Background:

Almost half of all 6.2 million deaths in children worldwide are caused by acute illnesses
such as pneumonia, diarrhea, and injuries and occur disproportionately in low- and
middle-income countries (LMICs). These acute illnesses are mostly treatable if diagnosed
and managed in a timely fashion. According to estimates, about half of these children can
be saved through better emergency care.

Emergency medical care at the scene and during transportation is, therefore, critical to
improving health outcomes. The "Chain of Survival" for cardiac arrest, the "Golden hour"
of trauma, and the "FAST" program for stroke rely heavily on high-quality Emergency
Medical Systems (EMS). For many emergency conditions, triage and care decisions during
transportation play a critical role in the eventual outcome. EMS with staff that are
well-trained in pediatric acute/emergency care are scarce even in high-income countries,
and largely non-existent in LMICs.

There is a critical need - globally, but particularly in LMICs - to address this
expertise gap during the most critical time period while a child is transported to a
fixed emergency care facility. Such solutions can contribute to potentially saving
thousands of children every year.

Formal EMS systems consist of a universal access number (such as 911) that connect the
community to ambulances with equipment, supplies, protocols, and, most importantly,
trained healthcare providers through specialized call centers. In low resource settings,
the contribution of effective transportation to health outcomes becomes far more
significant. Studies show that the lack of EMS contributed to two-thirds of all trauma
deaths, 52% of maternal and perinatal deaths, and 20% of newborn deaths in LMICs. Mobile
health technology available today has the potential to rapidly bridge the expertise gap
in prehospital settings. While there is a sound theoretical basis for such intervention,
there is no evidence on the use of ambulance-based teleconsultation (ABT) for children.

Pakistan, the setting of this study, ranks third for the number of deaths among children.
On average, every twelfth child who dies worldwide is a Pakistani child. Unpublished data
from Karachi, Pakistan, shows a very high acuity level amongst children transported by
ambulances. The only modern ambulance service and our partner in this project, Sindh
Integrated Emergency & Health Services (SIEHS), transported 36,501 children between Jan
1, 2018, and Dec 31, 2019. Of these, 12,200 (33%) were triaged as serious or
life-threatening emergencies using the globally accepted standard called the Medical
Priority Dispatch System.

The current process of care of the critically ill child: Currently, when a family calls
the SIEHS Universal Access Number (1021), the call taker/dispatcher team in the
Command-and-Control Center (CCC) asks a set of standard questions to determine the
patients' location and estimate the potential severity of their condition. The dispatcher
then locates the nearest ambulance and passes on the location information and severity
code to the ambulance crew. On arrival at the scene, the EMTs provide emergency care as
per existing clinical protocols until they reach the destination hospital. The ambulance
staff "signs-out" patients to the hospital staff and shares their history and any
treatment provided.

Through this study, the investigators aim to test the efficacy of ABT by measuring a
change in the outcome measure of PEWS for acutely ill children from the scene of
injury/illness to the pediatric emergency department (PED) through a cluster-randomized
trial.

Study Procedures:

We will randomly assign 60 ambulances to control and ABT intervention groups (30 each)
using a stratified random sampling design. We will assign 30 ambulances, five from each
of the six administrative zones of SIEHS - to receive the ABT setup. We will compare
changes in PEWS as noted by the EMTs at the scene of illness/injury and the PEWS noted by
triage nurses in the emergency department between ABT and control.

Sample Size:

For this study, a total of 600 children will be enrolled. All EMTs at the SIEHS (~272
currently) and all telemedicine physicians at CLF(24 currently) will be included in
delivering the intervention. For pediatric patients, we based our sample size calculation
on the ability to detect a clinically significant difference as captured by a medium to
large effect size (0.6-0.8). We estimate that we will need a total sample size of 600
patients in the study (300 in each arm) to detect a medium to large difference with a
standard deviation of 2.0-3.0, a power of 80%, and a significance of 0.05 (two-sided).

Recruitment:

Patients transported by the intervention ambulances will be enrolled in the intervention
arm and those in control ambulances will be in the control arm. The distribution of
patients to these ambulances is random based on the location of the patient and the
ambulance at the time of the emergency call. Upon arrival, a trained EMT will approach
the parents/guardian, make an initial assessment for eligibility, explain the study
intervention, and recruit them to the interventional or control group.

Parents will be consented by the EMTs. EMTs who will obtain consent will receive training
on communication and the appropriate approach to consenting parents for research studies.
Based on our preliminary qualitative study findings, we will obtain written consent
followed by an opt-out strategy.

The right to withdraw from the study will be respected in the study. Parents can withdraw
from the study by contacting the research through a telephone contact number they will
receive during the consent process. Also, the research team will contact all participants
after 72 hours and provide again a chance for parents to withdraw from the study. In case
the participants do not withdraw during the call by the study team or by the data lock
date, data will be de-identified included in the analysis.

Equipment Installation:

The SIEHS, CLF, and AKU (Aga Khan University) teams (in coordination with our
human-factor engineering consultant, PD) are responsible for the selection and
installation of equipment. The study investigators have equipped ambulances in the
intervention arm for real-time, bi-directional, audio-video communication, allowing
virtual interactions between EMTs, patients, caretakers, and TMPs; 1- An IP phone with a
4G router supports the communication and connection with the TMPs, 2- To ensure hand-free
interaction with the patients, all EMTs wear a headset to communicate with the TMPs, 3-
The 360 rotation camera has been installed to allow live video transmission to TMP. The
video stream has been integrated into the pre-existing telemedicine platform at CLF
through their proprietary software. 4- A tablet with qualrtics form has been installed in
the ambualnce for recording consent and PEWS data. 5- A 4G internet device with router is
present in all ambulances to allow constant signals.

Investigators have used existing data privacy standards at CLF and ensure
password-protected login, role-based access control, hypertext transfer protocol secure
encryption, and transfer through a virtual private network. All installed equipment has a
quality check and has been certificated in accordance with local standards before use. If
device troubleshooting is needed, technical assistance is provided in person or remotely
if indicated. Equipment evaluation is collected in the SIEHS equipment checklist, and
following variables are assessed: phone, camera, and tablet.

Data Collection:

We will use the Modified Brighton PEWS as the outcome indicator to test the effectiveness
of ABT on patient outcomes. The standard PEWS table has been added to the current
clinical form of SIEHS and triage form at CLF EDs. EMTs will obtain consent, calculate
the PEWS score, and communicate the initial PEWS scores to the SIEHS command and control
center and enter it in the Qualtrics form provided by the WCM. At the time of drop off,
the second set of PEWS will be enetered on Qualtrics by the EMT and the child will be
handed over to the hospital. Every morning, the SMRS data coordinator will email an excel
spreadsheet of all cases transferred by SMRS to CLF hospitals. Simultaneously, CLF will
calculate the triage PEWS and share it with the study coordinator at WCM. The difference
in PEWS score (primary outcome) measured by the EMTs from initial evaluation, drop off
evaluation, and at ED triage will be calculated and compared between patients receiving
regular care versus ABT consultation.