- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03707964
Crisis Resource Management Improvement Through Intellectual Questioning of Authority (CRITIQue)
March 2, 2021 updated by: National University Hospital, Singapore
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Singapore, Singapore, 119085
- National University Hospital, Singapore
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Refusal for informed consent, or
- Refusal for video recording during simulation sessions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
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.
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Standard didactic interactive session on Advanced Cardiac Life Support (ACLS) principles.
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Experimental: Intervention
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.
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Focused crisis resource management training which targets at the cognitive skills needed to monitor and challenge a superior's decision.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Influence of the confederate's gender on participant's ability to challenge incorrect decisions
Time Frame: 20 minutes
|
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.
|
20 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative analysis of themes surrounding hierarchy and challenging authority
Time Frame: 10 minutes
|
Themes elicited during open disclosure and discussion during debrief session with participants
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gene Chan, MBBS, National University Hospital, Singapore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2019
Primary Completion (Actual)
September 20, 2020
Study Completion (Actual)
November 20, 2020
Study Registration Dates
First Submitted
October 12, 2018
First Submitted That Met QC Criteria
October 15, 2018
First Posted (Actual)
October 16, 2018
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 2, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- CRITIQue
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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