Clinical trial NCT02152436: Simulation-based Curriculum to Enhance Culture of Safety in Operating Rooms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 259
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surgical interventions in Grenoble University Hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of surgical interventions having at least on communication failure with a consequence
timeFrame: After 3 months of audit
Secondary outcomes:
measure: Compliance to the safety checklist in the operating room
timeFrame: measured during each surgical intervention, before anesthesia, before incision and at the end of surgery
measure: 6 items survey estimating teamwork quality
timeFrame: measured at the end of each surgical intervention, an average of 2.5 hours
measure: Number of adverse events occuring in the OR declared to the institution
timeFrame: After 3 months of audit
measure: Surgical Apgar score
timeFrame: measured at the end of each surgical intervention, an average of 2.5 hours
measure: Nature of communication failure and consequences
timeFrame: measured during each surgical procedure, for an average of 2.5 hours
measure: rate of communication failures
timeFrame: measured during each surgical procedure, for an average of 2.5 hours
measure: Survey on safety culture for employees working in the OR
timeFrame: After 3 months of audit
measure: Count of team members and number of passage in the OR
timeFrame: measured during each surgical procedure, for an average of 2.5 hours
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Operating rooms of Grenoble University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Pierre Albaladejo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: