Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000166178
Ethics application status
Approved
Date submitted
31/01/2019
Date registered
5/02/2019
Date last updated
5/02/2020
Date data sharing statement initially provided
5/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Supporting supervisors to improve return-to-work outcomes of injured or ill workers
Scientific title
Assessment of the impacts of behaviourally-informed interventions provided to supervisors on return to work outcomes of injured or ill workers
Secondary ID [1] 297237 0
Nil
Universal Trial Number (UTN)
U1111-1227-5913
Trial acronym
RTW-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental disorders 311299 0
Musculoskeletal disorders 311300 0
Condition category
Condition code
Mental Health 309928 309928 0 0
Depression
Mental Health 309929 309929 0 0
Anxiety
Musculoskeletal 309930 309930 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention materials in this study is a supervisor support package that is specifically designed for this study. Therefore, no references are available. The materials are all in electronic format.

The materials are developed based on the literature review, consultation with academics in the RTW field, rehabilitation experts and case managers who will be involved in the roll out of the intervention.
The intervention package includes:
• ‘Early contact’ reminder email
o A checklist for new cases
o An ‘early contact’ conversation starter
o An introductory video
• ‘Keep in touch’ reminder email
o Checklist
o ‘Regular check-ins’ conversation starter
• ‘Preparing to return’ reminder email
o ‘Preparing to return’ conversation starter
o Suitable duties guide
• ‘First week back’ reminder email
• ‘First three months’ reminder email

The materials are aimed at better supporting supervisors and helping to address cognitive overload. It is theorized that this would lead to injured workers feeling supported by their supervisors and good supervisors and employee relationships. Supportive relationships at work, particularly that of supervisors have been shown to be an important factor in stable return to work of injured workers.

The reminders and materials will be sent by case managers to supervisors at appropriate times throughout the process (five specific time points tailored to the stage that a particular case is at).

Intervention code [1] 313488 0
Rehabilitation
Intervention code [2] 313489 0
Behaviour
Comparator / control treatment
This is not a randomized controlled trial so there will be no control group. However, the comparison group for the study will be workers who have been involved in the return to work (RTW) process prior to the roll out of intervention materials (i.e. those who underwent the RTW process in 2018).
Control group
Historical

Outcomes
Primary outcome [1] 318855 0
Return to work status as assessed by the administrative data (Human resource department statistics) on whether a person has returned from their leave. This is a binary outcome variable.
Timepoint [1] 318855 0
RTW status one month after enrolment
Primary outcome [2] 318856 0
Time to return to work. This is assessed using administrative data (i.e. the amount of leave taken) (Human Resource Department statistics)
Timepoint [2] 318856 0
At the commencement of the intervention period for the comparison group and at the end of the intervention phase for the treatment group
Secondary outcome [1] 366265 0
Supervisor's level of confidence in managing an employee on RTW and their behaviors. This will be assessed using a survey. The survey is specifically designed for this study but adapted some items from:
Munir, F., et al. (2012). Returning employees back to work: developing a measure for supervisors to support return to work (SSRW). Journal of occupational rehabilitation, 22(2), 196-208.
Timepoint [1] 366265 0
At the commencement of the intervention period for the comparison group and at the end of the intervention phase for the treatment group
Secondary outcome [2] 366266 0
Employee's rating of helpfulness of supervisor contact. This will be assessed using a survey. The survey specifically designed for this study but has adapted and used questions from:
Dimitriadis, C., LaMontagne, A. D., Lilley, R., Hogg-Johnson, S., Sim, M., & Smith, P. (2017). Cohort profile: workers’ compensation in a changing Australian labour market: the return to work (RTW) study. BMJ open, 7(11), e016366.
Safe Work Australia. (2018). National Return to Work Survey 2018 Questionnaire. Canberra: Safe Work Australia.
Timepoint [2] 366266 0
At the commencement of the intervention period for the comparison group and at the end of the intervention phase for the treatment group
Secondary outcome [3] 366277 0
Perceived level of supervisor support. This will be assessed using a survey. The survey specifically designed for this study but has adapted and used questions from:

Dimitriadis, C., LaMontagne, A. D., Lilley, R., Hogg-Johnson, S., Sim, M., & Smith, P. (2017). Cohort profile: workers’ compensation in a changing Australian labour market: the return to work (RTW) study. BMJ open, 7(11), e016366.
Safe Work Australia. (2018). National Return to Work Survey 2018 Questionnaire. Canberra: Safe Work Australia.
Timepoint [3] 366277 0
At the commencement of the intervention period for the comparison group and at the end of the intervention phase for the treatment group

Eligibility
Key inclusion criteria
The key inclusion criteria are employees, managers and case managers involved in a return to work process at participating agencies who are aged over 18 years and sickness absence for longer than ten days (of the employee).
Injured/ill employees who require a RTW process from the intervention launch date, along with relevant managers, will be in scope for the study as treatment group participants. Managers and employees with recent experience of the standard return to work process prior to the intervention will be included as a comparison group.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Employees who are in extreme physical or mental distress
Employees who are involved in challenging relationships with their managers (if alternative managers cannot be used for intervention delivery due to the nature of the situation)
Note: case managers will be able to provide further information on who these employees are in order to exclude them from the study

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomization involved
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
The evaluation will comprise a convergent integrated mixed-methods design. This means that the evaluation will rely on both qualitative and quantitative data that will be collected simultaneously. This is in comparison to designs where results from one component inform other components. The design will be integrated, which means that we will collect qualitative and quantitative data on the same issues, rather than using different methods for different questions or content. The data from interviews and focus groups will be integrated with quantitative data from surveys and an administrative data collection.
Summary and descriptive statistics will be used to describe the sample. Additionally, a number of bivariate associations will be undertaken, such as cross-tabulating time on leave with satisfaction, or type of injury with satisfaction. The pattern of associations will be examined to determine the likelihood of individual Type 1 errors.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2019
Actual
4/02/2019
Date of last participant enrolment
Anticipated
11/07/2019
Actual
28/06/2019
Date of last data collection
Anticipated
30/09/2019
Actual
30/09/2019
Sample size
Target
80
Accrual to date
Final
176
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301791 0
Government body
Name [1] 301791 0
Department of Jobs and Small Business
Country [1] 301791 0
Australia
Funding source category [2] 301794 0
Government body
Name [2] 301794 0
Department of Prime Minister and Cabinet
Country [2] 301794 0
Australia
Primary sponsor type
Government body
Name
Behavioural Economics Team of the Australian Government, PM&C
Address
1 National Cct, Barton, ACT, 2600
Country
Australia
Secondary sponsor category [1] 301534 0
Government body
Name [1] 301534 0
Applied and Behavioural Economics Section
Address [1] 301534 0
10/14 Mort St, Canberra ACT 2601
Country [1] 301534 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302503 0
Bellberry Human Research Ethics Committee F [EC00455]
Ethics committee address [1] 302503 0
Ethics committee country [1] 302503 0
Australia
Date submitted for ethics approval [1] 302503 0
22/11/2018
Approval date [1] 302503 0
29/01/2019
Ethics approval number [1] 302503 0
2018-11-978

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

Contacts
Principal investigator
Name 90438 0
Dr Su Mon Kyaw-Myint
Address 90438 0
Behavioural Economics Team of the Australian Government (BETA)
Department of Prime Minister and Cabinet
1 National Cct, Barton, ACT, 2600
Country 90438 0
Australia
Phone 90438 0
+61 02 6271 5263
Fax 90438 0
Email 90438 0
[email protected]
Contact person for public queries
Name 90439 0
Su Mon Kyaw-Myint
Address 90439 0
Behavioural Economics Team of the Australian Government (BETA)
Department of Prime Minister and Cabinet
1 National Cct, Barton, ACT, 2600
Country 90439 0
Australia
Phone 90439 0
+61 02 6271 5263
Fax 90439 0
Email 90439 0
[email protected]
Contact person for scientific queries
Name 90440 0
Su Mon Kyaw-Myint
Address 90440 0
Behavioural Economics Team of the Australian Government (BETA)
Department of Prime Minister and Cabinet
1 National Cct, Barton, ACT, 2600
Country 90440 0
Australia
Phone 90440 0
+61 02 6271 5263
Fax 90440 0
Email 90440 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
Data is considered too sensitive to share even if de-identified


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.