Effects of Regulatory Tools on Work Environment and Employee Health

May 5, 2022 updated by: National Institute of Occupational Health, Norway

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2555

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Andenes, Norway, 8483
        • Hjemmetjenesten i Andøy kommune
      • Askvoll, Norway, 6988
        • Hjemmetjenesten i Askvoll kommune
      • Aure, Norway, 6689
        • Hjemmetjenesten i Aure kommune
      • Aurland, Norway, 1421
        • Hjemmetjenesten i Aurland kommune
      • Ballangen, Norway, 8540
        • Hjemmetjenesten i Ballangen kommune
      • Bjørkelangen, Norway, 1940
        • Hjemmetjenesten i Aurskog Høland kommune
      • Borkenes, Norway, 9475
        • Hjemmetjenesten i Kvæfjord kommune
      • Brattvåg, Norway, 6270
        • Hjemmetjenesten i Haram kommune
      • Breivikbotn, Norway, 9593
        • Hjemmetjenesten i Hasvik kommune
      • Bryne, Norway, 4349
        • Hjemmetjenesten i Time kommune
      • Burfjord, Norway, 9161
        • Hjemmetjenesten i Kvænangen kommune
      • Bø, Norway, 3833
        • Hjemmetjenesten i Bø
      • Dokka, Norway, 2882
        • Hjemmetjenesten i Nordre Land kommune
      • Drammen, Norway, 3015
        • Hjemmetjenesten i Drammen kommune
      • Drangedal, Norway, 3750
        • Hjemmetjenesten i Drangedal kommune
      • Drøbak, Norway, 1443
        • Hjemmetjenesten i Frogn kommune
      • Eide, Norway, 6490
        • Hjemmetjenesten i Eide kommune
      • Eivindvik, Norway, 5966
        • Hjemmetjenesten i Gulen kommune
      • Elverum, Norway, 2408
        • Hjemmetjenesten i Elverum kommune
      • Evenskjer, Norway, 9439
        • Hjemmetjenesten i Skånland kommune
      • Evje, Norway, 4735
        • Hjemmetjenesten i Evje og Hornnes kommune
      • Fagernes, Norway, 2900
        • Hjemmetjenesten i Nord-Aurdal kommune
      • Fauske, Norway, 8200
        • Hjemmetjenesten i Fauske kommune
      • Fedje, Norway, 5947
        • Hjemmetjenesten i Fedje kommune
      • Flekkefjord, Norway, 4400
        • Hjemmetjenesten i Flekkefjord kommune
      • Fosnavåg, Norway, 6699
        • Hjemmetjenesten i Herøy kommune
      • Fyresdal, Norway, 3870
        • Hjemmetjenesten i Fyresdal kommune
      • Gjerstad, Norway, 4980
        • Hjemmetjenesten i Gjerstad kommune
      • Gol, Norway, 3550
        • Hjemmetjenesten i Gol kommune
      • Hareid, Norway, 6060
        • Hjemmetjenesten i Hareid kommune
      • Hokksund, Norway, 3301
        • Hjemmetjenesten i Øvre Eiker kommune
      • Hov, Norway, 2860
        • Hjemmetjenesten i Søndre Land kommune
      • Hønefoss, Norway, 3502
        • Hjemmetjenesten i Ringerike kommune
      • Iveland, Norway, 4724
        • Hjemmetjenesten i Iveland kommune
      • Jessheim, Norway, 2051
        • Hjemmetjenesten i Ullensaker kommune
      • Jevnaker, Norway, 3520
        • Hjemmetjenesten i Jevnaker kommune
      • Jørpeland, Norway, 4100
        • Hjemmetjenesten i Strand kommune
      • Kirkenær, Norway, 2661
        • Hjemmetjenesten i Grue kommune
      • Kleppe, Norway, 4352
        • Hjemmetjenesten i Klepp kommune
      • Korgen, Norway, 8646
        • Hjemmetjenesten i Hemnes kommune
      • Kragerø, Norway, 3791
        • Hjemmetjenesten i Kragerø kommune
      • Kvinesdal, Norway, 4480
        • Hjemmetjenesten i Kvinesdal kommune
      • Langesund, Norway, 3993
        • Hjemmetjenesten i Bamble kommune
      • Larsnes, Norway, 6084
        • Hjemmetjenesten i Sande kommune Møre og Romsdal
      • Leikanger, Norway, 6863
        • Hjemmetjenesten i Leikanger kommune
      • Leinesfjorden, Norway, 8283
        • Hjemmetjenesten i Steigen kommune
      • Leirfjord, Norway, 8890
        • Hjemmetjenesten i Leirfjord kommune
      • Leknes, Norway, 8376
        • Hjemmetjenesten i Vestvågøy kommune
      • Lesja, Norway, 2665
        • Hjemmetjenesten i Lesja kommune
      • Lillesand, Norway, 4790
        • Hjemmetjenesten i Lillesand
