Physician FatigueREPOPREGARDNCT05146856
Impact of a Day Without Clinical Activity Before Night Shift on Non-technical Skills of Intensive Care Residents
An observational study of Physician Fatigue, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
In this proposal, investigators seek to address conclusively two knowledge gaps: 1) the lack of data on the impact of a schedule including a day off clinic before night shift on performances of residents in anesthesia or critical care medicine and 2) the lack of data on the relationship between resident sleep… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physician Fatigue
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2021to Sep 2023
- 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: The investigators will include volunteer residents in anesthesia of critical care medicine of Gabriel Montpied university hospital of Clermont Ferrand.
Who may be able to join
- residents in Anesthesia or Critical care medicine
- Who effect night shift in intensive care unit
- Able to take a day off clinic before night shift
- Able to give consent
Who cannot join
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
Vedat Eljezi contact
France1 site
Clermont-Ferrand University Hospital
Clermont-Ferrand, 63000
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Alexandre LAUTRETTE
About this study
Official title: Impact of a Modified Schedule Including a Day Without Clinical Activity Before Night Shift on Non-technical Skills of French Residents in Intensive Care Unit, a Prospective Randomized Multi Center Study: REPOPREGARD Protocol Study
In this proposal, investigators seek to address conclusively two knowledge gaps: 1) the lack of data on the impact of a schedule including a day off clinic before night shift on performances of residents in anesthesia or critical care medicine and 2) the lack of data on the relationship between resident sleep deprivation and their non technical skills impairment. Investigators designed a prospective, randomized, blinded in cross over evaluation of medical pratices. Investigators will compare resident's performance during a high fidelity simulation session, on crisis managment in intensive care unit, after a night shift in intensive care unit, of residents who work on an intervention schedule with no clinical activity before night shift, with resident's performance of residents who had a traditionnal schedule including an usual clinical day before night shift. Investigators also assess cognitive performances, sleepiness and self esteem before and after night shift. Investigators specific aims will be:
To test the hypothesis that residents working on an intervention schedule will have non technical skills, assessed by Ottawa GRS global score, significantly less impaired after a night shift, than those on traditionnal schedule
To test the hypothesis that residents working on an interveniton schedule will have cognitive performances, sleepiness and self esteem less impaired after night shift than those on a traditionnal schedule
Read the detailed description
Main objective of this study is to compare the non-technical skills after night shift, of anaesthesia and critical care residents who did not have clinical activity before the night shift with those who had at least 8 hours of clinical activity before. The workforce is constrained by the number of residents in training at Clermont-Ferrand and Lyon University Public Hospital. Thus, it is possible to consider the inclusion of 60 residents for 55 evaluable. With such numbers, the clinically relevant difference of 6 points for the Ottawa GRS score (for a standard deviation of 11) can be demonstrated with an alpha risk of bilateral error of 5% and a power of 80%. Two interim analyzes will be carried out including the first 20 interns and then 20 additional interns (therefore for 40 interns) with the aim of stopping the study for "effectiveness", more precisely stopping the study for evidence of a statistically significant difference for the primary outcome measure, with risks of first error observed respectively at 0.0005 and 0.014 comparisons (correction due to multiples). A simulation of the statistical power will also be proposed during the performance of these analyzes; if necessary, a new estimation of the workforce will be proposed to the competent authorities. Investigators do not plan loss of follow up.
- Conditions
- Physician Fatigue
- Keywords
- Personnel Staffing and Scheduling, High fidelity simulation, Medical Errors / prevention & control, Psychomotor Performance / physiology, Sleep, Work Schedule Tolerance, Internship and Residency / organization & administration, Cross-Over Studies, Humans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Residents in control group have a usual day with clinical activity before night shift | |
| Intervention | Residents in intervention group have a day off clinic before night shift (i.e day off or day with university activity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residents' non technical skills after a night shift
Measured by Ottawa Global Rated Scale global score assessed during a high fidelity simulation session of crisis managment. Global score is comprise between 7 for a performance expected from a beginner and 42 for a performance expeted from an expert.
