Clinical trial NCT03855163: Effects of Regulatory Tools on Work Environment and Employee Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Health
Sick Leave
Occupational Exposure
Keywords: Mental Distress
Musculoskeletal Pain
Work-related
Cluster Randomized Trial
Effect Evaluation
Lead sponsor: National Institute of Occupational Health, Norway
Sponsor class: OTHER_GOV
Collaborators: name: Norwegian Labour Inspection Authority
First posted: 2019-02-26
Enrollment: 2555
Sex: ALL
Minimum age (years): 16
Maximum age (years): 67
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster-randomized controlled trial
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes in self reported occupational exposures
timeFrame: Self-Reported Occupational Exposures will be assessed 2 months prior to the interventions and 12 months post interventions
measure: Changes in psychological distress HSCL-5
timeFrame: Psychological Distress will be assessed 2 months prior to the interventions and 12 months post interventions
measure: Changes in musculoskeletal pain
timeFrame: Musculoskeletal Pain will be assessed 2 months prior to the interventions and 12 months post interventions
measure: Changes in physician-certified absence from work, number of events (17 days or more) per 100 employee-years
timeFrame: The absence rate will be assessed during the one year prior to the interventions and during the one year after the interventions
Secondary outcomes:
Other outcomes:
Locations:
city: Tysvær
country: Norway
facility: Hjemmetjenesten i Tysvær kommune
state: Aksdal
city: Vebenstad
country: Norway
facility: Hjemmetjenesten i Averøy kommune
state: Averøy
city: Evenes
country: Norway
facility: Hjemmetjenesten i Evenes kommune
state: Bogen
city: Dønnes
country: Norway
facility: Hjemmetjenesten i Dønna kommune
state: Dønna
city: Åsnes
country: Norway
facility: Hjemmetjenesten i Åsnes kommune
state: Flisa
city: Luster
country: Norway
facility: Hjemmetjenesten i Luster kommune
state: Gaupne
city: Teigebyen
country: Norway
facility: Hjemmetjenesten i Nannestad kommune
state: Nannestad
city: Storfjord
country: Norway
facility: Hjemmetjenesten i Storfjord kommune
state: Oteren
city: Åmot
country: Norway
facility: Hjemmetjenesten i Åmot kommune
state: Rena
city: Redalen
country: Norway
facility: Hjemmetjenesten i Rendalen kommune
state: Rendalen
city: Moss
country: Norway
facility: Hjemmetjenesten i Råde kommune
state: Råde
city: Gloppen
country: Norway
facility: Hjemmetjenesten i Gloppen kommune
state: Sandane
city: Skår
country: Norway
facility: Hjemmetjenesten i Skjåk kommune
state: Skjåk
city: Sund
country: Norway
facility: Hjemmetjenesten i Sund kommune
state: Skogsvåg
city: Smørås
country: Norway
facility: Hjemmetjenesten i Smøla kommune
state: Smøla
city: Leirvik
country: Norway
facility: Hjemmetjenesten i Stord kommune
state: Stord
city: Mysen
country: Norway
facility: Hjemmetjenesten i Trøgstad kommune
state: Trøgstad
city: Ålesund
country: Norway
facility: Hjemmetjenesten i Giske kommune
state: Valderøya
city: Vang
country: Norway
facility: Hjemmetjenesten i Vang kommune
state: Valdres
city: Nordland
country: Norway
facility: Hjemmetjenesten i Vega kommune
state: Vega
city: Linnes
country: Norway
facility: Hjemmetjenesten i Lindesnes kommune
state: Vest-Agder
city: Andenes
country: Norway
facility: Hjemmetjenesten i Andøy kommune
city: Askvoll
country: Norway
facility: Hjemmetjenesten i Askvoll kommune
city: Aure
country: Norway
facility: Hjemmetjenesten i Aure kommune
city: Aurland
country: Norway
facility: Hjemmetjenesten i Aurland kommune
city: Ballangen
country: Norway
facility: Hjemmetjenesten i Ballangen kommune
city: Bjørkelangen
country: Norway
facility: Hjemmetjenesten i Aurskog Høland kommune
city: Borkenes
country: Norway
facility: Hjemmetjenesten i Kvæfjord kommune
city: Brattvåg
country: Norway
facility: Hjemmetjenesten i Haram kommune
city: Breivikbotn
country: Norway
facility: Hjemmetjenesten i Hasvik kommune
city: Bryne
country: Norway
facility: Hjemmetjenesten i Time kommune
city: Burfjord
country: Norway
facility: Hjemmetjenesten i Kvænangen kommune
city: Bø
country: Norway
facility: Hjemmetjenesten i Bø
city: Dokka
country: Norway
facility: Hjemmetjenesten i Nordre Land kommune
city: Drammen
country: Norway
facility: Hjemmetjenesten i Drammen kommune
city: Drangedal
country: Norway
facility: Hjemmetjenesten i Drangedal kommune
city: Drøbak
country: Norway
facility: Hjemmetjenesten i Frogn kommune
city: Eide
country: Norway
facility: Hjemmetjenesten i Eide kommune
city: Eivindvik
country: Norway
facility: Hjemmetjenesten i Gulen kommune
city: Elverum
country: Norway
facility: Hjemmetjenesten i Elverum kommune
city: Evenskjer
country: Norway
facility: Hjemmetjenesten i Skånland kommune
city: Evje
country: Norway
facility: Hjemmetjenesten i Evje og Hornnes kommune
city: Fagernes
country: Norway
facility: Hjemmetjenesten i Nord-Aurdal kommune
city: Fauske
country: Norway
facility: Hjemmetjenesten i Fauske kommune
city: Fedje
country: Norway
facility: Hjemmetjenesten i Fedje kommune
city: Flekkefjord
country: Norway
facility: Hjemmetjenesten i Flekkefjord kommune
city: Fosnavåg
country: Norway
facility: Hjemmetjenesten i Herøy kommune
city: Fyresdal
country: Norway
facility: Hjemmetjenesten i Fyresdal kommune
city: Gjerstad
country: Norway
facility: Hjemmetjenesten i Gjerstad kommune
city: Gol
country: Norway
facility: Hjemmetjenesten i Gol kommune
city: Hareid
country: Norway
facility: Hjemmetjenesten i Hareid kommune
city: Hokksund
country: Norway
facility: Hjemmetjenesten i Øvre Eiker kommune
city: Hov
country: Norway
facility: Hjemmetjenesten i Søndre Land kommune
city: Hønefoss
country: Norway
facility: Hjemmetjenesten i Ringerike kommune
city: Iveland
country: Norway
facility: Hjemmetjenesten i Iveland kommune
city: Jessheim
country: Norway
facility: Hjemmetjenesten i Ullensaker kommune
city: Jevnaker
country: Norway
facility: Hjemmetjenesten i Jevnaker kommune
city: Jørpeland
country: Norway
facility: Hjemmetjenesten i Strand kommune
city: Kirkenær
country: Norway
facility: Hjemmetjenesten i Grue kommune
city: Kleppe
country: Norway
facility: Hjemmetjenesten i Klepp kommune
city: Korgen
country: Norway
facility: Hjemmetjenesten i Hemnes kommune
city: Kragerø
country: Norway
facility: Hjemmetjenesten i Kragerø kommune
city: Kvinesdal
country: Norway
facility: Hjemmetjenesten i Kvinesdal kommune
city: Langesund
country: Norway
facility: Hjemmetjenesten i Bamble kommune
city: Larsnes
country: Norway
facility: Hjemmetjenesten i Sande kommune Møre og Romsdal
city: Leikanger
country: Norway
facility: Hjemmetjenesten i Leikanger kommune
city: Leinesfjorden
country: Norway
facility: Hjemmetjenesten i Steigen kommune
city: Leirfjord
country: Norway
facility: Hjemmetjenesten i Leirfjord kommune
city: Leknes
country: Norway
facility: Hjemmetjenesten i Vestvågøy kommune
city: Lesja
country: Norway
facility: Hjemmetjenesten i Lesja kommune
city: Lillesand
country: Norway
facility: Hjemmetjenesten i Lillesand
city: Lonevåg
country: Norway
facility: Hjemmetjenesten i Osterøy kommune
city: Lærdal
country: Norway
facility: Hjemmetjenesten i Lærdal kommune
city: Løten
country: Norway
facility: Hjemmetjenesten i Løten kommune
city: Midsund
country: Norway
facility: Hjemmetjenesten i Midsund kommune
city: Mo I Rana
country: Norway
facility: Hjemmetjenesten i Rana kommune
city: Moen
country: Norway
facility: Hjemmetjenesten i Målselv kommune
city: Mosjøen
country: Norway
facility: Hjemmetjenesten i Vefsen kommune
city: Mysen
country: Norway
facility: Hjemmetjenesten i Eidsberg kommune
city: Nesbyen
country: Norway
facility: Hjemmetjenesten i Nes kommune Buskerud
city: Nodeland
country: Norway
facility: Hjemmetjenesten i Songdalen kommune
city: Norheimsund
country: Norway
facility: Hjemmetjenesten i Kvam kommune
city: Notodden
country: Norway
facility: Hjemmetjenesten i Notodden kommune
city: Odda
country: Norway
facility: Hjemmetjenesten i Odda kommune
city: Otta
country: Norway
facility: Hjemmetjenesten i Sel kommune
city: Prestfoss
country: Norway
facility: Hjemmetjenesten i Sigdal kommune
city: Rakkestad
country: Norway
facility: Hjemmetjenesten i Rakkestad kommune
city: Randaberg
country: Norway
facility: Randaberg kommune
city: Re
country: Norway
facility: Hjemmetjenesten i Re kommune
city: Risør
country: Norway
facility: Hjemmetjenesten i Risør kommune
city: Rjukan
country: Norway
facility: Hjemmetjenesten i Tinn kommune
city: Roa
country: Norway
facility: Hjemmetjenesten i Lunner kommune
city: Rosendal
country: Norway
facility: Hjemmetjenesten i Kvinnherad kommune
city: Rødberg
country: Norway
facility: Hjemmetjenesten i Nore og Uvdal kommune
city: Røyse
country: Norway
facility: Hjemmetjenesten i Hole kommune
city: Sagstua
country: Norway
facility: Hjemmetjenesten i Nord-Odal kommune
city: Sand
country: Norway
facility: Hjemmetjenesten i Suldal kommune
city: Sauda
country: Norway
facility: Hjemmetjenesten i Sauda kommune
city: Sauland
country: Norway
facility: Hjemmetjenesten i Hjartdal kommune
city: Selje
country: Norway
facility: Hjemmetjenesten i Selje kommune
city: Seljord
country: Norway
facility: Hjemmetjenesten i Seljord kommune
city: Skarnes
country: Norway
facility: Hjemmetjenesten i Sør-Odal kommune
city: Skjærhalden
country: Norway
facility: Hjemmetjenesten i Hvaler kommune
city: Sola
country: Norway
facility: Hjemmetjenesten i Sola kommune
city: Spydeberg
country: Norway
facility: Hjemmetjenesten i Spydeberg kommune
city: Stordal
country: Norway
facility: Hjemmetjenesten i Stordal kommune
city: Storslett
country: Norway
facility: Hjemmetjenesten i Nordreisa kommune
city: Straumen
country: Norway
facility: Hjemmetjenesten i Sørfold kommune
city: Straumsjøen
country: Norway
facility: Hjemmetjenesten i Bø kommune Nordland
city: Sunndalsøra
country: Norway
facility: Hjemmetjenesten i Sunndal kommune
city: Sveio
country: Norway
facility: Hjemmetjenesten i Sveio kommune
city: Svolvær
country: Norway
facility: Hjemmetjenesten i Vågan kommune
city: Sykkylven
country: Norway
facility: Hjemmetjenesten i Sykkylven kommune
city: Sørreisa
country: Norway
facility: Hjemmetjenesten i Sørreisa kommune
city: Tvedestrand
country: Norway
facility: Hjemmetjenesten i Tvedestrand kommune
city: Tynset
country: Norway
facility: Hjemmetjenesten i Tynset kommune
city: Tysse
country: Norway
facility: Hjemmetjenesten i Samnanger kommune
city: Uggdal
country: Norway
facility: Hjemmetjenesten i Tysnes kommune
city: Vennesla
country: Norway
