Patient SimulationNCT02105883
The Effect of Identification Badge on Situation Awareness During High Fidelity Simulation
A study testing Use of identification badge during scenarios in people with Patient Simulation and Awareness, run by Université de Montréal at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate if the use of identification badge (role and place) during high-fidelity simulation as an impact on situation awareness. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patient Simulation, Awareness, Reality Testing
- What is being tested?
- Use of identification badge during scenarios
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Aug 2014
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- anesthesiology residents (university of montreal) who participate to simulation course on crisis resources management
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate if the use of identification badge (role and place) during high-fidelity simulation as an impact on situation awareness.
Read the detailed description
High-fidelity simulation is well recognized as an educational tool. Mr. Issenberg completed a review(2005) that determined features of high-fidelity simulation training that lead to effective learning. It this review, it is mentioned that the validity of the simulator (realism) is essential to help learners to increase their skills and sharpen their responses. It is essential to get and maintain engagement during high-fidelity simulation and it pass by an increase in realism and situation awareness. The purpose of this study is to evaluate if the use of identification badge (physical and conceptual realism) during high-fidelity simulation as an impact on situation awareness and engagement.
- Conditions
- Patient Simulation, Awareness, Reality Testing, Residency
- Being tested
- Use of identification badge during scenarios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of identification badge during scenariosOther
| Study group | Role | What they receive |
|---|---|---|
| Scenario C (control) | No intervention | no badge |
| Scenario B (badge) | Active comparator | Use of Identification badge during scenarios (roles and places) Receives: Other: Use of identification badge during scenarios |
What is being measured
The primary outcome is the main question the study is designed to answer.
Situation awareness
Subjects answer a 4 questions survey on situation awareness with 7 answers choices (1-strongly disagree... 7-strongly agree)
- I know where I was in the beginning of the scenario
- I know where I was during the scenario
- I know the role of each participant in the beginning of the scenario
- I Know the role of each participant during the scenario
Measured: 2 days
Secondary outcomes (1)
Subject's engagement in high-fidelity simulation
Subject answer a 2 questions survey on engagement with a 7 answers choices (1- strongly disagree...7-strongly agree)
- I felt emotionally concerned during the scenario
- The scenario was enough realistic to get engaged in the clinical situation
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Centre d'apprentissage des attitudes et des habiletés cliniques (CAAHC)
- Responsible party
- Principal investigator, Issam Tanoubi, Université de Montréal
- Investigators
- Issam Tanoubi, MD, Study director, Université de MontréalMarie-Eve Belanger, MD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105883
- Sponsor's protocol ID
- MEB-2014
- Status last verified
- Dec 2014
- First submitted
- 25 Mar 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Identification Badge on Situation Awareness During High Fidelity Simulation
- ClinicalTrials.gov ID
- NCT02105883
- Acronym / sponsor ID
- MEB-2014
- Conditions
- Patient Simulation, Awareness, Reality Testing, Residency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Centre d'apprentissage des attitudes et des habiletés cliniques (CAAHC)
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 7 Apr 2014 (estimated)
- 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.
The purpose of this study is to evaluate if the use of identification badge (role and place) during high-fidelity simulation as an impact on situation awareness.
Detailed description
High-fidelity simulation is well recognized as an educational tool. Mr. Issenberg completed a review(2005) that determined features of high-fidelity simulation training that lead to effective learning. It this review, it is mentioned that the validity of the simulator (realism) is essential to help learners to increase their skills and sharpen their responses. It is essential to get and maintain engagement during high-fidelity simulation and it pass by an increase in realism and situation awareness. The purpose of this study is to evaluate if the use of identification badge (physical and conceptual realism) during high-fidelity simulation as an impact on situation awareness and engagement.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scenario C (control) | No intervention | –no badge |
| Scenario B (badge) | Active comparator | Other: Use of identification badge during scenariosUse of Identification badge during scenarios (roles and places) |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- anesthesiology residents (university of montreal) who participate to simulation course on crisis resources management
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 |
|---|---|---|
| Use of identification badge during scenarios | Other | Scenario B (badge) |
Primary outcome
Situation awareness
Time frame: 2 days
Subjects answer a 4 questions survey on situation awareness with 7 answers choices (1-strongly disagree... 7-strongly agree) 1. I know where I was in the beginning of the scenario 2. I know where I was during the scenario 3. I know the role of each participant in the beginning of the scenario 4. I Know the role of each participant during the scenario
1 secondary outcome
Subject's engagement in high-fidelity simulation
Time frame: 2 days
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 2 Dec 2014.
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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.
Issam Tanoubi, MD study director
Université de Montréal
Marie-Eve Belanger, MD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of identification badge during scenarios in people with Patient Simulation and Awareness, run by Université de Montréal at 1 site in Canada.
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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Situation awareness (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2014.