Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000887875
Ethics application status
Approved
Date submitted
20/08/2012
Date registered
21/08/2012
Date last updated
21/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The study of human factors, self reflection and introspection by anaesthetists after a simulated critical incident
Scientific title
The study of human factors, self reflection and introspection by anaesthetists after a simulated critical incident
Secondary ID [1] 281063 0
Nil
Universal Trial Number (UTN)
U1111-1133-6766
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human factors after a simulated critical incident in theatre 287203 0
Self reflection by anaesthetists after a simulated critical incident 287204 0
Introspection by anaesthetists after a simulated critical incident 287205 0
Condition category
Condition code
Anaesthesiology 287533 287533 0 0
Anaesthetics
Public Health 287544 287544 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Senior anaesthetists will participate in a simulated scenario of a critical incident in theatre. The scenario will run for approximately 20 minutes.

This will be followed by a debrief where the participant will watch how they performed in the scenario and discuss and self assess their decisions, actions, use of resources, communication techniques, situational awareness and outcomes. It is expected that this debrief will last for not longer than 1.5 hours

A second debrief will occur 3 to 4 weeks after the simulation where participants will reflect on the events and whether or not the experience has initiated any changes in practice or identified gaps in knowledge and expertise and any action taken or to be taken. It is anticipated that this debrief will last approximately 1 hour.
Intervention code [1] 285518 0
Not applicable
Comparator / control treatment
This is a qualitative study where each participant will essentially be their own control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287781 0
Preferred decision making processes: during the first debrief session, participants will be asked to discuss their preferred decision making processess in a crisis situation, e.g. follow algorithms or trust intuition and/or past experience
Timepoint [1] 287781 0
At the time of the first debrief
Primary outcome [2] 287782 0
Ability to reflect on decisions made during the critical scenario, and if necessary change practices: during the second debrief participants will be asked to discuss any changes to their behaviour as a result of participating in the scenario
Timepoint [2] 287782 0
At the time of the second debrief
Secondary outcome [1] 298824 0
Percieved workload will be assessed using the NASA Task Load Index (NASA- TLX
Timepoint [1] 298824 0
Immediately after the simulated event

Eligibility
Key inclusion criteria
Participants must be senior consultant anaesthetists, eligible to apply for fellowship with the Australian and New Zealand College of Anaesthetists
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not eligible for fellowship with the Australian and New Zealand College of Anaesthetists

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285845 0
Self funded/Unfunded
Name [1] 285845 0
Country [1] 285845 0
Primary sponsor type
Individual
Name
Anna Maria Carrera
Address
Dept of Anaesthesia Pain Medicine and Hyperbaric Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 284666 0
Individual
Name [1] 284666 0
Dr Graham Lowry
Address [1] 284666 0
Dept of Anaesthesia Pain Medicine and Hyperbaric Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5001
Country [1] 284666 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287868 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 287868 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5001
Ethics committee country [1] 287868 0
Australia
Date submitted for ethics approval [1] 287868 0
Approval date [1] 287868 0
01/03/2011
Ethics approval number [1] 287868 0
110302

Summary
Brief summary
This study will investigate the means and mechanisms by which self reflection and introspection mediate adaptive behaviours and complex decision making during simulated anaesthesthetic critical incidents.

It will also explore whether simulation can be used effectively by experienced specialist anaesthetists to self identify gaps in skills and knowledge, increase awareness of personally preferred decision making methods and strategies aimed at optimising clinician welfare.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34596 0
Address 34596 0
Country 34596 0
Phone 34596 0
Fax 34596 0
Email 34596 0
Contact person for public queries
Name 17843 0
Anna Maria Carrera
Address 17843 0
Dept of Anaesthesia Pain Medicine and Hyperbaric Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5001
Country 17843 0
Australia
Phone 17843 0
+61 8 8222 5858
Fax 17843 0
+61 8 8222 0037
Email 17843 0
[email protected]
Contact person for scientific queries
Name 8771 0
Anna Maria Carrera
Address 8771 0
Dept of Anaesthesia Pain Medicine and Hyperbaric Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5001
Country 8771 0
Australia
Phone 8771 0
+61 8 8222 5858
Fax 8771 0
+61 8 8222 0037
Email 8771 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.