NCT03428269

Brief Summary

Detection of patient deterioration is a major healthcare problem. Indeed, acute clinical deterioration of the patient is often preceded by changes of several physiological parameters within 6 to 24h before the event occurs. The combination of i) early detection ii) rapid response and iii) efficient clinical management influences the patient's prognosis. Education of nurses, who are frontline healthcare providers, is therefore essential. Serious games might represent an interesting immersive educational tool to train a large number of healthcare professionals with high flexibility but assessment of their learning efficacy should be demonstrated. A serious game named LabforGames Warning has been developed for nursing students with the aims of improving their ability to detect clinical deterioration and to promote adequate interprofessional communication. The objective of this study will be to compare the respective value of digital simulation (using the above mentioned serious game) and a traditional teaching method to improve the clinical reasoning skills necessary to detect patient deterioration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

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

January 30, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

January 30, 2018

Last Update Submit

November 20, 2018

Conditions

Simulation

Keywords

simulationclinical reasoningpatient deterioration

Outcome Measures

Primary Outcomes (1)

  • clinical reasoning skills

    assessed by the global score of script concordance tests (score between 0 to 100)

    20 minutes at the end of the session

Secondary Outcomes (3)

  • self efficacy

    1 minutes at end of the session

  • satisfaction

    1 minutes at end of the session

  • retention of clinical reasoning skills

    20 minutes one month after

Study Arms (2)

simulation by gaming group

EXPERIMENTAL

In the simulation by gaming group, the students will individually play with two cases of the LabforGames Warning game (postoperative hemorrhage case and brain trauma in elderly case). After each case, a debriefing to which with all players will participate will be conducted by an instructor.

Other: simulation by gaming (LabForGames Warning)

traditional education group

ACTIVE COMPARATOR

In traditional education group, the students will individually work on the two same cases but the two vignettes and adjoining questions will be presented and answered by the student on a paper sheet. Then a global review of the two cases and the major messages to be retained will be presented by a teacher.

Other: traditional education

Interventions

simulation by gaming (LabForGames Warning)OTHER

comparison of the efficacy of two educational methods to improve the clinical reasoning skills of nursing students facing patient deterioration

simulation by gaming group
traditional educationOTHER

comparison of the efficacy of two educational methods to improve the clinical reasoning skills of nursing students facing patient deterioration

traditional education group

Eligibility Criteria

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

You may qualify if:

  • nursing students

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

IFSI Sud Francilien

Corbeil-Essonnes, 91100, France

Location

IFSI etampes

Étampes, 91150, France

Location

IFSI Perray Vaucluse

Sainte-Geneviève-des-Bois, 91700, France

Location

IFSI Paul Guiraud

Villejuif, 94 806, France

Location

Related Publications (2)

  • Dory V, Gagnon R, Vanpee D, Charlin B. How to construct and implement script concordance tests: insights from a systematic review. Med Educ. 2012 Jun;46(6):552-63. doi: 10.1111/j.1365-2923.2011.04211.x.

    PMID: 22626047BACKGROUND

  • Blanie A, Amorim MA, Benhamou D. Comparative value of a simulation by gaming and a traditional teaching method to improve clinical reasoning skills necessary to detect patient deterioration: a randomized study in nursing students. BMC Med Educ. 2020 Feb 19;20(1):53. doi: 10.1186/s12909-020-1939-6.

    PMID: 32075641DERIVED

Study Officials

  • Antonia BLANIE, MD

    Université Paris-Sud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel assignment, not blinded, randomized study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 9, 2018

Study Start

February 1, 2018

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

November 23, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)