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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Acceptability of Intervention
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Acceptability of Intervention
时间窗: 6 months
Outcome to assess whether participants find the intervention acceptable. This will be self-reported in participant interviews at 6 months.
Fidelity of intervention (PAW Toolkit)
时间窗: 3 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.
Recruitment to the study
时间窗: Baseline
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.
Fidelity of intervention (OT support calls)
时间窗: 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.
Retention to the study at 3 months
时间窗: 3 months
Number of participants who complete the first follow-up outcome measures survey.
Retention to the study at 6 months
时间窗: 6 months
Number of participants who complete the second follow-up outcome measures survey.
次要结局
- Work presenteeism(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Work Ability(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Work Self-Efficacy(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Job satisfaction(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Job stressfulness(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Turnover intentions(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Depression(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Anxiety(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Impairments in work and activities(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Health resource use questionnaire(Cumulative health resource use at time 0 (baseline), time 1 (3 months), time 2 (6 months))
- Social support at work(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Work presenteeism(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Work Ability(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Work Self-Efficacy(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Job satisfaction(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Job stressfulness(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Turnover intentions(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Depression(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Impairments in work and activities(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Health resource use questionnaire(Cumulative health resource use at time 0 (baseline), time 1 (3 months), time 2 (6 months))
- Anxiety(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Health-related quality of life(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)
- Social support at work(To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).)