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

NCT07027813 | Recruiting DMC

• 2 other identifiers: 21-080238794R33HD103049-03
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Emergencies; mHealth; Child Health; Critical Illness

Keywords

Emergency Medical Services; Ambulance; Telemedicine

Outcome Measures

Primary Outcomes (2)

• Change in Pediatric Early Warning Signs (PEWS) Score

  PEWS Score is "0" for a normal patient, and ranges between "1-9" depending upon severity of illness i.e., higher PEWS scores referring to higher severity of illness. Modified Brighton PEWS used in our study accounts for Respiratory rate, Heart Rate, and Appearance.

  At the ambulance pick up and hospital drop off (>20 minutes)

• Pediatric Early Warning Signs (PEWS) Score at the ambulance drop off

  PEWS Score is "0" for a normal patient, and ranges between "1-9" depending upon severity of illness i.e., higher PEWS scores referring to higher severity of illness. Modified Brighton PEWS used in our study accounts for Respiratory rate, Heart Rate, and Appearance.

  At the ambulance drop off (>20 minutes)

Secondary Outcomes (4)

• Percent of completed Telemedicine Calls

  During ambulance ride (>20 minutes)

• Satisfaction of Emergency Medical Technicians and Telemedicine Physicians as measured by the System Usability Survey

  1 month after the end of trial i.e., completion of study

• Outcome at end of Emergency Department (ED) Visit

  On arrival to the ED triage

• 72 hour outcome after the Emergency Department (ED) Visit

  Within 72 hours of reaching the ED

Study Arms (4)

Control Group

ACTIVE COMPARATOR

Patients who are being transported through ambulance but do not receive telemedicine.

Other: Control

Intervention Group

EXPERIMENTAL

Patients who are transported through ambulance and receive telemedicine support via physicians using mHealth.

Other: Telemedicine

Telemedicine Physicians (TMPs)

NO INTERVENTION

Telemedicine physicians will be providing teleconsultation in the intervention arm for the treatment of pediatric patients during ambulance transport.

Emergency Medical Technicians (EMTs)

NO INTERVENTION

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.

Interventions

Control OTHER

Provision of ambulance transport without any telemedicine support.

Also known as: Simple Ambulance transport

Control Group

Telemedicine OTHER

Provision of Telemedicine support to pediatric patients during ambulance transport.

Also known as: mHealth

Intervention Group

Eligibility Criteria

• Age: 1 Minute - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children transported without an adult parent or guardian
• EMERGENCY MEDICAL TECHNICIANS (EMTs)
• EMTs currently employed by the SIEHS EMS service.
• EMTs who refuse to participate or consent to the study.
• TELEMEDICINE PHYSICIANS (TMPs)
• TMPs currently employed by the CLF Telemedicine services.
• TMPs who refuse to participate or consent to the study.

Sponsors & Collaborators

• Aga Khan University: collaborator
• Weill Medical College of Cornell University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

ACTIVE NOT RECRUITING

ChildLife Foundation

Karachi, Sindh, Pakistan

RECRUITING

Sindh Integrated Emergency and Health Services (SIEHS)

Karachi, Sindh, Pakistan

RECRUITING

Related Publications (43)

• Levels and trends in child mortality 2015. New York: 1. United Nations Children's Fund (UNICEF). 2015.

  BACKGROUND

• Committing to Child Survival: A Promise Renewed: Progress Report 2014. New York: 1. United Nations Children's Fund (UNICEF). 2014.

  BACKGROUND

• Molyneux E, Ahmad S, Robertson A. Improved triage and emergency care for children reduces inpatient mortality in a resource-constrained setting. Bull World Health Organ. 2006 Apr;84(4):314-9. doi: 10.2471/blt.04.019505. Epub 2006 Apr 13.

  PMID: 16628305 BACKGROUND

• GBD Results Tool, GHDx, IHME. 2019; http://ghdx.healthdata.org/gbd-results-tool. Accessed November 1, 2019

  BACKGROUND

• International Statistical Classification of Diseases and Related Health Problems (ICD-11). 25 May 20192019;Newsroom.

  BACKGROUND

• Thaddeus S, Maine D. Too far to walk: maternal mortality in context. Soc Sci Med. 1994 Apr;38(8):1091-110. doi: 10.1016/0277-9536(94)90226-7.

  PMID: 8042057 BACKGROUND

• Hsia RY, Thind A, Zakariah A, Hicks ER, Mock C. Prehospital and Emergency Care: Updates from the Disease Control Priorities, Version 3. World J Surg. 2015 Sep;39(9):2161-7. doi: 10.1007/s00268-015-2997-5.

