Reducing Pain-Related Sickness Absence Through Workplace Health Literacy: A Hybrid II Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-68
SponsorNational Research Centre for the Working Environment, Denmark

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

There are no exclusion criterias for employees/managers

Trial design

Design model

Crossover

Treatments tested in this trial

  • Cognitive behavioural therapy-inspired digital education on pain and communication

    Behavioral

    The main content of the intervention consists of 4 elements: 1. An educational day session for the local workplace champion, with a main focus on the ability to faciliate a digital education for the employees and managers. 2. An initial needs and resource assessment at the workplace focused on pain and health literacy, with participants from all organizational layers; employee, managers, HR and the workplace champion. The assessment aims to empower workplaces to self-assess their needs, contributing to own autonomy and direction. The session is facilitated by the researcher. 3. 2\*2 hours and 1\*2 hour booster session of digital education for the employees and managers seperately, focusing on pain knowledge and communication, and finding solutions for work. 4. A period of 4 months with structured 10-minutes 1:1 dialogues between an employee and the manager every 3-5 weeks, using the tools and communication from the educational content.

  • Local work environment guidelines

    Other intervention

    While waiting for cross over, the control group can use available resources within the local working environment initiatives at the workplace.

Treatment groups

193 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Pain-related sickness absence

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?"

Time frame
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.
2

Implementation appropriateness

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).

Time frame
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.

Secondary outcomes

1

Pain intensity

Pain intensity of the participating employees will be self-assessed through a numeric range scale (NRS). The evaluation will be conducted through a questionnaire sent by a text message at baseline, once a month, and after the intervention has ended. The NRS consists of 0 to 10 scale, where 0 is equivalent to no pain, and 10 indicates the worst possible pain.

Time frame
From baseline, before entering the stepped wedge control period, to the end of treatment at 16 weeks

Other outcomes

1

Adoption

The implementation adoption is evaluated through: How many workplaces express willingness to implement the health literacy intervention? This element is evaluated through interviews with HR and managers. This approach ensures a comprehensive assessment of the study's adoption characteristics, contributing to a nuanced understanding of participant demographics and workplace contexts.

Time frame
Adoption is evaluated at the end of intervention, at 16 weeks.
2

Organizational Workplace Health Literacy

The Organizational Workplace Health Literacy will be assessed through a questionnaire that is currently under development at the NFA. The questionnaire will consist of two inter-dependent parts answered on a 4 items rated on a Likert scale (e.g., strongly disagree to strongly agree): a part answered by an employee, and a part answered by a manager. Together, these two parts will express the level of Organizational Workplace Health Literacy within the local workplace. The evaluation will be conducted through a questionnaire sent by a text message at baseline, once a month, and after the intervention has ended.

Time frame
Organizational Workplace Health Literacy will be assessed at baseline, once a month and at the end of the intervention after 16weeks.
3

Implementation fidelity

Implementation fidelity will assess as to what extent the health literacy intervention is implemented according to the intended protocol, and what are the key factors influencing fidelity, including adherence to intervention components and the degree of customization to fit the diverse workplace contexts. Implementation fidelity will be evaluated at three levels: Workplace champion: The WEPs will undergo an educational day ahead of intervention start, with a main focus on the ability to facilitate the digital education. Implementation fidelity is assessed by questioning how and/or if the Workplace champions can facilitate the planned intervention elements. This is assessed through interviews. Employees and managers: A part of the digital education will be to use communication tools when finding solutions to identified problems. Fidelity will be assessed through a questionnaire.

Time frame
Workplace champion, employees and managers will be interviewed at intervention end after 16 weeks.
4

Cost evaluation

The economic evaluation will compare the occupational health literacy intervention with usual care from the employer's perspective. Staff time: Workers' and managers' participation in intervention activities (registration of participation in activities that are not directly part of daily work (e.g. a workshop/meeting for planning the activities)). Staff costs are referenced through Implementation Reach. Participants' and managers' costs will subsequently be valued based on their average yearly gross salaries, including overhead costs. Costs will include time and materials used to deliver the intervention, as well as costs from pain-related sickness absence and reduced productivity while at work (presenteeism). Consumables: Materials (print-outs and posters) as well as fruit/snack/coffee at meetings will be assessed. These costs will be valued using invoices. Results will be reported as cost-effectiveness, return on investment, and benefit-cost ratio.

Time frame
Costs are collected continously throughout the project period.

Locations

This trial has no locations.

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