NCT03884114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

March 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2019

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

March 18, 2019

Last Update Submit

July 16, 2020

Conditions

Keywords

technology-enhanced simulationserious gamesmultiple choice questionnairesmedical education

Outcome Measures

Primary Outcomes (1)

  • Items of the "asthma exacerbation performance score"

    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 Outcomes (2)

  • The total score on the "asthma exacerbation performance score"

    Baseline

  • The satisfaction of students using Likert-scales with each evaluation modality

    Baseline

Study Arms (1)

All participants

OTHER

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 simulationOther: Simulation gameOther: Multiple choice questionnaire

Interventions

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).

All participants

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.

All participants

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.

All participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université Paris Descartes

Paris, 75270, France

Location

Related Publications (4)

  • 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. doi: 10.1111/j.1365-2923.1985.tb01314.x.

    PMID: 4010571BACKGROUND
  • Drummond D, Delval P, Abdenouri S, Truchot J, Ceccaldi PF, Plaisance P, Hadchouel A, Tesniere 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.

    PMID: 28731928BACKGROUND
  • 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.

    PMID: 28512082BACKGROUND
  • 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.

Related Links

Study Officials

  • David Drummond, MD, PhD

    Université Paris Descartes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 21, 2019

Study Start

March 20, 2019

Primary Completion

July 6, 2019

Study Completion

July 6, 2019

Last Updated

July 20, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

* 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

Shared Documents
STUDY PROTOCOL, 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

Locations