Pain-at-Work Toolkit (Definitive Trial)
Pain-at-Work Toolkit for Employees With Chronic Pain (Definitive Trial)
The Pain-at-Work Toolkit has been created together with people who live with chronic pain, employers, healthcare professionals, and a national pain charity. The aim of the toolkit is to help employees with ongoing pain feel more confident in managing their condition at work, know where to find support, and improve their workplace experience, so they can remain in the workforce. People with lived experience of chronic pain will help guide the project throughout, including reviewing study documents and helping choose what outcomes to measure.
The investigators will work with around 30 organisations from different types of workplaces in the UK and invite more than 600 employees who live with pain to take part in the study. Organisation's employees will either receive access to the Pain-at-Work Toolkit and the Pain-at-Work Managers Toolkit ( to help managers support their staff) or the usual care that their organisation offers. Participants will be asked to complete online surveys at three points during the study. Intervention participants may be asked to take part in an interview at the end of the study to find out more about their experiences.
The study will examine whether the toolkit improves people's experience of work, including their productivity and ability to remain productive in their jobs. The investigators will also explore whether the toolkit offers good value for money.
Finally, the investigators will examine how the toolkit is used in practice-what works well, what might need improving, and how it could be made available to more employees in the future. The investigators will do this by interviewing employers or stakeholders involved in the employment of, support for, or policy development for adults with chronic pain.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Background Chronic pain affects 28 million adults in the UK, significantly impacting their ability to be productive at work, feel fulfilled at work and/or remain in the active workforce. However, most people living with chronic pain cannot access work-related support from healthcare services, and the majority of employers do not routinely provide it. The Pain-at-Work Toolkit is a web-based resource that could help to reduce unfair differences in working lives for people with chronic pain, and positively impact their health and wellbeing, enhancing their productivity in the wider community. Co-created with people who live with pain, healthcare professionals and employers, this toolkit provides education and self-management advice to help people with chronic pain stay in, and thrive, at work.
The investigators tested the Pain-at-Work Toolkit in a preliminary trial in England ('feasibility trial' NCT05838677) . This showed that the Pain-at-Work Toolkit can be a very helpful support tool in the workplace for those living with chronic pain. The investigators recruited 18 organisations and 380 employees (50% and 217% more than expected, respectively), demonstrating that this toolkit meets a gap in employer provisions. Employees who received access to the toolkit valued its content and engaged with it without technical issues. Workers told investigators that their ability to work had improved after 6 months but these results need to be confirmed in a larger trial. Employers told investigators that they valued being able to offer it to their staff. The investigators are now updating the toolkit content to ensure it is relevant to employees across the UK.
The next step is to carry out a larger UK-wide study ('definitive trial'). The aim is to find out whether The Pain-at-Work Toolkit helps people to feel more able and confident at work, take fewer sick days, and be productive at work, and whether it provides good value for money.
The investigators will recruit at least 30 different organisations from across UK. These organisations will be randomly placed into one of two groups: one will access and use the Pain-at-Work Toolkit (the intervention group), and the other will continue as usual (the control group), to compare results fairly. A Pain-at-Work Manager Toolkit will be made available to line managers of organisations in the intervention group.
Over 600 employees will be recruited from these organisations. They will all be invited to complete online questionnaires at three time points: at recruitment, 3 months, and 6 months. The investigators will ask about their health and wellbeing, and factors relating to work, such as work ability, self-efficacy (confidence), sickness absence, work productivity, and intentions to leave.
This larger trial will include an 'implementation study'. This will involve conducting interviews with up to 60 people who have taken part in the trial and other stakeholders (such as employer representatives, line managers, HR or occupational health specialists, policymakers, professional bodies). The findings will shape our plans to make the Pain-at-Work Toolkit available widely to all workers with pain in the future.
Aims The aim of this study is to conduct a definitive cluster-randomised controlled trial, with a built-in process and implementation evaluation, to assess the effectiveness and cost-effectiveness of the Pain at Work Toolkit for improving work ability in working-age adults with chronic pain across a range of UK workplaces.
