NCT02758119

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

March 1, 2019

Enrollment Period

Same day

First QC Date

April 29, 2016

Results QC Date

December 16, 2017

Last Update Submit

June 27, 2019

Conditions

Education, Medical, UndergraduateOut-of-Hospital Cardiac ArrestSimulation Training

Outcome Measures

Primary Outcomes (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.

    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.

    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

Secondary Outcomes (3)

  • 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.

  • 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

  • Score (on the Checklist) on the First Attempt During the hands-on Session

    4 months after the hands-on session.

Study Arms (2)

Serious Game

EXPERIMENTAL

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

Online course

ACTIVE COMPARATOR

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

Interventions

Serious GameOTHER
Serious Game
Online courseOTHER
Online course

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Opposition to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département de Simulation iLumens, Université Paris Descartes

Paris, 75006, France

Location

Related Publications (5)

  • 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.

    PMID: 23624247BACKGROUND

  • 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. doi: 10.1111/j.1525-1497.2006.00341.x.

    PMID: 16637824BACKGROUND

  • 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.

    PMID: 23807104BACKGROUND

  • Creutzfeldt J, Hedman L, Fellander-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.

    PMID: 23217084BACKGROUND

  • 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: 28731928DERIVED

Related Links

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
David Drummond
Organization
iLumens
david.drummond@ilumens.org
0033144494848

Study Officials

  • David Drummond, MD

    University Paris René Descartes

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 2, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

July 5, 2019

Results First Posted

July 5, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)