Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441760
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-29
Brief Title:
Simulation Trial of Telemedical Support for Paramedics
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter Simulation-based Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
R01
Brief Summary:
In the United States the current standard of prehospital ie 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None