Serious Game Versus Online Course to Pre-train Medical Students on the Management of an Adult Cardiac Arrest.

• Sponsor: Ilumens (Other)
• Overall Status: Completed
• CT.gov ID: NCT02758119
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 20.5

Study Details

Study Description

Brief Summary

The objective of this study is to compare two forms of pre-training (an online narrative presentation and a serious game) to prepare 2nd year medical students for a hands-on training with physical simulators about out-of-hospital cardiac arrest management.

Condition or Disease	Intervention/Treatment	Phase
Education, Medical, Undergraduate; Out-of-Hospital Cardiac Arrest; Simulation Training	Other: Serious Game; Other: Online course	N/A

Detailed Description

Technology-enhanced simulation allows mastery learning. Mastery learning is a variety of competency-based education which has demonstrated its efficacy for skills acquisition and their transfer to actual settings. While traditional education defines fixed learning time and allows outcomes to vary, in mastery learning, all trainees must achieve a predefined level of proficiency while their learning time can vary. The main limitation of mastery learning is that it takes more time than non-mastery learning. This is of concern because the main barrier to simulation-based training is the lack of faculty time. Thus, new solutions should emerge to conciliate mastery learning and time constraints on physical simulators.

Pre-training with a "simulation game" may be a mean to reach this objective. Simulation games are serious games which are at the cross roads between (1) educational games which are "applications using the characteristics of video and computer games to create engaging and immersive learning experiences", and (2) simulation, the imitation of situations which can be encountered in real-life. They combine the advantages of educational games (active, personalized learning) and simulation (realistic and safe environment for experiential learning). By contrast, pre-training with an online course using a PowerPoint presentation with voiceover narration lecture is both passive and abstract.

The objective of this study is to evaluate the time-efficiency of pre-training using a simulation game versus an online course to reach mastery learning in the management of an adult out-of-hospital cardiac arrest.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Conciliating Mastery Learning and Time Constraints on High-fidelity Simulators: Serious Game Versus Online Course to Pre-train Medical Students on the Management of an Adult Cardiac Arrest.
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Serious Game Participants in the "serious game" group will be pre-trained before the hands-on sessions with the serious game "Staying Alive", available at http://www.stayingalive.fr/index_us.html This game aims at teaching the management of an out-of-hospital cardiac arrest to the general public and health professionals. In this game, the player faces a man who has experienced sudden cardiac arrest and learns the appropriate behavior, movements and techniques that can contribute to saving his life. The first level of the game lasts 4-5 minutes, depending on the skills of the player. It is a point and click game, displayed on a PC computer.	Other: Serious Game
Active Comparator: Online course Participants in the lecture group will watch individually a 4-min video of a PowerPoint presentation with voiceover narration, given in the medical school of Paris Descartes University. The video is edited to contain the same informations on out-of-hospital cardiac management than the serious game, with the same duration.	Other: Online course

Outcome Measures

Primary Outcome Measures

1. Median Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator at Day 8. [The hands-on session takes place 8 days after the first pre-training when the serious game or the online course are played/watched twice, and one day after the second pre-training when they are played/watched once more]

   Following the 2015 European Resuscitation Council guidelines, a checklist was developed for this study. This checklist allows the assessors to evaluate the participant's compliance with guidelines, and to determine if he/she needs to practice again on the scenario or if he/she reached the minimum passing score and can stop the training. The quality of the chest compressions provided is recorded automatically through the ResusciAnne Skill Reporter Software (Laerdal, Norways), and is integrated in the checklist.

Secondary Outcome Measures

1. Median Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator [4 months after the hands-on session.]

   Evaluation of skill retention.

2. Score (on the Checklist) on the First Attempt During the hands-on Session [The hands-on session takes place 8 days after the first pre-training when the serious game or the online course are played/watched twice, and one day after the second pre-training when they are played/watched once more]

   Name: Checklist for performance score of SCA management This checklist was adapted from the 2015 resuscitation guidelines. Points were given for the actions performed correctly in sequence and in time(sequence score, 0 to 4),and for the quality of the chest compressions (compression score,0 to 8). The minimum passing score on this checklist was 11 out of 12 (min 0-max 12), with the absolute requirement to score the maximum 4 points on the sequence score. Higher scores mean a better outcome.

3. Score (on the Checklist) on the First Attempt During the hands-on Session [4 months after the hands-on session.]

   Name: Checklist for performance score of SCA management This checklist was adapted from the 2015 resuscitation guidelines. Points were given for the actions performed correctly in sequence and in time(sequence score, 0 to 4),and for the quality of the chest compressions (compression score,0 to 8). The minimum passing score on this checklist was 11 out of 12 (min 0-max 12), with the absolute requirement to score the maximum 4 points on the sequence score. Higher scores mean a better outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Second-year medical students from the medical schools of Paris Descartes and Paris Diderot University who are not opposed to participate in the study.

Exclusion Criteria:

• Opposition to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Département de Simulation iLumens, Université Paris Descartes	Paris		France	75006

Sponsors and Collaborators

• Ilumens

Investigators

• Principal Investigator: David Drummond, MD, University Paris René Descartes

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Official website of the departement of simulation in healthcare, Paris Descartes University

Publications

• Cook DA, Brydges R, Zendejas B, Hamstra SJ, Hatala R. Mastery learning for health professionals using technology-enhanced simulation: a systematic review and meta-analysis. Acad Med. 2013 Aug;88(8):1178-86. doi: 10.1097/ACM.0b013e31829a365d. Review.
• Creutzfeldt J, Hedman L, Felländer-Tsai L. Effects of pre-training using serious game technology on CPR performance--an exploratory quasi-experimental transfer study. Scand J Trauma Resusc Emerg Med. 2012 Dec 6;20:79. doi: 10.1186/1757-7241-20-79.
• Mundell WC, Kennedy CC, Szostek JH, Cook DA. Simulation technology for resuscitation training: a systematic review and meta-analysis. Resuscitation. 2013 Sep;84(9):1174-83. doi: 10.1016/j.resuscitation.2013.04.016. Epub 2013 Apr 23. Review.
• Wayne DB, Butter J, Siddall VJ, Fudala MJ, Wade LD, Feinglass J, McGaghie WC. Mastery learning of advanced cardiac life support skills by internal medicine residents using simulation technology and deliberate practice. J Gen Intern Med. 2006 Mar;21(3):251-6.

• Responsible Party: Ilumens
• ClinicalTrials.gov Identifier: NCT02758119
• Other Study ID Numbers: Ilumens0002
• First Posted: May 2, 2016
• Last Update Posted: Jul 5, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest

Study Results

Participant Flow

Arm/Group Title	Online Course	Serious Game
Arm/Group Description	Participants in the lecture group will watch individually a 4-min video of a PowerPoint presentation with voiceover narration, given in the medical school of Paris Descartes University. The video is edited to contain the same informations on out-of-hospital cardiac management than the serious game, with the same duration. Online course	Participants in the "serious game" group will be pre-trained before the hands-on sessions with the serious game "Staying Alive", available at http://www.stayingalive.fr/index_us.html This game aims at teaching the management of an out-of-hospital cardiac arrest to the general public and health professionals. In this game, the player faces a man who has experienced sudden cardiac arrest and learns the appropriate behavior, movements and techniques that can contribute to saving his life. The first level of the game lasts 4-5 minutes, depending on the skills of the player. It is a point and click game, displayed on a PC computer. Serious Game
Period Title: Overall Study
STARTED	41	41
COMPLETED	39	40
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Serious Game	Online Course	Total
Arm/Group Description	Participants in the "serious game" group will be pre-trained before the hands-on sessions with the serious game "Staying Alive", available at http://www.stayingalive.fr/index_us.html This game aims at teaching the management of an out-of-hospital cardiac arrest to the general public and health professionals. In this game, the player faces a man who has experienced sudden cardiac arrest and learns the appropriate behavior, movements and techniques that can contribute to saving his life. The first level of the game lasts 4-5 minutes, depending on the skills of the player. It is a point and click game, displayed on a PC computer. Serious Game	Participants in the lecture group will watch individually a 4-min video of a PowerPoint presentation with voiceover narration, given in the medical school of Paris Descartes University. The video is edited to contain the same informations on out-of-hospital cardiac management than the serious game, with the same duration. Online course	Total of all reporting groups
Overall Participants	41	41	82
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	21	21	21
Sex: Female, Male (Count of Participants)
Female	27 65.9%	29 70.7%	56 68.3%
Male	14 34.1%	12 29.3%	26 31.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Last basic life support course taken, (Count of Participants)
Never	12 29.3%	20 48.8%	32 39%
< 12 months	4 9.8%	5 12.2%	9 11%
> 12 months	25 61%	16 39%	41 50%
Familiar with low-fidelity simulation (Count of Participants)
Count of Participants [Participants]	11 26.8%	12 29.3%	23 28%
Familiar with high-fidelity simulation (Count of Participants)
Count of Participants [Participants]	1 2.4%	0 0%	1 1.2%
Previous participation in CPA management (Count of Participants)
Count of Participants [Participants]	2 4.9%	0 0%	2 2.4%

Outcome Measures

1. Primary Outcome

Title	Median Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator at Day 8.
Description	Following the 2015 European Resuscitation Council guidelines, a checklist was developed for this study. This checklist allows the assessors to evaluate the participant's compliance with guidelines, and to determine if he/she needs to practice again on the scenario or if he/she reached the minimum passing score and can stop the training. The quality of the chest compressions provided is recorded automatically through the ResusciAnne Skill Reporter Software (Laerdal, Norways), and is integrated in the checklist.
Time Frame	The hands-on session takes place 8 days after the first pre-training when the serious game or the online course are played/watched twice, and one day after the second pre-training when they are played/watched once more

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Online Course	Serious Game
Arm/Group Description	Participants in the lecture group will watch individually a 4-min video of a PowerPoint presentation with voiceover narration, given in the medical school of Paris Descartes University. The video is edited to contain the same informations on out-of-hospital cardiac management than the serious game, with the same duration. Online course	Participants in the "serious game" group will be pre-trained before the hands-on sessions with the serious game "Staying Alive", available at http://www.stayingalive.fr/index_us.html This game aims at teaching the management of an out-of-hospital cardiac arrest to the general public and health professionals. In this game, the player faces a man who has experienced sudden cardiac arrest and learns the appropriate behavior, movements and techniques that can contribute to saving his life. The first level of the game lasts 4-5 minutes, depending on the skills of the player. It is a point and click game, displayed on a PC computer. Serious Game
Measure Participants	39	40
Median (Inter-Quartile Range) [minutes]	23	20.5

2. Secondary Outcome

Title	Median Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator
Description	Evaluation of skill retention.
Time Frame	4 months after the hands-on session.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Serious Game	Online Course
Arm/Group Description	Participants in the "serious game" group will be pre-trained before the hands-on sessions with the serious game "Staying Alive", available at http://www.stayingalive.fr/index_us.html This game aims at teaching the management of an out-of-hospital cardiac arrest to the general public and health professionals. In this game, the player faces a man who has experienced sudden cardiac arrest and learns the appropriate behavior, movements and techniques that can contribute to saving his life. The first level of the game lasts 4-5 minutes, depending on the skills of the player. It is a point and click game, displayed on a PC computer. Serious Game	Participants in the lecture group will watch individually a 4-min video of a PowerPoint presentation with voiceover narration, given in the medical school of Paris Descartes University. The video is edited to contain the same informations on out-of-hospital cardiac management than the serious game, with the same duration. Online course
Measure Participants	38	37
Median (Inter-Quartile Range) [Minutes]	11.7	12.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Online Course, Serious Game
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Score (on the Checklist) on the First Attempt During the hands-on Session
Description	Name: Checklist for performance score of SCA management This checklist was adapted from the 2015 resuscitation guidelines. Points were given for the actions performed correctly in sequence and in time(sequence score, 0 to 4),and for the quality of the chest compressions (compression score,0 to 8). The minimum passing score on this checklist was 11 out of 12 (min 0-max 12), with the absolute requirement to score the maximum 4 points on the sequence score. Higher scores mean a better outcome.
Time Frame	The hands-on session takes place 8 days after the first pre-training when the serious game or the online course are played/watched twice, and one day after the second pre-training when they are played/watched once more

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Serious Game	Online Course
Arm/Group Description	Participants in the "serious game" group will be pre-trained before the hands-on sessions with the serious game "Staying Alive", available at http://www.stayingalive.fr/index_us.html This game aims at teaching the management of an out-of-hospital cardiac arrest to the general public and health professionals. In this game, the player faces a man who has experienced sudden cardiac arrest and learns the appropriate behavior, movements and techniques that can contribute to saving his life. The first level of the game lasts 4-5 minutes, depending on the skills of the player. It is a point and click game, displayed on a PC computer. Serious Game	Participants in the lecture group will watch individually a 4-min video of a PowerPoint presentation with voiceover narration, given in the medical school of Paris Descartes University. The video is edited to contain the same informations on out-of-hospital cardiac management than the serious game, with the same duration. Online course
Measure Participants	40	39
Median (Inter-Quartile Range) [units on a scale]	6	6

4. Secondary Outcome

Title	Score (on the Checklist) on the First Attempt During the hands-on Session
Description	Name: Checklist for performance score of SCA management This checklist was adapted from the 2015 resuscitation guidelines. Points were given for the actions performed correctly in sequence and in time(sequence score, 0 to 4),and for the quality of the chest compressions (compression score,0 to 8). The minimum passing score on this checklist was 11 out of 12 (min 0-max 12), with the absolute requirement to score the maximum 4 points on the sequence score. Higher scores mean a better outcome.
Time Frame	4 months after the hands-on session.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Serious Game	Online Course
Arm/Group Description	Participants in the "serious game" group will be pre-trained before the hands-on sessions with the serious game "Staying Alive", available at http://www.stayingalive.fr/index_us.html This game aims at teaching the management of an out-of-hospital cardiac arrest to the general public and health professionals. In this game, the player faces a man who has experienced sudden cardiac arrest and learns the appropriate behavior, movements and techniques that can contribute to saving his life. The first level of the game lasts 4-5 minutes, depending on the skills of the player. It is a point and click game, displayed on a PC computer. Serious Game	Participants in the lecture group will watch individually a 4-min video of a PowerPoint presentation with voiceover narration, given in the medical school of Paris Descartes University. The video is edited to contain the same informations on out-of-hospital cardiac management than the serious game, with the same duration. Online course
Measure Participants	38	37
Median (Inter-Quartile Range) [units on a scale]	9	9

Adverse Events

Arm/Group Title	Online Course		Serious Game
Arm/Group Description	Participants in the lecture group will watch individually a 4-min video of a PowerPoint presentation with voiceover narration, given in the medical school of Paris Descartes University. The video is edited to contain the same informations on out-of-hospital cardiac management than the serious game, with the same duration. Online course		Participants in the "serious game" group will be pre-trained before the hands-on sessions with the serious game "Staying Alive", available at http://www.stayingalive.fr/index_us.html This game aims at teaching the management of an out-of-hospital cardiac arrest to the general public and health professionals. In this game, the player faces a man who has experienced sudden cardiac arrest and learns the appropriate behavior, movements and techniques that can contribute to saving his life. The first level of the game lasts 4-5 minutes, depending on the skills of the player. It is a point and click game, displayed on a PC computer. Serious Game
All Cause Mortality
	Online Course		Serious Game
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Online Course		Serious Game
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Online Course		Serious Game
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/41 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.