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Simulation-based Curriculum to Enhance Culture of Safety in Operating Rooms

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02152436
Acronym
PROPECS
Enrollment
259
Registered
2014-06-02
Start date
2013-11-30
Completion date
2015-07-31
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Brief summary

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.

Detailed description

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.

Interventions

OTHERSimulation - based curriculum

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

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Frequency of surgical interventions having at least on communication failure with a consequenceAfter 3 months of audit

Secondary

MeasureTime frame
Compliance to the safety checklist in the operating roommeasured during each surgical intervention, before anesthesia, before incision and at the end of surgery
6 items survey estimating teamwork qualitymeasured at the end of each surgical intervention, an average of 2.5 hours
Number of adverse events occuring in the OR declared to the institutionAfter 3 months of audit
Surgical Apgar scoremeasured at the end of each surgical intervention, an average of 2.5 hours
rate of communication failuresmeasured during each surgical procedure, for an average of 2.5 hours
Survey on safety culture for employees working in the ORAfter 3 months of audit
Count of team members and number of passage in the ORmeasured during each surgical procedure, for an average of 2.5 hours
Nature of communication failure and consequencesmeasured during each surgical procedure, for an average of 2.5 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026