Medical Education, Simulation, Crisis Resource ManagementCRITIQueNCT03707964
Crisis Resource Management Improvement Through Intellectual Questioning of Authority
A study testing Crisis Resource Management Skill Training and Standard ACLS Training in people with Medical Education, Simulation, Crisis Resource Management, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This is a randomized controlled trial examining the effectiveness of a teaching intervention on residents' and medical students' ability to challenge clearly wrong decisions by a superior during a simulated life-threatening crisis. Participants will be randomly allocated into the control or intervention arm. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Medical Education, Simulation, Crisis Resource Management
- What is being tested?
- Crisis Resource Management Skill Training and Standard ACLS Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Mar 2019to 20 Nov 2020
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical officers or Internal medicine, surgical and emergency medicine residents who are in their 2nd post-graduate year of training, or
- Phase V medical students from Yong Loo Lin School of Medicine, National University of Singapore
Who cannot join
- Refusal for informed consent, or
- Refusal for video recording during simulation sessions
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized controlled trial examining the effectiveness of a teaching intervention on residents' and medical students' ability to challenge clearly wrong decisions by a superior during a simulated life-threatening crisis. Participants will be randomly allocated into the control or intervention arm. The intervention arm will receive education on crisis resource management (CRM) and teaching targeting the cognitive skills required to monitor and challenge a superior's decision, and conflict resolution tools. Participants will then take part in a simulation scenario 2 to 4 weeks later and will be assessed based on 6 challenge points, followed by a debrief session.
- Being tested
- Crisis Resource Management Skill Training, Standard ACLS Training
- Keywords
- Medical Education, Simulation, Crisis Resource Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisis Resource Management Skill TrainingOther
Focused crisis resource management training which targets at the cognitive skills needed to monitor and challenge a superior's decision.
Standard ACLS TrainingOther
Standard didactic interactive session on Advanced Cardiac Life Support (ACLS) principles.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Subjects allocated to the control arm will receive standard didactic interactive session on Advanced Cardiac Life Support (ACLS) principles, as part of their regular teaching schedule. Receives: Other: Standard ACLS Training |
| Intervention | Experimental | Subjects allocated to the intervention arm will receive education on crisis resource management (CRM) and teaching targeting the cognitive skills required to monitor and challenge a superior's decision, and conflict resolution tools, in addition to standard didactic interactive session on Advanced Cardiac Life Support (ACLS) principles. Receives: Other: Crisis Resource Management Skill Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of a teaching intervention on participants' ability to challenge clearly wrong decisions by a superior during a simulated life-threatening crisis
Comparison of the best modified Advocacy-Inquiry Score (mAIS) responses of the 6 challenge opportunities between the intervention and control groups. The mAIS is a modification of the Advocacy-Inquiry method which includes five scoring levels with the addition of a sixth level when a trainee attempts to take over management of the case.
Measured: 20 minutes
Secondary outcomes (1)
Influence of the confederate's gender on participant's ability to challenge incorrect decisions
Comparison of the median modified Advocacy-Inquiry Score (mAIS) responses between the subjects exposed to male versus female confederate specialist. The mAIS is a modification of the Advocacy-Inquiry method which includes five scoring levels with the addition of a sixth level when a trainee attempts to take over management of the case.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start11 Mar 2019
- Primary completion20 Sep 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Education, Simulation, Crisis Resource ManagementStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gene Chan, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707964
- Sponsor's protocol ID
- CRITIQue
- Acronym
- CRITIQue
- Status last verified
- Mar 2021
- First submitted
- 12 Oct 2018
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crisis Resource Management Improvement Through Intellectual Questioning of Authority
- ClinicalTrials.gov ID
- NCT03707964
- Acronym / sponsor ID
- CRITIQue / CRITIQue
- Keywords
- Medical Education, Simulation, Crisis Resource Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 16 Oct 2018 (actual)
- 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 is a randomized controlled trial examining the effectiveness of a teaching intervention on residents' and medical students' ability to challenge clearly wrong decisions by a superior during a simulated life-threatening crisis. Participants will be randomly allocated into the control or intervention arm. The intervention arm will receive education on crisis resource management (CRM) and teaching targeting the cognitive skills required to monitor and challenge a superior's decision, and conflict resolution tools. Participants will then take part in a simulation scenario 2 to 4 weeks later and will be assessed based on 6 challenge points, followed by a debrief session.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Standard ACLS TrainingSubjects allocated to the control arm will receive standard didactic interactive session on Advanced Cardiac Life Support (ACLS) principles, as part of their regular teaching schedule. |
| Intervention | Experimental | Other: Crisis Resource Management Skill TrainingSubjects allocated to the intervention arm will receive education on crisis resource management (CRM) and teaching targeting the cognitive skills required to monitor and challenge a superior's decision, and conflict resolution tools, in addition to standard didactic interactive session on Advanced Cardiac Life Support (ACLS) principles. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medical officers or Internal medicine, surgical and emergency medicine residents who are in their 2nd post-graduate year of training, or
- Phase V medical students from Yong Loo Lin School of Medicine, National University of Singapore
Key exclusion criteria (2 listed)
- Refusal for informed consent, or
- Refusal for video recording during simulation sessions
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 |
|---|---|---|
| Crisis Resource Management Skill TrainingFocused crisis resource management training which targets at the cognitive skills needed to monitor and challenge a superior's decision. | Other | Intervention |
| Standard ACLS TrainingStandard didactic interactive session on Advanced Cardiac Life Support (ACLS) principles. | Other | Control |
Primary outcome
Effect of a teaching intervention on participants' ability to challenge clearly wrong decisions by a superior during a simulated life-threatening crisis
Time frame: 20 minutes
Comparison of the best modified Advocacy-Inquiry Score (mAIS) responses of the 6 challenge opportunities between the intervention and control groups. The mAIS is a modification of the Advocacy-Inquiry method which includes five scoring levels with the addition of a sixth level when a trainee attempts to take over management of the case.
1 secondary outcome
Influence of the confederate's gender on participant's ability to challenge incorrect decisions
Time frame: 20 minutes
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 3 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Gene Chan, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crisis Resource Management Skill Training and Standard ACLS Training in people with Medical Education, Simulation, Crisis Resource Management, run by National University Hospital, Singapore at 1 site in Singapore.
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 2 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 3 Mar 2021. 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 Singapore. 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. Some participants in this study may receive a placebo. 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?
Effect of a teaching intervention on participants' ability to challenge clearly wrong decisions by a superior during a simulated life-threatening crisis (time frame: 20 minutes). 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 3 Mar 2021.