      • Lonevåg, Norway, 5282
        • Hjemmetjenesten i Osterøy kommune
      • Lærdal, Norway, 6886
        • Hjemmetjenesten i Lærdal kommune
      • Løten, Norway, 2341
        • Hjemmetjenesten i Løten kommune
      • Midsund, Norway, 6475
        • Hjemmetjenesten i Midsund kommune
      • Mo I Rana, Norway, 8622
        • Hjemmetjenesten i Rana kommune
      • Moen, Norway, 9321
        • Hjemmetjenesten i Målselv kommune
      • Mosjøen, Norway, 8657
        • Hjemmetjenesten i Vefsen kommune
      • Mysen, Norway, 1850
        • Hjemmetjenesten i Eidsberg kommune
      • Nesbyen, Norway, 3540
        • Hjemmetjenesten i Nes kommune Buskerud
      • Nodeland, Norway, 4685
        • Hjemmetjenesten i Songdalen kommune
      • Norheimsund, Norway, 5600
        • Hjemmetjenesten i Kvam kommune
      • Notodden, Norway, 3672
        • Hjemmetjenesten i Notodden kommune
      • Odda, Norway, 5750
        • Hjemmetjenesten i Odda kommune
      • Otta, Norway, 2670
        • Hjemmetjenesten i Sel kommune
      • Prestfoss, Norway, 3350
        • Hjemmetjenesten i Sigdal kommune
      • Rakkestad, Norway, 1891
        • Hjemmetjenesten i Rakkestad kommune
      • Randaberg, Norway, 4070
        • Randaberg kommune
      • Re, Norway, 3164
        • Hjemmetjenesten i Re kommune
      • Risør, Norway, 4952
        • Hjemmetjenesten i Risør kommune
      • Rjukan, Norway, 3661
        • Hjemmetjenesten i Tinn kommune
      • Roa, Norway, 2740
        • Hjemmetjenesten i Lunner kommune
      • Rosendal, Norway, 5470
        • Hjemmetjenesten i Kvinnherad kommune
      • Rødberg, Norway, 3630
        • Hjemmetjenesten i Nore og Uvdal kommune
      • Røyse, Norway, 3530
        • Hjemmetjenesten i Hole kommune
      • Sagstua, Norway, 2120
        • Hjemmetjenesten i Nord-Odal kommune
      • Sand, Norway, 4230
        • Hjemmetjenesten i Suldal kommune
      • Sauda, Norway, 4200
        • Hjemmetjenesten i Sauda kommune
      • Sauland, Norway, 3692
        • Hjemmetjenesten i Hjartdal kommune
      • Selje, Norway, 6740
        • Hjemmetjenesten i Selje kommune
      • Seljord, Norway, 3840
        • Hjemmetjenesten i Seljord kommune
      • Skarnes, Norway, 2100
        • Hjemmetjenesten i Sør-Odal kommune
      • Skjærhalden, Norway, 1680
        • Hjemmetjenesten i Hvaler kommune
      • Sola, Norway, 4097
        • Hjemmetjenesten i Sola kommune
      • Spydeberg, Norway, 1820
        • Hjemmetjenesten i Spydeberg kommune
      • Stordal, Norway, 6250
        • Hjemmetjenesten i Stordal kommune
      • Storslett, Norway, 9156
        • Hjemmetjenesten i Nordreisa kommune
      • Straumen, Norway, 8226
        • Hjemmetjenesten i Sørfold kommune
      • Straumsjøen, Norway, 8475
        • Hjemmetjenesten i Bø kommune Nordland
      • Sunndalsøra, Norway, 6601
        • Hjemmetjenesten i Sunndal kommune
      • Sveio, Norway, 5559
        • Hjemmetjenesten i Sveio kommune
      • Svolvær, Norway, 8300
        • Hjemmetjenesten i Vågan kommune
      • Sykkylven, Norway, 6230
        • Hjemmetjenesten i Sykkylven kommune
      • Sørreisa, Norway, 9310
        • Hjemmetjenesten i Sørreisa kommune
      • Tvedestrand, Norway, 4901
        • Hjemmetjenesten i Tvedestrand kommune
      • Tynset, Norway, 2500
        • Hjemmetjenesten i Tynset kommune
      • Tysse, Norway, 5660
        • Hjemmetjenesten i Samnanger kommune
      • Uggdal, Norway, 5686
        • Hjemmetjenesten i Tysnes kommune
      • Vennesla, Norway, 4701
        • Hjemmetjenesten i Vennesla kommune
      • Vinje, Norway, 3890
        • Hjemmetjenesten i Vinje kommune
      • Vinstra, Norway, 2640
        • Hjemmetjenesten i Nord-Fron kommune
      • Volda, Norway, 6100
        • Hjemmetjenesten i Volda kommune
      • Ål, Norway, 3570
        • Hjemmetjenesten i Ål kommune
      • Åmli, Norway, 4865
        • Hjemmetjenesten i Åmli kommune
      • Årdalstangen, Norway, 6885
        • Hjemmetjenesten i Årdal kommune
