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

NCT02152436 | Completed

• 1 other identifier: 2013-32
• Study Type: observational
• Target: 259
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• Frequency of surgical interventions having at least on communication failure with a consequence

  After 3 months of audit

Secondary Outcomes (8)

• 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

Study Arms (2)

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

Interventions

Simulation - based curriculum 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

After simulation-based curriculum

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Surgical interventions in Grenoble University Hospital

You may qualify if:

• All surgical interventions occuring in Grenoble University Hospital, North site, between November and January

You may not qualify if:

• Interventions supposed to last more than 4 hours
• Interventions in situations of vital emergencies

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Operating rooms of Grenoble University Hospital

Grenoble, 38000, France

Location

Study Officials

• Pierre Albaladejo, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: June 2, 2014
• Study Start: November 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 6, 2017

Record last verified: 2017-10

Locations

FR (1)