Reducing Pain-Related Sickness Absence Through Workplace Health Literacy: A Hybrid II Study
Prevention of Pain-Related Sickness Absence Through Organizational Workplace Health Literacy Intervention - A Hybrid II Study.
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
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.
- 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.
A stepped-wedge design is a type of a crossover study in which clusters cross over from the control arm to the intervention arm at different randomized time points. The clusters will be formed based on working teams (consisting of approximately 15 workers), randomly assigned to a step (of implementation of the intervention) four months apart.
During the control phase/step, the participants receive standard care. In the workplace context, this implies that the control group can address work environment and health and safety issues through discussions within their health and safety organization. In Denmark, for workplaces with 10-34 employees, collaboration on health and safety is mandated to be organized within a health and safety organization, comprising one or more supervisors and one or more elected health and safety representatives, with the employer or a representative of the employer serving as chairman. This health and safety organization is tasked with both day-to-day and overarching responsibilities related to health and safety. Furthermore, workplaces or teams within the control group retain the option to seek assistance from trained work environment professionals external to their workplace if they choose to do so.
The intervention consists of 4 elements;
- A training day for the local workplace champion.
- Needs and resource assessment at the workplace
- Digital education in pain, communication and solutions for employees and managers
- Structured 1:1 dialogues between workers and their supervisor.
Method This project builds and extends upon a successful pilot of an organizational workplace health literacy (OWHL) intervention. Guided by the revised Medical Research Council (MRC) framework, the project aims to further develop, refine, and evaluate the effectiveness and implementation of the intervention and its core components to support the creation of a scalable workplace intervention suitable for implementation in production sites. The project will address the pilot study's limitations by
- randomizing to reduce bias,
- focus on an initial workplace needs assessment integrating a newly developed self-assessment workplace tool
- Integrating a cost-effective digital Educational Program, and
- tailoring implementation strategies to the particular target group and context/setting to ensure optimal uptake.
Addressing these limitations of the pilot study is essential to strengthen the validity of the findings and enhance the intervention's practical applicability.
Study setting and population The study population encompasses the 280.000 workers employed within production in Denmark, whereof 42 % are 50 years old, or older. This large working group is characterized by high physical and psychosocial work demands, with known potential challenges within safety communication between management and employees working the machines. Additionally, production workers experience around 10 days of sickness absence per year, report that they are overworked, and have elevated levels of pain, with a weekly pain prevalence of 43%. Consequently, this group is predisposed to an elevated risk of long-term sickness absence, and, in the most severe circumstances, premature withdrawal from the labor market.
Randomization and blinding To avoid contamination between workers, cluster randomization will performed, with each working team constituting a cluster. The randomization will be balanced on the size of the working teams. A blinded independent data manager will perform a computer-generated randomization. Blinding of participants is not possible, owing to the nature of the trial. Data collection will be performed using questionnares delivered through text messages, and data managers and research personnel collecting/handling data will be blinded to group allocation if deemed practically feasible.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Mia Nyvang Stilling, PhD student
- Telefonnummer: +4551795855
- E-Mail: mng@nfa.dk
Studieren Sie die Kontaktsicherung
- Name: Sebastian Venge Skovlund, PhD
- E-Mail: svs@nfa.dk
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion criterias 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.
Exclusion Criteria:
- There are no exclusion criterias for employees/managers
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Intervention group
The intervention group receives the described intervention targeting improved occupational health literacy, consisting of three components:
|
The main content of the intervention consists of 4 elements:
|
|
Sonstiges: Control Group
While waiting for cross over, the control group can use available resources within the local working environment initiatives at the workplace.
|
While waiting for cross over, the control group can use available resources within the local working environment initiatives at the workplace.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pain-related sickness absence
Zeitfenster: 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?"
|
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.
|
|
Implementation appropriateness
Zeitfenster: 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). |
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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pain intensity
Zeitfenster: From baseline, before entering the stepped wedge control period, to the end of treatment at 16 weeks
|
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.
|
From baseline, before entering the stepped wedge control period, to the end of treatment at 16 weeks
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Adoption
Zeitfenster: Adoption is evaluated at the end of intervention, at 16 weeks.
|
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. |
Adoption is evaluated at the end of intervention, at 16 weeks.
|
|
Organizational Workplace Health Literacy
Zeitfenster: Organizational Workplace Health Literacy will be assessed at baseline, once a month and at the end of the intervention after 16weeks.
|
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. |
Organizational Workplace Health Literacy will be assessed at baseline, once a month and at the end of the intervention after 16weeks.
|
|
Implementation fidelity
Zeitfenster: Workplace champion, employees and managers will be interviewed at intervention end after 16 weeks.
|
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. |
Workplace champion, employees and managers will be interviewed at intervention end after 16 weeks.
|
|
Cost evaluation
Zeitfenster: Costs are collected continously throughout the project period.
|
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. |
Costs are collected continously throughout the project period.
|
|
Reach
Zeitfenster: Reach will be documented continuously by the workplace champion and delivered for the researcher at intervention end, at 16 weeks.
|
Reach is evaluated through a workplace champion registrating in an Excel document the of number of partcipants pr. educational session. This document is shared with the researchers at the end of the intervention. This will provide information about the adoption of the study. These registrations not only facilitate an understanding of the number of participants and workplaces involved but also provide essential details for characterizing the adoption (e.g., workplace size and type - public vs. private). This approach ensures a comprehensive assessment of the study's adoption characteristics, contributing to a nuanced understanding of participant demographics and workplace contexts. |
Reach will be documented continuously by the workplace champion and delivered for the researcher at intervention end, at 16 weeks.
|
|
Implementation
Zeitfenster: The interview will take place at the end of intervention, at 16 weeks.
|
Implementation will be evaluated through interviews of the workplace champions.
These interviews, conducted via phone, Teams, or in-person workplace visits, will span 15-45 minutes and aim to gather comprehensive insights into the experiences of implementing and administering the intervention.
The focus will be on understanding the factors contributing to the success or failure of implementation, exploring possibilities for sustainability, and informing future dissemination and implementation efforts if the intervention proves effective.
|
The interview will take place at the end of intervention, at 16 weeks.
|
|
Maintenance
Zeitfenster: 4 months after the intervention has ended.
|
Maintenance is evaluated through interviews with managers and HR and will express how many workplaces sustain the outlined activities after interventions ends.
When evaluating HR maintenance, there will also be a focus on which adaptions to workplace politics and policies there may have been made.
These adaptions will be further explored by comparing the written action plans to HR being interviewed about the actual local adaptions.
|
4 months after the intervention has ended.
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- F-26029871
- 186523 (Andere Zuschuss-/Finanzierungsnummer: TrygFonden)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .