REVAR: Repeated Versus Varied Simulation Scenarios to Teach Medical Students the Management of a Pediatric Asthma Exacerbation

• Sponsor: Ilumens (Other)
• Overall Status: Completed
• CT.gov ID: NCT02754310
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 16.9

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Education, Medical	Other: Variation of scenarios; Other: Repeated scenarios	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Repeated Versus Varied Simulation Scenarios to Teach Medical Students the Management of a Pediatric Asthma Exacerbation: A Randomized Controlled Study
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Repeated scenarios 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, .	Other: Repeated scenarios; The same scenario of a moderate pediatric asthma exacerbation is repeated three times.
Experimental: Varied scenarios 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.	Other: Variation of scenarios; Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.

Outcome Measures

Primary Outcome Measures

1. Management Score on Transfer Scenario n°1 [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.

Secondary Outcome Measures

1. Management Score on Transfer Scenario n°2 [One week]

   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.

2. Management Score on Evaluation Scenario n°1 [One week]

   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.

3. Management Score on Evaluation Scenario n°2 [One week]

   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.

4. Management Score on Transfer Scenario n°3 [4 months]

   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.

5. Management Score on Transfer Scenario n°4 [4 months]

   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.

6. Management Score on Evaluation Scenario n°1 [4 months]

   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.

7. Management Score on Evaluation Scenario n°2 [4 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Third year medical students from Paris Descartes and Paris Diderot medical faculties.

• Who are not opposed to participated in the study

Exclusion Criteria:

• Opposition to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Département de Simulation iLumens, Université Paris Descartes	Paris		France	75006

Sponsors and Collaborators

• Ilumens

Investigators

• Principal Investigator: David Drummond, MD, University Paris René Descartes

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• iLumens is the department of simulation in healthcare of the University Paris Descartes in Paris

Publications

• Cook 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. Review.
• 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.

• Responsible Party: David Drummond, Dr David Drummond, Ilumens
• ClinicalTrials.gov Identifier: NCT02754310
• Other Study ID Numbers: ILUMENS0001
• First Posted: Apr 28, 2016
• Last Update Posted: Jun 28, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by David Drummond, Dr David Drummond, Ilumens: Education, medical; Simulation Training

Study Results

Participant Flow

Arm/Group Title	Varied Scenarios	Repeated Scenarios
Arm/Group Description	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. Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.	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, . Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times.
Period Title: Overall Study
STARTED	42	43
COMPLETED	42	43
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Varied Scenarios	Repeated Scenarios	Total
Arm/Group Description	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. Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.	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, . Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times.	Total of all reporting groups
Overall Participants	42	43	85
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	22	22	22
Sex: Female, Male (Count of Participants)
Female	29 69%	27 62.8%	56 65.9%
Male	13 31%	16 37.2%	29 34.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Asthma (Count of Participants)
Count of Participants [Participants]	2 4.8%	3 7%	5 5.9%
Medical Experience in pediatrics (Count of Participants)
Count of Participants [Participants]	3 7.1%	8 18.6%	11 12.9%
Familiar with low-fidelity manikins (Count of Participants)
Count of Participants [Participants]	39 92.9%	40 93%	79 92.9%

Outcome Measures

1. Primary Outcome

Title	Management Score on Transfer Scenario n°1
Description	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.
Time Frame	One week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Varied Scenarios	Repeated Scenarios
Arm/Group Description	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. Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.	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, . Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times.
Measure Participants	42	43
Median (Inter-Quartile Range) [units on a scale]	8.3	8.0

2. Secondary Outcome

Title	Management Score on Transfer Scenario n°2
Description	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.
Time Frame	One week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Varied Scenarios	Repeated Scenarios
Arm/Group Description	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. Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.	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, . Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times.
Measure Participants	42	43
Median (Inter-Quartile Range) [units on a scale]	3.0	4.0

3. Secondary Outcome

Title	Management Score on Evaluation Scenario n°1
Description	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.
Time Frame	One week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Varied Scenarios	Repeated Scenarios
Arm/Group Description	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. Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.	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, . Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times.
Measure Participants	42	43
Median (Inter-Quartile Range) [units on a scale]	14.1	15.0

4. Secondary Outcome

Title	Management Score on Evaluation Scenario n°2
Description	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.
Time Frame	One week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Varied Scenarios	Repeated Scenarios
Arm/Group Description	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. Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.	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, . Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times.
Measure Participants	42	43
Median (Inter-Quartile Range) [units on a scale]	9.0	7.0

5. Secondary Outcome

Title	Management Score on Transfer Scenario n°3
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Varied Scenarios	Repeated Scenarios
Arm/Group Description	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. Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.	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, . Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times.
Measure Participants	42	43
Median (Inter-Quartile Range) [units on a scale]	13.0	12.3

6. Secondary Outcome

Title	Management Score on Transfer Scenario n°4
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Varied Scenarios	Repeated Scenarios
Arm/Group Description	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. Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.	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, . Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times.
Measure Participants	42	43
Median (Inter-Quartile Range) [units on a scale]	2.0	3.0

7. Secondary Outcome

Title	Management Score on Evaluation Scenario n°1
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Varied Scenarios	Repeated Scenarios
Arm/Group Description	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. Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.	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, . Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times.
Measure Participants	42	43
Median (Inter-Quartile Range) [units on a scale]	13.6	13.8

8. Secondary Outcome

Title	Management Score on Evaluation Scenario n°2
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Varied Scenarios	Repeated Scenarios
Arm/Group Description	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. Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.	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, . Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times.
Measure Participants	42	43
Median (Inter-Quartile Range) [units on a scale]	7.5	7.5

Adverse Events

Arm/Group Title	Repeated Scenarios		Varied Scenarios
Arm/Group Description	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, . Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times.		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. Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.
All Cause Mortality
	Repeated Scenarios		Varied Scenarios
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Repeated Scenarios		Varied Scenarios
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Repeated Scenarios		Varied Scenarios
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/42 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.