Deploying Emergency Bystander Internet Training

NCT ID: NCT05909917

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 658 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-15
• Study Completion Date: 2024-08-31

Brief Summary

The primary aim of this study is to evaluate the efficacy of a massive open online course (MOOC) for training lay first responders in sub-Saharan Africa. The research team will assess educational outcomes of first responder training implemented at program locations in Nigeria, Sierra Leone, Uganda, and Kenya, through previously validated pre- and post-course survey instruments, standardized patient assessments, and incident reporting. The research team will investigate efficacy of MOOC training amongst diverse populations with variable technology literacy and utilize data gathered to develop more efficient means of disseminating basic first aid training information.

Detailed Description

Low- and middle-income countries (LMIC) bear the brunt of non-intentional traumatic injury. In fact, millions of people die from injury each year, with 90% of the mortality faced by LMICs. An additional 650 million people suffer from disabilities resulting from similar causes worldwide. The expansion of emergency medical services (EMS) in low- and middle-income countries could address 45% of all deaths and 36% of the total disease burden in low-income countries. However, emergency care, let alone prehospital emergency medical services, are often not priorities in LMICs. Though injury is the leading prehospital condition in Africa, 91.3% of the African population has no EMS available and there is no evidence of EMS systems in 61% of African countries. Sub-Saharan Africa is particularly affected, as available data on emergency care demonstrates the current combination of high patient volume and mortality make emergency care an urgent area of focus for future mortality-reducing interventions, especially as 80% of injury deaths occur in the prehospital setting in low-resource settings compared with just 59% in developed settings. Several studies investigating programs training lay first responders to treat the previously unaddressed traumatic injury burden were undertaken beginning in the mid- to late-1990's.

Subsequent to those initial studies, the World Health Organization (WHO) recommended establishing lay first responder systems as the first step toward developing formal emergency medical services in 2004. However, global uptake of the guidelines has been limited, even as injury has become the leading cause of death for young people between ages 15 and 45. Most LMICs lack organized EMS systems, while ambulances have been used primarily for interfacility transport, rather than as emergency care vehicles. Since the 2004 WHO announcement, many programs have attempted to leverage pre-existing networks of first responders, such as commercial drivers, lay persons, and bystanders, who currently already provide a large proportion of prehospital transport and occasionally also provide first aid in LMICs. As such, EMS system development since has been incongruous and varied, though the lay first responders (LFR) Model has demonstrated program success across heterogeneous across regions. Despite the World Health Organization recommendation and studies completed subsequently, the first aid provided by laypeople to victims of trauma requires additional programs and studies investigating first responder training, program scalability, and clinical implications for trauma patients. To meet these needs, the primary objectives of this study are to evaluate the educational efficacy and clinical impact of a Massive Open Online Course (MOOC) for LFR training through international roll-out.

A randomized control trial design with two arms will be identically deployed in four settings: Sierra Leone (Makeni), Nigeria (Lagos), Uganda (Mukono), and Kenya (Kakamega). In the control arm, participants will be assigned to a previously validated half-day first responder course and assessed for knowledge acquisition and clinical skills performance. In the experimental arm, participants will be assigned to a novel half-day MOOC course and similarly assessed for knowledge acquisition and clinical skills performance. Trainees in both arms will be monitored for knowledge retention and skill usage post-training. Outcomes will demonstrate the relative efficacy of the novel MOOC course as compared to traditional in-person training methods, and may inform LFR program scalability in future EMS capacity building efforts.

Conditions

Trauma; Trauma Injury

Keywords

Pre-Hospital; First Responder; First Aid; Education

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

In-Person

Participants will undergo a previously validated, half-day first responder training course, taught live in-person by local instructors in each study location. Participant knowledge acquisition will be measured via a 23-question pre/post-training assessment, administered in person. Participant skill performance will be measured via direct observation grading of a standardized patient encounter, performed in person.

Group Type: ACTIVE_COMPARATOR

Half-Day First Responder Training

Intervention Type: OTHER

Participants in both study arms will undergo a half-day first responder training course designed for laypeople. The course will consist of five curricular categories: scene management, airway and breathing, hemorrhage control, fracture management, and victim transport. Course material will not differ between in-person and virtual arms, however the method of information dissemination will vary.

Virtual

In a controlled computer laboratory setting, participants will undergo an experimental first responder training course consisting of a half-day of pre-recorded video, lecture notes, and illustrations. Participant knowledge acquisition will be measured via a 23-question pre/post-training assessment, administered in person. Participant skill performance will be measured via direct observation grading of a standardized patient encounter, performed in person.

Group Type: EXPERIMENTAL

Half-Day First Responder Training

Intervention Type: OTHER

Participants in both study arms will undergo a half-day first responder training course designed for laypeople. The course will consist of five curricular categories: scene management, airway and breathing, hemorrhage control, fracture management, and victim transport. Course material will not differ between in-person and virtual arms, however the method of information dissemination will vary.

Interventions

Half-Day First Responder Training

Participants in both study arms will undergo a half-day first responder training course designed for laypeople. The course will consist of five curricular categories: scene management, airway and breathing, hemorrhage control, fracture management, and victim transport. Course material will not differ between in-person and virtual arms, however the method of information dissemination will vary.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Commercial transportation providers

Exclusion Criteria

• Does not possess means of transportation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LFR International

UNKNOWN

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Zachary Eisner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zachary Eisner, BS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Masinde Muliro University of Science and Technology

Kakamega, Kakamega County, Kenya

Health Emergency Initiative

Lagos, Lagos, Nigeria

School of Clinical Sciences

Makeni, Northern Province, Sierra Leone

Vision for Trauma Care in Africa

Mukono, Central Region, Uganda

Countries

Kenya; Nigeria; Sierra Leone; Uganda

Other Identifiers

HUM00228774

Identifier Type: -

Identifier Source: org_study_id