Feasibility and Efficacy of Ambulance-Based m-Health for Pediatric Emergencies (FEAMER) Trial
NCT ID: NCT07027813
Last Updated: 2026-01-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
900 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-06-04
Study Completion Date
2026-09-30
Brief Summary
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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.
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Detailed Description
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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 staff well-trained in pediatric acute/emergency care are scarce, even in high-income countries, and essentially 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 connects the community to ambulances equipped with the necessary 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 bridge the expertise gap in prehospital settings rapidly. 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 in 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 patient's 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. Upon arrival at the scene, EMTs provide emergency care in accordance with established clinical protocols until they reach the destination hospital. The ambulance staff "signs out" patients to the hospital staff, sharing 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 EMTs at the scene of illness/injury and the PEWS noted by triage nurses in the emergency department between the ABT and control groups.
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 a total sample size of 600 patients will be required for the study (300 in each arm) to detect a medium to significant difference with a standard deviation of 2.0-3.0, a power of 80%, and a significance level of 0.05 (two-sided).
Recruitment:
Patients transported by the intervention ambulances will be enrolled in the intervention arm, while those transported by the 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/guardians, make an initial assessment for eligibility, explain the study intervention, and recruit them to the interventional or control group.
Parents will be consented to by the EMTs. EMTs who will obtain consent will receive training on effective communication and the appropriate approach to obtaining consent from 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. Parents can withdraw from the study by contacting the research through a telephone contact number they will receive during the consent process. Additionally, the research team will contact all participants after 72 hours and offer them another opportunity to withdraw from the study. If participants do not withdraw during the call by the study team or by the data lock date, their data will be de-identified and 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 a Qualtrics form has been installed in the ambulance for recording consent and PEWS data. 5- A 4G internet device with a router is present in all ambulances to allow constant signals.
Investigators have utilized existing data privacy standards at CLF to ensure password-protected login, role-based access control, secure Hypertext Transfer Protocol (HTTP) encryption, and data transfer through a virtual private network (VPN). All installed equipment undergoes a quality check and is certified in accordance with local standards before use. If device troubleshooting is required, technical assistance is provided in person or remotely, as needed. Equipment evaluation is collected in the SIEHS equipment checklist, and the 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, communicate the initial PEWS scores to the SIEHS command and control center, and enter them in the Qualtrics form provided by the WCM. At the time of drop off, the second set of PEWS will be entered 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), as measured by EMTs from initial evaluation, drop-off evaluation, and ED triage, will be calculated and compared between patients receiving regular care and those receiving ABT consultation.
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 staff well-trained in pediatric acute/emergency care are scarce, even in high-income countries, and essentially 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 connects the community to ambulances equipped with the necessary 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 bridge the expertise gap in prehospital settings rapidly. 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 in 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 patient's 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. Upon arrival at the scene, EMTs provide emergency care in accordance with established clinical protocols until they reach the destination hospital. The ambulance staff "signs out" patients to the hospital staff, sharing 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 EMTs at the scene of illness/injury and the PEWS noted by triage nurses in the emergency department between the ABT and control groups.
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 a total sample size of 600 patients will be required for the study (300 in each arm) to detect a medium to significant difference with a standard deviation of 2.0-3.0, a power of 80%, and a significance level of 0.05 (two-sided).
Recruitment:
Patients transported by the intervention ambulances will be enrolled in the intervention arm, while those transported by the 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/guardians, make an initial assessment for eligibility, explain the study intervention, and recruit them to the interventional or control group.
Parents will be consented to by the EMTs. EMTs who will obtain consent will receive training on effective communication and the appropriate approach to obtaining consent from 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. Parents can withdraw from the study by contacting the research through a telephone contact number they will receive during the consent process. Additionally, the research team will contact all participants after 72 hours and offer them another opportunity to withdraw from the study. If participants do not withdraw during the call by the study team or by the data lock date, their data will be de-identified and 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 a Qualtrics form has been installed in the ambulance for recording consent and PEWS data. 5- A 4G internet device with a router is present in all ambulances to allow constant signals.
