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

23 november 2021 uppdaterad av: University Hospital, Clermont-Ferrand

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

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

60

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Clermont-Ferrand, Frankrike, 63000
        • Clermont-Ferrand University Hospital
        • Huvudutredare:
          • Alexandre LAUTRETTE

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Residents' non technical skills after a night shift
Tidsram: 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.
Immediatly after the end of the night shift

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Residents' non technical skill before a night shift
Tidsram: Baseline, before 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.
Baseline, before the night shift
Cognitive performances : Phasic alert test
Tidsram: Before the night shift
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
Tidsram: After the night shift up to 12 hours
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
Tidsram: Before the night shift
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
Tidsram: After the night shift up to 12 hours
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
Tidsram: Before the night shift
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
Tidsram: After the night shift up to 12 hours
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
Tidsram: Before the night shift
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
Tidsram: After the night shift up to 12 hours
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
Tidsram: Before the night shift
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
Tidsram: After the night shift up to 12 hours
refers to the notion of the speed of information processing, score obtained from computer tool
After the night shift up to 12 hours
Sleepiness
Tidsram: Before the night shift
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
Tidsram: After the night shift up to 12 hours
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
Tidsram: Before the night shift
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
Tidsram: After the night shift up to 12 hours
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

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

1 december 2021

Primärt slutförande (Förväntat)

1 juni 2023

Avslutad studie (Förväntat)

1 september 2023

Studieregistreringsdatum

Först inskickad

18 oktober 2021

Först inskickad som uppfyllde QC-kriterierna

23 november 2021

Första postat (Faktisk)

7 december 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 december 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 november 2021

Senast verifierad

1 oktober 2021

Mer information

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