- To determine the effectiveness of the Pain-at-Work Toolkit for improving work ability in working-age adults with chronic pain
- To determine intervention fidelity.
- To explore the relationship between implementation fidelity and outcomes.
- To understand the barriers and facilitators to successful implementation and rollout.
- To generate strategies for future implementation, maintenance, and scalability.
Protocol/ Method
The study consists of 3 work packages:
- Effectiveness trial (WP1),
- Health economic evaluation (WP2),
- Process and implementation evaluation (WP3).
Setting is community, comprised of employment settings in different sectors (public, private, third) in UK, varying in size (small:10-49 workers; medium: 50-249 workers; large: >250 workers).
Sample size estimate: The aim is to recruit a minimum of 30 worksites ("clusters"), approximately 15 per arm. Up to 685 participants ("employees") will be recruited from these clusters.
Up to 60 participants (employees and stakeholders) will be invited to take part in the interview study. In the case of intervention employees, this will be after the 6-month survey has been completed. Stakeholders may be interviewed at any time during the study duration, but if they are from the intervention organisation, it is likely this will be after the employees have completed their 6-month survey.
Interviews will ascertain participants' views about the Pain-at-Work Toolkit, trial processes and outcome measures, and any perceived changes in individual or organisational outcomes.
Organisations are randomised to either i) active control group (SAU: support as usual), or ii) SAU plus Pain-at-Work Toolkit and Pain-at-Work Manager's Toolkit.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Holly Blake, PhD
- Número de teléfono: +44 (0)115 95 15559
- Correo electrónico: holly.blake@nottingham.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: Wendy J Chaplin, PhD
- Número de teléfono: +44 (0)115 74 85786
- Correo electrónico: Wendy.Chaplin@nottingham.ac.uk
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Working-age adults (employees), aged 18 and over,
- Working in a participating organisation in the UK.
- With chronic pain interfering with their ability to undertake or enjoy productive work,
- Able to comprehend the English language and provide informed consent.
Exclusion Criteria:
- Working-age adults (employees), aged 18 and over,
- Working in a participating organisation in the UK.
- With chronic pain interfering with their ability to undertake or enjoy productive work,
- Able to comprehend the English language and provide informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention
This is a cluster randomized trial.
The level of randomization is organization.
Participants (employees) receive Pain-at-Work Toolkit + Pain-at-Work Manager's Toolkit+ Support as Usual
|
This is a workplace trial, participating organisations will be randomized to intervention or control.
Otros nombres:
Support as Usual
|
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Comparador activo: Contol
This is a cluster randomized trial.
The level of randomization is organization.
Participants (employees) receive Support as Usual
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Support as Usual
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Work Ability
Periodo de tiempo: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
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Using the Work Ability Index 3 items (WAI).
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To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Aceptabilidad de la intervención
Periodo de tiempo: 6 meses
|
Resultado para evaluar si los participantes encuentran aceptable la intervención.
Esto será autoinformado en las entrevistas de los participantes a los 6 meses.
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6 meses
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Estrés laboral
Periodo de tiempo: Evaluar el cambio entre el tiempo 0 (línea de base), el tiempo 1 (3 meses) y el tiempo 2 (6 meses).
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Medida global de un solo artículo.
Usando el ítem: 'En general, ¿qué tan estresante encuentra su trabajo?' con respuestas en una escala de 5 puntos que van desde 1 = 'nada estresante' hasta 5 = 'extremadamente estresante'.
Una puntuación más alta indica un peor resultado.
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Evaluar el cambio entre el tiempo 0 (línea de base), el tiempo 1 (3 meses) y el tiempo 2 (6 meses).
|
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Intenciones de facturación
Periodo de tiempo: Evaluar el cambio entre el tiempo 0 (línea de base), el tiempo 1 (3 meses) y el tiempo 2 (6 meses).
|
Medida global de un solo artículo.
Usando el ítem: '¿Está considerando dejar su trabajo debido a su dolor?' (sí o no).
