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Comparison of Three Modalities to Assess Clinical Competence of Medical Students (SIMEVAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884114
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Ilumens

Brief Summary:

This study, focusing on the management of pediatric asthma exacerbations, assesses the clinical skills of medical students using three different evaluation tools: (i) the simulation game "Effic'Asthme" developed to train individuals on the management of pediatric asthma exacerbations; (ii) a multiple choice questionnaire (MCQ) on the same subject developed for the purpose of the study and (iii) high fidelity (HF)-simulation, considered as the gold-standard for its enhanced realism.

Its objective is to determine which of the simulation game or the MCQ reflects the best the clinical competence of medical students evaluated on a HF simulator.


Condition or disease Intervention/treatment Phase
Educational Problems Other: High-fidelity simulation Other: Simulation game Other: Multiple choice questionnaire Not Applicable

Detailed Description:

The assessment of medical students' clinical competence has long been of concern to educational institutions. Objective structural clinical examination (OSCE) and assessments in high-fidelity (HF) simulation settings represent interesting evaluation modalities but are associated with huge costs, especially when they are used for large-scale standardized assessments. Multiple choice questionnaires (MCQ) remain the most common evaluation tool in medical schools.

Simulation games may represent an interesting compromise between the cheap but limited assessment allowed by MCQs, and the comprehensive but highly expensive assessment allowed by OSCE and HF simulation.

This study, focusing on the management of pediatric asthma exacerbations, assesses the clinical skills of medical students using three different evaluation tools: (i) the simulation game "Effic'Asthme" developed to train individuals on the management of pediatric asthma exacerbations; (ii) a MCQ on the same subject developed for the purpose of the study and (iii) HF-simulation, considered as the gold-standard for its enhanced realism.

Its objective is to determine which of the simulation game or the MCQ reflects the best the clinical competence of medical students evaluated on a HF simulator.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Sequential Assignment
Intervention Model Description: All medical students are evaluated using a high-fidelity simulation environment, then using a serious game, then using multiple choice questionnaire, all on the same topic.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Clinical Competence of Medical Students: a Comparison of High-fidelity Simulation, Serious Game and Multiple-choice Questions
Actual Study Start Date : March 20, 2019
Actual Primary Completion Date : July 6, 2019
Actual Study Completion Date : July 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
All participants
All participants are evaluated on a scenario of pediatric asthma exacerbation using three different evaluation tools: (i) the simulation game EfficAsthme developed to train individuals on the management of pediatric asthma exacerbations; (ii) a MCQ on the same subject developed for the purpose of the study and (iii) HF-simulation, considered as the gold-standard for its enhanced realism.
Other: High-fidelity simulation
The first evaluation modality studied is high fidelity (HF) simulation. In our study, this modality is considered to be the gold-standard assessment method of clinical assessment, because HF simulation corresponds to the modality which reflects the best clinical competence in hospital settings. The HF pediatric manikin used (SimBaby), is able to reproduce all the signs of an asthma exacerbation (coughing, wheezing, tachypnea, chest indrawing, seesaw respiration, cyanosis). In the simulation room, participants can use the same items that those present in the simulation game (a glass of water, paracetamol, short acting beta-agonist, controller treatment (Fluticasone), an asthma spacer with a facial mask, saline nose drops to perform nasal irrigation, oral steroids in tablets (prednisone), and a phone).

Other: Simulation game
EfficAsthme is a simulation game used on a tablet computer. This simulation game was developed to train parents on the management of asthma exacerbations of their children. For the purpose of the study, EfficAsthme is diverted from its original use to assess students' clinical skills. The training scenario "A polluted atmosphere" is used in this study. Participants need to observe the signs presented by the child, and to determine the severity of the asthma exacerbation. From a menu on the right of the screen, the participant can choose several actions, especially to provide the short acting beta-agonist.

Other: Multiple choice questionnaire
The third evaluation modality corresponds to a multiple choice questionnaire (MCQ) including 15 questions. As for HF-simulation and the simulation game, the MCQ starts with the same briefing and continues with 15 questions regarding the management of a moderate asthma exacerbation.




Primary Outcome Measures :
  1. Items of the "asthma exacerbation performance score" [ Time Frame: Baseline ]

    This score uses a scale designed for the purpose of the study, the "Asthma exacerbation performance score", ranging from 0 to 19, 19 being the highest rate meaning that all the actions were correctly performed (1 point per action correctly performed).

    This score will allow to calculate the degree of correlation calculated by Kappa coefficient for each action performed or answer provided, between the simulation game and the high fidelity simulation session on the one hand; and between the multiple choice questionnaire and the high fidelity simulation session on the other hand;

    Then, we will compare the median Kappa coefficients for each condition, and determine which of the multiple choice questionnaire or the simulation game reflects the best the clinical competence of medical students observed during a high-fidelity simulation session.



Secondary Outcome Measures :
  1. The total score on the "asthma exacerbation performance score" [ Time Frame: Baseline ]

    The total scores of this checklist will allow to calculate:

    • the degree of correlation of the scores using this checklist between the simulation game and the high-fidelity simulation session using spearman correlation,
    • the degree of correlation of the scores using this checklist between the simulation game and the multiple choice questionnaire using spearman correlation

    It will also allow to compare the median scores of the students between the three modalities of assessment (high fidelity simulation, simulation game and multiple choice questionnaire), and the dispersion of the scores between the three modalities.


  2. The satisfaction of students using Likert-scales with each evaluation modality [ Time Frame: Baseline ]
    The satisfaction of students with the simulation game, and with the multiple choice questionnaire, will be assessed using a questionnaire with Likert-scales.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • medical students from Paris 5 University who meet the following criteria

    • Being in their fifth year of medical school
    • Having passed their pediatric exam in the previous 15 days
    • Willing to participate in the study

Exclusion Criteria:

  • refusal to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884114


Locations
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France
Université Paris Descartes
Paris Cedex 06, France, 75270
Sponsors and Collaborators
Ilumens
Investigators
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Principal Investigator: David Drummond, MD, PhD Université Paris Descartes
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ilumens
ClinicalTrials.gov Identifier: NCT03884114    
Other Study ID Numbers: Ilumens0003
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
  • Participants' characteristics anonymized
  • Participants' correct and incorrect actions and answers when evaluated on the 3 different modalities: multiple choice questionnaire, high-fidelity simulation and simulation game
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: From baseline to 2 years after completion of the study.
Access Criteria: Individual patient date, study protocol and statistical analysis plan will be available upon request to david.drummond@ilumens.org

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ilumens:
technology-enhanced simulation
serious games
multiple choice questionnaires
medical education