Occupational DiseasesNCT05039398
'Dialogue and Guidance' - a Policy Intervention for Improved OHS Among Workplaces With WEA Violations
A study testing Treatment as usual, Dialogue and guidance over telephone and Dialogue and guidance at physical meeting in people with Occupational Diseases and Occupational Injuries, run by Danish Labor Inspectorate at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Occupational Diseases, Occupational Injuries, Safety Issues
- What is being tested?
- Treatment as usual, Dialogue and guidance over telephone and Dialogue and guidance at physical meeting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Working Environment Authority
Copenhagen, Copenhagen Ø, 2100
Thomas S. Rexen, Msc
About this study
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
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.
- Conditions
- Occupational Diseases, Occupational Injuries, Safety Issues
- Being tested
- Treatment as usual, Dialogue and guidance over telephone, Dialogue and guidance at physical meeting
- Medical subject headings
- Occupational Diseases, Occupational Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usualBehavioural
The workplace receives dialogue and guidance during the WEA workplace inspection as per WEA standard practice.
Dialogue and guidance over telephoneBehavioural
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.
Dialogue and guidance at physical meetingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Comparison group | Active comparator | Not described Receives: Behavioral: Treatment as usual |
| Telephone D&G | Experimental | Not described Receives: Behavioral: Dialogue and guidance over telephone |
| Physical meeting D&G | Experimental | Not described Receives: Behavioral: Dialogue and guidance at physical meeting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Through study completion, approx. 12-18 months
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)
Measured: Through study completion, approx. 12-18 months
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)
Measured: Baseline to 6 months follow-up
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)
Measured: Baseline to 6 months follow-up
Secondary outcomes (5)
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)
Measured: Baseline to 6 months follow-up
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)
Measured: Baseline to 6 months follow-up
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)
Measured: Baseline to 6 months follow-up
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)
Measured: Baseline to 6 months follow-up
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)
Measured: Through study completion, approx. 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Jun 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Labor Inspectorate
- Sponsor type
- Other government
- Collaborators
- National Research Centre for the Working Environment, Denmark
- Responsible party
- Principal investigator, Johan Simonsen Abildgaard, National Research Centre for the Working Environment, Denmark
- Investigators
- Johan S. Abildgaard, PhD, Principal investigator, The National Research Centre for the Working Environment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039398
- Sponsor's protocol ID
- AT-D&V
- Status last verified
- Sep 2021
- First submitted
- 1 Jun 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05039398
- Acronym / sponsor ID
- AT-D&V
- Conditions
- Occupational Diseases, Occupational Injuries, Safety Issues
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Danish Labor InspectorateOther government
- Collaborators
- National Research Centre for the Working Environment, Denmark
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Comparison group | Active comparator | Behavioral: Treatment as usual |
| Telephone D&G | Experimental | Behavioral: Dialogue and guidance over telephone |
| Physical meeting D&G | Experimental | Behavioral: Dialogue and guidance at physical meeting |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as usualThe workplace receives dialogue and guidance during the WEA workplace inspection as per WEA standard practice. | Behavioural | Comparison group |
| Dialogue and guidance over telephoneIn 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. | Behavioural | Telephone D&G |
| Dialogue and guidance at physical meetingIn 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. | Behavioural | Physical meeting D&G |
Primary outcome
WEA notices - specific
Time frame: Through study completion, approx. 12-18 months
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: 1. prohibition notice (+ topic-code) 2. immediate notice (+ topic-code) 3. 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
Time frame: Through study completion, approx. 12-18 months
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: 1. prohibition notice (all) 2. immediate notice (all) 3. notice with time limit (all) Register data provided by the Danish Labour Authority (Intervention is hypothesized to lead to fewer notices)
OHS problem solution
Time frame: Baseline to 6 months follow-up
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
Time frame: Baseline to 6 months follow-up
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)
5 secondary outcomes
OHS motivation
Time frame: Baseline to 6 months follow-up
OHS priority
Time frame: Baseline to 6 months follow-up
OHS practice efficacy
Time frame: Baseline to 6 months follow-up
Diffusion of OHS knowledge
Time frame: Baseline to 6 months follow-up
Other WEA reactions
Time frame: Through study completion, approx. 12-18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan S. Abildgaard, PhD principal investigator
The National Research Centre for the Working Environment
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual, Dialogue and guidance over telephone and Dialogue and guidance at physical meeting in people with Occupational Diseases and Occupational Injuries, run by Danish Labor Inspectorate at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas S. Rexen, Msc (+45 70 12 12 88, AT@AT.DK), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WEA notices - specific (time frame: Through study completion, approx. 12-18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.