Condition category
Not Applicable
Date applied
12/04/2016
Date assigned
18/04/2016
Last edited
14/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Occupational health care (OHC) aims to keep employees healthy and safe at work and manage any risks in the workplace. Research has shown that healthy employees are good for business and it’s important that OHCs and employers work together. Their cooperation results in the most efficient and valuable results, namely improved wellbeing and productivity at workplaces. This project looks at increasing occupational health (OH)/workplace co-operation by focusing on its quality, effectiveness and good practices.
Who can participate?
All employees of the workplaces that are clients of the OHC units recruited to the study.

What does the study involve?
OHC units are randomly allocated to one of two groups. Those in group 1 are placed in the intervention group Those in group 2 are placed in the control group. Doctors and nurses working in occupational health services in the intervention group are trained to improve their assessment and recording of work relatedness or potential impact on work ability of each primary care visit. As a patient visits a doctor with a complaint, the doctor assesses the patient’s diagnosis with regard to work-relatedness or impact on work ability. This assessment is recorded on an electronic patient register. Once weekly an OH nurse accesses all client visits within the electronic register, which are tagged in the system as being work related or which have been tagged as potentially impacting on work ability and ensures that relevant procedures for addressing work ability are initiated. These procedures are case-specific, but may involve some of the following: a workplace assessment; rehabilitation; meetings with employers, occupational health professionals and the employee; referral to specialists (occupational health psychologists, occupational health physiotherapists, others). Occupational health doctors working in occupational health services in the control group may assess and record work relatedness and impact on work ability. No effort is made for special follow up by occupational nurses, cases are dealt with within usual team meetings.

What are the possible benefits and risks of participating?
Participating in the intervention causes no harm to patients, service providers or client organisations. This improved follow up could present a new model of activities within occupational health, that connects health care with prevention of work disability.

Where is the study run from?
A number of OH centres that are part of the Dextra Pihlajalinna consortium.

When is the study starting and how long is it expected to run for?
November 2015 to June 2018

Who is funding the study?
European Social Fund

Who is the main contact?
Professor Jukka Uitti

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jukka Uitti

ORCID ID

Contact details

School of Health Sciences
University of Tampere. Medisiinarinkatu 3.
Tampere
33014
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Does an intervention to increase assessment and recording of work related primary care visits' relation to work in occupational health services combined with enhanced follow-up reduce rates of work disability pensions as measured by disability pensions and sickness absences and disability pensions when compared with no intervention after two years? A cluster randomized controlled trial.

Acronym

Study hypothesis

Enhanced recording and assessment of primary care visits’ work relatedness and diagnoses’ impact on work ability of primary care visits and of occupational diseases at occupational health care units will initiate improved follow-up to address work-related problems, and through that, will reduce rates of work disability as defined by disability pensions and sickness absences and disability pensions among client organisations' employees at two years from start of intervention.

Ethics approval

Pirkanmaa Hospital District review board, 10/03/2016, ref: R16041

Study design

Pragmatic cluster randomised controlled intervention trial. The trial will be conducted at 22 occupational health units (multisite).

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Work ability/work disability

Intervention

Intervention arm: Doctors and nurses working in occupational health services are trained to improve their assessment and recording of work relatedness or potential impact on work ability of each primary care visit. As a patient visits a doctor with a complaint, the doctor assesses the patient’s diagnosis with regard to work-relatedness or impact on work ability. This assessment is recorded on an electronic patient register. Once weekly an OH nurse accesses all client visits within the electronic register, which are tagged in the system as being work related or which have been tagged as potentially impacting on work ability and ensures that relevant procedures for addressing work ability are initiated. These procedures are case-specific, but may involve some of the following: a workplace assessment; rehabilitation; meetings with employers, occupational health professionals and the employee; referral to specialists (occupational health psychologists, occupational health physiotherapists, others).

Control: Usual care. Occupational health doctors may assess and record work relatedness and impact on work ability. No effort is made for special follow up by occupational nurses, cases are dealt with within usual team meetings.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Reduction in medium term (3-9 days) sickness absences from the workplace after the intervention up to two years of follow up as measured by OHS records

Secondary outcome measures

1. Reduction in long-term (9+ days) sickness absences from the workplace after the intervention until two years of follow up as measured by OHS records
2. Reduction in short term (up to three days) sickness absences from the workplace during the following two years from the start of the intervention as measured by self report or OHS report of sickness absence
3. Reduction of sickness absences of 60 days and over after the intervention until two years of follow up as measured by OHS records
4. Reduction of any form of work disability pensions as measured by an employee registering as receiving work disability pension on the central pensions register up to two years from the intervention

Overall trial start date

01/11/2015

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

All employees of the client organisations of the selected intervention arm occupational health care units will be eligible.

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

55000

Participant exclusion criteria

N/A

Recruitment start date

14/04/2016

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Finland

Trial participating centre

Dextra Pihlajalinna Akaa - Kirkkotori 10
Akaa
37800
Finland

Trial participating centre

Kamppi
Kampinkuja 2
Helsinki
00100
Finland

Trial participating centre

Hämeenkyrö
Härkikuja 2
Hämeenkyrö
39100
Finland

Trial participating centre

Jyväskylä
Cygnaeuksenkatu 8
Jyväskylä
40100
Finland

Trial participating centre

Mänttä-Vilppula
Koneenhoitajankatu 2
Mänttä
37100
Finland

Trial participating centre

Nokia
Välikatu 14
Nokia
37100
Finland

Trial participating centre

Parkano
Parkanontie 48
Parkano
39700
Finland

Trial participating centre

Pietarsaari
Alholmintie 43
Pietarsaari
68600
Finland

Trial participating centre

Levi, Sirkka
Levintie 1590
Sirkka
99130
Finland

Trial participating centre

Kehräsaari
Kehräsaari B, 3.krs
Tampere
33200
Finland

Trial participating centre

Valkeakoski
Kirjaskatu 7
Valkeakoski
37600
Finland

Trial participating centre

Munkkivuori
Raumantie 1 a
Helsinki
00350
Finland

Trial participating centre

Ikaalinen
Vanha Tampereentie 18-20
Ikaalinen
39500
Finland

Trial participating centre

Kangasala
Kaarninkuja 3
Kangasala
36220
Finland

Trial participating centre

Kankaanpää
Kuninkaanlähteenkatu 8
Kankaanpää
38700
Finland

Trial participating centre

Lappeenranta
Kaukaankatu 30
Lappeenranta
53200
Finland

Trial participating centre

Kuusankoski
Marskinkatu 1
Kuusankoski
45700
Finland

Trial participating centre

Pieksämäki
Myllykatu 12
Myllykatu
76100
Finland

Trial participating centre

Rauma
Tikkalantie 6
Rauma
26100
Finland

Trial participating centre

Vantaa
Teknobulevardi 3-5, D-talo
Vantaa
01530
Finland

Trial participating centre

Ylöjärvi
Mikkolantie 9
Ylöjärvi
33470
Finland

Trial participating centre

Jämsä
Sairaalantie 11
Jämsä
42100
Finland

Sponsor information

Organisation

University of Tampere

Sponsor details

Kalevantie 4
Tampere
33014
Finland

Sponsor type

University/education

Website

http://www.uta.fi

Funders

Funder type

Government

Funder name

European Social Fund

Alternative name(s)

Fonds Social Européen, Europäische Sozialfonds, Fondo Social Europeo, Fonds Social Européen, Europäische Sozialfonds, ESF

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Intention to publish date

01/12/2018

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes