Authors' objectives: Staff sickness absenteeism and presenteeism (attending work while unwell) incur high costs to the NHS, are associated with adverse patient outcomes and have been exacerbated by the COVID-19 pandemic. The main causes are mental and musculoskeletal ill health with cardiovascular risk factors common. To undertake a feasibility study to inform the design of a definitive randomised controlled trial of the effectiveness and cost effectiveness of a health screening clinic in reducing absenteeism and presenteeism amongst the National Health Service staff. Staff sickness absenteeism and presenteeism (attending work while unwell) incur high costs to the NHS, are associated with adverse patient outcomes and have been exacerbated by the COVID-19 pandemic. The main causes are mental and musculoskeletal ill health with cardiovascular risk factors also common. The aim of this pilot trial was to assess the feasibility of a definitive randomised controlled trial (RCT) evaluating the clinical and cost effectiveness of a health screening clinic compared to usual care, in reducing sickness absenteeism and presenteeism amongst NHS staff. The key objectives were to: describe recruitment rates describe participant characteristics and assess generalisability compared to the hospital workforce describe intervention screening assessment results describe recommended referrals and their uptake assess the feasibility of measuring the outcomes relating to the definitive trial, and obtain an estimate of the standard deviation of the proposed primary outcomes for a full RCT assess levels of contamination between intervention and usual care arms to inform RCT design (individual vs. cluster RCT) describe and explain the fidelity to the intervention and evaluate the barriers and enablers to participation describe the views, experiences and satisfaction of participants and those delivering the health checks quantify the costs of undertaking the screening service and its consequences.

Authors' results and conclusions: Three hundred and fourteen participants were consented (236 randomised), the majority within 4 months. The recruitment rate of 314/3788 (8.3%) invited was lower than anticipated (meeting red for this criteria), but screening identified that 57/118 (48.3%) randomised were eligible for referral to either general practitioner (81%), mental health (18%) and/or physiotherapy services (30%) (green). Early trial closure precluded determination of attendance at referrals, but 31.6% of those eligible reported intending to attend (amber). Fifty-one of the 80 (63.75%) planned qualitative interviews were conducted. Quantitative and qualitative data from the process evaluation indicated that the electronic database-driven screening intervention and data collection were efficient, promoting good fidelity, although needing more personalisation at times. Recruitment and delivery of the full trial would benefit from a longer development period to better understand local context, develop effective strategies for engaging with underserved groups, provide longer training and better integration with referral services. Delivery of the pilot was limited by the impact of COVID-19 with staff redeployment, COVID-research prioritisation and reduced availability of community and in-house referral services. While recruitment was rapid, it did not fully represent ethnic minority groups and truncated follow-up due to funding limitations prevented full assessment of attendance at recommended services and secondary outcomes. There is both a clinical need (evidenced by 48% screened eligible for a referral) and perceived benefit (data from the qualitative interviews) for this National Health Service staff health screening clinic. The three stop/go criteria were red, green and amber; therefore, the Trial Oversight Committee recommended that a full-scale trial should proceed, but with modifications to adapt to local context and adopt processes to engage better with underserved communities. Three thousand seven hundred and eighty-eight of the 24,344 NHS staff across the four sites were invited to take part. Of the 353 eligible respondents, 314 consented (8.3% of those invited and 65.4% of our planned target of n = 480). Two hundred and thirty-six were randomised into the study; n = 118 to the intervention screening arm and 118 to usual care. One hundred and one (85.6%) attended and completed the screening clinic. Only 26/236 (11.0%) participants reached the 26-week follow-up. Primary outcomes and stop/go criteria Three hundred and fourteen of the 3788 [8.3% (95% CI 7.4% to 9.2%)] invited staff gave their consent to participate, which meets the red stop/go criterion for recruitment. Fifty-seven of the 118 [48.3% (95% CI 39.0% to 57.7%)] participants randomised to the intervention arm were eligible for referral to at least one service, which meets the green stop/go criterion for referral. Eighteen of the 57 [31.6% (95% CI 19.9% to 45.2%)] participants eligible for a referral accepted a referral to at least one service, which meets the amber stop–go progression criterion for attendance, although the CIs were wide. Most reported minimal/mild anxiety, but 11 (10.9%) were classified as having moderate and 5 (5.0%) severe anxiety. Most people reported minimal/mild depression, but 13 (12.9%) reported moderate/moderately severe depression and 4 (4.0%) severe depression. Most participants had no significant back pain, although eight (7.9%) were at medium risk and two (2.0%) at high risk on the StarT Back tool. Twenty-seven (27.0%) scored with medium risk for other types of pain and five (5.0%) high risk. Thirty-eight (38.0%) participants were classified as overweight and 32 (32.0%) obese. Forty-six (46.0%) were self-reported as physically active. Twelve (11.9%) reported increasing/higher risk of alcohol dependence and 10 (9.9%) were current smokers. Of those eligible for the cardiovascular risk score (QRISK2), nine (14.5%) had medium risk (10–19.9%) and two (3.2%) had a high risk of developing cardiovascular disease (CVD) in the next 10 years. Despite significant delays, truncation and amendments required due to the COVID-19 pandemic, we were able to assess the most important aspects of the feasibility of a RCT to evaluate the clinical and cost effectiveness of a novel hospital-based staff health screening clinic in reducing absenteeism and presenteeism. Recruitment was feasible in a short space of time, and delivery of the intervention feasible, efficient and acceptable. Although a lower proportion of staff were recruited than anticipated, this was offset by the findings of the screening assessments which revealed significant health needs of those attending with 48% requiring referral to additional services. The three stop/go criteria were red, green and amber; therefore, the TOC recommended that a full-scale trial should proceed, but with modifications (see below) to adapt to local context and adopt processes to engage better with underserved communities, to improve both reach and effectiveness. Implications/modifications for full trial design There was no evidence of contamination; therefore, an individual RCT would remain the design of choice. Wait-list controls might also be a potential option to encourage people to participate. While our approach to recruitment was successful for many (most people responded to an e-mail), additional strategies would be needed to recruit the underserved groups, and specific minority staff network groups and leaders should be engaged in order to do so. Messaging to potential participants needs to be clearer in order to reduce concerns about confidentiality, optimise recruitment and manage expectations. More flexible clinic times/alternative options could be explored to improve inclusion. Electronic data capture was considered convenient, but extra training and practice should be provided to ensure sufficient familiarity and personalisation. Consideration (on a site-by-site basis) of clearer referral pathways is important for the full trial, in order to optimise attendance at referrals and realise health outcomes. Further consideration should also be given to the mental health screening tools used, as qualitative interviews with staff revealed their concerns that occupational stress and burnout may not be adequately identified and treated. There was no evidence from this study that self-reported absenteeism data should replace human resources (HR) data as the potential primary outcome as correlation between the two was poor. Acknowledging the 25% dropout between consent and randomisation, the amount of data collected and length of questionnaires should be reviewed prior to a full trial. Resource use and cost data were relatively straightforward to collect, although it was evident that more detailed site-by-site data collection would be required in a full trial, to reflect the full range of clinic organisation scenarios.

