Healthy and safe workplaces within the construction industry

ISRCTN	ISRCTN16548039
DOI	https://doi.org/10.1186/ISRCTN16548039
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Karolinska Institute
Funder	AFA Försäkring

Submission date: 02/01/2020
Registration date: 12/02/2020
Last edited: 11/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Poor mental health is the dominant cause of sick leave in Sweden today and we have strong reasons to believe that certain work environment conditions is one contributing factor. We know which these conditions are, however, we don't know how to change them. This means that we lack knowledge on what methods are effective in improving organisational and social work conditions and stress in the workplace.

Interventions to address work-related stress are increasing but are mainly secondary or tertiary. Secondary interventions are directed at individuals at risk of developing stress responses. Tertiary interventions focus on treating existing diagnosed conditions. Primary interventions, on the other hand, are preventive and aim to deal with organisational factors as causal stress agents. The aim of the study is to evaluate an organisational primary intervention with the aim to improve organisational and social work conditions and reduce stress within the construction industry.

Who can participate?
Managers and employees within the two studied regions in the construction company.

What does the study involve?
The study involves one intervention and one matched control group. For the intervention group, the project contains three phases. In the first phase we conducted a needs assessment using a formative evaluation. Interviews were carried out and a survey in order to answer the questions: What works well and what needs to be improved regarding the organizational and social work environment?

In the second phase researchers and representatives from different levels and districts worked together to prioritize outcomes and define essential intervention elements. We also discussed and formulated suggestions for how the intervention could be implemented in a good way. In the third phase implementation and evaluation take place.

The control group participates through answering the baseline and follow-up survey.

What are the possible benefits and risks of participating?
Benefits: Reduced stress and improved work conditions.
Risks: Lack of improvements may cause disappointment among participants which in turn may lead to a more negative perception of work.

Where is the study run from?
Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden

When is the study starting and how long is it expected to run for?
May 2019 to December 2021

Who is funding the study?
AFA Insurance, Sweden

Who is the main contact?
Dr Gun Johansson
gun.johansson@ki.se

Contact information

Dr Gun Johansson
Scientific

Solnavägen 4
Stockholm
11365
Sweden

ORCID ID	0000-0003-1877-8569
Phone	+46 (0)733 628362
Email	gun.johansson@ki.se

Study information

Primary study design	Interventional
Study design	This is a controlled trial with one intervention and one control group with a 12 month follow-up
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Evaluation of a primary organisational co-created intervention with the aim to improve organisational and social work conditions and decrease stress within the construction industry
Study objectives	Given that the managers adhere to the intervention we expect to see a greater improvement in work conditions (role clarity, influence, work pace, quantitative job demands), team effectiveness and stress in the intervention group compared to the control group.
Ethics approval(s)	Approved 21/05/2019, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02, Uppsala, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: 2019-02662
Health condition(s) or problem(s) studied	Work related stress
Intervention	Current interventions as of 14/02/2020: The core intervention components are: 1. Assessment for first line managers Assessment = making structured and collective (involving blue-collar workers) planning for all elements of the production (planning for blue-collar workers) 2. Duties clarification for project managers Duties clarification and staffing plan = making clear role descriptions for all members of the production teams (white-collar workers), visualizing the plan and revising it continuously throughout the project. The staffing plan is closely related to the duties clarification and should also be scrutinized and revised. 3. For the support function team ("operational support") the highest manager will give feedback on the results of the survey and together with the team conduct a tailored action plan. Hence, the intervention activities will not be assessment and duties clarification for this group. The study involves one intervention and one matched control group. For the intervention group, the project contains three phases. In the first phase we conducted a needs assessment using a formative evaluation. Interviews were carried out and a survey in order to answer the questions: What works well and what needs to be improved regarding the organizational and social work environment? In the second phase researchers and representatives from different levels and districts worked together to prioritize outcomes and define essential intervention elements. We also discussed and formulated suggestions for how the intervention could be implemented in a good way. In the third phase implementation and evaluation take place. The control group participates through answering the baseline and follow-up survey. Previous interventions: The core intervention components are: 1. Assessment for first line managers Assessment = making structured and collective (involving blue-collar workers) planning for all elements of the production (planning for blue-collar workers) 2. Duties clarification for project managers Duties clarification and staffing plan = making clear role descriptions for all members of the production teams (white-collar workers), visualizing the plan and revising it continuously throughout the project. The staffing plan is closely related to the duties clarification and should also be scrutinized and revised. 3. For the two support function teams (employees not dedicated to a project) the highest manager will give feedback on the results of the survey and together with the team conduct a tailored action plan. Hence, the intervention activities will not be assessment and duties clarification. The study involves one intervention and one matched control group. For the intervention group, the project contains three phases. In the first phase we conducted a needs assessment using a formative evaluation. Interviews were carried out and a survey in order to answer the questions: What works well and what needs to be improved regarding the organizational and social work environment? In the second phase researchers and representatives from different levels and districts worked together to prioritize outcomes and define essential intervention elements. We also discussed and formulated suggestions for how the intervention could be implemented in a good way. In the third phase implementation and evaluation take place. The control group participates through answering the baseline and follow-up survey.
Intervention type	Behavioural
Primary outcome measure(s)	Current primary outcome measure as of 26/04/2021: Stress, measured with the COPSOQ III questionnaire at baseline, 12, and 24 months Previous primary outcome measure: Stress, measured with the COPSOQ III questionnaire at baseline and 12 months
Key secondary outcome measure(s)	Current secondary outcome measures as of 26/04/2021: 1. Quantitative demands, measured with the COPSOQ III questionnaire at baseline, 12, and 24 months 2. Role clarity, measured with the COPSOQ III questionnaire at baseline, 12, and 24 months 3. Psychosocial safety climate, measured with questionnaire at baseline, 12, and 24 months 4. Team effectiveness, measured with questionnaire at baseline, 12, and 24 months 5. Staffing, measured with questionnaire at baseline, 12, and 24 months 6. Planning, measured with questionnaire at baseline, 12, and 24 months Previous secondary outcome measures as of 14/02/2020: 1. Quantitative demands, measured with the COPSOQ III questionnaire at baseline and 12 months 2. Role clarity, measured with the COPSOQ III questionnaire at baseline and 12 months 3. Psychosocial safety climate, measured with questionnaire at baseline and 12 months 4. Team effectiveness, measured with questionnaire at baseline and 12 months 5. Staffing, measured with questionnaire at baseline and 12 months 6. Planning, measured with questionnaire at baseline and 12 months Previous secondary outcome measures: 1. Quantitative demands, measured with the COPSOQ III questionnaire at baseline and 12 months 2. Work pace, measured with the COPSOQ III questionnaire at baseline and 12 months 3. Role clarity, measured with the COPSOQ III questionnaire at baseline and 12 months 4. Influence, measured with the COPSOQ III questionnaire at baseline and 12 months 5. Psychosocial safety climate, questionnaire at baseline and 12 months 6. Team effectiveness, questionnaire at baseline and 12 months
Completion date	31/12/2021

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	838
Total final enrolment	634
Key inclusion criteria	1. Working in the recruited organisation at the time of recruitment and the follow-up endpoint 2. Age 18-65
Key exclusion criteria	1. Regional manager 2. District managers
Date of first enrolment	31/05/2019
Date of final enrolment	31/12/2021

Locations

Countries of recruitment

Sweden

Study participating centre

Institute of environmental medicine Karolinska Institutet

Gothenburg
41250
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		23/09/2022	11/10/2022	Yes	No
Protocol article	protocol	30/03/2020	02/04/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
26/04/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2021 to 31/12/2021.
2. The overall trial end date has been changed from 30/06/2021 to 31/12/2021 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 30/12/2021 to 30/06/2022.
4. The primary outcome measure has been updated.
5. The secondary outcome measures have been updated.
03/09/2020: The intention to publish date was changed from 01/03/2020 to 30/12/2021.
02/04/2020: Publication reference added.
14/02/2020: The following changes were made to the trial record:
1. The interventions and secondary outcome measures were updated.
2. The recruitment end date was changed from 31/05/2019 to 30/06/2021.
07/01/2020: Trial’s existence confirmed by Swedish Ethical Review Authority (Etikprövningsmyndigheten)