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Completed

NCT Number: NCT03855163

Effects of Regulatory Tools on Work Environment and Employee Health

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.

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Key information

Conditions

Occupational Health Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Occupational Exposure Pain Pathological Conditions, Signs and Symptoms Sick Leave Signs and Symptoms

Age range

16 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hjemmetjenesten i Tysvær kommune, Tysvær, Aksdal, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inspection visits

Behavioral

Normative intervention aimed at enforcing compliance with legal occupational health and safety requirements

Guidance workshops

Behavioral

Pedagogical intervention aimed to motivate managers and employee representatives to comply with legal occupational health and safety requirements

Online risk assessment tool

Behavioral

Pedagogical intervention aimed to motivate managers and employee representatives to comply with legal occupational health and safety requirements

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Institute of Occupational Health, Norway

Other Gov

Collaborators

  • Norwegian Labour Inspection Authority

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Feb 26, 2019
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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