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Trial record 33 of 561 for:    Recruiting, Not yet recruiting, Available Studies | Teaching

Crisis Resource Management Improvement Through Intellectual Questioning of Authority (CRITIQue)

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ClinicalTrials.gov Identifier: NCT03707964
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Tracking Information
First Submitted Date  ICMJE October 12, 2018
First Posted Date  ICMJE October 16, 2018
Last Update Posted Date October 16, 2018
Estimated Study Start Date  ICMJE October 15, 2018
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 15, 2018)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Crisis Resource Management Improvement Through Intellectual Questioning of Authority
Official Title  ICMJE Crisis Resource Management Improvement Through Intellectual Questioning of Authority
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:

Deliberate deception (by not informing of the aim of assessing for ability to challenge authority) will be used to blind the participants. However, open disclosure and explanation of the rationale for deception will be conducted during the debriefing sessions and participants will be extensively counselled.

The confederate specialist will also be blinded to the allocation of the control or intervention arm of participants.

All sessions will be video recorded and assessed in random order by two independent raters blinded to group allocation, using the modified Advocacy-Inquiry Score (mAIS).

Primary Purpose: Other
Condition  ICMJE Medical Education, Simulation, Crisis Resource Management
Intervention  ICMJE
  • Other: Crisis Resource Management Skill Training
    Focused crisis resource management training which targets at the cognitive skills needed to monitor and challenge a superior's decision.
  • Other: Standard ACLS Training
    Standard didactic interactive session on Advanced Cardiac Life Support (ACLS) principles.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Standard ACLS Training
  • 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.
    Intervention: Other: Crisis Resource Management Skill Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 15, 2018)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2020
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ying Wei Yau, MBBS 6772 5000 ying_wei_yau@nuhs.edu.sg
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03707964
Other Study ID Numbers  ICMJE CRITIQue
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gene Chan, MBBS National University Hospital, Singapore
PRS Account National University Hospital, Singapore
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP