM) physicians.

Treatment:

Other: Video teleconsultation

Audio support arm with EM physicians

Active Comparator group

Description:

EMS providers randomized into this arm will receive audio support by usual care Emergency Medicine (EM) physicians.

Treatment:

Other: Audio support