Efficacy of teleconsultation to improve prehospital patient safety for critically ILL infants and children - a multicenter, simulation-based randomized control trial

Active Project Grant Awarded Last action

Award ID
R01HD115574
Recipient
Awarding agency
Obligated
$3,154,070

Award facts

Completion date 44% complete
Place of performance
Roxbury, MA 02118, USA

Award details come from USAspending.gov.

Description

Abstract
The emergency medical services (EMS) 2050 agenda for future systems envisions that telehealth tools could make prehospital care safer and more effective, but few EMS systems use video technology. Teleconsultation with pediatric experts reduces in-hospital errors in children, but whether IT prevents prehospital harm-a national priority-is unknown. To guide EMS systems, we need prehospital trials demonstrating patient safety benefits for critically ILL infants and children, a high risk group for prehospital error. Video use could also help EMS systems track and measure INTERVENTION effects as the most common method, chart review, underestimates safety event (care could/did cause harm) prevalence and may lack sensitivity to measure changes in care safety and quality with real-world use. The R01 objective is to test the efficacy of teleconsultation to reduce harm in a controlled prehospital setting using in situ simulation, an innovative technique to test early stage INTERVENTION effects on clinical processes with real multidisciplinary teams in actual prehospital environments. In prior KL2/K23 awards, we designed a prototype platform using scalable low-cost technology, validated a simulation model and tool-kit to study safety events in critical pediatric transports, and demonstrated INTERVENTION acceptability and feasibility in a pilot simulation randomized controlled trial (RCT). Now, we will test INTERVENTION efficacy (aim 1) and compare safety surveillance methods (aim 2) to target two critical gaps. In aim 1, we will test the efficacy of teleconsultation with pediatric emergency physicians using video (INTERVENTION) versus usual care physicians using audio (CONTROL) communication with EMS teams to reduce serious safety events (cause moderate-severe harm/death, primary outcome) in the simulation model. In aim 2, we will compare the frequency, type, and reasons for differences in serious safety event detection (primary outcome) when using video review versus chart review methods. We will conduct a multicenter, single-blind, parallel-arm, simulation RCT in the pediatric emergency care applied research network (PECARN) and its EMS affiliates to enroll a diverse cohort and leverage EMS collaborations and research infrastructure for high-quality generalizable results. We will randomize real-world EMS-physician teams to teleconsultation or CONTROL arms. Each team will complete 4 standardized, video-recorded, simulated transports in real ambulances. EMS providers will document care in a simulated EMS medical record to create a unique dataset of paired video and chart records. In aim 1, we will measure between group differences after blinded raters use video review to score serious safety events on the simulation tool-kit checklist. In aim 2, raters will use an EMS chart review tool to identify serious safety events in paired video and chart records using both review methods in a randomized crossover design. This R01 will generate the first efficacy evidence for teleconsultation as an innovative prehospital INTERVENTION for children by demonstrating reduced harm in high- risk prehospital settings and illuminating patient safety blind spots in surveillance methods. We will advance the field by providing the scientific basis for EMS systems to adopt new models of care to achieve EMS 2050 goals.

Transactions

Action Obligated Date
Amendment $99,517
Amendment $746,787
Amendment $748,636
Original award $812,343

Subawards

Subrecipient Amount Awarded
Children's Hospital LOS Angeles "Enrolling Site investigators:The site-PI is responsible for supervising the site-RC to review site EMS protocols, equipment, and EMR systems to prepare for… $100,315
University Of California, Davis Dr. Nishijima will be a core team co-investigator. As the EMS Scientific Advisor for the PRIME node, Dr. Nishijima will be the primary mentor for Dr. Boyle… $25,404
University Of Utah "Dr. Barney will be responsible for all aspects of the proposed DCC including preparation of reports to the funding agency, representation at teleconferences… $143,181
The Regents Of The University Of Colorado Enrolling Site investigators: The site-PI is responsible for supervising the site-RC to review site EMS protocols, equipment, and EMR systems to prepare for… $15,740
Yale Univ Simulation research and patient safety expert Marc Auerbach, MD, MSc: Dr. Auerbach will be a coinvestigator on the lead study team. He will work with the… $23,217
Children's Research Institute The site-PI, Caleb Ward, is responsible for supervising the site-RC to review site EMS protocols, equipment, and EMR systems to prepare for simulations; and IRB… $32,321
University Of Utah Dr. Barney will be responsible for all aspects of the proposed DCC including preparation of reports to the funding agency, representation at teleconferences and… $151,838
University Of California, Davis Dr. Nishijima will be a core team co-investigator. As the EMS Scientific Advisor for the PRIME node, Dr. Nishijima will be the primary mentor for Dr. Boyle… $25,404
The Research Foundation For The State University Of New York Prehospital research advisor; E. Brooke Lerner, PhD: Dr. Lerner will be a co-investigator on the lead study team. She will provide prehospital research… $100,317
The Regents Of The University Of Colorado Enrolling Site investigators: The site-PI is responsible for supervising the site-RC to review site EMS protocols, equipment, and EMR systems to prepare for… $95,065
Yale Univ Simulation research and patient safety expert Marc Auerbach, MD, MSc: Dr. Auerbach will be a co-investigator on the lead study team. He will work with the study… $28,690
University Of California, Davis Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized… $25,404
University Of Utah $223,785
Yale Univ $112,219
The Research Foundation For The State University Of New York $35,819
Children's Research Institute Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized… $4,594
The Regents Of The University Of Colorado Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized… $26,468
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Quick answers

Who received award R01HD115574?

R01HD115574 was awarded to Boston Medical Center Corporation by National Institute of Child Health and Human Development (National Institutes of Health) on September 1, 2024.

How much is award R01HD115574 worth?

$3,154,070 has been obligated on R01HD115574.

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