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

NCT ID: NCT02152436

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

259 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Surgery

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Before simulation-based curriculum

125 surgical interventions will be observed and outcomes will be measured before simulation-based curriculum

No interventions assigned to this group

After simulation-based curriculum

125 surgical interventions will be observed and outcomes will be measured after simulation-based curriculum

Simulation - based curriculum

Intervention Type OTHER

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

Interventions

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Simulation - 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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Albaladejo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Operating rooms of Grenoble University Hospital

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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2013-32

Identifier Type: -

Identifier Source: org_study_id