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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Other: Simulation - based curriculum

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.

• Study Type: Observational
• Enrollment (Actual): 259

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38000
    • Operating rooms of Grenoble University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Surgical interventions in Grenoble University Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before simulation-based curriculum; 125 surgical interventions will be observed and outcomes will be measured before simulation-based curriculum
After simulation-based curriculum; 125 surgical interventions will be observed and outcomes will be measured after simulation-based curriculum	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of surgical interventions having at least on communication failure with a consequence	After 3 months of audit

Secondary Outcome Measures

Outcome Measure	Time Frame
Compliance to the safety checklist in the operating room	measured during each surgical intervention, before anesthesia, before incision and at the end of surgery
6 items survey estimating teamwork quality	measured at the end of each surgical intervention, an average of 2.5 hours
Number of adverse events occuring in the OR declared to the institution	After 3 months of audit
Surgical Apgar score	measured at the end of each surgical intervention, an average of 2.5 hours
Nature of communication failure and consequences	measured during each surgical procedure, for an average of 2.5 hours
rate of communication failures	measured during each surgical procedure, for an average of 2.5 hours
Survey on safety culture for employees working in the OR	After 3 months of audit
Count of team members and number of passage in the OR	measured during each surgical procedure, for an average of 2.5 hours

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Pierre Albaladejo, MD, PhD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2013-32 (Other Identifier: AP HM)