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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03428269
Other study ID # LabForSims-003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date April 30, 2018

Study information

Verified date November 2018
Source Université Paris-Sud
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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. The investigators are interested to explore the relative benefits of gaming over other methods of training and how can non-technical skills be improved by gaming. A serious game named LabforGames Warning has been developed by the investigators with the aims of improving nursing students' capacity to detect patient deterioration and to promote adequate interprofessional communication. It includes four different scenarios in various clinical conditions (postoperative hemorrhage, pediatric diarrhea and hypovolemia, brain trauma in an elderly patient, abdominal occlusion in a psychiatric patient) but in all of them deterioration of the patient status occurs in three consecutive steps (minimal, moderate and severe). Each scenario can be used separately but all can also be played sequentially. The game can be used in a dedicated room with several computers allowing several students to play at the same time (multiplayer format). It can also be played alone by accessing the university website with each student being given a login and a password (single player format). The game conception emphasizes the fact the each student can play the game several times until his (her) score reaches an excellent result. When the game is played in a room of the medical/nursing school with 15-20 students performing at the same time, a common interactive debriefing is provided by an instructor at the end of each scenario in addition to the feedback included in the game itself. A pre-formatted feedback is indeed provided on the screen of the computer at the end of each step of the scenario and emphasizes the major lessons to be understood and retained for this part of the game. When the player uses the serious game alone during an internet-based session, the debriefing is limited to the pre-formatted feedback.

The nursing student is seated in front of the screen of the computer and uses a mouse to move objects and respond to questions. Initially, the player is informed on the clinical environment of the game and technical information (how to manipulate the items on the screen) is provided. Responses provided by the student in the consecutive stages of the scenario are scored (a scoring system has been previously established by the instructors who developed the game) and a feedback explaining the main issues (errors or imperfect responses) is also provided on the computer screen. At each clinical step during a given scenario, the player has the possibility to call a physician but the content of the information provided and the details of the request are examined and scored.

In the present study, the objective will be to compare the respective educational value of the above mentioned serious game and a traditional teaching method to improve the clinical reasoning skills necessary to detect patient deterioration.

This randomized study will be performed in the simulation center of Paris Sud University (LabForSIMS). After informed consent, 2nd year nursing students from nursing schools will be included and randomized into two groups: simulation by gaming group and traditional teaching group (control group).

In the simulation by gaming group, students will individually play with two scenarios of LabforGames Warning (postoperative hemorrhage after hip replacement and brain trauma in an elderly patient).

In the traditional teaching group, an instructor will present and discuss the same two vignettes with a similar number of students (i.e. 15 students). Information is presented using paper and a PowerPoint slide kit. The duration of the course will be similar to that of the serious game session.

The student's clinical reasoning skills will be measured by script concordance tests (SCT) to assess the retention of the clinical reasoning skills. A series of 80 SCT related to the learning objectives of the session will be presented to each group immediately after the session and one month thereafter. In addition, the perceived satisfaction and the effectiveness of the instructional design will be assessed using a questionnaire at the end of the session.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date April 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- nursing students

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Other:
simulation by gaming (LabForGames Warning)
comparison of the efficacy of two educational methods to improve the clinical reasoning skills of nursing students facing patient deterioration
traditional education
comparison of the efficacy of two educational methods to improve the clinical reasoning skills of nursing students facing patient deterioration

Locations

Country Name City State
France IFSI Sud Francilien Corbeil-Essonnes
France IFSI etampes Étampes
France IFSI Perray Vaucluse Sainte-Geneviève-des-Bois
France IFSI Paul Guiraud Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Université Paris-Sud

Country where clinical trial is conducted

France, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 self efficacy measured by a Likert scale between 1 to 10 1 minutes at end of the session
Secondary satisfaction measured by a Likert scale between 1 to 10) 1 minutes at end of the session
Secondary retention of clinical reasoning skills assessed by the global score of script concordance tests 20 minutes one month after
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