Simulation Team Training in Ambulatory SurgeryCECNCT01808001
Simulation Team Training and Critical Event Checklist Use for Optimizing the Management of Critical Perioperative Events in an Ambulatory Surgical Facility
An observational study of Simulation Team Training in Ambulatory Surgery, run by Women's College Hospital at 1 site in Canada.
Trial summary
This study will determine if operating room teams manage a simulated event more effectively using a critical event checklist. Performance will be evaluated using a score based on how closely they follow a protocol for critical event management; a 'team' score and a score based on clinical recovery of the simulated… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Simulation Team Training in Ambulatory Surgery
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Dec 2014
- 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: Health care professionals
Who may be able to join
- Eligibility Criteria for Participation:
- RN in active practice
- Anesthesiologist in active practice
- Surgeon in active practice
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Critical Event Checklist Use for Management of Critical Events in Ambulatory Surgery
This study will determine if operating room teams manage a simulated event more effectively using a critical event checklist. Performance will be evaluated using a score based on how closely they follow a protocol for critical event management; a 'team' score and a score based on clinical recovery of the simulated patient. All teams will receive a debriefing session after managing 4 scenarios. Teams will return and manage 4 further scenarios after a period of 6-9 months.
The investigators will be testing the hypothesis that both clinical and behavioral team performance will improve with the use of Critical Event Checklists. The investigators also expect that health professional (participant) could attain knowledge related to the importance of non-technical skills and the use of CECs in the management of critical events.
What is being measured
The primary outcome is the main question the study is designed to answer.
professional health care teams' behavioural performance is measured using a previously validated non-technical skills (NTS) tool (TEAM)and key process checklists
Measured: 1.5 years
Secondary outcomes (1)
questionnaires in participants' opinion of the educational intervention, willingness to participate in annual simulated scenario training, effect on subsequent clinical performance and opinion re: best sites for CEC placement
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation Team Training in Ambulatory SurgeryStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808001
- Sponsor's protocol ID
- 2012-0030-B
- Acronym
- CEC
- Status last verified
- Feb 2013
- First submitted
- 27 Feb 2013
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Event Checklist Use for Management of Critical Events in Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT01808001
- Acronym / sponsor ID
- CEC / 2012-0030-B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Mar 2013 (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.
This study will determine if operating room teams manage a simulated event more effectively using a critical event checklist. Performance will be evaluated using a score based on how closely they follow a protocol for critical event management; a 'team' score and a score based on clinical recovery of the simulated patient. All teams will receive a debriefing session after managing 4 scenarios. Teams will return and manage 4 further scenarios after a period of 6-9 months.
The investigators will be testing the hypothesis that both clinical and behavioral team performance will improve with the use of Critical Event Checklists. The investigators also expect that health professional (participant) could attain knowledge related to the importance of non-technical skills and the use of CECs in the management of critical events.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Health care professionals
Key inclusion criteria (4 listed)
- Eligibility Criteria for Participation:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
professional health care teams' behavioural performance is measured using a previously validated non-technical skills (NTS) tool (TEAM)and key process checklists
Time frame: 1.5 years
1 secondary outcome
questionnaires in participants' opinion of the educational intervention, willingness to participate in annual simulated scenario training, effect on subsequent clinical performance and opinion re: best sites for CEC placement
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
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?
An observational study of Simulation Team Training in Ambulatory Surgery, run by Women's College Hospital 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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 19 Nov 2013. 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?
Results are not available in the source record.
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?
professional health care teams' behavioural performance is measured using a previously validated non-technical skills (NTS) tool (TEAM)and key process checklists (time frame: 1.5 years). 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 19 Nov 2013.