Back to results'Dialogue and Guidance' - a Policy Intervention for Improved OHS Among Workplaces With WEA Violations
Primary Purpose
Occupational Diseases, Occupational Injuries, Safety Issues
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Treatment as usual
Dialogue and guidance over telephone
Dialogue and guidance at physical meeting
Sponsored by
About this trial
This is an interventional prevention trial for Occupational Diseases
Eligibility Criteria
Subjects under inspection are workplaces, and respondents of the questionnaires are the workplace manager and a work environment representative or shop steward.
Inclusion Criteria:
• Workplaces (production units) who receives a WEA notice during WEA inspection through the period of intervention. The following WEA notices are included:
- Immediate improvement notice
- Notice with time limit (material)
Exclusion Criteria:
- Companies with 0-1 employees.
- Production units from the construction industry met on temporary worksites (such as construction sites) that have more than one employee and does not have a certified occupational health and safety management system.
- Companies receiving notices only about issues in the formal/procedural aspects of the work environment (such as flaws in the workplace risk assessment) and no other notices.
- Companies receiving more than four reactions from WEA at the inspection (as these receive a competency notice and are not included in the study).
- Companies that receive a prohibition notice by the WEA inspector due to severity of work environment violations.
- A WEA improvement notice is not eligible for inclusion in the study if the workplace has entered into a collaborative agreement with WEA on improvement of the issue, or if they have received a competency notice on the WEA issue.
- Companies receiving WEA inspections in relation to initiatives targeting social dumping
Sites / Locations
- Working Environment AuthorityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Comparison group
Telephone D&G
Physical meeting D&G
Arm Description
Outcomes
Primary Outcome Measures
WEA notices - specific
Change from baseline WEA inspection in number of WEA notices of the same specific type (topic-code specific) at next WEA inspection (approx. 12-18 months after).
WEA notices included for study:
prohibition notice (+ topic-code)
immediate notice (+ topic-code)
notice with time limit (+ topic-code)
Register data provided by the Danish Labour Authority
(Intervention is hypothesized to lead to fewer notices)
WEA notices - all
Change from baseline WEA inspection in number of received WEA notices at next WEA inspection (approx. 12-18 months after).
WEA notices included for study:
prohibition notice (all)
immediate notice (all)
notice with time limit (all)
Register data provided by the Danish Labour Authority
(Intervention is hypothesized to lead to fewer notices)
OHS problem solution
Comparison of item score between intervention groups and comparison group on the following:
• One single item on if they solved the OHS problem that led to WEA notice (response categories: yes, no, partially).
(Intervention is hypothesized to lead to higher rates of having solved the OHS problems in question)
Sustainable OHS solutions
Comparison of an index score consisting of two items scored on a 5-point Likert-scale between intervention groups and comparison group on whether the implemented solution to WEA violation has led to sustainable changes in the workplace .
Sample item: "The implemented OHS solution to solve the WEA violation makes it unlikely that a similar OHS problem will arise in the future" An index score is calculated from the mean of the two items (i.e. the index has a range from 1 to 5) Higher scores equals higher sustainability of OHS solutions.
(intervention is hypothesized to lead to higher values)
Secondary Outcome Measures
OHS motivation
Comparison of item score between intervention groups and comparison group on three single items related to workplace OHS motivation measured on a 5-point Likert-scale.
The items are:
"The employees are very motivated to improve the work environment" "The management is very motivated to improve the work environment" "Working with the OHS solution has made the people involved more motivated to work on OHS problems" Higher scores equals higher OHS motivation.
(intervention is hypothesized to lead to higher values)
OHS priority
Comparison of scale score between intervention groups and comparison group on the following:
• Scale measuring OHS priority consisting of three 5-point Likert-scale items from the national workplace-survey 'Work Environment Activities in Danish Workplaces'.
Sample item: "The workplace prioritizes prevention of OHS problems highly". A scale score is calculated from the mean of the items (i.e. the scale has a range from 1 to 5 ). Higher scores equals higher OHS priority.
(intervention is hypothesized to lead to higher values)
OHS practice efficacy
Comparison of item score between intervention groups and comparison group on the following:
• A scale consisting of six 5-point Likert-scale items developed for the D&V-project measuring OHS practice behaviours.
Sample items include e.g.:
"We follow up on whether OHS initiatives have the desired effect" "We continuously solve the OHS problems that arise" A scale score is calculated from the mean of the items (i.e. the scale has a range from 1 to 5) Higher scores equals higher OHS practice efficacy.
(intervention is hypothesized to lead to higher values)
Diffusion of OHS knowledge
Comparison of an index consisting of two items scored on a 5-point Likert-scale between intervention groups and comparison group on whether the knowledge from implemented solution to WEA violation has been spread to other areas/problems.
Sample item: "We are good at disseminating OHS knowledge in our organization".
An index score is calculated from the mean of the two items (i.e. the index has a range from 1 to 5) Higher scores equals higher diffusion of OHS solutions.
(intervention is hypothesized to lead to higher values)
Other WEA reactions
Change from baseline WEA inspection in number of other WEA reactions by next WEA inspection (approx. 12-18 months after).
Other WEA reaction includes the following:
Ruling without obligation to act
Investigation notice (§ 21 notice)
Competence notice
Guidance
(Intervention is hypothesized to lead to fewer reactions)
Full Information
NCT ID
NCT05039398
First Posted
June 1, 2021
Last Updated
September 2, 2021
Sponsor
Danish Labor Inspectorate
Collaborators
National Research Centre for the Working Environment, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT05039398
Brief Title
'Dialogue and Guidance' - a Policy Intervention for Improved OHS Among Workplaces With WEA Violations
Official Title
A Policy Developed Intervention With Additional Participatory Dialogue and Guidance for Improved Occupational Health and Safety (OHS) Among Workplaces With WEA (Working Environment Authority) Violations
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Labor Inspectorate
Collaborators
National Research Centre for the Working Environment, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
With the aim to inspire and motivate workplaces in their work to prevent and reduce occupational health and safety hazards, the Danish Working Environment Authority (WEA) developed the intervention 'Dialogue and Guidance' aimed at workplaces receiving notices (prohibition notice, immediate improvement notice and notice with time limit) from WEA during inspections. At present, WEA gives dialogue and guidance as standard practice during WEA inspections to all workplaces receiving a notice with the purpose to help workplaces resolve the occupational health and safety problem that led to the notice. In the intervention 'Dialogue and Guidance' the experimental groups are receiving additional dialogue and guidance at a subsequent meeting (over the telephone or physical presence) that takes place after the inspection and after the deadline for appealing the notice has expired. The control group is receiving dialogue and guidance during inspection as usual.
The aim of this RCT study is to evaluate the policy-developed intervention with additional 'Dialogue and Guidance' in regards to the effect on motivation and priority of occupational health and safety work at the workplace after 6 months follow-up and for WEA notices by next WEA inspection (approx. follow-up by 12-18 months).
Study is risk assessed and approved under Danish Data Protection Agency via the National Research Centre for the Working Environment's umbrella approval.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occupational Diseases, Occupational Injuries, Safety Issues
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Each workplace assigned for inspection by the WEA is randomized to either of two intervention groups (physical meeting dialogue and guidance, telephone meeting dialogue and guidance) or a control group. If the workplace receives a WEA notice of material violations of work environment regulations, the workplace receives an offer for dialogue and guidance if they are in one of the two intervention groups. The comparison group receives treatment as usual.
Randomization as follows:
1/3 are randomized to treatment-as-usual comparison status 1/3 are randomized to receive dialogue and guidance over telephone 1/3 are randomized to receive dialogue and guidance at a physical meeting
Masking
None (Open Label)
Masking Description
None (Open Label) During inspection by the WEA the intervention status is masked for both the inspector and the assessed workplace. After the inspection is complete and all violation notices are sent to the company, the intervention group additionally receives invitation to a dialogue and guidance meeting. From this point the intervention is not masked.
Allocation
Randomized
Enrollment
4500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Comparison group
Arm Type
Active Comparator
Arm Title
Telephone D&G
Arm Type
Experimental
Arm Title
Physical meeting D&G
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
The workplace receives dialogue and guidance during the WEA workplace inspection as per WEA standard practice.
Intervention Type
Behavioral
Intervention Name(s)
Dialogue and guidance over telephone
Intervention Description
In addition to receiving dialogue and guidance during WEA workplace inspection as standard practice by the WEA, the "Dialogue and guidance over telephone" receives up to 2 hours of supplemental dialogue and guidance after WEA inspection with the WEA inspector. This is conducted over the telephone.
Intervention Type
Behavioral
Intervention Name(s)
Dialogue and guidance at physical meeting
Intervention Description
In addition to receiving dialogue and guidance during WEA workplace inspection as standard practice by the WEA, the "Dialogue and guidance at physical meeting" receives up to 2 hours of supplemental dialogue and guidance after WEA inspection with the WEA inspector. This is conducted as a physical meeting.
Primary Outcome Measure Information:
Title
WEA notices - specific
Description
Change from baseline WEA inspection in number of WEA notices of the same specific type (topic-code specific) at next WEA inspection (approx. 12-18 months after).
WEA notices included for study:
prohibition notice (+ topic-code)
immediate notice (+ topic-code)
notice with time limit (+ topic-code)
Register data provided by the Danish Labour Authority
(Intervention is hypothesized to lead to fewer notices)
Time Frame
Through study completion, approx. 12-18 months
Title
WEA notices - all
Description
Change from baseline WEA inspection in number of received WEA notices at next WEA inspection (approx. 12-18 months after).
WEA notices included for study:
prohibition notice (all)
immediate notice (all)
notice with time limit (all)
Register data provided by the Danish Labour Authority
(Intervention is hypothesized to lead to fewer notices)
Time Frame
Through study completion, approx. 12-18 months
Title
OHS problem solution
Description
Comparison of item score between intervention groups and comparison group on the following:
• One single item on if they solved the OHS problem that led to WEA notice (response categories: yes, no, partially).
(Intervention is hypothesized to lead to higher rates of having solved the OHS problems in question)
Time Frame
Baseline to 6 months follow-up
Title
Sustainable OHS solutions
Description
Comparison of an index score consisting of two items scored on a 5-point Likert-scale between intervention groups and comparison group on whether the implemented solution to WEA violation has led to sustainable changes in the workplace .
Sample item: "The implemented OHS solution to solve the WEA violation makes it unlikely that a similar OHS problem will arise in the future" An index score is calculated from the mean of the two items (i.e. the index has a range from 1 to 5) Higher scores equals higher sustainability of OHS solutions.
(intervention is hypothesized to lead to higher values)
Time Frame
Baseline to 6 months follow-up
Secondary Outcome Measure Information:
Title
OHS motivation
Description
Comparison of item score between intervention groups and comparison group on three single items related to workplace OHS motivation measured on a 5-point Likert-scale.
The items are:
"The employees are very motivated to improve the work environment" "The management is very motivated to improve the work environment" "Working with the OHS solution has made the people involved more motivated to work on OHS problems" Higher scores equals higher OHS motivation.
(intervention is hypothesized to lead to higher values)
Time Frame
Baseline to 6 months follow-up
Title
OHS priority
Description
Comparison of scale score between intervention groups and comparison group on the following:
• Scale measuring OHS priority consisting of three 5-point Likert-scale items from the national workplace-survey 'Work Environment Activities in Danish Workplaces'.
Sample item: "The workplace prioritizes prevention of OHS problems highly". A scale score is calculated from the mean of the items (i.e. the scale has a range from 1 to 5 ). Higher scores equals higher OHS priority.
(intervention is hypothesized to lead to higher values)
Time Frame
Baseline to 6 months follow-up
Title
OHS practice efficacy
Description
Comparison of item score between intervention groups and comparison group on the following:
• A scale consisting of six 5-point Likert-scale items developed for the D&V-project measuring OHS practice behaviours.
Sample items include e.g.:
"We follow up on whether OHS initiatives have the desired effect" "We continuously solve the OHS problems that arise" A scale score is calculated from the mean of the items (i.e. the scale has a range from 1 to 5) Higher scores equals higher OHS practice efficacy.
(intervention is hypothesized to lead to higher values)
Time Frame
Baseline to 6 months follow-up
Title
Diffusion of OHS knowledge
Description
Comparison of an index consisting of two items scored on a 5-point Likert-scale between intervention groups and comparison group on whether the knowledge from implemented solution to WEA violation has been spread to other areas/problems.
Sample item: "We are good at disseminating OHS knowledge in our organization".
An index score is calculated from the mean of the two items (i.e. the index has a range from 1 to 5) Higher scores equals higher diffusion of OHS solutions.
(intervention is hypothesized to lead to higher values)
Time Frame
Baseline to 6 months follow-up
Title
Other WEA reactions
Description
Change from baseline WEA inspection in number of other WEA reactions by next WEA inspection (approx. 12-18 months after).
Other WEA reaction includes the following:
Ruling without obligation to act
Investigation notice (§ 21 notice)
Competence notice
Guidance
(Intervention is hypothesized to lead to fewer reactions)
Time Frame
Through study completion, approx. 12-18 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Subjects under inspection are workplaces, and respondents of the questionnaires are the workplace manager and a work environment representative or shop steward.
Inclusion Criteria:
• Workplaces (production units) who receives a WEA notice during WEA inspection through the period of intervention. The following WEA notices are included:
Immediate improvement notice
Notice with time limit (material)
Exclusion Criteria:
Companies with 0-1 employees.
Production units from the construction industry met on temporary worksites (such as construction sites) that have more than one employee and does not have a certified occupational health and safety management system.
Companies receiving notices only about issues in the formal/procedural aspects of the work environment (such as flaws in the workplace risk assessment) and no other notices.
Companies receiving more than four reactions from WEA at the inspection (as these receive a competency notice and are not included in the study).
Companies that receive a prohibition notice by the WEA inspector due to severity of work environment violations.
A WEA improvement notice is not eligible for inclusion in the study if the workplace has entered into a collaborative agreement with WEA on improvement of the issue, or if they have received a competency notice on the WEA issue.
Companies receiving WEA inspections in relation to initiatives targeting social dumping
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas S. Rexen, Msc
Phone
+45 70 12 12 88
Email
AT@AT.DK
First Name & Middle Initial & Last Name or Official Title & Degree
Jesper Sørensen, Msc
Phone
+45 70 12 12 88
Email
AT@AT.DK
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan S. Abildgaard, PhD
Organizational Affiliation
The National Research Centre for the Working Environment
Official's Role
Principal Investigator
Facility Information:
Facility Name
Working Environment Authority
City
Copenhagen
State/Province
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas S. Rexen, Msc
12. IPD Sharing Statement
Learn more about this trial
'Dialogue and Guidance' - a Policy Intervention for Improved OHS Among Workplaces With WEA Violations
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