Focus of Study is Teaching Crisis Resource ManagementNCT01653704
Learning Crisis Resource Management: Practicing Versus Observational Role in Simulation Training
A study testing observational role and active role in people with Focus of Study is Teaching Crisis Resource Management, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The purpose of this study is to compare the effectiveness in learning crisis resource management (CRM) principles when being an active participant in simulation-based education versus being an observer participant. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Focus of Study is Teaching Crisis Resource Management
- What is being tested?
- observational role and active role
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- emergency medicine residents from the University of Ottawa
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Ottawa Skills and Simulation Centre
Ottawa, Ontario, K1Y3E9
About this study
The purpose of this study is to compare the effectiveness in learning crisis resource management (CRM) principles when being an active participant in simulation-based education versus being an observer participant. The investigators hypothesize that active participants will improve their CRM skills more than observer participants.
Read the detailed description
This will be a prospective randomized controlled study. Participants will be randomized to one of two groups with stratification according to their level of training: the active group and the observer group. Each participant of the active group will be paired with one of the participants from the observer group. The active participant will manage individually a simulated crisis scenario (pretest) while the paired observer participant will observe the scenario from outside the simulation room using a video transmission system. Immediately after, both participants will be debriefed by a trained instructor focused on CRM principles. The same active and observer participants will then individually manage another simulated crisis scenario (post-test). Two independent raters, blinded to the study design and to the randomization groups, will review the videos of all scenarios in a random order and rate each participant on their CRM performance using a global rating scale (GRS).
- Being tested
- observational role, active role
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational roleBehavioural
observational role in crisis scenario
active roleBehavioural
active role in managing crisis scenario
| Study group | Role | What they receive |
|---|---|---|
| active management of crises scenario | Experimental | participants assigned to actively manage a crisis scenario Receives: Behavioral: active role |
| Observer role in crisis scenario | Active comparator | Observational role in management of crises scenario Receives: Behavioral: observational role |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Ottawa GRS Score
The Ottawa GRS scale is a reliable and valid scale used to measure CRM performance in high fidelity simulation. The scale assesses five main CRM categories: leadership, problem solving, situational awareness, resource allocation and communication skills. In addition to these five categories, there is a category on overall performance of the participant. Each category is measured on a 7 point Likert scale with descriptive anchors to provide guidelines on alternating points along the scale. The categorical scores will be summed to give a total score of 6 to 42. Higher values represent a better outcome.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focus of Study is Teaching 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Lai, MD, Principal investigator, University of OttawaSylvain Boet, MD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653704
- Sponsor's protocol ID
- 20120008-01H
- Status last verified
- Jan 2019
- First submitted
- 16 Jul 2012
- Last updated
- 14 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lai A, Haligua A, Dylan Bould M, Everett T, Gale M, Pigford AA, Boet S. Learning crisis resource management: Practicing versus an observational role in simulation training - a randomized controlled trial. Anaesth Crit Care Pain Med. 2016 Aug;35(4):275-81. doi: 10.1016/j.accpm.2015.10.010. Epub 2016 Mar 14.
PubMed 26987738
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Crisis Resource Management: Practicing Versus Observational Role in Simulation Training
- ClinicalTrials.gov ID
- NCT01653704
- Acronym / sponsor ID
- 20120008-01H
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Posted 14 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness in learning crisis resource management (CRM) principles when being an active participant in simulation-based education versus being an observer participant. The investigators hypothesize that active participants will improve their CRM skills more than observer participants.
Detailed description
This will be a prospective randomized controlled study. Participants will be randomized to one of two groups with stratification according to their level of training: the active group and the observer group. Each participant of the active group will be paired with one of the participants from the observer group. The active participant will manage individually a simulated crisis scenario (pretest) while the paired observer participant will observe the scenario from outside the simulation room using a video transmission system. Immediately after, both participants will be debriefed by a trained instructor focused on CRM principles. The same active and observer participants will then individually manage another simulated crisis scenario (post-test). Two independent raters, blinded to the study design and to the randomization groups, will review the videos of all scenarios in a random order and rate each participant on their CRM performance using a global rating scale (GRS).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active management of crises scenario | Experimental | Behavioral: active roleparticipants assigned to actively manage a crisis scenario |
| Observer role in crisis scenario | Active comparator | Behavioral: observational roleObservational role in management of crises scenario |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- emergency medicine residents from the University of Ottawa
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational roleobservational role in crisis scenario | Behavioural | Observer role in crisis scenario |
| active roleactive role in managing crisis scenario | Behavioural | active management of crises scenario |
Primary outcome
Total Ottawa GRS Score
Time frame: 1 day
The Ottawa GRS scale is a reliable and valid scale used to measure CRM performance in high fidelity simulation. The scale assesses five main CRM categories: leadership, problem solving, situational awareness, resource allocation and communication skills. In addition to these five categories, there is a category on overall performance of the participant. Each category is measured on a 7 point Likert scale with descriptive anchors to provide guidelines on alternating points along the scale. The categorical scores will be summed to give a total score of 6 to 42. Higher values represent a better outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26987738Lai A, Haligua A, Dylan Bould M, Everett T, Gale M, Pigford AA, Boet S. Learning crisis resource management: Practicing versus an observational role in simulation training - a randomized controlled trial. Anaesth Crit Care Pain Med. 2016 Aug;35(4):275-81. doi: 10.1016/j.accpm.2015.10.010. Epub 2016 Mar 14.
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.
Anita Lai, MD principal investigator
University of Ottawa
Sylvain Boet, MD principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing observational role and active role in people with Focus of Study is Teaching Crisis Resource Management, run by Ottawa Hospital Research Institute 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 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: finished, as of the sponsor's last update on 14 Jan 2019. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Ottawa GRS Score (time frame: 1 day). 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 NCT01653704, 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 14 Jan 2019.