NCT03707964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 11, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

October 12, 2018

Last Update Submit

March 2, 2021

Conditions

Keywords

Medical EducationSimulationCrisis Resource Management

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 minutes

Secondary Outcomes (1)

  • Influence of the confederate's gender on participant's ability to challenge incorrect decisions

    20 minutes

Other Outcomes (1)

  • Qualitative analysis of themes surrounding hierarchy and challenging authority

    10 minutes

Study Arms (2)

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.

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.

Other: Crisis Resource Management Skill Training

Interventions

Focused crisis resource management training which targets at the cognitive skills needed to monitor and challenge a superior's decision.

Intervention

Standard didactic interactive session on Advanced Cardiac Life Support (ACLS) principles.

Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Refusal for informed consent, or
  • Refusal for video recording during simulation sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital, Singapore

Singapore, 119085, Singapore

Location

Study Officials

  • Gene Chan, MBBS

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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).
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 16, 2018

Study Start

March 11, 2019

Primary Completion

September 20, 2020

Study Completion

November 20, 2020

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations