- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Grenoble, Francia, 38000
- Operating rooms of Grenoble University Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Frequency of surgical interventions having at least on communication failure with a consequence
Lasso di tempo: After 3 months of audit
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After 3 months of audit
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Compliance to the safety checklist in the operating room
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: After 3 months of audit
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After 3 months of audit
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Surgical Apgar score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Pierre Albaladejo, MD, PhD, University Hospital, Grenoble
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 2013-32 (Altro identificatore: AP HM)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .