Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000912189
Ethics application status
Approved
Date submitted
14/06/2019
Date registered
28/06/2019
Date last updated
13/10/2020
Date data sharing statement initially provided
28/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effects of a resilience intervention to on burnout levels in general practice registrars
Scientific title
A case-control evaluation of the effects of the 'Building Resilience – Sustaining Practice' resilience workshop on burnout levels in South Australian General Practice registrars
Secondary ID [1] 298476 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burnout 313251 0
Condition category
Condition code
Mental Health 311689 311689 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention title: "Building Resilience – Sustaining Practice"
The workshop focuses on the stressors and demands that are placed upon general practice registrars as a consequence of the requirements of their work, and also their commitment, pride in their work and often perfectionist nature. The training is based on concepts of positive psychology and has elements of the work of Professor Martin Seligman, Dr Michelle McQuaid and Kathryn McEwen. The training addresses the components of the Resilience at Work (R@W) Sustain 7© measure which is a measure of workplace resilience developed by Dr Kathryn McEwen. Participants will receive a series of interactive face-to-face modules involving lectures, group discussions, mindfulness activities and reflection. This will be a one-day workshop run by a general practitioner and resilience training facilitator. At the beginning of the workshop, participants will be supplied with a workbook specifically designed for this workshop containing activities that they will complete during the workshop, as well as further information and activities for them following the workshop. Workshops will be conducted face-to-face at the offices of participants' training organisation. Participants will only be eligible to attend one workshop. Workshops will not be tailored to individuals or groups. Participants will self-select to participate in the workshop and the research; participate in the workshop without the research; or participate only in the research.
Intervention code [1] 314726 0
Behaviour
Comparator / control treatment
There will be a no-treatment control group who will only complete a series of surveys.
Control group
Active

Outcomes
Primary outcome [1] 320392 0
The primary outcome is changes in burnout levels, as measured by the Maslach Burnout Inventory – Human Services Survey (for Medical Personnel).
Timepoint [1] 320392 0
For each workshop, baseline burnout levels will be assessed on enrolment prior to the workshop. Burnout levels will be assessed again at 4 weeks (primary endpoint) and 3 months post-intervention
Secondary outcome [1] 371451 0
Changes in the seven domains of occupational resilience, as measured by the R@W-7 scale.
Timepoint [1] 371451 0
Occupational resilience will be assessed simultaneously with burnout i.e. on enrolment prior to the workshop and again at 4 weeks and 3 months post-intervention.

Eligibility
Key inclusion criteria
All senior general practice registrars training with GPEx Ltd (https://www.gpex.com.au)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any person who is not a general practice registrar who is training with GPEx Ltd. Additionally, general practice registrars training with GPEx who are not classified as 'senior' registrars (i.e. in their first or second training term) are also not eligible.

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Each workshop is designed to facilitate between 8 and 30 participants, however participants will be given a choice regarding participation in the research. Given three workshops are scheduled, we assumed a total of 30 attendees for all three workshops who choose to participate in the research. Based on previous experience with recruitment of general practice registrars for survey-based research, we estimated approximately 30 senior registrars would complete surveys acting as controls. To analyse the effectiveness of the intervention, we plan to run independent-samples t-tests for each burnout dimension (emotional exhaustion, depersonalisation and personal accomplishment) comparing changes in burnout levels between and within the intervention and control groups. A-priori power analyses assuming a sample size of 30 participants per group, alpha of .05 and power of .8 indicate this study will be sufficiently powered to identify a moderate effect size (Cohen’s d = .74).

Additionally, registrars will be eligible to participate in interviews where qualitative feedback on the workshop will be sought.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
22/06/2019
Date of last participant enrolment
Anticipated
7/02/2020
Actual
22/06/2019
Date of last data collection
Anticipated
15/05/2020
Actual
Sample size
Target
60
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 303022 0
Other Collaborative groups
Name [1] 303022 0
GPEx Ltd.
Country [1] 303022 0
Australia
Funding source category [2] 303081 0
University
Name [2] 303081 0
The University of Adelaide
Country [2] 303081 0
Australia
Funding source category [3] 303082 0
Government body
Name [3] 303082 0
Department of Education, Australian Government – PhD Stipend
Country [3] 303082 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
The University of Adelaide, North Terrace Campus, Adelaide, South Australia 5005
Country
Australia
Secondary sponsor category [1] 302999 0
Charities/Societies/Foundations
Name [1] 302999 0
GPEx Ltd.
Address [1] 302999 0
132 Greenhill Road, Unley, South Australia, 5061
Country [1] 302999 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303570 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 303570 0
Ethics committee country [1] 303570 0
Australia
Date submitted for ethics approval [1] 303570 0
05/03/2019
Approval date [1] 303570 0
09/05/2019
Ethics approval number [1] 303570 0
H-2019-072

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

Contacts
Principal investigator
Name 94122 0
Dr Diana Dorstyn
Address 94122 0
School of Psychology, Level 5 Hughes Building, The University of Adelaide North Terrace Campus, Adelaide South Australia 5005
Country 94122 0
Australia
Phone 94122 0
+61 08 8313 0649
Fax 94122 0
Email 94122 0
[email protected]
Contact person for public queries
Name 94123 0
Diana Dorstyn
Address 94123 0
School of Psychology, Level 5 Hughes Building, The University of Adelaide North Terrace Campus, Adelaide South Australia 5005
Country 94123 0
Australia
Phone 94123 0
+61 08 8313 0649
Fax 94123 0
Email 94123 0
[email protected]
Contact person for scientific queries
Name 94124 0
Diana Dorstyn
Address 94124 0
School of Psychology, Level 5 Hughes Building, The University of Adelaide North Terrace Campus, Adelaide South Australia 5005
Country 94124 0
Australia
Phone 94124 0
+61 08 8313 0649
Fax 94124 0
Email 94124 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
Permission was not sought from the ethics committee for sharing of this data. Due to the highly personal nature of the data being collected, the research team agreed to not seek permission for this data to be publicly available.


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.