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Effects of Regulatory Tools on Work Environment and Employee Health

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ClinicalTrials.gov Identifier: NCT03855163
Recruitment Status : Completed
First Posted : February 26, 2019
Last Update Posted : May 6, 2022
Sponsor:
Collaborator:
Norwegian Labour Inspection Authority
Information provided by (Responsible Party):
National Institute of Occupational Health, Norway

Study Description
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Brief Summary:
This study evaluates the effects of the Labour Inspection Authority's regulatory tools on workplace exposures to prevent employee ill health. Norwegian municipal enterprises with employees in the home care sector have been randomized to three different experimental groups and to one control group. We hypothesize a significant lower level of work environmental exposures and health complaints, after adjusting for pre-intervention measures, in the experimental groups compared to the control group.

Condition or disease Intervention/treatment Phase
Occupational Health Sick Leave Occupational Exposure Behavioral: Inspection visits Behavioral: Guidance workshops Behavioral: Online risk assessment tool Not Applicable

Detailed Description:

A variety of work environmental exposures are shown to cause ill health. Compliance with occupational health and safety legislation and regulation is assumed to prevent work-related ill health. The Norwegian Labour Inspection Authority oversees that enterprises comply with the requirements of the working environment laws and regulations. The agency possesses two key regulatory tools to ensure compliance, i.e. inspections and guidance.

Inspections are used to check whether enterprises meet legal requirements. If inspectors reveal violations to legal requirements, the Labour Inspection Authority may respond with orders, coercive fines, and shutdown of operations and in worst-case report enterprises to the police.

Guidance are used to notify the enterprises of the legal requirements pertaining to work environmental standards, and to advice the employers and employee representatives concerning the most effective means of realizing compliance with the legal requirements.

Enterprises randomized to the experimental groups will receive one of three different intervention activities from the Labour Inspection Authority, i.e. targeted inspection visits, participation on a one-day workshop led by two inspectors on how to reach compliance with occupational health and safety (OHS) standards, or participation in an online risk assessment course for conducting written objectives in relation to health, environment and safety activities.

The interventions will be carried out at the organizational level (enterprise), whereas the effects of the interventions on working environment and health complaints will be measured at the individual level (employee). Two months before the Labour Inspection Authority perform their interventions, a baseline questionnaire assessing self-reported organizational, psychosocial and mechanical work factors and health complaints will be sent to all home-care workers employed in the included municipal enterprises. The effects of the different interventions on work environment and employee health will be evaluated through questionnaire measurements 6, 12 and 20 months post interventions.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2555 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cluster-randomized controlled trial
Masking: Single (Investigator)
Masking Description: the study group assignment is kept hidden from the data-analysts and manuscript writers after allocation
Primary Purpose: Prevention
Official Title: Effectiveness of the Labour Inspection Authority's Regulatory Tools on Work Environment and Employee Health - Study Protocol for a Cluster Randomized Controlled Trial Among Norwegian Home-care Workers
Actual Study Start Date : March 5, 2019
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : February 25, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Inspection visits
Regulatory tool to ensure enterprise compliance with legal requirements
 Behavioral: Inspection visits
Normative intervention aimed at enforcing compliance with legal occupational health and safety requirements
Experimental: Guidance workshops
Regulatory tool applied to inform and advise enterprises on legal requirements and how to realize compliance with such requirements
 Behavioral: Guidance workshops
Pedagogical intervention aimed to motivate managers and employee representatives to comply with legal occupational health and safety requirements
Experimental: Online risk assessment tool
Regulatory tool applied to aid enterprises in conducting written objectives concerning health, environment and safety activities
 Behavioral: Online risk assessment tool
Pedagogical intervention aimed to motivate managers and employee representatives to comply with legal occupational health and safety requirements
No Intervention: Control group
The Labour Inspection Authority will not preform any intervention activities in enterprises assign to the control group


Outcome Measures
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Primary Outcome Measures :
  1. Changes in self reported occupational exposures [ Time Frame: Self-Reported Occupational Exposures will be assessed 2 months prior to the interventions and 12 months post interventions ]
    Psychosocial, organizational and mechanical factors at work will be assessed by the General Nordic Questionnaire for Psychological and Social Factors at Work (QPSNordic) and with items adapted from the following questionnaire developed by Statistics Norway: "Working environment, survey on living conditions". The wording of the questions are typically: "how often in your job do you have to … " (e.g. suppress emotions in order to appear neutral on the outside?), or "In the course of your work" ... (e.g. do you need to squat or kneel?). Level of exposure is assessed by frequency scoring on a five-point scale ranging from "1 = very seldom or never" to "5 = very often or always"

  2. Changes in psychological distress HSCL-5 [ Time Frame: Psychological Distress will be assessed 2 months prior to the interventions and 12 months post interventions ]
    Hopkins Symptom Checklist (HSCL-5), is a self-administered 5-item instrument, each item is on a four-point scale ranging from 1="not at all" to 4="extremely". Participants are asked to assess symptoms during the past 2 weeks prior to answering the questionnaire. The average item score is calculated by dividing the total score of the number of items answered (ranging between 1.00 and 4.00).

  3. Changes in musculoskeletal pain [ Time Frame: Musculoskeletal Pain will be assessed 2 months prior to the interventions and 12 months post interventions ]
    Self-reported intensity of pain in five anatomic sites; neck, shoulder, back, arm, and leg. Each question is phrased: "Have you been troubled by… (e.g. neck pain) the last 4 weeks? Response alternatives are: 1) "not troubled", 2) "a little troubled", 3) "rather intensely troubled" and 4)" very intensely troubled"

  4. Changes in physician-certified absence from work, number of events (17 days or more) per 100 employee-years [ Time Frame: The absence rate will be assessed during the one year prior to the interventions and during the one year after the interventions ]
    Data from the Norwegian Labour and Welfare Administration's sickness benefit register. This register provides complete registrations of all sickness absence episodes-including the length and medical diagnosis-which are compensated by the national insurance sickness benefit. As a general rule, everybody working or living in Norway is covered by the Norwegian national social insurance.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 67 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All employees in municipal enterprises that provide home care services with a minimum of 20 employees and a maximum of 100 employees.

Exclusion Criteria:

  • Employees in municipal enterprises that have received an inspection from the Labour Inspectorate in the years 2017 and 2018.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855163


Locations
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Sponsors and Collaborators
National Institute of Occupational Health, Norway
Norwegian Labour Inspection Authority
Investigators
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Principal Investigator: Håkon A Johannessen, PhD National Institute of Occupational Health
More Information
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Additional Information:

Publications:
M. Dallner, A.-L. Elo, F. Gamberale, V. Hottinen, S. Knardahl, K. Lindström, A. Skogstad, E. Ørhede. Validation of the General Nordic Questionnaire (QPSNordic) for psychological and social factors at work. Nordic Council of Ministers, Copenhagen (2000)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Occupational Health, Norway
ClinicalTrials.gov Identifier: NCT03855163    
Other Study ID Numbers: 201700498
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available 3 years after study completion
Access Criteria: Data access request will be reviewed by NSD - Norwegian Centre for Research Data
URL: https://nsd.no/nsd/english/index.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Occupational Health, Norway:
Mental Distress
Musculoskeletal Pain
Work-related
Cluster Randomized Trial
Effect Evaluation