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

July 16, 2020 updated by: Ilumens

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris Cedex 06, France, 75270
        • Université Paris Descartes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ilumens

Investigators

  • Principal Investigator: David Drummond, MD, PhD, Université Paris Descartes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2019

Primary Completion (ACTUAL)

July 6, 2019

Study Completion (ACTUAL)

July 6, 2019

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (ACTUAL)

March 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2020

Last Update Submitted That Met QC Criteria

July 16, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Ilumens0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Time Frame

From baseline to 2 years after completion of the study.

IPD Sharing Access Criteria

Individual patient date, study protocol and statistical analysis plan will be available upon request to david.drummond@ilumens.org

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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