Emergencies3D-QUAMUNCT03478579
Non-technical Skills of Emergency Physicians in a Virtual Emergency Department
An observational study of Emergencies, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The investigators will study nontechnical skills of emergency physicians in a virtual standardized emergency room and their impact on quality of care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergencies
- What is being tested?
- observational
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2018to 1 Dec 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Emergency physicians working in the French Midi-Pyrénées region
Who may be able to join
- Active emergency physicians working in an ED of the French Midi-Pyrenees region
- Two years of practice in emergency medicine or more
- Volunteer to participate in the study
Who cannot join
- Emergency physician working in another setting than ED, outside the Midi-Pyrenees region, or practicing emergency medicine for less than 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nontechnical Skills Assessment of Emergency Physicians and Quality of Care in a Virtual Emergency Department
The investigators will study nontechnical skills of emergency physicians in a virtual standardized emergency room and their impact on quality of care.
Read the detailed description
The ability to manage multiple patients and anticipate the risk of error related to task interruptions or disruptions has been identified among relevant non-technical skills (NTS) for practicing emergency medicine. However, the link between these skills and the quality of care has not been quantified. NTS are usually analyzed by qualitative methods such as interviews, direct observations, or questionnaires that have low performance according to the GRADE system (Grading of Recommendations, Assessment, Development and Evaluation).
The investigators have created and validated an experimental model of a virtual, authentic and realistic Emergency Department (ED). The platform has been modelled in a "Second Life" environment. The NTS of emergency physicians will be assessed and recorded during simulated care of multiple virtual patients. The NTS association with ED length of stay and disposition decision will be analyzed. This study will be an internal pilot study and will include 30 emergency physicians who practice emergency medicine for at least two years.
Sessions will be performed in the Toulouse Institute of Health Care Simulation, Toulouse University Hospital. They will be composed of three stages: briefing (30 minutes), simulated practice (3 hours), and debriefing with an explicit interview (30 minutes). Two researchers and a computer technician will supervise the sessions. The data will be obtained by analyzing the video recorded during the simulated practice and the interview.
- Conditions
- Emergencies
- Being tested
- observational
- Keywords
- serious game, simulation, virtual emergency department, nontechnical skills
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
No intervention, it is observational study
| Study group | Role | What they receive |
|---|---|---|
| Emergency physicians | The observational group will be composed of emergency physicians working in the French Midi-Pyrenees region. Physicians must work since 2 years in emergency service Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nontechnical skills
The nontechnical skills will be assessed by the Anaesthetists' Non-Technical Skills (ANTS) system.
Measured: 3 hours
Secondary outcomes (5)
Quality of care will be measured by a composite criteria (process and result)
Quality of care will be measured by a composite criterion associating a process indicator and a result indicator :
- The process indicator is the average time to medical care of patients
- The result indicator corresponds to the relevance of the choice of the orientation of each patient by the emergency doctor at the end of medical care
Measured: 3 hours
ED length of stay
The quality of care will be assessed by ED length of stay : ED length of stay will be measured from triage completion to disposition decision
Measured: 3 hours
The authenticity of the virtual emergency medicine service
Evaluation of the consistency : perceived internal consistency in the proposed rules and situations will be assessed using a 4-item questionnaire by answering yes or no
Measured: 3 hours
The authenticity of the virtual emergency medicine service
Evaluation of the realism (the assumed resemblance with a real life reference) will be evaluated through a questionnaire containing 3 areas of comparison between the virtual and real environment (layout of the premises, duration of the actions, staff / patient ratio) with as answer possible for each comparison: Realistic or not realistic.
Measured: 3 hours
The authenticity of the virtual emergency medicine service
Evaluation of the relevance (necessary to allow users to take ownership of the problems posed by the designers) will be assessed through direct observation with a yes / no evaluation of the acceptance to use the virtual environment, to test the environment, to make choices during the scenario and to control the environment.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Jun 2018
- Primary completion1 Sep 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Lauque, MD, Study chair, Toulouse CHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478579
- Sponsor's protocol ID
- RC 31/16/8763
- Acronym
- 3D-QUAMU
- Status last verified
- Feb 2022
- First submitted
- 8 Jun 2017
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nontechnical Skills Assessment of Emergency Physicians and Quality of Care in a Virtual Emergency Department
- ClinicalTrials.gov ID
- NCT03478579
- Acronym / sponsor ID
- 3D-QUAMU / RC 31/16/8763
- Conditions
- Emergencies
- Keywords
- serious game, simulation, virtual emergency department, nontechnical skills
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 27 Mar 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.
The investigators will study nontechnical skills of emergency physicians in a virtual standardized emergency room and their impact on quality of care.
Detailed description
The ability to manage multiple patients and anticipate the risk of error related to task interruptions or disruptions has been identified among relevant non-technical skills (NTS) for practicing emergency medicine. However, the link between these skills and the quality of care has not been quantified. NTS are usually analyzed by qualitative methods such as interviews, direct observations, or questionnaires that have low performance according to the GRADE system (Grading of Recommendations, Assessment, Development and Evaluation).
The investigators have created and validated an experimental model of a virtual, authentic and realistic Emergency Department (ED). The platform has been modelled in a "Second Life" environment. The NTS of emergency physicians will be assessed and recorded during simulated care of multiple virtual patients. The NTS association with ED length of stay and disposition decision will be analyzed. This study will be an internal pilot study and will include 30 emergency physicians who practice emergency medicine for at least two years.
Sessions will be performed in the Toulouse Institute of Health Care Simulation, Toulouse University Hospital. They will be composed of three stages: briefing (30 minutes), simulated practice (3 hours), and debriefing with an explicit interview (30 minutes). Two researchers and a computer technician will supervise the sessions. The data will be obtained by analyzing the video recorded during the simulated practice and the interview.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency physicians | – | Other: observationalThe observational group will be composed of emergency physicians working in the French Midi-Pyrenees region. Physicians must work since 2 years in emergency service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency physicians working in the French Midi-Pyrénées region
Key inclusion criteria (3 listed)
- Active emergency physicians working in an ED of the French Midi-Pyrenees region
- Two years of practice in emergency medicine or more
- Volunteer to participate in the study
Key exclusion criteria (1 listed)
- Emergency physician working in another setting than ED, outside the Midi-Pyrenees region, or practicing emergency medicine for less than 2 years.
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 |
|---|---|---|
| observationalNo intervention, it is observational study | Other | Emergency physicians |
Primary outcome
Nontechnical skills
Time frame: 3 hours
The nontechnical skills will be assessed by the Anaesthetists' Non-Technical Skills (ANTS) system.
5 secondary outcomes
Quality of care will be measured by a composite criteria (process and result)
Time frame: 3 hours
ED length of stay
Time frame: 3 hours
The authenticity of the virtual emergency medicine service
Time frame: 3 hours
The authenticity of the virtual emergency medicine service
Time frame: 3 hours
The authenticity of the virtual emergency medicine service
Time frame: 3 hours
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 3 Feb 2022.
- 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.
Dominique Lauque, MD study chair
Toulouse CHU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies, run by University Hospital, Toulouse at 1 site 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 3 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 3 Feb 2022. 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 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?
Nontechnical skills (time frame: 3 hours). 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 3 Feb 2022.