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

• ClinicalTrials.gov Identifier: NCT03884114
• Recruitment Status: Completed
• First Posted: March 21, 2019
• Last Update Posted: July 20, 2020
• Sponsor: Ilumens
• Information provided by (Responsible Party): Ilumens

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

France

Université Paris Descartes

Paris Cedex 06, France, 75270

Sponsors and Collaborators

Ilumens

Investigators

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

More Information

Additional Information:

Site showing the simulation game "EfficAsthme" developed 

Publications:

Norcini JJ, Swanson DB, Grosso LJ, Webster GD. Reliability, validity and efficiency of multiple choice question and patient management problem item formats in assessment of clinical competence. Med Educ. 1985 May;19(3):238-47.

Drummond D, Delval P, Abdenouri S, Truchot J, Ceccaldi PF, Plaisance P, Hadchouel A, Tesnière A. Serious game versus online course for pretraining medical students before a simulation-based mastery learning course on cardiopulmonary resuscitation: A randomised controlled study. Eur J Anaesthesiol. 2017 Dec;34(12):836-844. doi: 10.1097/EJA.0000000000000675.

Adjedj J, Ducrocq G, Bouleti C, Reinhart L, Fabbro E, Elbez Y, Fischer Q, Tesniere A, Feldman L, Varenne O. Medical Student Evaluation With a Serious Game Compared to Multiple Choice Questions Assessment. JMIR Serious Games. 2017 May 16;5(2):e11. doi: 10.2196/games.7033.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fonteneau T, Billion E, Abdoul C, Le S, Hadchouel A, Drummond D. Simulation Game Versus Multiple Choice Questionnaire to Assess the Clinical Competence of Medical Students: Prospective Sequential Trial. J Med Internet Res. 2020 Dec 16;22(12):e23254. doi: 10.2196/23254.

• Responsible Party: Ilumens
• ClinicalTrials.gov Identifier: NCT03884114
• Other Study ID Numbers: Ilumens0003
• First Posted: March 21, 2019
• 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

• 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