Crisis Resource ManagementPICSNCT01067378
Peer Debriefing Versus Instructor Debriefing for Interprofessional Simulation Based Education
A study testing Peer-led debriefing and Expert instructor debriefing in people with Crisis Resource Management, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Crisis management is important for operating room practice and non-technical skills are acknowledged as key to ensure patient safety in these situations. Unfortunately, it can be difficult to find instructors with appropriate experience. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crisis Resource Management
- What is being tested?
- Peer-led debriefing and Expert instructor debriefing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Jul 2012
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Operating room (OR) nurses from St. Michael's Hospital and University of Toronto Anesthesia and Surgery Residents/Fellows
Who cannot join
- OR nurses from other hospitals and Residents/Fellows from other programs
Trial locations and contacts
1 site in 1 country.
Canada1 site
Allan Waters' Family Patient Simulation Centre
Toronto, Ontario, M5B 1W8
About this study
Official title: Peer Debriefing Versus Instructor Debriefing for Interprofessional Simulation Based Education (PICS
Crisis management is important for operating room practice and non-technical skills are acknowledged as key to ensure patient safety in these situations. Unfortunately, it can be difficult to find instructors with appropriate experience. A peer-led team debriefing is led by the team it self rather than an external expert instructor but remains a reflective process. Incorporating peer-led debriefing compared to expert-led debriefing may increase access to an interprofessional crisis resource management course using simulation.
The goals of the study are to observe the effect of an interprofessional peer-led team debriefing in the change in performance of non-technical skills of team performance and to compare it with the "gold standard" of expert-led debriefing on the performance of non-technical skills during a simulated operating room crisis.
The investigators hypothesize that interprofessional peer-led debriefing will improve the performance of non-technical skills of the team during simulated intraoperative crisis management and that this improvement will be equivalent to the "gold standard" expert-led debriefing.
- Conditions
- Crisis Resource Management
- Being tested
- Peer-led debriefing, Expert instructor debriefing
- Keywords
- Interdisciplinary Health Team, Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-led debriefingOther
Expert instructor debriefingOther
| Study group | Role | What they receive |
|---|---|---|
| Expert instructor debriefing | Active comparator | Expert instructor debriefing Receives: Other: Expert instructor debriefing |
| Peer-led debriefing | Experimental | Peer-led debriefing Receives: Other: Peer-led debriefing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of non-technical skills of the teams.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crisis Resource ManagementStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067378
- Sponsor's protocol ID
- SMH09172
- Acronym
- PICS
- Status last verified
- Nov 2015
- First submitted
- 1 Feb 2010
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Boet S, Bould MD, Sharma B, Revees S, Naik VN, Triby E, Grantcharov T. Within-team debriefing versus instructor-led debriefing for simulation-based education: a randomized controlled trial. Ann Surg. 2013 Jul;258(1):53-8. doi: 10.1097/SLA.0b013e31829659e4.
PubMed 23728281
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Debriefing Versus Instructor Debriefing for Interprofessional Simulation Based Education (PICS
- ClinicalTrials.gov ID
- NCT01067378
- Acronym / sponsor ID
- PICS / SMH09172
- Conditions
- Crisis Resource Management
- Keywords
- Interdisciplinary Health Team, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Feb 2010 (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.
Crisis management is important for operating room practice and non-technical skills are acknowledged as key to ensure patient safety in these situations. Unfortunately, it can be difficult to find instructors with appropriate experience. A peer-led team debriefing is led by the team it self rather than an external expert instructor but remains a reflective process. Incorporating peer-led debriefing compared to expert-led debriefing may increase access to an interprofessional crisis resource management course using simulation.
The goals of the study are to observe the effect of an interprofessional peer-led team debriefing in the change in performance of non-technical skills of team performance and to compare it with the "gold standard" of expert-led debriefing on the performance of non-technical skills during a simulated operating room crisis.
The investigators hypothesize that interprofessional peer-led debriefing will improve the performance of non-technical skills of the team during simulated intraoperative crisis management and that this improvement will be equivalent to the "gold standard" expert-led debriefing.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expert instructor debriefing | Active comparator | Other: Expert instructor debriefingExpert instructor debriefing |
| Peer-led debriefing | Experimental | Other: Peer-led debriefingPeer-led debriefing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Operating room (OR) nurses from St. Michael's Hospital and University of Toronto Anesthesia and Surgery Residents/Fellows
Key exclusion criteria (1 listed)
- OR nurses from other hospitals and Residents/Fellows from other programs
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 |
|---|---|---|
| Peer-led debriefing | Other | Peer-led debriefing |
| Expert instructor debriefing | Other | Expert instructor debriefing |
Primary outcome
Performance of non-technical skills of the teams.
Time frame: 1 year
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 17 Nov 2015.
- Results publication: PubMed 23728281Boet S, Bould MD, Sharma B, Revees S, Naik VN, Triby E, Grantcharov T. Within-team debriefing versus instructor-led debriefing for simulation-based education: a randomized controlled trial. Ann Surg. 2013 Jul;258(1):53-8. doi: 10.1097/SLA.0b013e31829659e4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-led debriefing and Expert instructor debriefing in people with Crisis Resource Management, run by Unity Health Toronto at 1 site in Canada.
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 1 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 17 Nov 2015. 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 Canada. 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?
Performance of non-technical skills of the teams. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01067378, which also lists 1 linked publication.
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 17 Nov 2015.