Authors' methods: Individually randomised controlled pilot trial of the staff health screening clinic compared with usual care, including qualitative process evaluation. Four United Kingdom National Health Service hospitals from two urban and one rural Trust. Hospital employees who had not previously attended a pilot health screening clinic at Queen Elizabeth Hospital Birmingham. Nurse-led staff health screening clinic with assessment for musculoskeletal health (STarT musculoskeletal; STarT Back), mental health (patient health questionnaire-9; generalised anxiety disorder questionnaire-7) and cardiovascular health (NHS health check if aged ≥ 40, lifestyle check if < 40 years). Screen positives were given advice and/or referral to services according to UK guidelines. The three coprimary outcomes were recruitment, referrals and attendance at referred services. These formed stop/go criteria when considered together. If any of these values fell into the ‘amber’ zone, then the trial would require modifications to proceed to full trial. If all were ‘red’, then the trial would be considered unfeasible. Secondary outcomes collected to inform the design of the definitive randomised controlled trial included: generalisability, screening results, individual referrals required/attended, health behaviours, acceptability/feasibility of processes, indication of contamination and costs. Outcomes related to the definitive trial included self-reported and employee records of absenteeism with reasons. Process evaluation included interviews with participants, intervention delivery staff and service providers. Descriptive statistics were presented and framework analysis conducted for qualitative data. Due to the COVID-19 pandemic, outcomes were captured up to 6 months only. A multicentre, two-arm, parallel group, open-label, 1 : 1 individually randomised pilot RCT of a complex intervention comparing a staff health screening clinic with usual care. Three large urban hospitals and one rural district general hospital in the West Midlands. All employees in the participating hospitals were eligible to participate except those who had previously attended a pilot health screening clinic at Queen Elizabeth Hospital Birmingham (QEHB) or who were currently taking part in another non-COVID drug trial or similar health and well-being trial. Participants were informed of the trial through staff meetings, noticeboards, posters and ward champions, and invited (with up to three reminders) through multiple approaches including e-mail and personal invitation. Wards were chosen to reflect the characteristics of the hospital. Data collection Potential participants joined the trial via weblink to a custom-designed electronic trial data collection platform hosted by the Birmingham Clinical Trials Unit. Eligibility questions, consent and a baseline questionnaire were completed prior to randomisation. Intervention Staff health screening clinic with two stages: screening assessment for three components: mental health, musculoskeletal health and cardiovascular health, followed by appropriate advice and/or referral, according to level of risk, to appropriate services for management according to NHS/National Institute for Health and Care Excellence (NICE) recommendations. The screening assessment was delivered by trained research nurses using a standardised protocol. All data were captured by a customised database with prompts to guide the research nurses. Local pathways were used for referrals to lifestyle, physiotherapy, psychological and primary care services. Participants reporting relevant conditions already being treated did not receive the referral element of that component. A results letter detailing findings and recommendations was sent to participants and their general practitioners (GPs) for appropriate action. This pilot trial was originally planned to have a 52-week follow-up period to fully test the processes for a definitive trial, but this was reduced to 26 weeks due to the pandemic delays and funding restrictions. Primary outcomes and stop/go criteria Three coprimary outcomes were originally planned to inform progression to the definitive trial: Recruitment (consented) as a proportion of those invited. Referral to any recommended services as a result of the three screening components (usually GP, local physiotherapy/community psychological services) – intervention arm only. Attendance at any recommended services at 26 weeks (self-report) – intervention arm only. We defined ‘referral’ as anyone who was eligible for a referral, that is they recorded a suitable risk value and were not already being treated for that condition. Due to the pandemic, only a small number of participants completed the 26-week follow-up assessment. Therefore, acceptance of the referral (signifying intention), which was collected during the screening assessment, was used as a proxy for attendance. The three coprimary outcomes formed stop/go criteria when considered together. If any of these values fell into the ‘amber’ zone, then the trial would require modifications to proceed to full trial. If all were ‘red’, then the trial would be considered unfeasible. Secondary outcomes were collected to inform the design of the definitive RCT and any modifications required.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hsdr/17/42/42

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hsdr/KDST3869

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/KDST3869

Organisation Name: NIHR Health Services and Delivery Research programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk