- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07293572
Disaster Medicine Training for Pre-Clinical Medical Students at the University of Tripoli, Libya (DM-Course RCT)
"The Impact of Specialized Training Course on Pre-clinical Medical Students' in Tripoli University , Performance in Disaster Medicine: A Randomized Controlled Trial"
Libya has faced several natural and human-made disasters in recent years, highlighting the need to strengthen disaster preparedness and response capacity. Storm Daniel in Derna in 2023 caused severe flooding, loss of life, and large-scale displacement. Other Libyan communities have also been affected by floods, water-related hazards, armed conflict, landmines, and unexploded ordnance. These events show the vulnerability of local communities and the need for structured disaster medicine education, especially among medical students who may contribute to emergency response in future crises.
This study evaluates the effectiveness of a structured disaster medicine training program for pre-clinical medical students at the Faculty of Medicine, University of Tripoli. The program includes both theoretical and practical components delivered by university faculty with experience in clinical skills and emergency response, together with members of the Libyan Red Crescent who have extensive field experience in disasters and emergencies. Training topics include disaster concepts, disaster response, first aid, psychological support, emergency communication and coordination, prevention of disease outbreaks, volunteer safety, environmental sanitation, landmine and war-remnant awareness, and safe and respectful management of deceased persons.
The study uses a Randomized Controlled Trial (RCT) design. Eligible students are assigned to either an intervention group, which receives the disaster medicine training, or a control group, which does not receive the training during the study period. The intervention group receives approximately 20 to 30 hours of structured training. Learning outcomes are assessed using a baseline knowledge test, a mid-training test, and an Objective Structured Clinical Examination (OSCE). The OSCE scenarios are reviewed by emergency physicians, disaster medicine experts, and university faculty. Student assessments are scored using coded identifiers to reduce bias and protect participant confidentiality.
The main aim of this study is to determine whether structured disaster medicine training improves knowledge, practical skills, and readiness among pre-clinical medical students. The findings may help guide improvements in medical education in Libya and may also provide a useful model for disaster preparedness training in other resource-limited or conflict-affected settings.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This completed Randomized Controlled Trial (RCT) evaluated the effect of a structured disaster medicine training program on knowledge, practical skills, confidence, and readiness among pre-clinical medical students at the Faculty of Medicine, University of Tripoli.
The study was designed in response to the need for stronger disaster medicine education in undergraduate medical training. Libya has experienced several natural and human-made emergencies in recent years. Storm Daniel caused severe flooding and major loss of life in Derna in 2023. Other Libyan communities, including Tarhuna and Zliten, have also been affected by floods and water-related hazards. In addition, armed conflict, displacement, landmine hazards, and unexploded ordnance continue to create important public health and emergency response challenges. These events highlight the need to prepare future physicians with basic disaster response competencies before clinical practice.
Eligible pre-clinical medical students were randomly assigned to either an intervention group or a control group. The intervention group received the structured disaster medicine training before the study assessments, while the control group received delayed training after completion of the study assessments. This design allowed all participants to benefit from the training while maintaining a valid comparison between groups during the assessment period.
The training program included approximately 20 to 30 hours of theoretical and practical sessions. Sessions were delivered by university faculty with experience in clinical skills and emergency response, together with trainers from the Libyan Red Crescent who had extensive field experience in disaster and emergency response.
The training covered core topics in disaster medicine, including disaster concepts, disaster response systems, first aid, psychological support, communication and coordination during emergencies, prevention of disease outbreaks, volunteer safety, environmental sanitation, landmine and war-remnant awareness, and safe and respectful management of deceased persons.
The main objectives of the study were to assess baseline disaster medicine knowledge and preparedness among pre-clinical medical students, evaluate the effect of structured disaster medicine training on theoretical knowledge, evaluate practical skills using Objective Structured Clinical Examination (OSCE) scenarios, assess students' confidence and readiness to participate in emergency response, and provide recommendations for integrating disaster medicine training into the undergraduate medical curriculum in Libya.
