ANZCTR - Registration

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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]

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

Musculoskeletal disorders

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Musculoskeletal

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]

Rehabilitation

Intervention code [2]

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]

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]

RTW status one month after enrolment

Primary outcome [2]

Time to return to work. This is assessed using administrative data (i.e. the amount of leave taken) (Human Resource Department statistics)

Timepoint [2]

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]

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]

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]

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]

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]

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]

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?

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

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]

Government body

Name [1]

Department of Jobs and Small Business

Address [1]

10/14 Mort St, Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Department of Prime Minister and Cabinet

Address [2]

1 National Cct, Barton, ACT, 2600

Country [2]

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]

Government body

Name [1]

Applied and Behavioural Economics Section

Address [1]

10/14 Mort St, Canberra ACT 2601

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Human Research Ethics Committee F [EC00455]

Ethics committee address [1]

129 Glen Osmond Rd
Eastwood SA 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/11/2018

Approval date [1]

29/01/2019

Ethics approval number [1]

2018-11-978

Summary

Brief summary

The primary goal of the Return to Work study is to help supervisors to better support their injured or ill workers so that these workers can achieve sustainable return to work (RTW). Previous research has found that improved supervisor and employee relationships could assist in sustainable RTW. However, supervisors may be unsure about how to best support the employee, or they may get busy or overwhelmed. The study's main hypothesis is that addressing supervisors’ cognitive overload, decision fatigue and availability bias through behavioural interventions may improve worker-supervisor relationships and consequently improve sustainable return to work rates.
This study will evaluate the effect of materials package for supervisors to assist them in supporting their injured or ill workers during their absence and through the various stages of the return to work process. The outcomes examined in this study include the RTW rate, supervisor confidence and behaviours in supporting their employees, employee's perceived level of support from their supervisor and perceived usefulness of intervention materials.

Trial website

Not applicable

Trial related presentations / publications

Not applicable

Public notes

The stages and processes of the intervention are:
1. When first absent- When case managers first become aware of the case, managers will be sent an 'early contact email' with 'a conversation guide for early contact'. The email will also include a link to a short video about the RTW process and the RTW checklist (all developed specifically for this project)
2. while absent- About two weeks after the initial email (early contact email), case managers will send the 'stay in touch' email. This email includes a conversation guide for keeping in touch as well as reminding the supervisor to put in calendar reminders to regularly reach out to their injured/ill worker. If the injured/ill worker returned to work quickly, their manager may not receive this step of the intervention.
3. when about to return to work- If an expected RTW date is known, a week before this date, case managers will send another email to managers about preparing RTW. This email will include a conversation guide for RTW discussion and will also include suitable duties guide to assist managers in identifying suitable duties for their injured/ill worker. 
4. first week back - After the worker's first week back at work, case manager will send another reminder email which includes conversation guide for this stage of RTW process.
5. 3 months after RTW- This is the final stage of the intervention. The email reminds the manager to review whether the RTW arrangement is working as intended and if adjustments need to be made. 

Case managers are employees of the organisations who are rehabilitation professionals. Their qualifications may vary but they are usually highly experienced. 

The mode of delivery of all intervention materials is email. All interventions materials are electronic documents, videos, emails. 
All elements of the intervention are delivered once usually. But this may depend on factors such as how long the worker was absent from work, how quickly case managers became aware of the case, whether they knew in advance a worker's RTW date before the worker returned to work. No experience of absence and RTW from injury/illness is identical, thus we have gone for a tailored approach.
The setting of the intervention was in the workplace.
We did not monitor adherence to intervention as this was not feasible in this study.

Contacts

Principal investigator

Name

Dr Su Mon Kyaw-Myint

Address

Behavioural Economics Team of the Australian Government (BETA)
Department of Prime Minister and Cabinet
1 National Cct, Barton, ACT, 2600

Country

Australia

Phone

+61 02 6271 5263

Fax

sumon.kyaw-myint@pmc.gov.au

Contact person for public queries

Name

Su Mon Kyaw-Myint

Address

Behavioural Economics Team of the Australian Government (BETA)
Department of Prime Minister and Cabinet
1 National Cct, Barton, ACT, 2600

Country

Australia

Phone

+61 02 6271 5263

Fax

sumon.kyaw-myint@pmc.gov.au

Contact person for scientific queries

Name

Su Mon Kyaw-Myint

Address

Behavioural Economics Team of the Australian Government (BETA)
Department of Prime Minister and Cabinet
1 National Cct, Barton, ACT, 2600

Country

Australia

Phone

+61 02 6271 5263

Fax

sumon.kyaw-myint@pmc.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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