Effects of Regulatory Tools on Work Environment and Employee Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Occupational Health, Sick Leave, Occupational Exposure

Intervention / Treatment
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* Behavioral: Inspection visits
* Behavioral: Guidance workshops
* Behavioral: Online risk assessment tool


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: cluster-randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspection visits<br>Regulatory tool to ensure enterprise compliance with legal requirements | Behavioral: Inspection visits<br>* Normative intervention aimed at enforcing compliance with legal occupational health and safety requirements<br>|
| Experimental: Guidance workshops<br>Regulatory tool applied to inform and advise enterprises on legal requirements and how to realize compliance with such requirements | Behavioral: Guidance workshops<br>* Pedagogical intervention aimed to motivate managers and employee representatives to comply with legal occupational health and safety requirements<br>|
| Experimental: Online risk assessment tool<br>Regulatory tool applied to aid enterprises in conducting written objectives concerning health, environment and safety activities | Behavioral: Online risk assessment tool<br>* Pedagogical intervention aimed to motivate managers and employee representatives to comply with legal occupational health and safety requirements<br>|
| No Intervention: Control group<br>The Labour Inspection Authority will not preform any intervention activities in enterprises assign to the control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in self reported occupational exposures | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental Distress, Musculoskeletal Pain, Work-related, Cluster Randomized Trial, Effect Evaluation