Investigators have utilized existing data privacy standards at CLF to ensure password-protected login, role-based access control, secure Hypertext Transfer Protocol (HTTP) encryption, and data transfer through a virtual private network (VPN). All installed equipment undergoes a quality check and is certified in accordance with local standards before use. If device troubleshooting is required, technical assistance is provided in person or remotely, as needed. Equipment evaluation is collected in the SIEHS equipment checklist, and the 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, communicate the initial PEWS scores to the SIEHS command and control center, and enter them in the Qualtrics form provided by the WCM. At the time of drop off, the second set of PEWS will be entered 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), as measured by EMTs from initial evaluation, drop-off evaluation, and ED triage, will be calculated and compared between patients receiving regular care and those receiving ABT consultation.
Conditions
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Emergencies
mHealth
Child Health
Critical Illness
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Cluster Randomized Trial
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Control Group
Patients who are being transported through ambulance but do not receive telemedicine.
Group Type
ACTIVE_COMPARATOR
Control
Intervention Type
OTHER
Provision of ambulance transport without any telemedicine support.
Intervention Group
Patients who are transported through ambulance and receive telemedicine support via physicians using mHealth.
Group Type
EXPERIMENTAL
Telemedicine
Intervention Type
OTHER
Provision of Telemedicine support to pediatric patients during ambulance transport.
Telemedicine Physicians (TMPs)
Telemedicine physicians will be providing teleconsultation in the intervention arm for the treatment of pediatric patients during ambulance transport.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Emergency Medical Technicians (EMTs)
EMTs are trained in both control and intervention settings. The delivery of intervention will depend on the ambulance that they will be operating in during the transport.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Telemedicine
Provision of Telemedicine support to pediatric patients during ambulance transport.
Intervention Type
OTHER
Control
Provision of ambulance transport without any telemedicine support.
Intervention Type
OTHER
Other Intervention Names
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mHealth
Simple Ambulance transport
Eligibility Criteria
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Inclusion Criteria
* 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
• EMTs currently employed by the SIEHS EMS service.
• TMPs currently employed by the CLF Telemedicine services.
* 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
• EMTs currently employed by the SIEHS EMS service.
• TMPs currently employed by the CLF Telemedicine services.
Exclusion Criteria
• Children transported without an adult parent or guardian
EMERGENCY MEDICAL TECHNICIANS (EMTs)
• EMTs who refuse to participate or consent to the study.
TELEMEDICINE PHYSICIANS (TMPs)
• TMPs who refuse to participate or consent to the study.
EMERGENCY MEDICAL TECHNICIANS (EMTs)
• EMTs who refuse to participate or consent to the study.
TELEMEDICINE PHYSICIANS (TMPs)
• TMPs who refuse to participate or consent to the study.
Minimum Eligible Age
1 Minute
Maximum Eligible Age
14 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sponsor Role
collaborator
Aga Khan University
OTHER
Sponsor Role
collaborator
Weill Medical College of Cornell University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Junaid Razzak, MD,PhD,FACEP
Role: PRINCIPAL_INVESTIGATOR
Weill Cornell School of Medicine, NY
Locations
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Aga Khan University Hospital
Karachi, Sindh, Pakistan
Site Status
ACTIVE_NOT_RECRUITING
ChildLife Foundation
Karachi, Sindh, Pakistan
Site Status
RECRUITING
Sindh Integrated Emergency and Health Services (SIEHS)
Karachi, Sindh, Pakistan
Site Status
RECRUITING
Countries
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Pakistan
Central Contacts
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Facility Contacts
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Ali Kashan, MBBS
Role: primary
+92-21-111-111-823
Role: backup
References
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Related Links
Access external resources that provide additional context or updates about the study.
https://www.siehs.org/
Sindh Rescue and Medical Services launched at the Sindh Secretariat: Aman Foundation
http://childlifefoundation.org/
ChildLife Foundation (CLF)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21-08023879
Identifier Type: -
Identifier Source: org_study_id
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