Feasibility and Efficacy of Ambulance-Based m-Health for Pediatric Emergencies (FEAMER) Trial
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About
Investigaors 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 that purpose, the investigators will conduct a study in Karachi, Pakistan where they will calculate medical data for ill children at the time of ambulance pick up, hospital drop off, and at the hospital triage. During the transport, one group will receive the telemedicine call through a trained physician, while the other group will receive basic paramedic treatment. The investigators will then compare both groups.
Full description
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.
Enrollment
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Ages
Volunteers
Inclusion and exclusion criteria
CHILDREN
Inclusion criteria:
i. Age 0-14 years ii. Children transported by an SIEHS ambulance with a transport time of more than 20 minutes iii. Children presenting to ChildLife ED with a parent/ guardian present to consent iv. Children classified as "Charlie, Delta, Echo" on Medical Priority Dispatch System
Exclusion Criteria:
i. Children transported without an adult parent or guardian
EMERGENCY MEDICAL TECHNICIANS (EMTs)
Inclusion Criteria:
i. EMTs currently employed by the SIEHS EMS service.
Exclusion Criteria:
i. EMTs who refuse to participate or consent for the study.
TELEMEDICINE PHYSICIANS (TMPs)
Inclusion Criteria:
i. TMPs currently employed by the CLF Telemedicine services.
Exclusion Criteria:
i. TMPs who refuse to participate or consent for the study.
Trial design
Primary purpose
Allocation
Interventional model
Masking
900 participants in 4 patient groups
Trial contacts and locations
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Central trial contact
Sheza Hassan, MBBS; Junaid A. Razzak, MD,PhD,FACEP
Data sourced from clinicaltrials.gov
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