      • Ølen, Norway, 5580
        • Hjemmetjenesten i Vindafjord kommune
      • Ørje, Norway, 1870
        • Hjemmetjenesten i Marker kommune
      • Ørnes, Norway, 8150
        • Hjemmetjenesten i Meløy kommune
      • Østre Gausdal, Norway, 2651
        • Hjemmetjenesten i Gausdal kommune
      • Øyer, Norway, 2636
        • Hjemmetjenesten i Øyer kommune
    • Aksdal
      • Tysvær, Aksdal, Norway, 5575
        • Hjemmetjenesten i Tysvær kommune
    • Averøy
      • Vebenstad, Averøy, Norway, 6530
        • Hjemmetjenesten i Averøy kommune
    • Bogen
      • Evenes, Bogen, Norway, 8539
        • Hjemmetjenesten i Evenes kommune
    • Dønna
      • Dønnes, Dønna, Norway, 8820
        • Hjemmetjenesten i Dønna kommune
    • Flisa
      • Åsnes, Flisa, Norway, 2270
        • Hjemmetjenesten i Åsnes kommune
    • Gaupne
      • Luster, Gaupne, Norway, 6868
        • Hjemmetjenesten i Luster kommune
    • Nannestad
      • Teigebyen, Nannestad, Norway, 2030
        • Hjemmetjenesten i Nannestad kommune
    • Oteren
      • Storfjord, Oteren, Norway, 9046
        • Hjemmetjenesten i Storfjord kommune
    • Rena
      • Åmot, Rena, Norway, 2450
        • Hjemmetjenesten i Åmot kommune
    • Rendalen
      • Redalen, Rendalen, Norway, 2484
        • Hjemmetjenesten i Rendalen kommune
    • Råde
      • Moss, Råde, Norway, 1640
        • Hjemmetjenesten i Råde kommune
    • Sandane
      • Gloppen, Sandane, Norway, 6823
        • Hjemmetjenesten i Gloppen kommune
    • Skjåk
      • Skår, Skjåk, Norway, 2690
        • Hjemmetjenesten i Skjåk kommune
    • Skogsvåg
      • Sund, Skogsvåg, Norway, 5371
        • Hjemmetjenesten i Sund kommune
    • Smøla
      • Smørås, Smøla, Norway, 6570
        • Hjemmetjenesten i Smøla kommune
    • Stord
      • Leirvik, Stord, Norway, 5402
        • Hjemmetjenesten i Stord kommune
    • Trøgstad
      • Mysen, Trøgstad, Norway, 1860
        • Hjemmetjenesten i Trøgstad kommune
    • Valderøya
      • Ålesund, Valderøya, Norway, 6050
        • Hjemmetjenesten i Giske kommune
    • Valdres
      • Vang, Valdres, Norway, 2975
        • Hjemmetjenesten i Vang kommune
    • Vega
      • Nordland, Vega, Norway, 8980
        • Hjemmetjenesten i Vega kommune
    • Vest-Agder
      • Linnes, Vest-Agder, Norway, 4524
        • Hjemmetjenesten i Lindesnes kommune

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 67 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
Self-Reported Occupational Exposures will be assessed 2 months prior to the interventions and 12 months post interventions
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).
Psychological Distress will be assessed 2 months prior to the interventions and 12 months post interventions
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"
Musculoskeletal Pain will be assessed 2 months prior to the interventions and 12 months post interventions
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.
The absence rate will be assessed during the one year prior to the interventions and during the one year after the interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Occupational Health, Norway

Collaborators

Norwegian Labour Inspection Authority

Investigators

  • Principal Investigator: Håkon A Johannessen, PhD, National Institute of Occupational Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2019

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

February 25, 2022

Study Registration Dates

First Submitted

February 15, 2019

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201700498

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data for all primary outcome measures will be made available

IPD Sharing Time Frame

Data will be available 3 years after study completion

IPD Sharing Access Criteria

Data access request will be reviewed by NSD - Norwegian Centre for Research Data

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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