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Deploying Emergency Bystander Internet Training (DEBIT)

Primary Purpose

Trauma, Trauma Injury

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Half-Day First Responder Training
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Trauma focused on measuring Pre-Hospital, First Responder, First Aid, Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - Commercial transportation providers Exclusion Criteria: - Does not possess means of transportation

Sites / Locations

  • Masinde Muliro University of Science and TechnologyRecruiting
  • Health Emergency InitiativeRecruiting
  • School of Clinical SciencesRecruiting
  • Vision for Trauma Care in Africa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

In-Person

Virtual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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).
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.

Full Information

First Posted
June 9, 2023
Last Updated
August 20, 2023
Sponsor
University of Michigan
Collaborators
LFR International
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1. Study Identification

Unique Protocol Identification Number
NCT05909917
Brief Title
Deploying Emergency Bystander Internet Training
Acronym
DEBIT
Official Title
Deploying Emergency Bystander Internet Training (DEBIT) for Lay First Responders in Resource Limited Settings
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
LFR International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Trauma Injury
Keywords
Pre-Hospital, First Responder, First Aid, Education

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes assessors will be blinded to intervention arm randomization of participants.
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In-Person
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Virtual
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Half-Day First Responder Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knowledge Acquisition
Description
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).
Time Frame
3 months
Title
Clinical Skills Performance Checklist - Airway Management
Description
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).
Time Frame
3 months
Title
Clinical Skills Performance Checklist - Fracture Management
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Knowledge Retention
Description
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).
Time Frame
9 months
Title
Skill Usage
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Commercial transportation providers Exclusion Criteria: - Does not possess means of transportation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zachary Eisner, BS
Phone
734-936-5738
Email
zaeisner@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary Eisner, BS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masinde Muliro University of Science and Technology
City
Kakamega
State/Province
Kakamega County
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Ogana, MPH, BSN
Facility Name
Health Emergency Initiative
City
Lagos
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paschal Achunine, MBA
Facility Name
School of Clinical Sciences
City
Makeni
State/Province
Northern Province
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfred H Thullah, MA
Facility Name
Vision for Trauma Care in Africa
City
Mukono
State/Province
Central Region
Country
Uganda
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannington Muwaga, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Deploying Emergency Bystander Internet Training

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