- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05909917
Deploying Emergency Bystander Internet Training (DEBIT)
Deploying Emergency Bystander Internet Training (DEBIT) for Lay First Responders in Resource Limited Settings
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kakamega County
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Kakamega, Kakamega County, Kenya
- Masinde Muliro University of Science and Technology
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Lagos
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Lagos, Lagos, Nigeria
- Health Emergency Initiative
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Northern Province
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Makeni, Northern Province, Sierra Leone
- School of Clinical Sciences
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Central Region
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Mukono, Central Region, Uganda
- Vision for Trauma Care in Africa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Commercial transportation providers
Exclusion Criteria:
- Does not possess means of transportation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 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.
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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.
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Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Knowledge Acquisition
Time Frame: 3 months
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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).
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3 months
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Clinical Skills Performance Checklist - Airway Management
Time Frame: 3 months
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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).
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3 months
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Clinical Skills Performance Checklist - Fracture Management
Time Frame: 3 months
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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).
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Knowledge Retention
Time Frame: 9 months
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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).
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9 months
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Skill Usage
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Zachary Eisner, BS, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00228774
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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