NCT Number: NCT06441760
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
Interested in participating?
Request Info21 year and older
All sexes
Interventional
Not applicable
Children's Hospital Los Angeles, Los Angeles, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Post treatment usually 4 hours
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 hours
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 hours
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 hours
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 hours
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.
Time frame: Post treatment usually 4 hours
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.
Contact information is provided by the study sponsor or research team.
Robert Seitter, MS
CONTACT
Tehnaz Boyle, MD PhD
CONTACT
Boston Medical Center
Other
Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized Control Trial
Acronym: R01
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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