Feasibility and Efficacy of Ambulance-Based mhealth for Pediatric Emergencies (FEAMER) Trial - Introduction: The overall goal of our research project is to reduce the mortality and morbidity of children with
acute and emergency illnesses by improving care during ambulance transportation using telemedicine. In the
R21 phase, we proved the feasibility of conducting an ambulance-based telemedicine cluster randomized trial.
Specific Aims for the R33 phase: The R21 phase had three aims, while the R33 phase have the following two
aims, which remain unchanged from our initial proposal.
- SA 4: To test the efficacy of Ambulance Based Teleconsultation (ABT) by measuring a change in the
Pediatric Early Warning Signs (PEWS) of acutely ill children from the scene of injury/illness to the
pediatric emergency department (PED) through a cluster-randomized trial.
- SA 5: To develop the capacity of local partners in m-health research capacity.
Methodology: SA4 will be a prospective cluster randomized trial with each ambulance serving as a cluster. We
will use a stratified random sampling design to assign 30 ambulances to receive the ABT setup, while 30 others
will serve as control clusters. Our primary outcome will be a change in the Pediatric Early Warning Score from
the scene of illness/injury to the hospital triage/resuscitation room. Our secondary outcomes will be % of
completed calls, the satisfaction rate of EMTs and Telemedicine Physicians, and the outcome at the end of the
ED visit. We will work with our existing partners and use the same telemedicine setup as tested in the R21 phase.
We will use the SIEHS EMTs who were part of the intervention and control ambulances during the R21 phase to
work with the research team as trainers for the rest of the service. Our minimum required sample size of 600
(300 each in intervention and control clusters) remains unchanged. The only change in the data collection
process will be the incorporation of Emergency Department PEWS in the standard electronic medical record by
the ChildLife Foundation. This will ensure consistent and timely access to PEWS scores during the trial. As tested
in the R21 phase, we will store identifiable data in a codebook on a password-protected institutional drive
accessible to the research team only. After both sets of PEWS have been completed and follow-up consent has
been received, the data will be de-identified and made accessible for analysis. Concurrently, we will share data
on outcomes with the currently existing Data Safety Monitoring Board at 10%, 25%, 50%, 75%, and 100% levels
of enrollment. Table 1 summarizes the milestones for SA4.
For SA5, we will build capacity on telemedicine/telehealth research and will further strengthen expertise in
emergency care clinical trials in Pakistan. This will be achieved through quarterly webinars, two workshops, and
one national seminar. Additionally, we plan to support the training of SIEHS ambulance in modern prehospital
care systems through one study visit to a regional or international center of excellence.
Expected Outcomes: The findings from this research are expected to yield critical safety and efficacy data,
which will serve to address the shortage of well-trained medical personnel in pediatric emergency care within
low- and middle-income countries, potentially impacting more than 50% of global pediatric mortality.
Furthermore, the insights gained from this study can have significant relevance for underserved rural
communities in high-income countries, such as the United States. Particularly in regions where ambulance
services heavily rely on the commitment of part-time community volunteers, often operating across extended
distances.
