Title: Pilot Study of a randomised trial of a guided e-learning health promotion intervention based on management standards for the improvement of employee wellbeing and reduction of sickness absence
Funder: Department of Health (England)

Abstract: Design: This pilot study is the precursor of a cluster randomised controlled trial of an organisational level intervention with outcome data measured at the individual level (wellbeing is the primary outcome with common mental disorder being a secondary outcome) and the organisational level (sickness absence is the primary outcome at the organisational level) and cost-benefit of intervention. This preliminary study will test the acceptability of the trial feasibility of recruitment optimise the components of the intervention adherence and likely effectiveness of the intervention.Setting: The e-learning intervention will be undertaken by managers in one large pilot organisation with autonomous departments. Data will be collected from employees in the same workplaces. Target population: Men and women of working age working in an NHS Trust (the Cheshire and Wirral Partnership NHS Trust). Managers and employees from this organisation will be randomised to intervention and control groups. Intervention being evaluated: All managers in the clusters randomised to the intervention will receive the e-learning package. Rosemary Anderson the developer of the intervention will train facilitators to guide further implementation. We will identify the managers and groups of employees to be involved in the intervention. The intervention is an e-learning health promotion programme for managers with a focus on the six management standards domains: Change Control Demands Relationship Role and Support. We will use the Anderson Peak Performance e-learning module for managers (www.andersonpeakperformance.co.uk) based on the HSE management standards and the Management Standards indicator tool. We will pilot this programme in collaboration with Rosemary Anderson. The programme aims to improve managers’ capacity for helping employees improve their wellbeing and deal with stressful working conditions. The intended focus is on improving social support to employees improving communication improving organisational justice increasing information about job change and making sure that employees work is valued. We will also include strategies for changing /adjusting/rescheduling workloads and strategies for improving job autonomy such as working in semi-autonomous teams The format of the intervention is a series of linked topics with case examples and assessment. It will be presented over a 3 month period. The same intervention will be used for all managers within the intervention organisations. Use of the programme can be monitored to measure uptake of the intervention. Staff will be incentivised to use the intervention through management ‘buy-in’ publicity and receiving a certificate of completion as part of continuing professional development. We will also provide a ‘certificate of competence’ for managers as an added incentive for participating. We will present the programme in a way that will incentivise middle managers to participate showing that this can improve their working life.Measurement of outcomes: In this pilot study we will measure the recruitment and retention rates to the study the acceptance of the intervention and attitudes to the different components of the intervention. The pilot study will include both qualitative methods (focus groups and in-depth interviews) and quantitative methods to pilot the likely effectiveness of the outcomes to be used in the main study. In the main study the primary outcomes will be a) Employee wellbeing: pre-post changes in levels of wellbeing will be assessed using the Warwick Edinburgh Wellbeing Scale a brief 14 item scale assessing aspects of positive mental health including both hedonic and eudaimonic perspectives; b) Sickness absence: pre-post changes in sickness absence will be monitored using the existing reporting systems of each of the organisations recruited. The outcomes to be assessed include total sickness absence days per 100 person-years. Secondary outcomes include c) self-report sickness absence- short term (< 7 days) and medium-term (7-21 days) absence; the 12-item General Health Questionnaire (GHQ12) which measures psychological distress; e) self-report psychosocial work characteristics will be assessed using the standardised assessment tools for job strain (control & demands) and effort-reward imbalance. We will also pilot the feasibility of undertaking an economic assessment of the intervention at the organisational level. The primary and secondary outcomes will be assessed before the intervention and then at four months after the start of the intervention. Initial assessment of employee wellbeing will be carried out before the intervention at baseline and at 4 month follow-up. In this pilot study we will test the feasibility of the processes for collecting sickness absence data.Sample size: For the pilot study we will include three intervention clusters and one control cluster. We will recruit 120 employees per cluster to achieve a sample of 100 employees per cluster. The pilot study will provide evidence for the basic assumptions in our sample size calculations that will strengthen our calculations for the main study.Planned analyses: Pilot study analyses will be descriptive. We will estimate the participation rate and retention rate for managers completing the intervention. We will also collect and analyse electronic data on usage of the e-learning program. We will also estimate the participation rate and questionnaire response rate for employees in both intervention and control groups analysing the characteristics of non-participants specifically in terms of gender and job title. We will also examine the baseline sociodemographic data including age sex SOC group manual or non-manual occupation for those who drop out between baseline and follow up. During the pilot study we will also carry out in-depth interviews with key informants (eg CEO or Head of HR) to assess their views of the positive and negative impact of the intervention. We will also carry out three or more focus groups with 6-8 managers after the intervention to assess the acceptability ease of use and perceived usefulness of the intervention. We will also assess managers knowledge acquired through use of the programme.Project timetables: The duration of the study is 18 months. Ethical approval for the study will be obtained by month 2. Recruitment of an eligible organisation has taken place but we are also approaching back up organisations and this will be undertaken by month 2 although we will also have approached organisations before the formal start of the grant. Scoping for additional material to add to the intervention will take place in months 1 and 2. Baseline data collection will be carried out between months 4 and 6. The intervention will be carried out between months 7 and 9. Employee self report data at follow up will be collected between months 10 to 13. Focus groups and individual interviews will be carried out between months 11 to 13. Sickness absence data collection will be carried out during the same period as employee self report data. Data will be analysed between months 6 to 8 for baseline data and 11 to 14 for follow up data. The draft final report will be prepared by month 17 and the main paper will be prepared between months 17 to 18. Results will be fed back to participants in months 17 to 18.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: GENERIC HEALTH RELEVANCE