- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02152436
Simulation-based Curriculum to Enhance Culture of Safety in Operating Rooms (PROPECS)
Communication in the operating room (OR) is a key factor to prevent deleterious events for the patient. French national health authority made the implementation of safety checklist mandatory in operating rooms. The goal of this checklist is to improve teamwork and share key elements for better patient outcomes. Observational studies in the OR showed low compliance to this checklist, either on the way it is used or on the information implemented.
The primary objective of this project is to assess the efficacy of a simulation-based curriculum involving OR medical and non-medical personnel in order to improve communication in the OR.
Studieoversikt
Detaljert beskrivelse
Operating theater is a complex system where efficient communication is critical to patient safety. Patient safety check-list are used worldwide as a way to improve communication and teamwork in the operating room in order to decrease perioperative morbidity and mortality. Previous studies have shown that communication failure in the OR may be associated with adverse events. The improvement of safety culture (including communication and team work) may be obtained by simulation based training.
The primary objective of this before-after study is to assess the efficacy of a simulation-based curriculum involving OR medical and non medical personnel in order to improve communication in the OR.
In brief, in a first period, an audit to assess communication efficacy and teamwork will be realized during 125 surgical procedures. Communication failures and consequences will be recorded using a standardized form filled by trained personnel. In a second phase, all the OR personnel (surgeon, anesthesiologist, nurses) will be invited to participate to a special training on communication and teamwork. This curriculum will include formal presentations and also simulation-based training. Scenarios are built to improve the ability to communicate in specific situations (fire in the OR, haemorrhage, wrong side, anaphylaxis).
In a third phase, an audit on communication and teamwork, similar to the first phase will be realized. The primary endpoint is the frequency of surgical interventions having at least one communication failure with a consequence. The investigators expect a significant decrease in the rate of communication failures between phase 1 and 3. A fourth phase will consist in a last audit two years after phase 1 to evaluate long-term effect of this curriculum.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Grenoble, Frankrike, 38000
- Operating rooms of Grenoble University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- All surgical interventions occuring in Grenoble University Hospital, North site, between November and January
Exclusion Criteria:
- Interventions supposed to last more than 4 hours
- Interventions in situations of vital emergencies
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Before simulation-based curriculum
125 surgical interventions will be observed and outcomes will be measured before simulation-based curriculum
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After simulation-based curriculum
125 surgical interventions will be observed and outcomes will be measured after simulation-based curriculum
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Operating room medical and non-medical members will be asked to carry out a simulation session preceded by an educational maze with videos.
Outcomes will be compared and correlated after and before this curriculum
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Frequency of surgical interventions having at least on communication failure with a consequence
Tidsramme: After 3 months of audit
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After 3 months of audit
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Compliance to the safety checklist in the operating room
Tidsramme: measured during each surgical intervention, before anesthesia, before incision and at the end of surgery
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measured during each surgical intervention, before anesthesia, before incision and at the end of surgery
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6 items survey estimating teamwork quality
Tidsramme: measured at the end of each surgical intervention, an average of 2.5 hours
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measured at the end of each surgical intervention, an average of 2.5 hours
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Number of adverse events occuring in the OR declared to the institution
Tidsramme: After 3 months of audit
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After 3 months of audit
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Surgical Apgar score
Tidsramme: measured at the end of each surgical intervention, an average of 2.5 hours
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measured at the end of each surgical intervention, an average of 2.5 hours
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Nature of communication failure and consequences
Tidsramme: measured during each surgical procedure, for an average of 2.5 hours
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measured during each surgical procedure, for an average of 2.5 hours
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rate of communication failures
Tidsramme: measured during each surgical procedure, for an average of 2.5 hours
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measured during each surgical procedure, for an average of 2.5 hours
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Survey on safety culture for employees working in the OR
Tidsramme: After 3 months of audit
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After 3 months of audit
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Count of team members and number of passage in the OR
Tidsramme: measured during each surgical procedure, for an average of 2.5 hours
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measured during each surgical procedure, for an average of 2.5 hours
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Pierre Albaladejo, MD, PhD, University Hospital, Grenoble
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2013-32 (Annen identifikator: AP HM)
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