Validity Assessment of the "LabForGames Warning" Serious Game

The use of simulation in medical education has been associated with positive results in the acquisition of knowledge, skills, behaviors and patient outcome. Serious games are useful educational tools since they allow both theory and practice training for an important number of learners, simultaneously. However, few studies have evaluated the validity and effectiveness of serious games.

Our simulation unit (LabForSIMS- Faculté de Médecine Paris-Sud, France) has developed a serious game named "LabForGames Warning" for nursing students with the following learning objectives: to recognize and to address the degradation of a patient's clinical condition and to work on the issue of inter-professional communication. The aim of the present study is to determine content and construct validities of the "LabForGames Warning" serious game before its use as a healthcare professional training tool.

Study Overview

• Status: Completed
• Conditions: Education
• Intervention / Treatment: Other: serious game

Detailed Description

This observational single-center open study will be conducted in the simulation center of the Paris-Sud medical school (LabForSIMS). After written consent, the study population (nurses and nursing students) will attend a three hours simulation session with the "LabForGames Warning" serious game and will be divided into three groups :

• Nursing students
• New Nurses: Nurses with < 2 years experience
• Expert Nurses: Intensive nurses, with ≥ 4 years experience post graduate.

During three hours, each learner will play with the three different cases of the "LabForGames Warning" serious game then an auto-evaluation will be recorded.

The primary outcome measure was the evaluation of the construct validity:

The score (/100) and the duration (min) of each case of the serious game will be reported in order to assess whether the difference of the measures is related to the difference of skills between the three groups. An auto-evaluation of clinical reasoning will also be recorded.

The secondary outcome measure was the evaluation of content and face validities. For content validity, the content and parameters will be tested by the nurses ≥ 4 years experienced (Ten-point Likert scale) For face validity, the students' satisfaction and the resemblance between the virtual game and the real life clinical practice will be evaluated in the three groups (Ten-point Likert scale).

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94276
    • Faculté de médecine Paris Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Voluntary divided into three groups :

• "Nursing students" group
• "New nurses" group: Nurses with < 2 years experience
• "Expert nurses" group: Intensive nurses (with ≥ 4 years experience post graduate)

Description

Inclusion Criteria:

• Nursing students or nurses with < 2 years experience or intensive nurses (with ≥ 4 years experience post graduate)
• and having agreed to participate

Exclusion Criteria:

• Subjects incapable of giving consent: incapacitated (subjects under guardianship), minors (< 18 years)
• Refusal to participate in to the study Refusal to sign in the confidentiality clause

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
"Nursing students" group; nursing students	Other: serious game; During three hours, each learner will play with the three different cases of the "LabForGames Warning" serious game.
"New nurses" group; Nurses with < 2 years experience	Other: serious game; During three hours, each learner will play with the three different cases of the "LabForGames Warning" serious game.
"Expert nurses" group; Intensive nurses (with ≥ 4 years experience post graduate)	Other: serious game; During three hours, each learner will play with the three different cases of the "LabForGames Warning" serious game.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The score (/100) of each case of the serious game	The score (/100) of each case of the serious game will be reported in order to assess whether the difference of the measures is related to the difference of skills between the three groups (Evaluation of the construct validity). An auto-evaluation of clinical reasoning will also be recorded.	60 min
the duration (min) of each case of the serious game	The duration (min) of each case of the serious game will be reported in order to assess whether the difference of the measures is related to the difference of skills between the three groups (Evaluation of the construct validity).	60 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The content and parameters of the serious game	For content validity, the content and parameters of the serious game will be tested by the nurses ≥ 4 years experienced (Ten-point Likert scale)	30 min
Learners' satisfaction	For face validity, the learners' satisfaction and the resemblance between the virtual game and the real life clinical practice will be evaluated in the three groups (Ten-point Likert scale).	5 min
The resemblance between the virtual game and the real life clinical practice	For content validity, the resemblance between the virtual game and the real life clinical practice will be evaluated in the three groups (Ten-point Likert scale).	25 min

Collaborators and Investigators

• Sponsor: Université Paris-Sud
• Investigators: Principal Investigator: Antonia Blanié, M.D, Université Paris Sud, 91 400 Orsay, France

Publications and helpful links

General Publications

• Blanie A, Amorim MA, Meffert A, Perrot C, Dondelli L, Benhamou D. Assessing validity evidence for a serious game dedicated to patient clinical deterioration and communication. Adv Simul (Lond). 2020 May 27;5:4. doi: 10.1186/s41077-020-00123-3. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: simulation; validity; Medical Education; serious game
• Other Study ID Numbers: LabForSIMS-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No