Simulation Trial of Telemedical Support for Paramedics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorBoston Medical Center
About this 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.
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
EMS personnel providing interfacility transport and/or pediatric specialty transport
Resident physicians-in-training
Non-physician providers
Trial design
Design model
Parallel
Treatments tested in this trial
Video teleconsultation
Other interventionEach 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
Other interventionEach 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.
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: Teleconsultation video arm with PEM physiciansExperimental treatment 1 intervention
Group B: Audio support arm with EM physiciansActive comparator 1 intervention
Trial outcomes
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 hoursSecondary 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 hours2
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 hours3
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 hours4
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 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston Medical Center
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov