Evaluation of the effectiveness of a multi-component intervention at the workplace for the prevention and management of musculoskeletal pain in nursing staff: design of a study where hospital units are randomly selected to receive the intervention or usual care of occupational health. The INTEVAL_Spain project.
| ISRCTN | ISRCTN15780649 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15780649 |
| Secondary identifying numbers | FIS FEDER/ PI14/01959 |
- Submission date
- 25/05/2018
- Registration date
- 13/07/2018
- Last edited
- 06/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Musculoskeletal pain (MSP) is the most common work-related health problem in Europe and Spain; in order to reduce sickness absence this is one of the greatest health challenges. Previous interventions have been developed to improve the return-to-work of employees with MSP, but combined approaches and exhaustive evaluation are required. The objective of INTEVAL_Spain project is to evaluate the effectiveness of a multi-component intervention at the workplace to prevent and manage MSP in workers.
Who can participate?
Adult nursing staff who work in the study units
What does the study involve?
Hospital units are randomly allocated to one of two arms. Those in the first arm receive an intervention for 1 year, which is made up of three components:
a) Identifying and improving the working conditions associated with the onset of MSP
b) Diagnosis, management and support for workers with MSP
c) Regular activities associated with health benefits
Those in the control group only receive usual care.
Participants take a series of questionnaires before the intervention, and at 6 and 12 months.
What are the possible benefits and risks of participating?
There are no direct benefits or risks for those taking part in the study.
Where is the study run from?
1. Parc de Salut Mar (Spain)
2. Corporació Santaria Parc Tauli (Spain)
When is the study starting and how long is it expected to run for?
November 2015 to June 2019
Who is funding the study?
Carlos III Health Institute (Instituto de Salud Carlos II) (Spain)
Who is the main contact?
Mrs Mercè Soler Font (scientific)
merce.soler01@estudiant.upf.edu
Contact information
Scientific
Dr, Aiguader, 88
Barcelona
08003
Spain
| Phone | +34933160876 |
|---|---|
| merce.soler01@estudiant.upf.edu |
Public
Dr. Aiguader, 88
Barcelona
08003
Spain
| Phone | +34933160876 |
|---|---|
| cisal@upf.edu |
Study information
| Study design | Two-armed cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluation of the effectiveness of a multi-component intervention at the workplace for the prevention and management of musculoskeletal pain in nursing staff: design of a cluster-randomized controlled trial. The INTEVAL_Spain project. |
| Study acronym | INTEVAL_Spain |
| Study objectives | An innovative multicomponent intervention at the workplace that combines primary, secondary and tertiary prevention, and health promotion, will have a positive impact on musculoskeletal health in healthcare workers by reducing the frequency and duration of MSP and will be cost-effective for the company/hospital. Considering the prevalence of MSP in workers as a representative indicator of the impact on health, we estimate that this multicomponent intervention will reduce this outcome by 25%. |
| Ethics approval(s) | Clinical Research Ethical Committee of the Parc de Salut Mar (CEIC-Parc de Salut Mar), 14/07/2014, ref: 2014/5714/1 |
| Health condition(s) or problem(s) studied | Work related-musculoskeletal pain and sickness absence |
| Intervention | The study is designed as a two-armed cluster randomized controlled trial, with a late intervention control group where clusters are independent hospital units, and participants are the nursing staff- workers exposed to musculoskeletal risks. This study is a randomized trial, in which the employees are randomized after signing informed consent together with formal information about the study. A total of eight clusters have been selected for the randomization. The condition of being included in the intervention or the control group cannot be blinded. All clusters are Hospital Units where nurses and aids are at risk of high physical demands due to the characteristics of the patients cared for in them (dependents and semi-collaborative patients). All data collected from both groups (intervention and control groups) is anonymized before the analyses. An independent researcher assigns the clusters to the intervention or to the control group by a simple randomization stratified by center, obtaining 4 clusters in each group. The intervention is based on the available scientific evidence and consists of three components that encompass the three levels of prevention and health promotion: a) participatory ergonomics, to identify and improve the working conditions associated with the onset of MSP in workers b) case management, including early diagnosis and personalized management of workers with disabling MSP (secondary prevention) and the adaptation and facilitation of return to work after a sickness absence episode and/or workers’ maintenance in their jobs (tertiary prevention) c) health promotion, through activities scheduled during the second and third quarter until the end of the intervention, associated with evidence based health benefits (physical exercise, stress management, healthy eating and education on health beliefs). The intervention group also receive care as usual, and the control group will receive only usual care of occupational health. The intervention lasts one year, and data are collected at baseline, 6 and 12 months follow-up. |
| Intervention type | Mixed |
| Primary outcome measure | 1. Musculoskeletal self-perceived pain data are collected using the Spanish version of the Nordic Questionnaire, at baseline, 6 months and 12 months follow-up. 2. Sickness absence data are collected from one year before the intervention was implemented until the end of the intervention, and number of episodes and their duration is analyzed. |
| Secondary outcome measures | 1. Work functioning is measured by the Work Role Functioning Questionnaire-Spanish Version at baseline, 6 and 12 months follow up. 2. Quality of life is measured by the European Questionnaire 5 Dimensions 3 Levels ( EQ-5D-3L) at baseline, 6 and 12 months follow up. 3. Preventive culture is measured by the Institute for Work & Health Organizational Performance Metric (IWH-OPM), at baseline, 6 and 12 months follow up. |
| Overall study start date | 01/11/2015 |
| Completion date | 30/06/2019 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | From the sample calculations, 8 clusters of 20 to 60 participants each have agreed to participate. |
| Total final enrolment | 473 |
| Key inclusion criteria | 1. Nursing staff (nurses and aides) including employees in sickness absence who work in the study units/clusters 2. Voluntarily willing to participate in the study |
| Key exclusion criteria | 1. Temporary staff who work at the study units only infrequently and/or for short periods 2. Employees on leave, except on sickness absence, during most of the study period |
| Date of first enrolment | 01/05/2016 |
| Date of final enrolment | 01/09/2016 |
Locations
Countries of recruitment
- Spain
Study participating centres
08003
Spain
08208
Spain
Sponsor information
Research organisation
Dr. Aiguader
88 - PRBB Building
Barcelona
08003
Spain
| Phone | +34 933 160 876 |
|---|---|
| salutlaboral@upf.edu | |
"ROR" |
https://ror.org/042nkmz09 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- SaludISCIII, InstitutodeSaludCarlosIII, Instituto de Salud Carlos III | Madrid, Spain, Carlos III Institute of Health, Institute of Health Carlos III, Carlos III Health Institute, ISCIII
- Location
- Spain
No information available
Results and Publications
| Intention to publish date | 01/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publications in a high-impact peer reviewed journal during the period comprised from 01/09/2018 to 01/03/2019. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. The study participants signed a form to give their informed consent to participate in the study. The objectives and scope of the study were specified in the form, informing that all the personal data as well as the information provided at all times would be anonymous and would only be used in the INTEVAL study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 28/03/2019 | 23/11/2020 | Yes | No |
| Results article | 18/11/2019 | 19/07/2021 | Yes | No | |
| Other publications | Process evaluation | 06/10/2021 | 23/08/2023 | Yes | No |
| Other publications | Cost effectiveness | 05/08/2024 | 06/08/2024 | Yes | No |
Editorial Notes
06/08/2024: Publication reference added.
23/08/2023: Publication reference added.
19/07/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
23/11/2020: Publication reference added.
04/12/2018: Changed all references to ''musculoskeletal disorders'' to ''musculoskeletal pain''
