SurgeryPROPECSNCT02152436
Simulation-based Curriculum to Enhance Culture of Safety in Operating Rooms
An observational study of Surgery, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery
- What is being tested?
- Simulation - based curriculum
- How many people
- 259 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Surgical interventions in Grenoble University Hospital
Who may be able to join
- All surgical interventions occuring in Grenoble University Hospital, North site, between November and January
Who cannot join
- Interventions supposed to last more than 4 hours
- Interventions in situations of vital emergencies
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Surgery
- Being tested
- Simulation - based curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation - based curriculumOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Simulation - based curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of surgical interventions having at least on communication failure with a consequence
Measured: After 3 months of audit
Secondary outcomes (8)
Compliance to the safety checklist in the operating room
Measured: measured during each surgical intervention, before anesthesia, before incision and at the end of surgery
6 items survey estimating teamwork quality
Measured: 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
Measured: After 3 months of audit
Surgical Apgar score
Measured: measured at the end of each surgical intervention, an average of 2.5 hours
Nature of communication failure and consequences
Measured: measured during each surgical procedure, for an average of 2.5 hours
rate of communication failures
Measured: measured during each surgical procedure, for an average of 2.5 hours
Survey on safety culture for employees working in the OR
Measured: After 3 months of audit
Count of team members and number of passage in the OR
Measured: measured during each surgical procedure, for an average of 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startNov 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Albaladejo, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152436
- Sponsor's protocol ID
- 2013-32
- Acronym
- PROPECS
- Status last verified
- Oct 2017
- First submitted
- 20 Mar 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-based Curriculum to Enhance Culture of Safety in Operating Rooms
- ClinicalTrials.gov ID
- NCT02152436
- Acronym / sponsor ID
- PROPECS / 2013-32
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before simulation-based curriculum | – | –125 surgical interventions will be observed and outcomes will be measured before simulation-based curriculum |
| After simulation-based curriculum | – | Other: Simulation - based curriculum125 surgical interventions will be observed and outcomes will be measured after simulation-based curriculum |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surgical interventions in Grenoble University Hospital
Key inclusion criteria (1 listed)
- All surgical interventions occuring in Grenoble University Hospital, North site, between November and January
Key exclusion criteria (2 listed)
- Interventions supposed to last more than 4 hours
- Interventions in situations of vital emergencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation - based curriculumOperating 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 | Other | After simulation-based curriculum |
Primary outcome
Frequency of surgical interventions having at least on communication failure with a consequence
Time frame: After 3 months of audit
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Albaladejo, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of surgical interventions having at least on communication failure with a consequence (time frame: After 3 months of audit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.