Non-technical Skills of Emergency Physicians in a Virtual Emergency Department (3D-QUAMU)

February 2, 2022 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • CHU Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Emergency physicians working in the French Midi-Pyrénées region

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Emergency physician working in another setting than ED, outside the Midi-Pyrenees region, or practicing emergency medicine for less than 2 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: observational
No intervention, it is observational study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nontechnical skills
Time Frame: 3 hours
The nontechnical skills will be assessed by the Anaesthetists' Non-Technical Skills (ANTS) system.
3 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of care will be measured by a composite criteria (process and result)
Time Frame: 3 hours

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
3 hours
ED length of stay
Time Frame: 3 hours
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
3 hours
The authenticity of the virtual emergency medicine service
Time Frame: 3 hours
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
3 hours
The authenticity of the virtual emergency medicine service
Time Frame: 3 hours
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.
3 hours
The authenticity of the virtual emergency medicine service
Time Frame: 3 hours
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.
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Dominique Lauque, MD, Toulouse Chu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC 31/16/8763

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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