PROWORK: promoting a sustainable and healthy return to work toolkit for employers and their employees
| ISRCTN | ISRCTN90032009 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90032009 |
- Submission date
- 14/12/2020
- Registration date
- 15/12/2020
- Last edited
- 25/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
The purpose of the return to work pilot study is to provide employees on long-term sick leave with early and positive workplace communication that supports the employee’s wellbeing whilst on sick leave and when returning to work.
Many people go on long-term sick leave for lots of different reasons including back pain, poor mental health and conditions that might need treatment or recovery time. Sometimes, those on long-term sick leave might experience poor mental wellbeing even if that is not the reason for their sick leave. Research shows that poor mental wellbeing is linked to longer lengths of sickness absence. However, a number of studies show that employees who experience good quality communication and contact with their workplace can feel positive about their work, are more likely to feel ready to return to work and to also return to work earlier than they expected. They are also further likely to have a more positive work experience once they are back at work.
Our return to work pilot study, called PROWORK, provides employees who are on sick leave with an online toolkit they can access from a website. The online toolkit provides new guidance and step-by-step support from initial sick leave through to returning to work for the employee. The employee’s manager, workplace return-to-work contact or employer will be asked to use a similar online toolkit that provides them with step-by-step guidance in how to support the employee whilst on sick leave and when returning to work.
Our research wants to see how practical it is for employees on long term sick leave and the person responsible for managing their return to work to use the online toolkits and to follow the steps. We also want to see whether the toolkits are effective in reducing the number of days an employee is on long-term sick leave.
Who can participate?
1. Organisations interested in supporting their employees during sick leave and upon their return to work
2. Employees who are on long-term sick leave in the participating organisations
3. Line managers who are managing an employee on long term sick leave in the participating organisations
What does the study involve?
Participant organisations will be randomly allocated to the control group or the intervention group using the PROWORK intervention toolkit.
The PROWORK intervention is a multicomponent intervention promoting recovery and return to work in employees. The employee intervention toolkit has three distinct steps where each step outlines self-led actions the employee can take to support them whilst on sick leave and when returning to work step 1: managing sick leave, step 2: preparing to return to work, and step 3: Being back at work. Each step has self-led actions that are underpinned by behaviour change methods (commitment, social support, communication, action planning, goal-setting, self-monitoring, framing/reframing, reducing negative emotions, problem-solving and graded tasks). The use of the toolkit is supported by three 1-hour health coaching sessions.
What are the possible benefits and risk of participating?
1. Organisations in the intervention group will receive a report on the study outcomes and may continue using the intervention resources.
2. Organisations in the control group will receive a personalised report on their return to work processes
3. Employee participants receiving the intervention may experience health benefits and feel better supported by their line manager.
A potential risk is that the employee may feel coerced into participating by their employer (who will send the employee the study information after the employer has identified them as being on long-term sick leave). However, every effort will be made to reduce this risk by information the organisation on the study protocol, promoting the study before the trial starts and by the research team checking with each employee that their participation is entirely voluntary before consenting them.
Where is the study run from?
Loughborough University (UK)
When is the study starting and how long is it expected to run for?
September 2020 to October 2023
Who is funding the study?
Midlands Engine (UK)
Who is the main contact?
Dr Fehmidah Munir, f.munir@lboro.ac.uk
Contact information
Scientific
School of Sport, Exercise and Health Sciences
Loughborough University
Loughborough
LE11 3TU
United Kingdom
 ORCID ID |
0000-0002-5585-0243 |
|---|---|
| Phone | +44 (0)1509 228228 |
| f.munir@lboro.ac.uk |
Study information
| Study design | Two-arm randomized controlled pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request participant information sheet. |
| Scientific title | PROWORK - PROmoting a sustainable return to Work: Randomised controlled pilot study assessing a Return to Work toolkit and support for line managers and their employees on long-term sick leave |
| Study acronym | PROWORK |
| Study hypothesis | The PROWORK intervention reduces the number of days on long-term sick leave compared to usual care |
| Ethics approval(s) | Approved 27/11/2020, Loughborough Ethics Committee (Loughborough University, Loughborough, Leicestershire LE11 3TU, UK; +44 (0)1509 222423; regulatory@lboro.ac.uk), ref: 2020-1889-2041 |
| Condition | Reducing long-term sick leave in employees with a common mental health condition as a main condition or alongside another condition |
| Intervention | A cluster randomised controlled trial with large, medium and small employer organisations with the unit of randomisation being at the level of each organisation - The intervention arm will receive a multicomponent online intervention toolkit and health coaching (employee participants) and an online training and multicomponent intervention toolkit (line managers) - The control will receive usual practice The PROWORK intervention is a multicomponent intervention promoting recovery and return to work in employees. The employee intervention toolkit has three distinct steps where each step outlines self-led actions the employee can take to support them whilst on sick leave and when returning to work step 1: managing sick leave, step 2: preparing to return to work, and step 3: Being back at work. Each step has self-led actions that are underpinned by behaviour change methods (commitment, social support, communication, action planning, goal-setting, self-monitoring, framing/reframing, reducing negative emotions, problem-solving and graded tasks). The use of the toolkit is supported by three 1-hour health coaching sessions. The line manager online toolkit has three distinct steps which outline the actions and behaviours the line managers need to undertake to support the employee whilst on sick and when they have returned to work step 1: managing sick leave, step 2: preparing to return to work, and step 3: Being back at work. Each step is underpinned by behaviour change methods (commitment, instructions on how to perform a behaviour, demonstration of the behaviour, behavioural practice, action planning and problem-solving). The manager toolkit is supported by an online training module. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Feasibility outcome: quantitative data describing recruitment (types of organisations participating, number of employees on long-term sick leave eligible to take part, number of employees who consent to take part, number of line managers who consent to take part), intervention (e.g. number of participants completing the steps in the online toolkits, number of times each section of the toolkit is used and attrition, number of health coaching sessions received, online training viewed and completed) gathered using study logs and predesigned forms. The forms to capture the specific data will be unique to this study and developed for its purpose. This data will be captured at baseline, and then each month up to month 6 2. Number of days taken until first day of return to work (partial or full return) using organisational records and self-report. Data collected monthly (organisational records) and at 3 months and 6 months (self-report) |
| Secondary outcome measures | 1. Depression measured using the PHQ-9 at baseline, 3 months and six months 2. Anxiety measured using GAD-7 at baseline, 3 months and six months 3. Return to work measured by intentions to return to work scale, return-to-work self-efficacy scale and the readiness to return to work measured at baseline, 3 months and six months 4. workplace support and communication and support measured by six items developed by the research team at baseline, 3 months and six months 5. Work outcomes measured by the work productivity and activity impairment questionnaire at baseline, 3 months and six months 6. Quality of life measured by EQ5D-5L measured at baseline, 3 months and six months 7. demographic questions will be asked at baseline, 8. Use of health resources will be asked at baseline, 3 months and six months 9. Process evaluation interviews (experiences of participants, engagement with the intervention, barriers and facilitators) will take place at one time point (at 6 months for employees and line managers and at 9-12 months for employers) |
| Overall study start date | 01/09/2020 |
| Overall study end date | 31/10/2023 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | Employee: 1. To have been on sick leave for at least eight days and less than six weeks (42 days) |
| Participant exclusion criteria | Employee: 1. Under 18 years of age 2. On sick leave with a psychotic episode such as schizophrenia, or with substance abuse 3. On sick leave whilst under formal investigation for misconduct or in the formal process of disciplinary action 4. On sick leave being diagnosed with cancer and signed off work for at least 6 months 5. On sick leave due to a neurological condition (e.g. multiple sclerosis, Parkinson's disease, dementia) |
| Recruitment start date | 11/01/2021 |
| Recruitment end date | 31/10/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Epinal Way
Loughborough
LE11 3TU
United Kingdom
Sponsor information
University/education
Epinal Way
Loughborough
LE11 3TU
England
United Kingdom
| Phone | +44 (0)1509 222423 |
|---|---|
| J.A.Green@lboro.ac.uk | |
| Website | https://www.midlandsengine.org/ |
"ROR" |
https://ror.org/04vg4w365 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The pilot protocol will be published in 2021 in an open access journal. The main results will be published within 1 year of completing the pilot study. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the sensitive and contentious nature of the data being collected directly from business organisations. Consent to share data beyond the study has not been included in the participant consent forms. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V1 | 01/11/2020 | 04/01/2021 | No | No |
| Protocol article | 19/08/2022 | 22/08/2022 | Yes | No | |
| Other publications | Toolkit development | 02/09/2023 | 25/04/2025 | Yes | No |
Additional files
- ISRCTN90032009_PROTOCOL_V1_01Nov20.pdf
- Uploaded 04/01/2021
Editorial Notes
25/04/2025: Publication reference added.
22/08/2022: Publication reference added.
07/06/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2022 to 31/10/2023.
2. The overall end date was changed from 30/06/2022 to 31/10/2023.
3. The intention to publish date was changed from 01/07/2023 to 31/03/2024.
4. The plain English summary was updated to reflect these changes.
5. The total final enrolment was removed as recruitment is ongoing.
11/04/2022: The final enrolment number has been added.
06/12/2021: The following changes have been made:
1. The recruitment end date has been changed from 28/01/2022 to 31/03/2022.
2. The total target enrolment has been changed from 100 to 60.
3. The scientific title has been changed from "PROWORK - PROmoting a sustainable return to Work: Randomised controlled pilot study assessing the effect of providing a Return to Work toolkits and support for line managers and their employees on long-term sick leave" to "PROWORK - PROmoting a sustainable return to Work: Randomised controlled pilot study assessing a Return to Work toolkit and support for line managers and their employees on long-term sick leave".
13/09/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/09/2021 to 28/01/2022.
2. The overall trial end date has been changed from 30/04/2022 to 30/06/2022 and the plain English summary updated accordingly.
04/01/2021: Uploaded protocol Version 1, 01 November 2020 (not peer reviewed).
15/12/2020: Trial’s existence confirmed by Loughborough University.
