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Completed

NCT Number: NCT03884114

Comparison of Three Modalities to Assess Clinical Competence of Medical Students

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.

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Key information

Conditions

Educational Problems

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université Paris Descartes

Paris, 75270, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-fidelity simulation

Other

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).

Simulation game

Other

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.

Multiple choice questionnaire

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ilumens

Other

Registry information

Official study title

Assessment of Clinical Competence of Medical Students: a Comparison of High-fidelity Simulation, Serious Game and Multiple-choice Questions

Acronym: SIMEVAL

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2019
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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