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Feasibility and Efficacy of Ambulance-Based m-Health for Pediatric Emergencies (FEAMER) Trial

ConditionsEmergenciesmHealthChild HealthCritical Illness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-14
SponsorWeill Medical College of Cornell University

About this trial

Investigators hypothesize that in a low-resource setting, linking ambulances that transport acutely ill children to a remote pediatric emergency physician using a simple audio-video device will improve the quality of these children's medical decisions and health outcomes. For this purpose, the investigators will conduct a study in Karachi, Pakistan, where they will collect medical data for ill children at the time of ambulance pickup, hospital drop-off, and during hospital triage. During transport, one group will receive a telemedicine call from a trained physician, while the other group will receive basic paramedic treatment. The investigators will then compare both groups.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 0-14 years

Children transported by an SIEHS ambulance with a transport time of ≥20 minutes

Children presenting to the ChildLife Emergency Department with a parent/ guardian present in the ambulance to consent

Children classified as "Charlie, Delta, Echo" on the Medical Priority Dispatch System

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telemedicine

    Other intervention

    Provision of Telemedicine support to pediatric patients during ambulance transport.

  • Control

    Other intervention

    Provision of ambulance transport without any telemedicine support.

Treatment groups

900 Participants
are divided into 4 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention
Group C: Telemedicine Physicians (TMPs)No intervention 0 interventions
Group D: Emergency Medical Technicians (EMTs)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Pediatric Early Warning Signs (PEWS) Score

PEWS Score is "0" for a normal patient, and ranges between "1-9" depending upon severity of illness i.e., higher PEWS scores referring to higher severity of illness. Modified Brighton PEWS used in our study accounts for Respiratory rate, Heart Rate, and Appearance.

Time frame
At the ambulance pick up and hospital drop off (>20 minutes)
2

Pediatric Early Warning Signs (PEWS) Score at the ambulance drop off

PEWS Score is "0" for a normal patient, and ranges between "1-9" depending upon severity of illness i.e., higher PEWS scores referring to higher severity of illness. Modified Brighton PEWS used in our study accounts for Respiratory rate, Heart Rate, and Appearance.

Time frame
At the ambulance drop off (>20 minutes)

Secondary outcomes

1

Percent of completed Telemedicine Calls

Time frame
During ambulance ride (>20 minutes)
2

Satisfaction of Emergency Medical Technicians and Telemedicine Physicians as measured by the System Usability Survey

10 questions with a likert scale ranging from 1-5, with a higher score indicating better perceived usability.

Time frame
1 month after the end of trial i.e., completion of study
3

Outcome at end of Emergency Department (ED) Visit

ED mortality

Time frame
On arrival to the ED triage
4

72 hour outcome after the Emergency Department (ED) Visit

72 hour mortality after admission to the hospital

Time frame
Within 72 hours of reaching the ED

Other outcomes

Sponsors and contacts

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Weill Medical College of Cornell University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Aga Khan University

Collaborator

Source ClinicalTrials.gov
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