Study outcomes were assessed using a baseline knowledge test, a mid-training knowledge test, and an Objective Structured Clinical Examination (OSCE). The OSCE scenarios were reviewed by emergency physicians, disaster medicine experts, and university faculty. The study used a double-masked assessment approach. Participants were not informed of their group allocation during the assessment period, and outcome assessors scored the knowledge tests and OSCE stations using coded identifiers without access to group allocation. Investigators involved in outcome assessment and data handling were also masked to group allocation where operationally feasible.
Participation was voluntary. Written informed consent was obtained from all participants before enrollment, including consent for participation in the training and assessment process and for the use of their anonymized data for scientific research purposes. Participants were informed that they could withdraw at any time without penalty. Additional participant information was collected at each assessment point as required for study follow-up, while confidentiality was protected through coded identifiers. Data were analyzed anonymously.
Practical training activities and OSCE scenarios were conducted under supervision to minimize risk and ensure participant safety. The study followed approved ethical procedures and standard research principles for studies involving student participants.
The study aimed to determine whether structured disaster medicine training can improve disaster-related knowledge, practical response skills, confidence, and readiness among pre-clinical medical students. The findings may support future integration of disaster medicine training into medical education in Libya and similar resource-limited or conflict-affected settings.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Tripoli, Libya
- Faculty of Medicine, University of Tripoli
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pre-clinical medical students enrolled at the Faculty of Medicine, University of Tripoli.
- Aged 18 to 24 years.
- Able and willing to provide written informed consent.
- Not previously enrolled in any formal disaster medicine or emergency response training course.
- Available to attend the required training sessions and assessment activities, including the baseline knowledge test, mid-training knowledge test, and Objective Structured Clinical Examination (OSCE).
Exclusion Criteria:
- Students who have previously received structured training in disaster medicine or emergency response.
- Students currently participating in another educational or training program that may influence disaster preparedness outcomes.
- Students with conditions that prevent participation in simulation-based training or Objective Structured Clinical Examination (OSCE) activities, such as inability to perform required practical tasks.
- Students who refuse or are unable to provide written informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Disaster Medicine Training
Participants will receive the Specialized Training Course in Disaster and Emergency Medicine (lectures + skills sessions). Educational Intervention → Disaster and Emergency Medicine Specialized Training Course |
The intervention is a structured disaster medicine training program for pre-clinical medical students.
It combines theoretical teaching and supervised practical sessions delivered by university clinical skills instructors and experienced Libyan Red Crescent trainers.
The curriculum covers disaster concepts, emergency response systems, first aid, psychological support, emergency communication and coordination, outbreak prevention, volunteer safety, environmental sanitation, landmine and war-remnant awareness, and safe and respectful management of deceased persons.
Training is delivered over approximately 20 to 30 hours using lectures, case-based scenarios, supervised skills practice, and standardized educational materials.
Learning is assessed using baseline and mid-training knowledge tests and an Objective Structured Clinical Examination (OSCE), with scenarios reviewed by emergency physicians, disaster medicine experts, and university faculty.
Other Names:
|
|
No Intervention: Delayed Disaster Medicine Training Control
Participants will not receive the Specialized Training Course before the post-test.
They will continue their routine academic activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in disaster medicine knowledge score
Time Frame: Baseline (pre-test) and immediately post-intervention.
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Assessment of participants' knowledge in disaster and emergency medicine using a validated written test covering disaster response, first aid, communication, outbreak prevention, psychological support, and safety principles.
Scores from the intervention group will be compared to the control group at baseline and immediately after completion of the training.
Improvement in mean score indicates higher effectiveness of the intervention.
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Baseline (pre-test) and immediately post-intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance in OSCE (Objective Structured Clinical Examination)
Time Frame: Within 1 week after completion of the training.
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Evaluation of practical disaster-response skills using standardized OSCE stations validated by emergency medicine specialists.
Stations include first aid, communication, triage, psychological support, and safety procedures.
Examiners are blinded to group allocation.
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Within 1 week after completion of the training.
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Self-reported disaster preparedness and confidence
Time Frame: Immediately after training completion.
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Student self-assessment using a structured Likert-scale questionnaire measuring perceived readiness, confidence, and ability to respond to disaster scenarios.
The tool is adapted from previously validated disaster preparedness surveys.
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Immediately after training completion.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yasein K Elfaituri, Student, Faculty of Medicine - University of Tripoli
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
- DM-RCT-UT-2025-Yasein-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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