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Completed

NCT Number: NCT02152436

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Operating rooms of Grenoble University Hospital

Grenoble, 38000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: After 3 months of audit

Secondary outcomes

  1. 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

  2. 6 items survey estimating teamwork quality

    Time frame: measured at the end of each surgical intervention, an average of 2.5 hours

  3. Number of adverse events occuring in the OR declared to the institution

    Time frame: After 3 months of audit

  4. Surgical Apgar score

    Time frame: measured at the end of each surgical intervention, an average of 2.5 hours

  5. Nature of communication failure and consequences

    Time frame: measured during each surgical procedure, for an average of 2.5 hours

  6. rate of communication failures

    Time frame: measured during each surgical procedure, for an average of 2.5 hours

  7. Survey on safety culture for employees working in the OR

    Time frame: After 3 months of audit

  8. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: PROPECS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2014
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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