  PMID: 25847225 BACKGROUND

• Mock CN, Jurkovich GJ, nii-Amon-Kotei D, Arreola-Risa C, Maier RV. Trauma mortality patterns in three nations at different economic levels: implications for global trauma system development. J Trauma. 1998 May;44(5):804-12; discussion 812-4. doi: 10.1097/00005373-199805000-00011.

  PMID: 9603081 BACKGROUND

• Krug EG, Sharma GK, Lozano R. The global burden of injuries. Am J Public Health. 2000 Apr;90(4):523-6. doi: 10.2105/ajph.90.4.523.

  PMID: 10754963 BACKGROUND

• Mawani M, Kadir MM, Azam I, Mehmood A, McNally B, Stevens K, Nuruddin R, Ishaq M, Razzak JA. Epidemiology and outcomes of out-of-hospital cardiac arrest in a developing country-a multicenter cohort study. BMC Emerg Med. 2016 Jul 28;16(1):28. doi: 10.1186/s12873-016-0093-2.

  PMID: 27465304 BACKGROUND

• Merali HS, Lipsitz S, Hevelone N, Gawande AA, Lashoher A, Agrawal P, Spector J. Audit-identified avoidable factors in maternal and perinatal deaths in low resource settings: a systematic review. BMC Pregnancy Childbirth. 2014 Aug 16;14:280. doi: 10.1186/1471-2393-14-280.

  PMID: 25129069 BACKGROUND

• Waiswa P, Kallander K, Peterson S, Tomson G, Pariyo GW. Using the three delays model to understand why newborn babies die in eastern Uganda. Trop Med Int Health. 2010 Aug;15(8):964-72. doi: 10.1111/j.1365-3156.2010.02557.x.

  PMID: 20636527 BACKGROUND

• Alkire BC, Raykar NP, Shrime MG, Weiser TG, Bickler SW, Rose JA, Nutt CT, Greenberg SL, Kotagal M, Riesel JN, Esquivel M, Uribe-Leitz T, Molina G, Roy N, Meara JG, Farmer PE. Global access to surgical care: a modelling study. Lancet Glob Health. 2015 Jun;3(6):e316-23. doi: 10.1016/S2214-109X(15)70115-4. Epub 2015 Apr 27.

  PMID: 25926087 BACKGROUND

• Kuruvilla S, Bustreo F, Kuo T, Mishra CK, Taylor K, Fogstad H, Gupta GR, Gilmore K, Temmerman M, Thomas J, Rasanathan K, Chaiban T, Mohan A, Gruending A, Schweitzer J, Dini HS, Borrazzo J, Fassil H, Gronseth L, Khosla R, Cheeseman R, Gorna R, McDougall L, Toure K, Rogers K, Dodson K, Sharma A, Seoane M, Costello A. The Global strategy for women's, children's and adolescents' health (2016-2030): a roadmap based on evidence and country experience. Bull World Health Organ. 2016 May 1;94(5):398-400. doi: 10.2471/BLT.16.170431. Epub 2016 May 2. No abstract available.

  PMID: 27147772 BACKGROUND

• Gausche-Hill M, Ely M, Schmuhl P, Telford R, Remick KE, Edgerton EA, Olson LM. A national assessment of pediatric readiness of emergency departments. JAMA Pediatr. 2015 Jun;169(6):527-34. doi: 10.1001/jamapediatrics.2015.138.

  PMID: 25867088 BACKGROUND

• Houston R, Pearson GA. Ambulance provision for children: a UK national survey. Emerg Med J. 2010 Aug;27(8):631-6. doi: 10.1136/emj.2009.088880. Epub 2010 Jun 1.

  PMID: 20515914 BACKGROUND

• Patterson PD, Baxley EG, Probst JC, Hussey JR, Moore CG. Medically unnecessary emergency medical services (EMS) transports among children ages 0 to 17 years. Matern Child Health J. 2006 Nov;10(6):527-36. doi: 10.1007/s10995-006-0127-6. Epub 2006 Jul 1.

  PMID: 16816999 BACKGROUND

• Seidel, J. S., & Henderson, D. P. (Eds.). (1991). Emergency medical services for children: a report to the nation. National Center for Education in Maternal and Child Health.

  BACKGROUND

• Kironji AG, Hodkinson P, de Ramirez SS, Anest T, Wallis L, Razzak J, Jenson A, Hansoti B. Identifying barriers for out of hospital emergency care in low and low-middle income countries: a systematic review. BMC Health Serv Res. 2018 Apr 19;18(1):291. doi: 10.1186/s12913-018-3091-0.

  PMID: 29673360 BACKGROUND

• Sriram V, Gururaj G, Razzak JA, Naseer R, Hyder AA. Comparative analysis of three prehospital emergency medical services organizations in India and Pakistan. Public Health. 2016 Aug;137:169-75. doi: 10.1016/j.puhe.2016.02.022. Epub 2016 Apr 12.

  PMID: 27080583 BACKGROUND

• Zafar W, Siddiqui E, Ejaz K, Shehzad MU, Khan UR, Jamali S, Razzak JA. Health care personnel and workplace violence in the emergency departments of a volatile metropolis: results from Karachi, Pakistan. J Emerg Med. 2013 Nov;45(5):761-72. doi: 10.1016/j.jemermed.2013.04.049. Epub 2013 Sep 4.

  PMID: 24011477 BACKGROUND

• Jewkes F. Prehospital emergency care for children. Arch Dis Child. 2001 Feb;84(2):103-5. doi: 10.1136/adc.84.2.103. No abstract available.

  PMID: 11159280 BACKGROUND

• Rortgen D, Bergrath S, Rossaint R, Beckers SK, Fischermann H, Na IS, Peters D, Fitzner C, Skorning M. Comparison of physician staffed emergency teams with paramedic teams assisted by telemedicine--a randomized, controlled simulation study. Resuscitation. 2013 Jan;84(1):85-92. doi: 10.1016/j.resuscitation.2012.06.012. Epub 2012 Jun 30.

  PMID: 22750663 BACKGROUND

• Brokmann JC, Conrad C, Rossaint R, Bergrath S, Beckers SK, Tamm M, Czaplik M, Hirsch F. Treatment of Acute Coronary Syndrome by Telemedically Supported Paramedics Compared With Physician-Based Treatment: A Prospective, Interventional, Multicenter Trial. J Med Internet Res. 2016 Dec 1;18(12):e314. doi: 10.2196/jmir.6358.

  PMID: 27908843 BACKGROUND

• Lippman JM, Smith SN, McMurry TL, Sutton ZG, Gunnell BS, Cote J, Perina DG, Cattell-Gordon DC, Rheuban KS, Solenski NJ, Worrall BB, Southerland AM. Mobile Telestroke During Ambulance Transport Is Feasible in a Rural EMS Setting: The iTREAT Study. Telemed J E Health. 2016 Jun;22(6):507-13. doi: 10.1089/tmj.2015.0155. Epub 2015 Nov 24.

  PMID: 26600433 BACKGROUND

• Skorning M, Bergrath S, Rortgen D, Beckers SK, Brokmann JC, Gillmann B, Herding J, Protogerakis M, Fitzner C, Rossaint R; Med-on-@ix-Working Group. Teleconsultation in pre-hospital emergency medical services: real-time telemedical support in a prospective controlled simulation study. Resuscitation. 2012 May;83(5):626-32. doi: 10.1016/j.resuscitation.2011.10.029. Epub 2011 Nov 22.

  PMID: 22115932 BACKGROUND

• Lenssen N, Krockauer A, Beckers SK, Rossaint R, Hirsch F, Brokmann JC, Bergrath S. Quality of analgesia in physician-operated telemedical prehospital emergency care is comparable to physician-based prehospital care - a retrospective longitudinal study. Sci Rep. 2017 May 8;7(1):1536. doi: 10.1038/s41598-017-01437-5.

  PMID: 28484212 BACKGROUND

• Brokmann JC, Rossaint R, Muller M, Fitzner C, Villa L, Beckers SK, Bergrath S. Blood pressure management and guideline adherence in hypertensive emergencies and urgencies: A comparison between telemedically supported and conventional out-of-hospital care. J Clin Hypertens (Greenwich). 2017 Jul;19(7):704-712. doi: 10.1111/jch.13026. Epub 2017 May 30.

  PMID: 28560799 BACKGROUND

• Institute Of Medicine. IOM report: the future of emergency care in the United States health system. Acad Emerg Med. 2006 Oct;13(10):1081-5. doi: 10.1197/j.aem.2006.07.011. No abstract available.

  PMID: 17015421 BACKGROUND

• Price CI, Shaw L, Dodd P, Exley C, Flynn D, Francis R, Islam S, Javanbakht M, Lakey R, Lally J, McClelland G, McMeekin P, Rodgers H, Snooks H, Sutcliffe L, Tyrell P, Vale L, Watkins A, Ford GA. Paramedic Acute Stroke Treatment Assessment (PASTA): study protocol for a randomised controlled trial. Trials. 2019 Feb 12;20(1):121. doi: 10.1186/s13063-018-3144-z.

  PMID: 30755249 BACKGROUND

• Robinson MJ, Taylor J, Brett SJ, Nolan JP, Thomas M, Reeves BC, Rogers CA, Voss S, Clout M, Benger JR; AIRWAYS-2 study team. Design and implementation of a large and complex trial in emergency medical services. Trials. 2019 Feb 8;20(1):108. doi: 10.1186/s13063-019-3203-0.