facility: Hjemmetjenesten i Vennesla kommune
city: Vinje
country: Norway
facility: Hjemmetjenesten i Vinje kommune
city: Vinstra
country: Norway
facility: Hjemmetjenesten i Nord-Fron kommune
city: Volda
country: Norway
facility: Hjemmetjenesten i Volda kommune
city: Ål
country: Norway
facility: Hjemmetjenesten i Ål kommune
city: Åmli
country: Norway
facility: Hjemmetjenesten i Åmli kommune
city: Årdalstangen
country: Norway
facility: Hjemmetjenesten i Årdal kommune
city: Ølen
country: Norway
facility: Hjemmetjenesten i Vindafjord kommune
city: Ørje
country: Norway
facility: Hjemmetjenesten i Marker kommune
city: Ørnes
country: Norway
facility: Hjemmetjenesten i Meløy kommune
city: Østre Gausdal
country: Norway
facility: Hjemmetjenesten i Gausdal kommune
city: Øyer
country: Norway
facility: Hjemmetjenesten i Øyer kommune
Study officials:
affiliation: National Institute of Occupational Health
name: Håkon A Johannessen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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)
citation: Christensen JO, Nielsen MB, Finne LB, Knardahl S. Comprehensive profiles of psychological and social work factors as predictors of site-specific and multi-site pain. Scand J Work Environ Health. 2018 May 1;44(3):291-302. doi: 10.5271/sjweh.3706. Epub 2018 Jan 11.
citation: Andersen JH, Malmros P, Ebbehoej NE, Flachs EM, Bengtsen E, Bonde JP. Systematic literature review on the effects of occupational safety and health (OSH) interventions at the workplace. Scand J Work Environ Health. 2019 Mar 1;45(2):103-113. doi: 10.5271/sjweh.3775. Epub 2018 Oct 29.
citation: Mischke C, Verbeek JH, Job J, Morata TC, Alvesalo-Kuusi A, Neuvonen K, Clarke S, Pedlow RI. Occupational safety and health enforcement tools for preventing occupational diseases and injuries. Cochrane Database Syst Rev. 2013 Aug 30;2013(8):CD010183. doi: 10.1002/14651858.CD010183.pub2.
citation: Strand BH, Dalgard OS, Tambs K, Rognerud M. Measuring the mental health status of the Norwegian population: a comparison of the instruments SCL-25, SCL-10, SCL-5 and MHI-5 (SF-36). Nord J Psychiatry. 2003;57(2):113-8. doi: 10.1080/08039480310000932.
citation: Stromholm T, Pape K, Ose SO, Krokstad S, Bjorngaard JH. Psychosocial working conditions and sickness absence in a general population: a cohort study of 21,834 workers in Norway (The HUNT Study). J Occup Environ Med. 2015 Apr;57(4):386-92. doi: 10.1097/JOM.0000000000000362.
citation: Johannessen HA, Knardahl S, Emberland JS, Skare O, Finnanger Garshol B. Do regulatory tools instigate measures to prevent work-related psychosocial and ergonomic risk factors? A process evaluation of a Labour inspection authority trial in the Norwegian home-care services. BMC Res Notes. 2022 Nov 18;15(1):349. doi: 10.1186/s13104-022-06244-4.
citation: Finnanger Garshol B, Knardahl S, Emberland JS, Skare O, Johannessen HA. Effects of the Labour Inspectorate Authority's regulatory tools on psychosocial and biomechanical work factors in Norwegian home care services: a cluster randomised controlled trial. Occup Environ Med. 2022 Dec;79(12):807-815. doi: 10.1136/oemed-2022-108470. Epub 2022 Sep 27.
citation: Indregard AR, Knardahl S, Emberland JS, Skare O, Johannessen HA. Effectiveness of the Labour Inspection Authority's regulatory tools for work environment and employee health: study protocol for a cluster-randomised controlled trial among Norwegian home-care workers. BMJ Open. 2019 Nov 26;9(11):e031226. doi: 10.1136/bmjopen-2019-031226.