Cluster Randomised Feasibility Trial of the Pain at Work Toolkit in Employees With Chronic Pain

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

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.

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)

This study is an open-label, two-arm, multicentre, pragmatic cluster randomised controlled feasibility trial.

Intervention participants receive the PAW toolkit plus 3 x optional occupational therapy calls (approximately 30 minutes each) involving orientation to the PAW Toolkit and individually tailored advice and behavioural strategies for managing pain at work. This digital web-based toolkit is designed to support people with chronic pain in self-managing their condition at work. PAW offers evidence-based advice about chronic or persistent pain, disability rights, work capacity, pain self-management strategies and signposting to support.

Participants do not receive the PAW Toolkit but instead have treatment as usual (TAU) from their employer. The nature of TAU will be recorded as part of the feasibility study. Depending on the employing organisation, TAU may consist of (but is not limited to) any combination of the following: occupational health, counselling, line manager support, signposting to education about factors that may have positive or negative effects on chronic pain. Participants can access non-specialist telephone calls from a researcher to discuss their participation in the study.

Online toolkit providing advice and signposting to help people self-manage chronic or persistent pain at work. Access to optional phone call support from an occupational therapist providing individually tailored advice.

Treatment as usual which will vary depending on the employing organisation but may include, for example, line manager support, occupational health input etc. Access to optional non-specialist phone call support from a study researcher.

Number recruited to assess whether it would be possible to recruit to a definitive trial. The investigators will record the number recruited, characteristics of those recruited, and the timescale to recruit.

Outcome to assess whether participants find the intervention acceptable. This will be self-reported in participant interviews at 6 months.

Intervention fidelity will be checked through collection of usage data for the PAW Toolkit, to assess engagement with the intervention. This data will be collected through a feedback form at 3 months.

Intervention fidelity will be checked through recording of the uptake of occupational therapy support calls (to assess engagement with the intervention). This data will be collected through forms completed by the therapist at the time of each phone call which will be summed at 3 months.

Using the Work Limitations Questionnaire-25 (WLQ-25). To measure the degree to which pain interferes with specific components of job performance and the productivity impact of these work limitations. Scale range 0-111. Higher scores indicate worse outcome.

Using the Work Ability Index Item1 (WAI1). Assesses current work ability compared to highest work ability ever. Scale range is 0-10. Higher scores indicate better outcome.

Using the Work Self-Efficacy Scale (WSES). This includes 10 items assessing perceptions regarding specific work domains such as the capability to manage interpersonal relationships (colleagues and direct superiors), to work with colleagues with different characteristics and experiences, to behave efficaciously in the work context, to learn new working methods, to respect schedules and work deadlines, and to achieve assigned goals. Respondent rates capability on each item from 1 (Not well at all) to 5 (Very well). Higher score indicates better outcome.

Global single-item measure. Using the item: 'Taking everything into consideration, how do you feel about your job as a whole?' with responses ranging from 1 = extremely dissatisfied through to 5 = extremely satisfied. Higher score indicates better outcome.

Global single-item measure. Using the item: 'In general, how stressful do you find your job?' with responses on a 5 point scale ranging from 1 = 'not at all stressful' through to 5 = 'extremely stressful'. Higher score indicates worse outcome.

Global single item measure. Using the item: 'Are you considering leaving your job due to your pain?' (yes or no). Negative response is better outcome.

Using the Patient Health Questionnaire (PHQ-2). Scale is used to screen for depression. Scores ranges from 0-6. Higher scores indicate worse outcome.

Using the General Anxiety Disorder (GAD-7). Used as a screening tool and severity measure for generalised anxiety disorder. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Higher scores indicate worse outcome.

Using the EuroQol Five Dimensions Questionnaire (EQ-5D-5L). Comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Results in a 5-digit number that describes participant's health status, where higher scores indicate more severe or frequent problems.

Using the Work Productivity and Impairments Scale (WPAI-GH). Measures impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. The WPAI yields four types of scores: 1. Absenteeism (work time missed); 2. Presenteeism (impairment at work / reduced on-the-job effectiveness); 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism); 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity (worse outcomes).

Using a measure of health resource use (secondary and primary care; social care; private health care).

Using the Demand Control Support Questionnaire (DCSQ) - Social Support Sub-Scale consisting of 6 items covering: pleasant atmosphere, spirit of unity, colleagues support, helpful colleagues, relationship with superiors, relationship with colleagues. Respondents are asked to report their levels of agreement or disagreement on a four-point Likert scale. Higher values indicate better outcome (higher social support at work, score range 6-24).

Using items from the Work Transitions Index (WTI) covering employment status, occupation and working hours.

To document any changes in participant's employment status between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

Using UK Standard Job Skill Classification (Job Skill Level 1-4): Main job title and industry working in.

To document any changes in participant's nature of work between time 0 (baseline), time 1 (3 months) and time 2 (6 months).

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. 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

Protocol - details shared via clinical trials.gov and protocol manuscript (with informed consent form) to be submitted to an open access peer-reviewed journal within 6 months. Data Management Plan will be publicly available on https://dmponline.dcc.ac.uk prior to study start.

Protocol - baseline (registration) 6 months (submitted protocol for publication) Statistical analysis plan - baseline Informed consent form - 6 months (submitted protocol for publication)

Protocol - details shared via clinical trials.gov and protocol manuscript (with informed consent form) to be submitted to an open access peer-reviewed journal within 6 months. Data Management Plan will be publicly available on https://dmponline.dcc.ac.uk prior to ethical approval and study start.

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.

https://www.nuffieldfoundation.org/project/the-paw-trial-feasibility-and-acceptability-of-the-pain-at-work-toolkit