  PMID: 30736841 BACKGROUND

• Dishaw, M. T., & Strong, D. M. (1999). Extending the technology acceptance model with task- technology fit constructs. Information & management, 36(1), 9-21.

  BACKGROUND

• Zakria M, Muhammad F. Forecasting the population of Pakistan using ARIMA models. Pakistan Journal of Agricultural Sciences. 2009;46(3):214-223.

  BACKGROUND

• Kazmi JH, Zubair S. Estimation of vehicle damage cost involved in road traffic accidents in Karachi, Pakistan: a geospatial perspective. Procedia engineering. 2014;77:70-78.

  BACKGROUND

• Sriram VM, Naseer R, Hyder AA. Provision of prehospital emergency medical services in Punjab, Pakistan: Case study of a public sector provider. Surgery. 2017 Dec;162(6S):S12-S23. doi: 10.1016/j.surg.2017.02.015. Epub 2017 May 15.

  PMID: 28522129 BACKGROUND

• Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.

  PMID: 28126032 BACKGROUND

• Addissie A, Davey G, Newport MJ, Addissie T, MacGregor H, Feleke Y, Farsides B. A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting. BMC Med Ethics. 2014 May 2;15:35. doi: 10.1186/1472-6939-15-35.

  PMID: 24885049 BACKGROUND

• Mwaka E, Nakigudde J, Ali J, Ochieng J, Hallez K, Tweheyo R, Labrique A, Gibson DG, Rutebemberwa E, Pariyo G. Consent for mobile phone surveys of non-communicable disease risk factors in low-resource settings: an exploratory qualitative study in Uganda. Mhealth. 2019 Aug 19;5:26. doi: 10.21037/mhealth.2019.07.05. eCollection 2019.

  PMID: 31559271 BACKGROUND

• Deja E, Peters MJ, Khan I, Mouncey PR, Agbeko R, Fenn B, Watkins J, Ramnarayan P, Tibby SM, Thorburn K, Tume LN, Rowan KM, Woolfall K. Establishing and augmenting views on the acceptability of a paediatric critical care randomised controlled trial (the FEVER trial): a mixed methods study. BMJ Open. 2021 Mar 10;11(3):e041952. doi: 10.1136/bmjopen-2020-041952.

  PMID: 33692177 BACKGROUND

• Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, Taljaard M; Ottawa Ethics of Cluster Randomized Trials Consensus Group. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Med. 2012;9(11):e1001346. doi: 10.1371/journal.pmed.1001346. Epub 2012 Nov 20.

  PMID: 23185138 BACKGROUND

• Woolfall K, Frith L, Dawson A, Gamble C, Lyttle MD; CONNECT advisory group; Young B. Fifteen-minute consultation: an evidence-based approach to research without prior consent (deferred consent) in neonatal and paediatric critical care trials. Arch Dis Child Educ Pract Ed. 2016 Feb;101(1):49-53. doi: 10.1136/archdischild-2015-309245. Epub 2015 Oct 13. No abstract available.

  PMID: 26464416 BACKGROUND

• Offerman SR, Nishijima DK, Ballard DW, Chetipally UK, Vinson DR, Holmes JF. The use of delayed telephone informed consent for observational emergency medicine research is ethical and effective. Acad Emerg Med. 2013 Apr;20(4):403-7. doi: 10.1111/acem.12117.

  PMID: 23701349 BACKGROUND

• Babchuk WA. Glaser or Strauss? Grounded theory and adult education. Paper presented at: Proceedings of the 15th Annual Midwest Research-to-Practice Conference in Adult, Continuing, and Community Education1996.

  BACKGROUND

Related Links

• Sindh Rescue and Medical Services launched at the Sindh Secretariat: Aman Foundation
• ChildLife Foundation (CLF)

MeSH Terms

Conditions

Emergencies; Critical Illness

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Junaid Razzak, MD,PhD,FACEP

  Weill Cornell School of Medicine, NY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junaid A. Razzak, MD,PhD,FACEP

CONTACT

+1 (443) 722-9239; jur9123@med.cornell.edu

Sheza Hassan, MBBS

CONTACT

+1 (929) 621-3558; shh4019@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster Randomized Trial

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 19, 2025
• Study Start: June 4, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available at the end of trial completion when the findings are submitted to Eunice Kennedy Shriver National Institute of Child Health and Human Development in the form of a detailed report.
• Access Criteria: The data will be accessible upon request to the Principal investigator for researchers who intend to learn, adapt, or replicate from our trial findings.

Locations

PA (3)