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

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ClinicalTrials.gov Identifier: NCT02152436
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.


Condition or disease Intervention/treatment
Surgery 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.


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Study Type : Observational
Actual Enrollment : 259 participants
Observational Model: Other
Time Perspective: Prospective
Study Start Date : November 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

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




Primary Outcome Measures :
  1. Frequency of surgical interventions having at least on communication failure with a consequence [ Time Frame: After 3 months of audit ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Surgical interventions in Grenoble University Hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152436


Locations
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France
Operating rooms of Grenoble University Hospital
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Pierre Albaladejo, MD, PhD University Hospital, Grenoble

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02152436     History of Changes
Other Study ID Numbers: 2013-32
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017