Job retention vocational rehabilitation for employed people with inflammatory arthritis: adaptations to the Workwell trial due to the impact of the COVID-19 pandemic

Ching, A; Parker, J; Haig, A; Sutton, CJ; Cotterill, S; Forshaw, D; Culley, J; Hammond, A

Abstract

There are high levels of work disability, absenteeism (sick leave) and presenteeism (reduced productivity) amongst people with inflammatory arthritis. Workwell is a multi-centre, randomised controlled trial of job retention vocational rehabilitation for employed people with inflammatory arthritis. The trial tested the effectiveness and cost-effectiveness of the Workwell programme compared to receipt of written self-help information only. Both arms continued to receive usual care. In March 2020, due to the COVID-19 pandemic, the Workwell trial paused to recruitment and intervention delivery. To successfully re-start, protocol amendments were rapidly submitted and changes to existing trial procedures made.

The Workwell protocol was adapted in response to both the practical issues likely faced by many clinical research studies active across NHS sites during the pandemic, but also additional trial-specific challenges. A key eligibility criterion for the trial required participants to be in paid work for at least 15 hours per week. However, UK national lockdowns led to a substantial proportion of the workforce suddenly being furloughed or unable to work, and many people with arthritis taking immunosuppressive medications were asked to shield. Thus, the number of eligible participants reduced. Those continuing to work were harder to: identify as hospital clinics moved to remote delivery; screen, consent and then treat as hospital research staff and clinical therapists were re-deployed. New recruitment and consent strategies were applied and, where sites had reduced capacity, responsibilities were absorbed by the trial management team. Remote intervention delivery and electronic data capture were also implemented.

By rapidly adapting the Workwell protocol and procedures, the trial successfully reopened to recruitment in July 2020, only four months after trial pause. We were able to achieve recruitment figures above the pre-COVID target and maintain a high retention rate. In addition, we found many of the protocol changes beneficial, as these streamlined trial procedures, thus improving efficiency. It is likely that many strategies implemented in response to the pandemic may become standard practice in future research within trials of a similar design and methodology.

Citation

Ching, A., Parker, J., Haig, A., Sutton, C., Cotterill, S., Forshaw, D., …Hammond, A. (2022). Job retention vocational rehabilitation for employed people with inflammatory arthritis: adaptations to the Workwell trial due to the impact of the COVID-19 pandemic. Trials, 23, 1030. https://doi.org/10.1186/s13063-022-06941-2

• Journal Article Type: Article
• Acceptance Date: Nov 16, 2022
• Publication Date: Dec 20, 2022
• Deposit Date: Jan 4, 2023
• Publicly Available Date: Jan 4, 2023
• Journal: Trials
• Publisher: Springer Verlag
• Volume: 23
• Pages: 1030
• DOI: https://doi.org/10.1186/s13063-022-06941-2
• Keywords: COVID-19, Pandemic, Randomised Controlled Trial, Trial Management, Remote Intervention Delivery, Arthritis, Vocational Rehabilitation, Occupational Therapy, Work
• Publisher URL: https://doi.org/10.1186/s13063-022-06941-2
• Additional Information: Grant Number: 21761