Medical EducationNCT06092320
Does Teaching Before or After Simulation Improve Learning?
A study testing Simulation on Pediatric Status Epilepticus and Didactic Lecture on Pediatric Status Epilepticus in people with Medical Education and Simulation, run by University of British Columbia at 1 site in Canada.
Trial summary
The goal of the randomized educational intervention study is to test whether simulation preceding didactic teaching leads to improved knowledge and performance retention compared to a didactic lecture proceeding simulation for medical students Participants will be randomized to one of two different groups with reverse… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medical Education, Simulation
- What is being tested?
- Simulation on Pediatric Status Epilepticus and Didactic Lecture on Pediatric Status Epilepticus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Second year medical student at the University of British Columbia
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
John Ramsay, MD, (604) 875-2345, john.ramsay1@phsa.ca
About this study
Official title: Outcome of a Lecture Before vs After Simulation-based Education on Pediatric Status Epileptics: A Randomized Controlled Pilot Trial
The goal of the randomized educational intervention study is to test whether simulation preceding didactic teaching leads to improved knowledge and performance retention compared to a didactic lecture proceeding simulation for medical students
Participants will be randomized to one of two different groups with reverse orders for simulation and lectures.
Researchers will compare each group to see which way is better for learning.
- Conditions
- Medical Education, Simulation
- Being tested
- Simulation on Pediatric Status Epilepticus, Didactic Lecture on Pediatric Status Epilepticus
- Keywords
- Medical Education, Simulation, Pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation on Pediatric Status EpilepticusOther
The participants will complete a simulation session and debrief lead by a pediatric emergency medicine physician on status epilepticus.
Didactic Lecture on Pediatric Status EpilepticusOther
The participants will complete a lecture on pediatric status epilepticus
| Study group | Role | What they receive |
|---|---|---|
| Simulation - Didactic Lecture Group | Experimental | This group will start with a Simulation and debrief followed by a didactic lecture afterwards. They will then complete a simulation 2 months later. Receives: Other: Simulation on Pediatric Status Epilepticus; Other: Didactic Lecture on Pediatric Status Epilepticus |
| Didactic Lecture - Simulation Group | Experimental | This group will start with a didactic lecture and then complete a simulation and debrief. They will then complete a simulation 2 months later. Receives: Other: Simulation on Pediatric Status Epilepticus; Other: Didactic Lecture on Pediatric Status Epilepticus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in resuscitation performance retention score 2 months post-initial training assessed using global simulation performance score
The scoring sheet used will be the Global Simulation performance score a one to seven scale that assess over medical expertise performance in the simulation with higher values representing increased competence.
Measured: From initial simulation until repeat simulation 2 months later
Secondary outcomes (3)
Change in knowledge assessment score at 2 months post-initial training assessed using an MCQ
The knowledge test is a 15 questions multiple choice exam scored from 0 to 15 with higher numbers representing a higher score.
Measured: From initial knowledge test until repeat testing 2 months later
Learner satisfaction measured by Likert scale items after each simulation debrief
The Likert scale will be a one to five scale with higher scores representing increased satisfaction
Measured: Single time metric completed five minutes after initial simulation session
Time to resuscitation metrics
The following "time to" metrics will be measured from simulation start until completion of each activity within that simulation: glucose check, IV access, first-line anti-epileptic administration, second-line anti-epileptic administration, chemistry panel
Measured: The time for each metric will be measured once during the second evaluatory simulation 2 months after the initial simulation and participant enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start20 Sep 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Chan, University of British Columbia
- Investigators
- Melissa Chan, MD, Principal investigator, Provincial Health Services Authority British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092320
- Sponsor's protocol ID
- H22-03760
- Status last verified
- Jul 2024
- First submitted
- 3 Oct 2023
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of a Lecture Before vs After Simulation-based Education on Pediatric Status Epileptics: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT06092320
- Acronym / sponsor ID
- H22-03760
- Conditions
- Medical Education, Simulation
- Keywords
- Medical Education, Simulation, Pediatrics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the randomized educational intervention study is to test whether simulation preceding didactic teaching leads to improved knowledge and performance retention compared to a didactic lecture proceeding simulation for medical students
Participants will be randomized to one of two different groups with reverse orders for simulation and lectures.
Researchers will compare each group to see which way is better for learning.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation - Didactic Lecture Group | Experimental | Other: Simulation on Pediatric Status Epilepticus, Other: Didactic Lecture on Pediatric Status EpilepticusThis group will start with a Simulation and debrief followed by a didactic lecture afterwards. They will then complete a simulation 2 months later. |
| Didactic Lecture - Simulation Group | Experimental | Other: Simulation on Pediatric Status Epilepticus, Other: Didactic Lecture on Pediatric Status EpilepticusThis group will start with a didactic lecture and then complete a simulation and debrief. They will then complete a simulation 2 months later. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Second year medical student at the University of British Columbia
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation on Pediatric Status EpilepticusThe participants will complete a simulation session and debrief lead by a pediatric emergency medicine physician on status epilepticus. | Other | Didactic Lecture - Simulation Group, Simulation - Didactic Lecture Group |
| Didactic Lecture on Pediatric Status EpilepticusThe participants will complete a lecture on pediatric status epilepticus | Other | Didactic Lecture - Simulation Group, Simulation - Didactic Lecture Group |
Primary outcome
Change from baseline in resuscitation performance retention score 2 months post-initial training assessed using global simulation performance score
Time frame: From initial simulation until repeat simulation 2 months later
The scoring sheet used will be the Global Simulation performance score a one to seven scale that assess over medical expertise performance in the simulation with higher values representing increased competence.
3 secondary outcomes
Change in knowledge assessment score at 2 months post-initial training assessed using an MCQ
Time frame: From initial knowledge test until repeat testing 2 months later
Learner satisfaction measured by Likert scale items after each simulation debrief
Time frame: Single time metric completed five minutes after initial simulation session
Time to resuscitation metrics
Time frame: The time for each metric will be measured once during the second evaluatory simulation 2 months after the initial simulation and participant enrolment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Chan, MD principal investigator
Provincial Health Services Authority British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation on Pediatric Status Epilepticus and Didactic Lecture on Pediatric Status Epilepticus in people with Medical Education and Simulation, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Ramsay, MD ((604) 875-2345, john.ramsay1@phsa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in resuscitation performance retention score 2 months post-initial training assessed using global simulation performance score (time frame: From initial simulation until repeat simulation 2 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.