La respuesta negativa es un mejor resultado.
|
Evaluar el cambio entre el tiempo 0 (línea de base), el tiempo 1 (3 meses) y el tiempo 2 (6 meses).
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Depresión
Periodo de tiempo: Evaluar el cambio entre el tiempo 0 (línea de base), el tiempo 1 (3 meses) y el tiempo 2 (6 meses).
|
Uso del Cuestionario de Salud del Paciente (PHQ-2).
La escala se utiliza para detectar la depresión.
Las puntuaciones van de 0 a 6.
Las puntuaciones más altas indican un peor resultado.
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Evaluar el cambio entre el tiempo 0 (línea de base), el tiempo 1 (3 meses) y el tiempo 2 (6 meses).
|
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Ansiedad
Periodo de tiempo: Evaluar el cambio entre el tiempo 0 (valor inicial), el tiempo 1 (3 meses) y el tiempo 2 (6 meses).
|
Utilizando el Trastorno de Ansiedad General (GAD-7).
Se utiliza como herramienta de detección y medida de gravedad del trastorno de ansiedad generalizada.
La puntuación GAD-7 se calcula asignando puntuaciones de 0, 1, 2 y 3 a las categorías de respuesta "nada", "varios días", "más de la mitad de los días" y "casi todos los días". , respectivamente, y sumando las puntuaciones de las siete preguntas.
La puntuación total oscila entre 0 y 21.
Las puntuaciones más altas indican peores resultados.
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Evaluar el cambio entre el tiempo 0 (valor inicial), el tiempo 1 (3 meses) y el tiempo 2 (6 meses).
|
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Calidad de vida relacionada con la salud
Periodo de tiempo: Evaluar el cambio entre el tiempo 0 (valor inicial), el tiempo 1 (3 meses) y el tiempo 2 (6 meses).
|
Utilizando el cuestionario EuroQol de cinco dimensiones (EQ-5D-5L).
Consta de cinco dimensiones: movilidad, autocuidado, actividades habituales, dolor/malestar y ansiedad/depresión.
Cada dimensión tiene 5 niveles: sin problemas, problemas leves, problemas moderados, problemas severos y problemas extremos.
Las respuestas se codifican como números de un solo dígito que expresan el nivel de gravedad seleccionado en cada dimensión.
Por ejemplo, "problemas leves" (p. ej.
'Tengo ligeros problemas para caminar') siempre se codifica como '2'.
Los dígitos de las cinco dimensiones se pueden combinar en un código de 5 dígitos que describe el estado de salud del encuestado.
Las puntuaciones más altas indican peores resultados.
|
Evaluar el cambio entre el tiempo 0 (valor inicial), el tiempo 1 (3 meses) y el tiempo 2 (6 meses).
|
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Health-related quality of life VAS
Periodo de tiempo: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6months).
|
Evaluates health today in a single score.
The range 0-100.
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To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6months).
|
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Impairments in work and activities
Periodo de tiempo: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
|
Using the Work Productivity and Impairments Scale (WPAI-GH).
Measures impairments in both paid work and unpaid work.
It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days.
The WPAI yields four types of scores: 1. Absenteeism (work time missed); 2. Presenteeism (impairment at work / reduced on-the-job effectiveness); 3. Work productivity loss (overall work impairment/ absenteeism plus presenteeism); 4. Activity Impairment.
WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity (worse outcomes).
|
To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
|
|
Health resource use questionnaire
Periodo de tiempo: Cumulative health resource use at time 0 (baseline), time 1 (3 months), time 2 (6 months).
|
Using a health care resource use questionnaire to measure completion rates for items of resource use, such as frequency of use of secondary and primary care, social care, private health care, and medications.
Items are adapted from health economics data capture in previous research with pain populations.
Minimum score zero, no maximum.
Higher scores indicate greater frequency of resource use.
|
Cumulative health resource use at time 0 (baseline), time 1 (3 months), time 2 (6 months).
|
|
Social support at work
Periodo de tiempo: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
|
Using the Demand Control Support Questionnaire (DCSQ) - Social Support Sub-Scale, consisting of 6 items covering: pleasant atmosphere, spirit of unity, colleagues' support, helpful colleagues, relationship with superiors, relationship with colleagues.
Respondents are asked to report their levels of agreement or disagreement on a four-point Likert scale.
Higher values indicate better outcomes (higher social support at work, score range 6-24).
|
To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
|
|
Work Self-Efficacy
Periodo de tiempo: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
|
This included six items, three ask about current: confidence to work, manage their condition and that working would not make the condition worse.
The other three ask about future in one year: motivation to continue working, importance to continue and confidence to continue working.
All rated 0-10, higher score equals higher self-efficacy.
|
To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
|
|
Occupational Self-Efficacy
Periodo de tiempo: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
|
The Occupational Self-Efficacy Scale Short Form (OSS-SF) rated from stongly disagree to strongly agree asks six items about the ability to remain calm, problem solve, handle difficulties, use experience, meet goals and cope with problems and job demands.
|
To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
|
|
Pain severity
Periodo de tiempo: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
|
Measuring the current pain severity (0-10)
|
To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
|
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Technology Acceptance
Periodo de tiempo: 3 months intervention only
|
Using the technology acceptance model questionnaire to access the acceptability of the Pain at Work Toolkit and the intention to use.
Alongside and actual behaviour change.
|
3 months intervention only
|
|
Fidelity of intervention (Pain at Work Toolkit)
Periodo de tiempo: At 6 months
|
Intervention fidelity will be checked through collection of usage data for the Pain at Work Toolkit, to assess engagement with the intervention.
|
At 6 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Registros de ausencias por enfermedad informados por la organización
Periodo de tiempo: Evaluar el cambio entre el tiempo 0 (línea de base), el tiempo 1 (3 meses) y el tiempo 2 (6 meses).
|
Registros organizacionales de las tasas de ausencia por enfermedad de los empleados participantes.
|
Evaluar el cambio entre el tiempo 0 (línea de base), el tiempo 1 (3 meses) y el tiempo 2 (6 meses).
|
|
Naturaleza del trabajo
Periodo de tiempo: Para documentar cualquier cambio en la naturaleza del trabajo del participante entre el momento 0 (línea de base), el momento 1 (3 meses) y el momento 2 (6 meses).
|
Uso de la clasificación estándar de habilidades laborales del Reino Unido (nivel de habilidades laborales 1-4): título del trabajo principal e industria en la que trabaja.
|
Para documentar cualquier cambio en la naturaleza del trabajo del participante entre el momento 0 (línea de base), el momento 1 (3 meses) y el momento 2 (6 meses).
|
|
Employment Status
Periodo de tiempo: To document any changes in participant's employment status between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
|
Using items from the Work Transitions Index (WTI) covering employment status, occupation and working hours
|
To document any changes in participant's employment status between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Holly Blake, PhD, University of Nottingham
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRAS 367449
- OBF/FR-000025871 (Otro número de subvención/financiamiento: Nuffield Foundation / Arthritis UK Oliver Bird Fund)
- FMHS 120-0226 (Otro identificador: Faculty of Medicine and Health Sciences Ethics Committee, University of Nottingham, UK)
- 26011 (Otro identificador: Sponsor, University Of Nottingham, UK)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Protocol - details shared via clinical trials.gov and protocol manuscript (with informed consent form) to be submitted to an open access peer-reviewed journal within 6 months.
Data Management Plan will be publicly available on https://dmponline.dcc.ac.uk prior to study start.
Protocol - baseline (registration) 6 months (submitted protocol for publication) Statistical analysis plan - baseline Informed consent form - 6 months (submitted protocol for publication)
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Protocol - details shared via clinical trials.gov and protocol manuscript (with informed consent form) to be submitted to an open access peer-reviewed journal within 6 months.
Data Management Plan will be publicly available on https://dmponline.dcc.ac.uk prior to ethical approval and study start.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
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