Trial Outcomes & Findings for Repeated Versus Varied Simulation Scenarios to Teach Medical Students the Management of a Pediatric Asthma Exacerbation (NCT NCT02754310)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

85 participants

Primary outcome timeframe

One week

Results posted on

2019-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	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. Variation of scenarios: Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.	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, . Repeated scenarios: The same scenario of a moderate pediatric asthma exacerbation is repeated three times.
Overall Study STARTED	42	43
Overall Study COMPLETED	42	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varied Scenarios n=42 Participants 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.	Repeated Scenarios n=43 Participants 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 n=85 Participants Total of all reporting groups
Age, Continuous	22 years n=42 Participants	22 years n=43 Participants	22 years n=85 Participants
Sex: Female, Male Female	29 Participants n=42 Participants	27 Participants n=43 Participants	56 Participants n=85 Participants
Sex: Female, Male Male	13 Participants n=42 Participants	16 Participants n=43 Participants	29 Participants n=85 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Asthma	2 Participants n=42 Participants	3 Participants n=43 Participants	5 Participants n=85 Participants
Medical Experience in pediatrics	3 Participants n=42 Participants	8 Participants n=43 Participants	11 Participants n=85 Participants
Familiar with low-fidelity manikins	39 Participants n=42 Participants	40 Participants n=43 Participants	79 Participants n=85 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Varied Scenarios n=42 Participants 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.	Repeated Scenarios n=43 Participants 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.
Management Score on Transfer Scenario n°1	8.3 units on a scale Interval 7.4 to 10.0	8.0 units on a scale Interval 6.0 to 10.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Varied Scenarios n=42 Participants 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.	Repeated Scenarios n=43 Participants 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.
Management Score on Transfer Scenario n°2	3.0 units on a scale Interval 3.0 to 4.0	4.0 units on a scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Varied Scenarios n=42 Participants 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.	Repeated Scenarios n=43 Participants 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.
Management Score on Evaluation Scenario n°1	14.1 units on a scale Interval 13.0 to 16.0	15.0 units on a scale Interval 13.0 to 16.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Varied Scenarios n=42 Participants 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.	Repeated Scenarios n=43 Participants 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.
Management Score on Evaluation Scenario n°2	9.0 units on a scale Interval 7.5 to 9.0	7.0 units on a scale Interval 2.0 to 9.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Varied Scenarios n=42 Participants 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.	Repeated Scenarios n=43 Participants 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.
Management Score on Transfer Scenario n°3	13.0 units on a scale Interval 10.4 to 15.3	12.3 units on a scale Interval 9.8 to 16.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Varied Scenarios n=42 Participants 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.	Repeated Scenarios n=43 Participants 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.
Management Score on Transfer Scenario n°4	2.0 units on a scale Interval 2.0 to 3.0	3.0 units on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Varied Scenarios n=42 Participants 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.	Repeated Scenarios n=43 Participants 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.
Management Score on Evaluation Scenario n°1	13.6 units on a scale Interval 11.9 to 15.3	13.8 units on a scale Interval 11.0 to 15.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Varied Scenarios n=42 Participants 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.	Repeated Scenarios n=43 Participants 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.
Management Score on Evaluation Scenario n°2	7.5 units on a scale Interval 6.8 to 9.0	7.5 units on a scale Interval 5.0 to 9.0

Adverse Events

Repeated Scenarios

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Varied Scenarios

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr David Drummond

iLumens

Phone: +0033144494848

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place