Clinical trial NCT04000035: Health in Work - a Measure for Increased Coping and Work Inclusion
Official title: Health in Work - a Measure for Increased Coping and Work Inclusion - An Analysis of Effect of Preventive Information Given at the Workplace - Part 1: Quantitative Data Collection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Musculoskeletal Pain
Mental Health Wellness 1
Work-Related Condition
Keywords: sickness absence
psychosocial work environment
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: University of Tromso
name: Norwegian Labour and Welfare Administration
name: Helse Nord
First posted: 2019-06-27
Enrollment: 1383
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups: intervention and control
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Health in work - a measure for increased coping and work participation

-An effect analysis of a health- and work environment intervention at the workplace. Part 1:quantitative data collection

The main objective of this study is to investigate the effect of the workplace intervention in the new Norwegian national programme Health in work (HelseIArbeid) through a pragmatic cluster-randomized study.

The main hypothesis is that this interdisciplinary health and welfare intervention at the workplace reduces sick leave and improves mastering of common health problems more efficiently than a conventional welfare intervention. More specifically, it is hypothesized that the Health in work intervention has a better cost-effectiveness in terms of sick leave, use of health services and coping with common health problems indicated by an increased health-related quality of life.

Detailed description: The main objective of this study is to investigate the effect of the workplace intervention in the new Norwegian national concept Health in work (HelseIArbeid) through a pragmatic cluster-randomized study.

The interdisciplinary Health in work intervention consists of three information sessions over the course of one year, with work place processes in between. In the meetings, structured health information about musculoskeletal- and mental disorders is given and put in the context of working and the specific workplace. This includes possibilities to work despite health impairment, work inclusion measures, and discussion on how these could have an influence on the individual, group, management and organizational level. The process involves the workplaces' entire staff (employers and employees). It is an active process and workplaces are stimulated and expected to continue to work with these topics both between sessions and after the last meeting. The interdisciplinary intervention is carried out in a collaboration of qualified personnel from The Norwegian labour and welfare service (NAV) and qualified health personnel from the hospital department of rehabilitation medicine.

The main hypothesis is that this interdisciplinary health and welfare intervention at the workplace reduces sick leave and improves mastering of common health problems more efficiently than a conventional welfare intervention. Conventional workplace measures are given by personnel of NAV workplace service without specialist healthcare involvement, focusing mainly on work inclusion and psychosocial work environment. There are several types of interventions available and they will be customized to the workplace. This means that the control intervention is not standardized and will be varying according to the workplaces' demands.

Participating workplaces are recruited through NAV's conventional contact with workplaces based on an analysis of the workplaces' needs. In the workplaces or workplace units that are interested in participating in the project, the following will be distributed to all staff- including leaders- through the employers' email-list: Information about the project, the informed consent-form and a link to the first electronic questionnaire (Q1). The electronic questionnaire portal is open to answers for two weeks after the initial email. After this time period, the workplaces are randomized to either Health in work or control intervention. A one year intervention period follows as described above. The questionnaire is repeated 12 months (Q2) and 24 months (Q3) after randomization. Q1-3 include the same questions regarding health complaints, health mastering, health related quality of life, and work environment.

Work participation will be assessed at the unit level by data from the employers' sickness absence registers that include both self- and physician-certified sickness absence. Physician-certified sickness absence at the individual level will be gathered from the National register of sickness absence over a four year period from 2 years before randomization to 2 years after. Individual sickness absence will also be assessed by self-report from the questionnaires, considering the last three months prior to the questionnaire.

Data on healthcare utilization at the individual level will be obtained as self-reported data from the questionnaires, as well as objective data from the national register of control and health service refunds (KUHR database) and the Norwegian Patient Register (NPR). These registers include registrations of visits to general practitioners, emergency clinics, physiotherapists, radiologic- laboratory- and psychology/psychiatry and other specialised healthcare services. The study will use the registers' data on number of consultations and costs related to these.

All stakeholders involved in the interventions (workplaces/workplace units, specialist healthcare service and NAV) will keep records of the time used on the interventions (attendance, preparation, implementation, supplementary work, others). Costs related to the different interventions will be assessed from these reports.

Other outcome measures are based on self-reported questionnaire data including health-related quality of life, self-rated health, psychosocial work environment, subjective health complaints, health anxiety, social support and job satisfaction, described in more detail in the outcome section.

Health-economics analyses will be performed on these data in order to determine the cost-effectiveness in terms of sick leave, use of health services and coping with common health problems indicated by an increased health-related quality of life.

This project has a second part not registered here, gathering qualitative data about the Health in work intervention. This will investigate how the intervention works, what the participants´ impression of the intervention is and how the intervention can best be implemented, considering its planned future nationwide application.

CHANGE FROM 2020: Due to the global pandemic, the study was completely halted for a period of 6 months from mid-March through September 2020. Activity was slowly regained after that, but remained on a lower level than normal, fluctuating with changing infection rates in the region. Due to this, there were delays in both collection of informed-consent forms and allocation of workplace units, and the intervention period was prolonged. Consequently, the time-frame between questionnaires one and two was expanded, in collaboration with the reference group and approved by the steering committee. For units included before March 12th 2020, questionnaire Q2 and Q3 will be delayed by 12 months in order to assure that intervention activities can be carried out. For units included in the second half of 2020 the scheduled delay of questionnaire Q2 and Q3 will be 6 months. Units included in 2021 are expected to follow the one year intervention plan. We will take this into consideration in the final statistical analysis.

Eligibility criteria: Inclusion Criteria for workplaces/workplace units:

* minimum 8 employees
* accessible data on sickness absence (both self- and physician-certified) in the workplace/workplace unit for the past two years prior to inclusion

Inclusion Criteria for the individual employees:

* all staff employed \> 20% in the participating workplaces/workplace units
* Norwegian-speaking

Exclusion Criteria for workplaces/workplace units:

- ongoing profound reorganisation at the workplace/workplace unit (\>20% change of employees within workplace unit)

Exclusion Criteria for the individual employees:

- none

Primary outcomes:
measure: Change in overall sickness absence rates (self- and physician-certified) at the workplace (unit level)
timeFrame: Time period 24 months prior to randomization compared to the time period 12-24 months after randomization
measure: Change in healthcare utilization
timeFrame: Time period 24 months prior to randomization compared to the time period 12-24 months after randomization
measure: Change in health-related quality of life (HRQoL) by EQ-5D-5L utility value, including EQ-VAS score
timeFrame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
measure: Health-economic analyses
timeFrame: Time period 24 months prior to randomization through 24 months after randomization
Secondary outcomes:
measure: Change in physician-certified sickness absence rates (individual level)
timeFrame: Time period 24 months prior to randomization compared to the time period 12-24 months after randomization
measure: Change in self-certified sickness absence rates (individual level)
timeFrame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
measure: Change in psychosocial work environment by Demand-Control-Support-Questionnaire score
timeFrame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
measure: Change in social support from colleagues by NDSS-16 score
timeFrame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
measure: Change in job satisfaction by GJS score
timeFrame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
measure: Change in subjective health complaints by SHC score
timeFrame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
measure: Change in health anxiety by Whitheley index score
timeFrame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization; comparison with Tromsø Study 7
measure: Change in Satisfaction of life by SWLS score
timeFrame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of Nothern Norway
Study officials:
affiliation: UiT The artic University of Norway / Norwegian Welfare Service Troms
name: Nils Fleten, Phd
role: STUDY_DIRECTOR
References:
citation: Hoper AC, Terjesen CL, Fleten N. Comparing the New Interdisciplinary Health in Work Intervention With Conventional Monodisciplinary Welfare Interventions at Norwegian Workplaces: Protocol for a Pragmatic Cluster Randomized Trial. JMIR Res Protoc. 2022 Apr 7;11(4):e36166. doi: 10.2196/36166.