Simulation Trial of Telemedical Support for Paramedics

Emergencies Clinical Trial

— R01  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441760
• Other study ID #: H-44972
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2028

Study information

• Verified date: June 2024
• Source: Boston Medical Center
• Contact: Tehnaz Boyle, MD PhD
• Phone: 617-414-3682
• Email: tehnaz.boyle[@]bmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 420
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Cardiopulmonary Arrest
• Emergencies
• Heart Arrest
• Respiratory Insufficiency
• Status Epilepticus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	BostonMedical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post treatment usually 4 hours
Secondary	Composite team score	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
Secondary	Error in medication choice	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
Secondary	Error in weight-based medication dosing	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
Secondary	Equipment size error	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
Secondary	EMS protocol error	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
Secondary	Equipment Use Error	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