Measured: Immediatly after the end of the night shift
Secondary outcomes (15)
Residents' non technical skill before a night shift
Measured by Ottawa Global Rated Scale global score assessed during a high fidelity simulation session of crisis managment. Global score is comprise between 7 for a performance expected from a beginner and 42 for a performance expeted from an expert.
Measured: Baseline, before the night shift
Cognitive performances : Phasic alert test
refers to the notion of general wakefulness allowing to react quickly and appropriately to requests, score obtained from computer tool
Measured: Before the night shift
Cognitive performances : Phasic alert test
refers to the notion of general wakefulness allowing to react quickly and appropriately to requests, score obtained from computer tool
Measured: After the night shift up to 12 hours
Cognitive performances : Divided attention test
refers to the notion of paying attention to several things at the same time, score obtained from computer tool
Measured: Before the night shift
Cognitive performances : Divided attention test
refers to the notion of paying attention to several things at the same time, score obtained from computer tool
Measured: After the night shift up to 12 hours
Cognitive performances : Flexibility test with alternation
refers to the notion of displacement of the attentional focus, score obtained from computer tool
Measured: Before the night shift
Cognitive performances : Flexibility test with alternation
refers to the notion of displacement of the attentional focus, score obtained from computer tool
Measured: After the night shift up to 12 hours
Cognitive performances : Working memory test
refers to the notion of maintaining and updating when carrying out complex problems, score obtained from computer tool
Measured: Before the night shift
Cognitive performances : Working memory test
refers to the notion of maintaining and updating when carrying out complex problems, score obtained from computer tool
Measured: After the night shift up to 12 hours
Cognitive performances : Computerized Speed Cognitive Test
refers to the notion of the speed of information processing, score obtained from computer tool
Measured: Before the night shift
Cognitive performances : Computerized Speed Cognitive Test
refers to the notion of the speed of information processing, score obtained from computer tool
Measured: After the night shift up to 12 hours
Sleepiness
Measured by Karolinska Sleepiness scale, a score of 1 for a great tiredness to 9 for a very well awake state.
Measured: Before the night shift
Sleepiness
Measured by Karolinska Sleepiness scale, a score of 1 for a great tiredness to 9 for a very well awake state.
Measured: After the night shift up to 12 hours
Self esteem
Measured by Rosenberg Self Esteem scale, a score lower than 25 indicates a low self esteem and a score higher than 39 indicates a high self esteem.
Measured: Before the night shift
Self esteem
Measured by Rosenberg Self Esteem scale, a score lower than 25 indicates a low self esteem and a score higher than 39 indicates a high self esteem.
Measured: After the night shift up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study startDec 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physician FatigueStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146856
- Sponsor's protocol ID
- 2021 LAUTRETTE REPOPREGARDE
- Acronym
- REPOPREGARD
- Status last verified
- Oct 2021
- First submitted
- 18 Oct 2021
- Last updated
- 7 Dec 2021
- 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 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Modified Schedule Including a Day Without Clinical Activity Before Night Shift on Non-technical Skills of French Residents in Intensive Care Unit, a Prospective Randomized Multi Center Study: REPOPREGARD Protocol Study
- ClinicalTrials.gov ID
- NCT05146856
- Acronym / sponsor ID
- REPOPREGARD / 2021 LAUTRETTE REPOPREGARDE
- Conditions
- Physician Fatigue
- Keywords
- Personnel Staffing and Scheduling, High fidelity simulation, Medical Errors / prevention & control, Psychomotor Performance / physiology, Sleep, Work Schedule Tolerance, Internship and Residency / organization & administration, Cross-Over Studies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 7 Dec 2021 (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.
In this proposal, investigators seek to address conclusively two knowledge gaps: 1) the lack of data on the impact of a schedule including a day off clinic before night shift on performances of residents in anesthesia or critical care medicine and 2) the lack of data on the relationship between resident sleep deprivation and their non technical skills impairment. Investigators designed a prospective, randomized, blinded in cross over evaluation of medical pratices. Investigators will compare resident's performance during a high fidelity simulation session, on crisis managment in intensive care unit, after a night shift in intensive care unit, of residents who work on an intervention schedule with no clinical activity before night shift, with resident's performance of residents who had a traditionnal schedule including an usual clinical day before night shift. Investigators also assess cognitive performances, sleepiness and self esteem before and after night shift. Investigators specific aims will be:
To test the hypothesis that residents working on an intervention schedule will have non technical skills, assessed by Ottawa GRS global score, significantly less impaired after a night shift, than those on traditionnal schedule
To test the hypothesis that residents working on an interveniton schedule will have cognitive performances, sleepiness and self esteem less impaired after night shift than those on a traditionnal schedule
Detailed description
Main objective of this study is to compare the non-technical skills after night shift, of anaesthesia and critical care residents who did not have clinical activity before the night shift with those who had at least 8 hours of clinical activity before. The workforce is constrained by the number of residents in training at Clermont-Ferrand and Lyon University Public Hospital. Thus, it is possible to consider the inclusion of 60 residents for 55 evaluable. With such numbers, the clinically relevant difference of 6 points for the Ottawa GRS score (for a standard deviation of 11) can be demonstrated with an alpha risk of bilateral error of 5% and a power of 80%. Two interim analyzes will be carried out including the first 20 interns and then 20 additional interns (therefore for 40 interns) with the aim of stopping the study for "effectiveness", more precisely stopping the study for evidence of a statistically significant difference for the primary outcome measure, with risks of first error observed respectively at 0.0005 and 0.014 comparisons (correction due to multiples). A simulation of the statistical power will also be proposed during the performance of these analyzes; if necessary, a new estimation of the workforce will be proposed to the competent authorities. Investigators do not plan loss of follow up.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Residents in control group have a usual day with clinical activity before night shift |
| Intervention | – | –Residents in intervention group have a day off clinic before night shift (i.e day off or day with university activity) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will include volunteer residents in anesthesia of critical care medicine of Gabriel Montpied university hospital of Clermont Ferrand.
Key inclusion criteria (4 listed)
- residents in Anesthesia or Critical care medicine
- Who effect night shift in intensive care unit
- Able to take a day off clinic before night shift
- Able to give consent
Key exclusion criteria (1 listed)
- Refusal of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Residents' non technical skills after a night shift
Time frame: Immediatly after the end of the night shift
Measured by Ottawa Global Rated Scale global score assessed during a high fidelity simulation session of crisis managment. Global score is comprise between 7 for a performance expected from a beginner and 42 for a performance expeted from an expert.
15 secondary outcomes
Residents' non technical skill before a night shift
Time frame: Baseline, before the night shift
Cognitive performances : Phasic alert test
Time frame: Before the night shift
Cognitive performances : Phasic alert test
Time frame: After the night shift up to 12 hours
Cognitive performances : Divided attention test
Time frame: Before the night shift
Cognitive performances : Divided attention test
Time frame: After the night shift up to 12 hours
Cognitive performances : Flexibility test with alternation
Time frame: Before the night shift
Cognitive performances : Flexibility test with alternation
Time frame: After the night shift up to 12 hours
Cognitive performances : Working memory test
Time frame: Before the night shift
Cognitive performances : Working memory test
Time frame: After the night shift up to 12 hours
Cognitive performances : Computerized Speed Cognitive Test
Time frame: Before the night shift
Cognitive performances : Computerized Speed Cognitive Test
Time frame: After the night shift up to 12 hours
Sleepiness
Time frame: Before the night shift
Sleepiness
Time frame: After the night shift up to 12 hours
Self esteem
Time frame: Before the night shift
Self esteem
Time frame: After the night shift up to 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Individual participant dataSharing planned: No
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Burnout, Professional, Emotional Exhaustion
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.
Vedat Eljezi contact
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 Physician Fatigue, run by University Hospital, Clermont-Ferrand 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 4 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: status not confirmed, as of the sponsor's last update on 7 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33 4 73 754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residents' non technical skills after a night shift (time frame: Immediatly after the end of the night shift). 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 7 Dec 2021.