Impact of a Day Without Clinical Activity Before Night Shift on Non-technical Skills of Intensive Care Residents (REPOPREGARD)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Physician Fatigue

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Clermont-Ferrand University Hospital
    • Principal Investigator: Alexandre LAUTRETTE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigators will include volunteer residents in anesthesia of critical care medicine of Gabriel Montpied university hospital of Clermont Ferrand.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Refusal of participation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediatly after the end of the night shift

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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	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	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	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	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	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	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	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.	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.	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.	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.	After the night shift up to 12 hours

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Humans; Sleep; Personnel Staffing and Scheduling; Work Schedule Tolerance; Cross-Over Studies; High fidelity simulation; Psychomotor Performance / physiology; Medical Errors / prevention & control; Internship and Residency / organization & administration
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 2021 LAUTRETTE REPOPREGARDE

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