Education, MedicalREVARNCT02754310
Repeated Versus Varied Simulation Scenarios to Teach Medical Students the Management of a Pediatric Asthma Exacerbation
A study testing Variation of scenarios and Repeated scenarios in people with Education, Medical, run by Ilumens at 1 site in France.
Trial summary
Repeated exposure to simulated cases has been shown to improve performance, but repeating the same scenario may impair the ability of learners to transfer their knowledge and skills to slightly different situations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Education, Medical
- What is being tested?
- Variation of scenarios and Repeated scenarios
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Third year medical students from Paris Descartes and Paris Diderot medical faculties.
- Who are not opposed to participated in the study
Who cannot join
- Opposition to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Département de Simulation iLumens, Université Paris Descartes
Paris, 75006
About this study
Official title: Repeated Versus Varied Simulation Scenarios to Teach Medical Students the Management of a Pediatric Asthma Exacerbation: A Randomized Controlled Study
Repeated exposure to simulated cases has been shown to improve performance, but repeating the same scenario may impair the ability of learners to transfer their knowledge and skills to slightly different situations. The objective of this study is to compare the use of repeated versus varied simulation cases for teaching the management of pediatric asthma exacerbation to 3rd year medical students.
- Conditions
- Education, Medical
- Being tested
- Variation of scenarios, Repeated scenarios
- Keywords
- Education, medical, Simulation Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variation of scenariosOther
Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.
Repeated scenariosOther
The same scenario of a moderate pediatric asthma exacerbation is repeated three times.
| Study group | Role | What they receive |
|---|---|---|
| Repeated scenarios | Active comparator | Participants in the repeated scenario group will learn the management of a pediatric asthma exacerbation on the same scenario repeated three times. The scenario is a pediatric moderate asthma exacerbation not responding to treatment, . Receives: Other: Repeated scenarios |
| Varied scenarios | Experimental | Participants in the varied scenarios group will learn the management of a pediatric asthma exacerbation on three different scenarios: a moderate asthma exacerbation, a mild one, and a severe one, for the same length of time than the "repeated scenarios" group. In this group, there is a variation of scenarios. Receives: Other: Variation of scenarios |
What is being measured
The primary outcome is the main question the study is designed to answer.
Management Score on Transfer Scenario n°1
The transfer scenario n°1 is a new scenario that learners face for the first time. It is a pediatric asthma exacerbation rapidly worsening.
The scale "Asthma exacerbation rapidly worsening" includes different items related to the sequence, the dose, and the administration technique of the treatments. The score ranges between 0 and 10, 10 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1.
Measured: One week
Secondary outcomes (7)
Management Score on Transfer Scenario n°2
The transfer scenario n°2 is a new scenario that learners face for the first time. It is a pediatric pneumonia. Students are expected to realize that the child's presentation differs from an asthma exacerbation and should not start short-acting beta agonists nor steroids.
The scale "Pediatric Pneumonia" includes different items related to the sequence of the treatments administered. The score ranges between 0 and 4, 4 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1.
Measured: One week
Management Score on Evaluation Scenario n°1
The evaluation scenario n°1 is a scenario of a moderate asthma exacerbation not responding to treatment, used during the learning phase of both groups (3 times for the group "repetition" and just once for the group "variation").
The scale "moderate asthma exacerbation" includes different items related to the sequence, the dose, and the administration technique of the treatments. The score ranges between 0 and 16, 16 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1.
Measured: One week
Management Score on Evaluation Scenario n°2
The evaluation scenario n°2 is a scenario of a mild asthma exacerbation not responding to treatment, used during the learning phase of the "variation group".The scale "mild asthma exacerbation" includes different items related to the sequence, the dose, and the administration technique of the treatments. The score ranges between 0 and 9, 9 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1.
Measured: One week
Management Score on Transfer Scenario n°3
The transfer scenario n°3 is a new scenario that learners face for the first time. It is a severe asthma exacerbation improving before relapsing.The scale "Asthma exacerbation improving then relapsing" includes different items related to the sequence, the dose, and the administration technique of the treatments. The score ranges between 0 and 16, 16 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1.
Measured: 4 months
Management Score on Transfer Scenario n°4
The transfer scenario n°4 is a new scenario that learners face for the first time. It is a pediatric laryngitis. Students are expected to realize that the child's presentation differs from an asthma exacerbation and should not start short-acting beta agonists.
The scale "Pediatric laryngitis" includes different items related to the sequence and the dose of the treatments provided. The score ranges between 0 and 3, 3 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1.
Measured: 4 months
Management Score on Evaluation Scenario n°1
The evaluation scenario n°1 is a scenario of a moderate asthma exacerbation not responding to treatment, used during the learning phase of both groups (3 times for the group "repetition" and just once for the group "variation") The scale "moderate asthma exacerbation" includes different items related to the sequence, the dose, and the administration technique of the treatments. The score ranges between 0 and 16,16 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1.
Measured: 4 months
Management Score on Evaluation Scenario n°2
The evaluation scenario n°2 is a scenario of a mild asthma exacerbation not responding to treatment, used during the learning phase of the "variation group".
The scale "mild asthma exacerbation" includes different items related to the sequence, the dose, and the administration technique of the treatments. The score ranges between 0 and 16,16 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Education, MedicalStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilumens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Drummond, Ilumens
- Investigators
- David Drummond, MD, Principal investigator, University Paris René Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754310
- Sponsor's protocol ID
- ILUMENS0001
- Acronym
- REVAR
- Status last verified
- Mar 2019
- First submitted
- 26 Apr 2016
- Last updated
- 28 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tofil NM, Peterson DT, Wheeler JT, Youngblood A, Zinkan JL, Lara D, Jakaitis B, Niebauer J, White ML. Repeated versus varied case selection in pediatric resident simulation. J Grad Med Educ. 2014 Jun;6(2):275-9. doi: 10.4300/JGME-D-13-00099.1.
PubMed 24949131Cook DA, Hamstra SJ, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hatala R. Comparative effectiveness of instructional design features in simulation-based education: systematic review and meta-analysis. Med Teach. 2013;35(1):e867-98. doi: 10.3109/0142159X.2012.714886. Epub 2012 Sep 3.
PubMed 22938677
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Versus Varied Simulation Scenarios to Teach Medical Students the Management of a Pediatric Asthma Exacerbation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02754310
- Acronym / sponsor ID
- REVAR / ILUMENS0001
- Conditions
- Education, Medical
- Keywords
- Education, medical, Simulation Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- IlumensUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Posted 28 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Repeated exposure to simulated cases has been shown to improve performance, but repeating the same scenario may impair the ability of learners to transfer their knowledge and skills to slightly different situations. The objective of this study is to compare the use of repeated versus varied simulation cases for teaching the management of pediatric asthma exacerbation to 3rd year medical students.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repeated scenarios | Active comparator | Other: Repeated scenariosParticipants in the repeated scenario group will learn the management of a pediatric asthma exacerbation on the same scenario repeated three times. The scenario is a pediatric moderate asthma exacerbation not responding to treatment, . |
| Varied scenarios | Experimental | Other: Variation of scenariosParticipants in the varied scenarios group will learn the management of a pediatric asthma exacerbation on three different scenarios: a moderate asthma exacerbation, a mild one, and a severe one, for the same length of time than the "repeated scenarios" group. In this group, there is a variation of scenarios. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Third year medical students from Paris Descartes and Paris Diderot medical faculties.
- Who are not opposed to participated in the study
Key exclusion criteria (1 listed)
- Opposition to participate in the study
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 |
|---|---|---|
| Variation of scenariosThree different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation. | Other | Varied scenarios |
| Repeated scenariosThe same scenario of a moderate pediatric asthma exacerbation is repeated three times. | Other | Repeated scenarios |
Primary outcome
Management Score on Transfer Scenario n°1
Time frame: One week
The transfer scenario n°1 is a new scenario that learners face for the first time. It is a pediatric asthma exacerbation rapidly worsening. The scale "Asthma exacerbation rapidly worsening" includes different items related to the sequence, the dose, and the administration technique of the treatments. The score ranges between 0 and 10, 10 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1.
7 secondary outcomes
Management Score on Transfer Scenario n°2
Time frame: One week
Management Score on Evaluation Scenario n°1
Time frame: One week
Management Score on Evaluation Scenario n°2
Time frame: One week
Management Score on Transfer Scenario n°3
Time frame: 4 months
Management Score on Transfer Scenario n°4
Time frame: 4 months
Management Score on Evaluation Scenario n°1
Time frame: 4 months
Management Score on Evaluation Scenario n°2
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24949131Tofil NM, Peterson DT, Wheeler JT, Youngblood A, Zinkan JL, Lara D, Jakaitis B, Niebauer J, White ML. Repeated versus varied case selection in pediatric resident simulation. J Grad Med Educ. 2014 Jun;6(2):275-9. doi: 10.4300/JGME-D-13-00099.1.
- Background: PubMed 22938677Cook DA, Hamstra SJ, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hatala R. Comparative effectiveness of instructional design features in simulation-based education: systematic review and meta-analysis. Med Teach. 2013;35(1):e867-98. doi: 10.3109/0142159X.2012.714886. Epub 2012 Sep 3.
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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.
David Drummond, MD principal investigator
University Paris René Descartes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variation of scenarios and Repeated scenarios in people with Education, Medical, run by Ilumens at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 28 Jun 2019. 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 France. 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?
Yes. Results are posted in the registry (first posted 28 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Management Score on Transfer Scenario n°1 (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02754310, which also lists 2 linked publications.
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 28 Jun 2019.