SimulationNCT03428269
Serious Game Versus Traditional Teaching to Improve Clinical Reasoning Skills
A study testing simulation by gaming (LabForGames Warning) and traditional education in people with Simulation, run by Université Paris-Sud at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Simulation
- What is being tested?
- simulation by gaming (LabForGames Warning) and traditional education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Feb 2018to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- nursing students
Who cannot join
- none
Trial locations and contacts
4 sites in 1 country.
France4 sites
IFSI Sud Francilien
Corbeil-Essonnes, 91100
IFSI etampes
Étampes, 91150
IFSI Perray Vaucluse
Sainte-Geneviève-des-Bois, 91700
IFSI Paul Guiraud
Villejuif, 94 806
About this study
Official title: Comparative Value of a Serious Game and a Traditional Teaching Method to Improve Clinical Reasoning Skills Necessary to Detect Patient Deterioration: A Randomized Study in Nursing Students
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.
Read the detailed 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.
- Conditions
- Simulation
- Being tested
- simulation by gaming (LabForGames Warning), traditional education
- Keywords
- simulation, clinical reasoning, patient deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
traditional educationOther
comparison of the efficacy of two educational methods to improve the clinical reasoning skills of nursing students facing patient deterioration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: traditional education |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical reasoning skills
assessed by the global score of script concordance tests (score between 0 to 100)
Measured: 20 minutes at the end of the session
Secondary outcomes (3)
self efficacy
measured by a Likert scale between 1 to 10
Measured: 1 minutes at end of the session
satisfaction
measured by a Likert scale between 1 to 10)
Measured: 1 minutes at end of the session
retention of clinical reasoning skills
assessed by the global score of script concordance tests
Measured: 20 minutes one month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Feb 2018
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment, not blinded, randomized study
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Paris-Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonia Blanie, Université Paris-Sud
- Investigators
- Antonia BLANIE, MD, Principal investigator, Université Paris-Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428269
- Sponsor's protocol ID
- LabForSims-003
- Status last verified
- Nov 2018
- First submitted
- 30 Jan 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22626047Blanie 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.
PubMed 32075641
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Value of a Serious Game and a Traditional Teaching Method to Improve Clinical Reasoning Skills Necessary to Detect Patient Deterioration: A Randomized Study in Nursing Students
- ClinicalTrials.gov ID
- NCT03428269
- Acronym / sponsor ID
- LabForSims-003
- Conditions
- Simulation
- Keywords
- simulation, clinical reasoning, patient deterioration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Université Paris-SudUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment, not blinded, randomized study
| Arm | Type | Receives |
|---|---|---|
| simulation by gaming group | Experimental | Other: simulation by gaming (LabForGames Warning)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. |
| traditional education group | Active comparator | Other: traditional educationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- nursing students
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | simulation by gaming group |
| traditional educationcomparison of the efficacy of two educational methods to improve the clinical reasoning skills of nursing students facing patient deterioration | Other | traditional education group |
Primary outcome
clinical reasoning skills
Time frame: 20 minutes at the end of the session
assessed by the global score of script concordance tests (score between 0 to 100)
3 secondary outcomes
self efficacy
Time frame: 1 minutes at end of the session
satisfaction
Time frame: 1 minutes at end of the session
retention of clinical reasoning skills
Time frame: 20 minutes one month after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Background: PubMed 22626047Dory 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.
- Derived from this study: PubMed 32075641Blanie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia BLANIE, MD principal investigator
Université Paris-Sud
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulation by gaming (LabForGames Warning) and traditional education in people with Simulation, run by Université Paris-Sud at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical reasoning skills (time frame: 20 minutes at the end of the session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03428269, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.