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

NIH RePORTER · NIH · R33 · $258,943 · view on reporter.nih.gov ↗

Abstract

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. Ex...

Key facts

NIH application ID
11064186
Project number
4R33HD103049-03
Recipient
WEILL MEDICAL COLL OF CORNELL UNIV
Principal Investigator
Junaid Abdul Razzak
Activity code
R33
Funding institute
NIH
Fiscal year
2024
Award amount
$258,943
Award type
4C
Project period
2024-07-10 → 2027-06-30