Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001197527p
Ethics application status
Submitted, not yet approved
Date submitted
17/09/2024
Date registered
30/09/2024
Date last updated
30/09/2024
Date data sharing statement initially provided
30/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a wellbeing workshop for general practitioners
Scientific title
Evaluation of the impact of a wellbeing workshop on general practitioners' burnout and value fulfilment
Secondary ID [1] 312961 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
burnout 335134 0
Condition category
Condition code
Mental Health 331634 331634 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a wellbeing workshop, which is planned to be delivered to a variety of GPs and GP registrars as part of different events or programs (e.g., educational workshops, conferences). The workshops will vary in size from approximately 20-50 GPs/registrars. Attendees will be invited to also participate in the evaluation, but this will not be compulsory. As such, the workshops themselves do not comprise the research activity; rather the completion of the evaluation surveys is the research activity.
GPs and GP registrars will participate in a wellbeing workshop delivered either in-person or via videoconference. The workshop is designed specifically for GPs and GP registrars, providing them with psychoeducation regarding burnout and wellbeing and involving several activities for them to develop a personalised wellbeing plan (e.g., value translation, identification of a support network). The workshop emphasises attendees identifying and translating their values into activities, and planning for burnout should it arise. The activities will be completed individually on a worksheet, which attendees will be encouraged to complete following the workshop. The content delivered will be to the group as a whole rather than individualised, however individuals will be asked to apply to the content to their personal circumstances. The workshop will be delivered by a registered psychologist with a PhD in GP registrar burnout. Attendees will undertake one workshop, which will run for between 60 and 90 minutes, with no follow-up. In-person workshops will be conducted at pre-existing gatherings of GPs (e.g., supervisor workshops, GP conferences). Adherence will not be assessed per se, as 'adherence' would only involve attendance at a workshop, however follow-up surveys will explore attendees' ability to implement their wellbeing plans. The evaluation will comprise three surveys: one at baseline, a brief feedback survey one-week after the workshop, and a follow-up survey 3 months following the workshop.
Intervention code [1] 329494 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339364 0
Burnout
Timepoint [1] 339364 0
Baseline, 3-months follow-up
Primary outcome [2] 339438 0
Value fulfilment
Timepoint [2] 339438 0
Baseline, 3-months follow-up
Secondary outcome [1] 439672 0
Work/life balance
Timepoint [1] 439672 0
Baseline, 3-month follow-up
Secondary outcome [2] 439673 0
Self-care activities
Timepoint [2] 439673 0
Baseline, 3-month follow-up
Secondary outcome [3] 439998 0
Burnout
Timepoint [3] 439998 0
Baseline, 3-months follow-up
Secondary outcome [4] 439999 0
Feedback of workshop content and delivery
Timepoint [4] 439999 0
1-week post-workshop, 3-month follow-up

Eligibility
Key inclusion criteria
General practitioners (GPs) or general practice registrars attending a wellbeing workshop
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As a pilot evaluation, data will be collected and analysed to determine the impact of the workshop and seek feedback on improving the workshop. Formal power analyses have therefore not been undertaken.
Descriptive statistics will be calculated, and univariate analyses undertaken to compare baseline and 3-month follow-up outcomes (e.g., chi-square tests, t-tests). Qualitative feedback will be content analysed from the three surveys.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/11/2024
Actual
Date of last participant enrolment
Anticipated
25/03/2025
Actual
Date of last data collection
Anticipated
8/07/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317396 0
Charities/Societies/Foundations
Name [1] 317396 0
General Practice Supervision Australia
Country [1] 317396 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
General Practice Supervision Australia
Address
Country
Australia
Secondary sponsor category [1] 319684 0
None
Name [1] 319684 0
Address [1] 319684 0
Country [1] 319684 0
Other collaborator category [1] 283191 0
University
Name [1] 283191 0
University of Adelaide
Address [1] 283191 0
Country [1] 283191 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316121 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 316121 0
Ethics committee country [1] 316121 0
Australia
Date submitted for ethics approval [1] 316121 0
01/10/2024
Approval date [1] 316121 0
Ethics approval number [1] 316121 0

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

Contacts
Principal investigator
Name 136858 0
A/Prof Samia Toukhsati
Address 136858 0
General Practice Supervision Australia, PO Box 787, Gisborne, VIC 3437
Country 136858 0
Australia
Phone 136858 0
+61 0416 011 826
Fax 136858 0
Email 136858 0
[email protected]
Contact person for public queries
Name 136859 0
Samia Toukhsati
Address 136859 0
General Practice Supervision Australia, PO Box 787, Gisborne, VIC 3437
Country 136859 0
Australia
Phone 136859 0
+61 0416 011 826
Fax 136859 0
Email 136859 0
[email protected]
Contact person for scientific queries
Name 136860 0
Samia Toukhsati
Address 136860 0
General Practice Supervision Australia, PO Box 787, Gisborne, VIC 3437
Country 136860 0
Australia
Phone 136860 0
+61 0416 011 826
Fax 136860 0
Email 136860 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participant survey responses to closed questions will be available. Certain responses may be redacted from the public dataset to avoid risk of identifying participants (e.g., location/venue of workshop attended, date and time of responses, certain demographic features if small sample)
When will data be available (start and end dates)?
Data will be available immediately following publication, no end date
Available to whom?
Data will be made publicly available
Available for what types of analyses?
Data will be available for any type of analysis
How or where can data be obtained?
Data will be stored on the Open Science Framework. In the interim, please contact A.Prof Toukhsati at [email protected]


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.