Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized Control Trial
Project Number1R01HD115574-01
Contact PI/Project LeaderBOYLE, TEHNAZ PARAKH
Awardee OrganizationBOSTON MEDICAL CENTER
Description
Abstract Text
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.
Public Health Relevance Statement
PROJECT NARRATIVE
The Emergency Medical Services (EMS) 2050 Agenda for Future Systems envisions integration of telehealth
tools to make prehospital care safer and more effective, so we need to demonstrate whether this technology
can improve patient safety. This study tests the efficacy of using low-cost, mobile technology for infants and
children who need life-saving care outside hospitals in two ways—(1) using pediatric experts in hospitals to
support EMS clinicians in ambulances by video, and (2) reviewing video recorded EMS encounters as a
method to measure care safety and quality. If this strategy produces measurably safer care with real EMS-
physician teams in realistic simulated environments, it will provide the scientific basis for EMS systems to
adopt and use telehealth tools to improve care for children.
NIH Spending Category
No NIH Spending Category available.
Project Terms
AddressAdoptedAdoptionAdverse effectsAgreementAmbulancesApplied ResearchBenefits and RisksBlindedCaringCessation of lifeChildChild CareChildhoodClinicalCollaborationsCommunicationCommunity ServicesConsultationsCritical IllnessCritically ill childrenCrossover DesignData SetDecision MakingDetectionElectronicsEmergency CareEmergency Department PhysicianEmergency medical serviceEnrollmentEnvironmentEquipoiseEventFrequenciesFundingFutureGoalsHarm ReductionHealth Services ResearchHospital safetyHospitalsIn SituInfantInfrastructureInterdisciplinary StudyInterventionInvestmentsLifeMeasurableMeasuresMedical RecordsMentored Patient-Oriented Research Career Development AwardMethodsModelingOutcomeOutcome AssessmentOutcome MeasurePaperParamedical PersonnelPatientsPhysiciansPre-hospital settingPre-hospitalization carePrevalenceProcessProtocols documentationRadioRandomizedRandomized, Controlled TrialsRecordsReportingResearchResearch InfrastructureResuscitationRetinal blind spotRisk ReductionSafetyService delivery modelSingle-Blind StudyStandardizationSurveillance MethodsSystemTechniquesTechnologyTelephoneTestingTimeTreatment EfficacyVariantVideo Recordingacceptability and feasibilityarmclinical encounterclinical implementationcohortcostdesigneffectiveness trialefficacy researchefficacy testingevidence basehigh riskhigh risk populationimprovedimproved outcomeinnovationintervention effectmobile computingmodels and simulationmultidisciplinarypatient health informationpatient safetypediatric emergencypreventprimary outcomeprototyperandomized trialresuscitative caresafety studyservice providerssimulationteleconsultationtelehealthtooltreatment as usual
Eunice Kennedy Shriver National Institute of Child Health and Human Development
CFDA Code
865
DUNS Number
005492160
UEI
JZ8RQC4EMDZ5
Project Start Date
01-September-2024
Project End Date
31-August-2029
Budget Start Date
01-September-2024
Budget End Date
31-August-2025
Project Funding Information for 2024
Total Funding
$812,343
Direct Costs
$565,244
Indirect Costs
$247,099
Year
Funding IC
FY Total Cost by IC
2024
Eunice Kennedy Shriver National Institute of Child Health and Human Development
$812,343
Year
Funding IC
FY Total Cost by IC
Sub Projects
No Sub Projects information available for 1R01HD115574-01
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