Overview

This trial is active, not recruiting.

Condition surgery
Treatment simulation - based curriculum
Sponsor University Hospital, Grenoble
Collaborator Clinical Research Center, Grenoble University Hospital
Start date November 2013
End date July 2015
Trial size 259 participants
Trial identifier NCT02152436, 2013-32

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
125 surgical interventions will be observed and outcomes will be measured before simulation-based curriculum
125 surgical interventions will be observed and outcomes will be measured after simulation-based curriculum
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

Primary Outcomes

Measure
Frequency of surgical interventions having at least on communication failure with a consequence
time frame: After 3 months of audit

Secondary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Principal investigator Pierre Albaladejo, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University Hospital, Grenoble.