Prevention of Pain-Related Sickness Absence Through Organizational Workplace Health Literacy Intervention - A Hybrid II Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 193
- 主要终点
- Pain-related sickness absence
研究概览
简要总结
The primary aim of this study is investigate whether a workplace intervention targeting employees' and managers' understanding of pain and communication (called occupational health literacy) can reduce pain-related sick leave and help employees and managers to better understand and manage work-related health matters. The study also aims to learn how the program works, who it works best for (or not), and how it can be successfully used long-term in real workplaces, especially in production environments.
The study will e.g. examine whether the program:
- reduces the number of sick days caused by pain,
- lowers how much pain employees feel, and
- improves employees' and managers' understanding of health and how to improve it.
Expectation:
Employees who participate in the program will:
- take fewer sick days because of pain,
- experience less pain, and have better health knowledge and skills than employees who continue with normal workplace practices.
The study will identify:
- what makes the program difficult or easy to introduce at workplaces,
- which strategies help it succeed, and
- what factors make the program continue working over time.
Goal:
Help workplaces adopt and maintain the program successfully.
详细描述
The goal of this hybrid II randomized stepped wedge trial is to investigate if an organizational workplace health literacy intervention reduces pain-related sickness absence and pain intensity, and improves occupational health literacy - and to understand how and for whom the intervention can be successfully implemented and sustained in real-world workplaces within production sites.
- Effectiveness: To evaluate the effectiveness of the intervention on the primary outcome of pain-related sickness absence (days lost) and secondary outcomes of pain intensity and occupational health literacy.
Hypothesis: Receiving the intervention will lead to fewer pain-related sickness absence days, lower pain intensity scores, and higher occupational health literacy compared to receiving usual care during the control condition/phase. 2. Implementation - Barriers, Strategies and Mechanisms: To identify implementation barriers and targeted implementation strategies and to specify the underlying mechanisms of action supporting effective implementation and sustainability.
Objective: To enhance local adoption, implementation and sustainability of the intervention. 3. Implementation - Process: To provide an assessment of the implementation process, focusing on adoption, reach, fidelity, and sustainability across participating workplaces, and to identify contextual and processual factors that promote or hinder successful implementation.
Objective: Produce actionable implementation guidance and an evidence-informed strategy for broader roll-out and long-term maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •s for the workplaces are:
- •each team needs a minimum of 15 employees
- •the work environment organization at the workplace wants to participate in the study. All employees and managers are invited to participate.
排除标准
- •There are no exclusion criterias for employees/managers
结局指标
主要结局
Pain-related sickness absence
时间窗: The time frame will be from baseline to end of intervention at 16 weeks. Seeing that this is a stepped wedge RCT, baseline is before entering the control-period.
The primary outcome measure for effectiveness in this Hybrid 2 study, is self-reported pain-related sickness absence. Pain-related sickness absence will be assessed at baseline and every second week based on a questionnaire distributed by text messages to employees. The question to answer is: "In the last 4 weeks, how many days have you called in sick from work due to muscle pain?"
Implementation appropriateness
时间窗: IAM is evaluated at 16 weeks, and through "Maintenance" 4 months after intervention end. Adoption and Implementation is evaluated after intervention end at 16 weeks.
The primary implementation outcome in this Hybrid 2 study is Appropriateness. Appropriateness is evaluated with the IAM- Intervention Appropriateness Measure. It consists of 4 items rated on a Likert scale (e.g., strongly disagree to strongly agree), with statements such as whether the intervention seems fitting, suitable, applicable, or a good match for the setting. The measure will be evaluated by the Workplace champions, employees and managers through telephone interviews after the interventions ends at 16 weeks. Appropriateness is also explored through elements of the RE-AIM (secondary outcomes) evaluation (Adoption, Implementation and Maintenance) at 16 weeks through interviews (see secondary outcomes).
次要结局
- Pain intensity(From baseline, before entering the stepped wedge control period, to the end of treatment at 16 weeks)