NCT05039398

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

2.5 years

First QC Date

June 1, 2021

Last Update Submit

September 2, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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: 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)

    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: 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)

    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)

    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)

    Baseline to 6 months follow-up

Secondary Outcomes (5)

  • OHS motivation

    Baseline to 6 months follow-up

  • OHS priority

    Baseline to 6 months follow-up

  • OHS practice efficacy

    Baseline to 6 months follow-up

  • Diffusion of OHS knowledge

    Baseline to 6 months follow-up

  • Other WEA reactions

    Through study completion, approx. 12-18 months

Study Arms (3)

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

Interventions

The workplace receives dialogue and guidance during the WEA workplace inspection as per WEA standard practice.

Comparison group

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.

Telephone D&G

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.

Physical meeting D&G

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.
  • Companies receiving WEA inspections in relation to initiatives targeting social dumping

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Working Environment Authority

Copenhagen, Copenhagen Ø, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Occupational DiseasesOccupational Injuries

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Johan S. Abildgaard, PhD

    The National Research Centre for the Working Environment

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas S. Rexen, Msc

CONTACT

Jesper Sørensen, Msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

June 1, 2021

First Posted

September 9, 2021

Study Start

June 1, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations