Clinical trial NCT05838677: Pain at Work Toolkit in Employees With Chronic Pain
Official title: Multicentre Pragmatic Cluster Randomised Controlled Feasibility Trial to Assess Potential Effectiveness and Cost-effectiveness of the Pain at Work Toolkit in Employees With Chronic or Persistent Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Pain, Chronic
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Nuffield Trust
name: Versus Arthritis
name: University of Aberdeen
name: University of Exeter
name: Monash University
First posted: 2023-05-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an open-label, two-arm, multicentre, pragmatic cluster randomised controlled feasibility trial.
Primary purpose: OTHER

Brief summary: This project will test the feasibility and acceptability of the Pain at Work (PAW) Toolkit which aims to help employees self-manage chronic or persistent pain at work. Ultimately, the investigators want to discover if it improves employees' health, wellbeing, confidence to self-manage their condition, and reduces impacts on their ability to work and be productive at work. Prior to testing the effectiveness and cost-effectiveness of the PAW Toolkit in a large-scale randomised trial, the investigators are conducting a multicentre pragmatic cluster randomised controlled feasibility trial. This will establish whether the PAW Toolkit, and our research processes, are feasible and acceptable in workplace settings, and will inform the design of a future trial. In this feasibility study, organisations will be randomised at site level to receive the intervention (PAW Toolkit plus occupational therapist (OT) support calls) or control (treatment as usual) for any individual employees who consent to take part. The investigators aim to recruit around 120 participants ("individual employees") from around 8 sites ("clusters"). Data will be collected from employees and organisations at baseline, 3 months and 6 months, using online surveys. At 6 months, up tp 40 people from across different sites and job roles will be interviewed, including employees who have accessed the PAW Toolkit, and other stakeholders (people who have been involved in supporting them at work, such as their line manager).

The data will be used assess whether the intervention and the research processes are acceptable and feasible, and the information collected will be used to plan a large-scale randomised controlled trial.

Detailed description: Background:

Chronic or persistent pain affects around 28 million adults in the United Kingdom (UK), reducing quality of life and people's ability to work or be productive at work. Sickness absence and reduced productivity costs the UK economy £73 billion per year.

Access to work advice and support for people living with pain is variable. Most people with chronic pain do not receive work advice through healthcare services, and employers do not routinely provide education or support for people with chronic pain. The Pain at Work (PAW) Toolkit aims to equip people who have pain with the knowledge, skills and confidence to: effectively self-manage a painful condition at work; access help and support; enjoy a better work experience; remain in the workforce.

Aims:

The aim of the trial is to determine the feasibility of conducting a definitive cluster randomised controlled trial (cRCT) of the effectiveness and cost-effectiveness of the PAW Toolkit for working-age adults with chronic or persistent pain. To achieve this, the objectives are:

* To measure feasibility outcomes to assess whether it would be possible to recruit to a definitive trial (recruitment, retention).
* To test the feasibility of reaching different employee groups (e.g., age, gender, ethnicity, job role or type), sectors (e.g., public, private, third) and organisation types (e.g., small-to-medium, or large enterprises).
* To explore whether participants and employers find the intervention and trial design acceptable.
* To obtain an estimate of the intra-cluster correlation coefficient to inform the future sample size calculation for the main trial.
* To collect a range of outcome measures to help identify the most appropriate primary outcome for a definitive trial.
* To collect data to assess the feasibility of capturing health economic data in a future trial.
* To design a future trial and implementation plan.

Protocol/ Method:

Trial configuration includes 3 work packages (WP's): feasibility trial (WP1); health economics evaluation (WP2); nested interview study (WP3).

Setting is community, comprised of employment settings in different sectors (public, private, third) in England, varying in size (small:10-49 workers; medium: 50-249 workers; large: \>250 workers).

Sample size estimate: The aim is to recruit a minimum of 8 worksites ("clusters"), approximately 4 per arm. Up to 120 participants ("employees") will be recruited from these clusters over 12 months.

A nested interview study will be conducted, in which up to 40 people will be interviewed after 6 months. Participants in the interview study will include employees from the intervention arm, and stakeholders (identified by employees as having been involved in their support at work). Stakeholders may include line managers, company owners, human resources or occupational health specialists, or trade union representatives).

Organisations are randomised to either i) active control group (TAU: treatment as usual), or ii) TAU plus PAW Toolkit. Intervention participants can also opt in to receive up to 3 telephone calls with an occupational therapist. The content of the calls will include orientation to the PAW Toolkit and individually tailored advice on managing pain at work.

The following outcome measures will be collected (for detail, see Outcome Measures section):

A. Feasibility and acceptability outcomes:

B. Employer-reported outcome measures

C. Participant-reported outcome measures (PROMs)

Eligibility criteria: Inclusion Criteria (Organisations)

* organisations in England
* organisations with 10 or more employees.

Inclusion Criteria (Employee participants)

* working-age adults (employees)
* aged 18 and over
* self-reported chronic pain interfering with their ability to undertake or enjoy productive work
* able to comprehend English language
* able to provide informed consent.
* access to the internet to be able to access the web-based intervention and online surveys for data collection.

Exclusion Criteria (Organisations)

* organisations outside of England
* micro-organisations with fewer than 10 employees

Exclusion Criteria (Employee participants)

* unemployed at recruitment
* under 18 years of age
* no chronic pain at recruitment
* unable to comprehend English language
* unable to provide informed consent

Primary outcomes:
measure: Recruitment to the study
timeFrame: Baseline
measure: Acceptability of Intervention
timeFrame: 6 months
measure: Fidelity of intervention (PAW Toolkit)
timeFrame: 3 months
measure: Fidelity of intervention (OT support calls)
timeFrame: 3 months
measure: Retention to the study at 3 months
timeFrame: 3 months
measure: Retention to the study at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Work presenteeism
timeFrame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
measure: Work Ability
timeFrame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
measure: Work Self-Efficacy
timeFrame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
measure: Job satisfaction
timeFrame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
measure: Job stressfulness
timeFrame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
measure: Turnover intentions
timeFrame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
measure: Depression
timeFrame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
measure: Anxiety
timeFrame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
measure: Health-related quality of life
timeFrame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
measure: Impairments in work and activities
timeFrame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
measure: Health resource use questionnaire
timeFrame: Cumulative health resource use at time 0 (baseline), time 1 (3 months), time 2 (6 months)
measure: Social support at work
timeFrame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Other outcomes:
measure: Organisation-reported sickness absence records
timeFrame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
measure: Employment status
timeFrame: To document any changes in participant's employment status between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
measure: Nature of work
timeFrame: To document any changes in participant's nature of work between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Holly Blake, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blake H, Somerset S, Greaves S. The Pain at Work Toolkit for Employees with Chronic or Persistent Pain: A Collaborative-Participatory Study. Healthcare (Basel). 2021 Dec 29;10(1):56. doi: 10.3390/healthcare10010056.
citation: Blake H, Chaplin WJ, Wainwright E, Taylor G, McNamee P, McWilliams D, Abbott-Fleming V, Holmes J, Fecowycz A, Walsh DA, Walker-Bone K. The Web-Based Pain-at-Work Toolkit With Telephone Support for Employees With Chronic or Persistent Pain: Protocol for a Cluster Randomized Feasibility Trial. JMIR Res Protoc. 2023 Oct 30;12:e51474. doi: 10.2196/51474.