Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001314112
Ethics application status
Approved
Date submitted
29/08/2019
Date registered
26/09/2019
Date last updated
13/04/2021
Date data sharing statement initially provided
26/09/2019
Date results information initially provided
13/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lessons learned following episodes of intensive care unit crisis: what experienced Intensivists can teach their peers
Scientific title
Lessons learned following episodes of intensive care unit crisis: what experienced Intensivists can teach their peers
Secondary ID [1] 299340 0
Nil known or none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 314209 0
Condition category
Condition code
Mental Health 312571 312571 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will
1. Analyse personal recounts of senior Intensivists where they each describe episodes of care where patient management was compromised secondary to human error.
2. Explore the manner in which the senior clinicians dealt with the personal effects of the particular clinical events they describe, thereby providing an overview of the manner by which they mitigated their own adverse mental response.
3. Explore a framework for human factor training that will aid in the upstream preparation of future intensive care doctors.

Research personnel will undertake face-to-face interviews of individual Intensivists who have had more than 4 years of clinical experience working in the intensive care domain using a semi-scripted set of questions. There will be only one interview undertaken per participant, the duration of which will approximate 1 hour. Interviews will take place privately in office-space adjacent to the participants usual workplace, within their institution.

All interviews will be audio-recorded. Each recording will be transcribed into an individually encrypted electronic word document by one of the investigators (DD). The complete unedited electronic transcript will then be sent to the participant via email. Participants will then have the opportunity to edit the transcript before it is de-identified and analysed.
Intervention code [1] 315418 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321219 0
Qualitative data will be collected using a semi-structured interview guide, developed following a substantial literature review of the evidence and existing tools to measure/report recovery of the healthcare provider following adverse patient events.
Timepoint [1] 321219 0
Each participant will be interviewed once, for one hour.
Secondary outcome [1] 374353 0
Qualitative data may be collected during ad-hoc informal interviews between participants and the respective site investigator, after all primary data collection at all sites has been finalised around a potential simulation-based framework for future training of future intensive care doctors.
Timepoint [1] 374353 0
Ad hoc discussions from completion of data collection for up to 1 year.

Eligibility
Key inclusion criteria
Participants will need to be
1. Intensive Care Consultants (Intensivists) who have had a minimum of 4 years’ experience in the Intensive Care Unit environment.
2. Available to be interviewed within the period of time when Co-investigators are available to undertake site data collection.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who are
1. Intensive Care Consultants (Intensivists) who have had less than 4 years’ experience in the Intensive Care Unit environment.
2. Unavailable to be interviewed within the period of time when Co-investigators are available to undertake site data collection.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Interview data analysis will be undertaken using a thematic content approach, whereby the interviews will be transcribed and organised according to the questions posed, and then read and re-read to generate a start-list of codes.

Data will then be coded by at least 2 investigators according to this start-list (using nVivo software program). Emergent themes that fit the broad pattern of meaning will then be identified and then reviewed again to make sure they fit the data. Inter-relating themes will also be recognised to interpret the meaning of the themes.

It is planned that there will be between 5-8 participants enrolled at each site (minimum 15 sample size), representing approximately 60% of the incumbent number of Intensivists at each site. We feel that this number of participants from each site will represent a saturation of data. That is, the sampling of more data will not lead to more information related to the research questions, but rather a repetition of the same categories of information. There was no power calculation undertaken in reflection of a qualitative study, and no level of significance required as analysis is qualitative.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/10/2018
Date of last participant enrolment
Anticipated
14/02/2020
Actual
14/02/2020
Date of last data collection
Anticipated
14/02/2020
Actual
14/02/2020
Sample size
Target
37
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment hospital [1] 14665 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 14666 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 27694 0
6009 - Nedlands
Recruitment postcode(s) [2] 27695 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 21817 0
Israel
State/province [1] 21817 0
Jerusalem
Country [2] 21818 0
United States of America
State/province [2] 21818 0
Illinois; Birmingham; Kentucky

Funding & Sponsors
Funding source category [1] 303683 0
Charities/Societies/Foundations
Name [1] 303683 0
Raine Foundation
Country [1] 303683 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands
Western Australia 6009
Country
Australia
Secondary sponsor category [1] 303990 0
None
Name [1] 303990 0
Address [1] 303990 0
Country [1] 303990 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304208 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 304208 0
2nd Floor A Block
Hospital Avenue
NEDLANDS Western Australia 6009
Ethics committee country [1] 304208 0
Australia
Date submitted for ethics approval [1] 304208 0
19/12/2017
Approval date [1] 304208 0
01/05/2018
Ethics approval number [1] 304208 0

Summary
Brief summary
Healthcare providers may be vulnerable to psychological trauma in the aftermath of an adverse critical clinical incident, particularly if it is associated with a poor patient outcome. This may be especially evident amongst the medical fraternity, who often lead the management of the acutely deteriorating patient, and there is evidence of stress within this cohort in the literature, and the need for upstream preparation.

This project will involve interviewing experienced intensive care doctors about adverse critical clinical incidents whereby patient management was potentially compromised secondary to human error. The aims of the interview will be to explore the impact of the events on them, in terms of their thoughts and feelings and also to explore the coping mechanisms they applied to enable them to emerge from the event with some deeper understanding and resolution. These personal recounts will be transcribed, reviewed and qualitatively analysed in order to identify common human factor gaps in clinical management during adverse critical clinical incidents, and the manner in which the personal effects of these events were mitigated.

Results will inform the development of a framework of human factor training, possibly utilising simulation-based training that will aid in the upstream preparation of future critical care doctors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96142 0
Dr Diane Dennis
Address 96142 0
Intensive Care Unit
4th floor, G Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands 6009
Western Australia
Country 96142 0
Australia
Phone 96142 0
+61 418895086
Fax 96142 0
Email 96142 0
[email protected]
Contact person for public queries
Name 96143 0
Dr Diane Dennis
Address 96143 0
Intensive Care Unit
4th floor, G Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands 6009
Western Australia
Country 96143 0
Australia
Phone 96143 0
+61 418895086
Fax 96143 0
Email 96143 0
[email protected]
Contact person for scientific queries
Name 96144 0
Dr Diane Dennis
Address 96144 0
Intensive Care Unit
4th floor, G Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands 6009
Western Australia
Country 96144 0
Australia
Phone 96144 0
+61 418895086
Fax 96144 0
Email 96144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No permission to do so.


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
SourceTitleYear of PublicationDOI
EmbaseAdvice for doctors working or planning to work in intensive care: Summation from a qualitative study.2022https://dx.doi.org/10.5114/ait.2022.113278
N.B. These documents automatically identified may not have been verified by the study sponsor.