JMIR Publications

ABSTRACT

Background:

Chronic or persistent pain affects people’s ability to work or be productive at work, generating high societal and economic burden. However, the provision of work-related advice and support for people with chronic pain is variable or lacking. The Pain-at-Work (PAW) Toolkit was co-created with people who have lived experience of pain, healthcare professionals and employers. It aims to increase knowledge about employee rights, how to access support for managing a painful chronic condition in the workplace and provides advice on lifestyle behaviours that facilitate the management of chronic or persistent pain.

Objective:

To establish the feasibility of conducting a definitive cluster randomised controlled trial comparing access to the PAW Toolkit with 3 x telephone support calls from an occupational therapist (PAW) against treatment as usual (TAU: i.e., standard support from their employer). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety of a digital workplace health intervention delivered to vocationally active adults in employment settings in England. We will assess the feasibility of candidate primary and secondary outcomes and test research processes for a definitive trial.

Methods:

This is an open-label parallel two-arm pragmatic feasibility cluster randomised controlled trial, with exploratory health economics analysis and a nested qualitative interview study. We aim to recruit 120 participants from at least 8 workplace clusters (any type, >10 employees) in England. Recruitment of workplaces occurs via personal approach and recruitment of individual participants occurs online. Eligible participants are working-age adults ≥18 years, with internet access, self-reporting chronic or persistent pain interfering with their ability to undertake or enjoy productive work. A restricted 1:1 cluster-level randomisation is used to allocate employment settings to the PAW or TAU; participants are unblinded to group allocation. Following site and individual-level consent, participants complete online baseline survey (Time 0: T0) including measures of work capacity, health and wellbeing, and healthcare resource use. Follow-up is at 3 (Time 1: T1) and 6 months (Time 2: T2). Feasibility outcomes relate to recruitment, intervention fidelity (e.g., delivery, reach, uptake, engagement), retention, and follow-up. Qualitative evaluation (T2) is mapped to the COM-B model and will explore intervention acceptability to employees and employers, individual and contextual factors influencing the delivery and uptake of the intervention.

Results:

Ethical approval was obtained. Trial recruitment began in June 2023.

Conclusions:

The PAW Toolkit is the first evidence-based digital health intervention aimed at supporting self-management of chronic or persistent pain at work in vocationally active adults. The knowledge gained from the study will inform the design of a definitive trial including sample size estimation, approaches to cluster site identification, selection of primary and secondary outcomes, and the final health economic model. Findings will inform approaches to the future delivery of this digital health intervention. Clinical Trial: ClinicalTrials.gov: NCT05838677. Registered prospectively on 01 May 2023.