Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000749707
Ethics application status
Approved
Date submitted
6/04/2022
Date registered
25/05/2022
Date last updated
2/12/2022
Date data sharing statement initially provided
25/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Wellbeing and Burnout in Critical Care
Scientific title
The effect of Individualised Management Plans on wellbeing and managing burnout in critical care health professionals: a parallel, interventional, feasibility and realist informed pilot Randomized Control Trial
Secondary ID [1] 306615 0
None
Universal Trial Number (UTN)
U1111-1275-5268
Trial acronym
BT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wellbeing 325826 0
Burnout 325827 0
Stress 325828 0
Emotional Exhaustion 325829 0
Disengagement 325830 0
Cynicism 325831 0
Condition category
Condition code
Mental Health 323152 323152 0 0
Depression
Mental Health 323153 323153 0 0
Suicide
Mental Health 323154 323154 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group are required to attend an Individual Management Plan (IMP) and peer debrief session. The IMP is a once-off one-to-one consult with a clinical psychologist to collect information such as lifestyle behaviours and mental health assessments to provide immediate and simple management strategies (i.e. recommendations for positive sleeping habits, stress management techniques) within the session as usual practice and record as a case file. This should take no longer than 30 minutes per participant consult.

After participants complete the IMP, they will need to complete weekly debrief sessions for six weeks. It includes a semi-structured, group-based, virtual, informal, problem-solving-based peer debrief session. The debrief session is a focus group conversation. The peer debrief sessions aim to encourage social interactions and engagement between participants rather than to achieve structured debriefing objectives. The peer debrief will also incorporate the theory of social problem-solving. This includes guidance from the Clinical Psychologist/Clinical Psychologist Students and peers (other participants in the debrief group) to contribute guidance and techniques to attend to the voiced problem/stressor.

Adherence to IMP and debrief sessions will be monitored by the research team - where attendance will be done before the session. Participants that do not attend their respective sessions will be contacted by the research team to determine why they did not attend and if required, to reschedule into another IMP availability or another debrief session during the week.
Intervention code [1] 323237 0
Treatment: Other
Comparator / control treatment
The control group will include semi-structured, weekly (for 6 weeks) group-based virtual, peer debrief intervention managed by a Clinical Psychologist Student (overlooked by an experienced clinical psychologist). Each session will run for a duration of 60 minutes with a maximum of 10 participants in each group. The peer debriefing goals are not to achieve debriefing outcomes, but rather, to encourage social interaction and engagement between participants – enabling a platform to discuss concerns, problems, and feelings. The Clinical Psychologist will not provide active solutions unlike the intervention group's problem-solving-based peer debrief.
Control group
Active

Outcomes
Primary outcome [1] 330906 0
To assess the feasibility of recruitment, enrolment, and intervention delivery (composite outcome).
- Number of potential participants enrolled (recruited) in the trial (measured using an audit of study screening and enrolment logs)
- Number of potential participants excluded from the trial (measured using an audit of study screening and enrolment logs)
- Retention rate (measured using enrolment logs and attendance list)
Timepoint [1] 330906 0
Baseline, 6-weeks of intervention rollout
Primary outcome [2] 331084 0
To assess the feasibility of measurement tools (composite outcome).
- A completion rate of psychometric scale questionnaires and journaling (measured using an audit of study records)
- Completed assessment measures of journaling, psychometric scales, feedback questionnaire (measured using an audit of study records), and feedback semi-strcutured interviews
Timepoint [2] 331084 0
Baseline, 6-weeks of intervention rollout, post-intervention (completion of intervention), 1- and 3- month follow-up
Primary outcome [3] 331085 0
Acceptability of the intervention (composite outcome):
- Barriers (collected using a feedback questionnaire (designed specifically for this study) and feedback semi-structured interviews)
- Enablers (collected using a feedback questionnaire (designed specifically for this study) and feedback semi-structured interviews)
- Recommendations to family, friends, and colleagues (collected using a feedback questionnaire (designed specifically for this study)
Timepoint [3] 331085 0
Post-intervention (completion of intervention)
Secondary outcome [1] 408014 0
Secondary measures will include qualitative measures including online weekly journaling.
Timepoint [1] 408014 0
The online weekly journaling will be collected throughout six weeks of intervention (weekly).
Secondary outcome [2] 408674 0
Utrecht Work Engagement Scale
Timepoint [2] 408674 0
The scale survey will be collected at baseline, post-intervention (completion of intervention), 1- and 3- month follow-up.
Secondary outcome [3] 409629 0
Attrition Turnover Inventory
Timepoint [3] 409629 0
The scale survey will be collected at baseline, post-intervention (completion of intervention), 1- and 3- month follow-up.
Secondary outcome [4] 409631 0
Maslach Burnout Inventory
Timepoint [4] 409631 0
The scale survey will be collected at baseline, post-intervention (completion of intervention), 1- and 3- month follow-up.
Secondary outcome [5] 409632 0
Practice Environment Scale (i.e. factors that enhance or attenuate a healthcare professional's ability to practice skilfully and deliver high-quality care.)
Timepoint [5] 409632 0
The scale survey will be collected at baseline, post-intervention (completion of intervention), 1- and 3- month follow-up.
Secondary outcome [6] 409633 0
Problem-Solving Inventory
Timepoint [6] 409633 0
The scale survey will be collected at baseline, post-intervention (completion of intervention), 1- and 3- month follow-up.
Secondary outcome [7] 409634 0
Depression, Anxiety, and Stress Scale
Timepoint [7] 409634 0
The scale survey will be collected at baseline, post-intervention (completion of intervention), 1- and 3- month follow-up.
Secondary outcome [8] 409636 0
Positive and Negative Affect Schedule
Timepoint [8] 409636 0
The scale survey will be collected at baseline, post-intervention (completion of intervention), 1- and 3- month follow-up.
Secondary outcome [9] 409638 0
Feedback Questionnaire (designed specifically for this study)
Impact of the intervention:
- What did participants benefit? (collected at feedback questionnaire)
- Changes in participant's viewpoints (collected at feedback questionnaire)
Timepoint [9] 409638 0
Post-intervention (completion of intervention)

Eligibility
Key inclusion criteria
The eligibility criteria are as follows:
a. Participants are more than 18 years of age
b. Currently practising within an Australian or New Zealand critical care setting as a registered health professional, Physicians, Nurses, Allied Health.
c. Have access to a personal computer or device with camera and microphone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants will be excluded if they:
a. Are under any type of work compensation claims
b. Have contradictions to any of the interventions in both control and intervention groups
The trial will exclude participants that are considered as ‘high risk’ of self-harm or psychological harm,

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The majority of the analysis will be reported descriptively. Feasibility will be determined by assessing the measurement tools and recruitment process. Acceptability will be analysed by determining the barriers, enablers, and potential recommendations to family, friends, and colleagues. The feedback questionnaire and feedback semi-structured interview at post-intervention will be analysed using thematic analysis to provide a further descriptive understanding of the trial's feasibility and acceptability.

Quantitative data will include the collection of outcomes such as resilience, burnout, wellbeing, turnover, practice environment, emotional intelligence, depression, anxiety, and stress, positive and negative affect, and quality of life. Descriptive statistics (mean, standard deviation) will be used to report on the above outcomes, which will provide deeper insight into the characteristics of the population and indications of potential changes denoted as mean score differences between the four-time points (baseline, post-intervention, 1-month, and 3-months follow-up). In-subject effects will also be reported and presented in a tabular format (F, df, t-test, effect size, CI, and p-values). Debriefing field notes will be analysed using thematic analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2022
Actual
Date of last participant enrolment
Anticipated
11/12/2022
Actual
Date of last data collection
Anticipated
30/04/2023
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24690 0
New Zealand
State/province [1] 24690 0

Funding & Sponsors
Funding source category [1] 311121 0
Self funded/Unfunded
Name [1] 311121 0
Professor Di Chamberlain
Country [1] 311121 0
Australia
Funding source category [2] 311305 0
University
Name [2] 311305 0
Flinders University Research Student Maintenance (RSM)
Country [2] 311305 0
Australia
Primary sponsor type
Individual
Name
Professor Di Chamberlain
Address
Flinders University, Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 312458 0
None
Name [1] 312458 0
None
Address [1] 312458 0
None
Country [1] 312458 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310507 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 310507 0
Ethics committee country [1] 310507 0
Australia
Date submitted for ethics approval [1] 310507 0
28/03/2022
Approval date [1] 310507 0
21/11/2022
Ethics approval number [1] 310507 0
4703
Ethics committee name [2] 310651 0
University of Southern Queensland Human Research Ethics Committee
Ethics committee address [2] 310651 0
Ethics committee country [2] 310651 0
Australia
Date submitted for ethics approval [2] 310651 0
13/05/2022
Approval date [2] 310651 0
Ethics approval number [2] 310651 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117894 0
Prof Diane Chamberlain
Address 117894 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 117894 0
Australia
Phone 117894 0
+61 8 82013772
Fax 117894 0
Email 117894 0
Di.Chamberlain@flinders.edu.au
Contact person for public queries
Name 117895 0
Nurul Bahirah Binte Adnan
Address 117895 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 117895 0
Australia
Phone 117895 0
+61 8 82013772
Fax 117895 0
Email 117895 0
Nurul.Adnan@flinders.edu.au
Contact person for scientific queries
Name 117896 0
Nurul Bahirah Binte Adnan
Address 117896 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 117896 0
Australia
Phone 117896 0
+61 8 82013772
Fax 117896 0
Email 117896 0
Nurul.Adnan@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following data collection completion; no end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Contacting the principal investigator (Di.Chamberlain@flinders.edu.au), or via the study website (www.wellbeingandburnout.com).


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
EmbaseIs this the solution to wellbeing and burnout management for the critical care workforce? A parallel, interventional, feasibility and realist informed pilot randomized control trial protocol.2023https://dx.doi.org/10.1371/journal.pone.0285038
N.B. These documents automatically identified may not have been verified by the study sponsor.