Deploying Emergency Bystander Internet Training

Trauma Clinical Trial

— DEBIT  

Official title:

Deploying Emergency Bystander Internet Training (DEBIT) for Lay First Responders in Resource Limited Settings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909917
• Other study ID #: HUM00228774
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of Michigan
• Contact: Zachary Eisner, BS
• Phone: 734-936-5738
• Email: zaeisner[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Commercial transportation providers

Exclusion Criteria:

• Does not possess means of transportation

Related Conditions & MeSH terms

• Emergencies
• Trauma
• Trauma Injury
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Kenya	Masinde Muliro University of Science and Technology	Kakamega	Kakamega County
Nigeria	Health Emergency Initiative	Lagos
Sierra Leone	School of Clinical Sciences	Makeni	Northern Province
Uganda	Vision for Trauma Care in Africa	Mukono	Central Region

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	LFR International

Countries where clinical trial is conducted

Kenya,  Nigeria,  Sierra Leone,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge Acquisition	Acquisition will be measured using a 23-question test administered prior to the intervention and then immediately following training. Scores for the test range from 0 (no knowledge acquired) to 23 (all knowledge acquired).	3 months
Primary	Clinical Skills Performance Checklist - Airway Management	Performance will be assessed using a direct-observation checklist evaluating first-responder interventions on standardized patients. Participants will be assessed on one of two clinical scenarios: airway management and fracture management. The airway management checklist will have a total of 8 points with higher score indicating better performance (0-8, with 0 meaning failed performance and 8 meaning perfect performance).	3 months
Primary	Clinical Skills Performance Checklist - Fracture Management	Performance will be assessed using a direct-observation checklist evaluating first-responder interventions on standardized patients. Participants will be assessed on one of two clinical scenarios: airway management and fracture management. The fracture management checklist will have a total of 12 points with higher score indicating better performance (0-12, with 0 meaning failed performance and 12 meaning perfect performance).	3 months
Secondary	Knowledge Retention	Retention will be measured using the same 23-question test used to assess knowledge acquisition but administered at 6 months and then 9 months following the intervention. Scores for the test range from 0 (no retention) to 23 (all knowledge retained).	9 months
Secondary	Skill Usage	Usage will be tracked using incident report forms where participants reported using the skills acquired from the intervention to treat someone. Incident report forms will include de-identified patient information, care rendered by the first responder, location of the treated injury, mechanism of the treated injury, injury severity, and the hospital transportation method employed.	6 months