Effectiveness of improved assessment and recording of work related primary care visits combined with enhanced follow-up in reducing work disability: a cluster randomized controlled trial

ISRCTN	ISRCTN45728263
DOI	https://doi.org/10.1186/ISRCTN45728263
Protocol serial number	N/A
Sponsor	University of Tampere
Funder	European Social Fund

Submission date: 12/04/2016
Registration date: 18/04/2016
Last edited: 16/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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 study 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?
Prof. Jukka Uitti

Contact information

Prof Jukka Uitti
Scientific

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

Study information

Primary study design	Interventional
Study design	Pragmatic cluster randomised controlled intervention trial. The trial will be conducted at 22 occupational health units (multisite).
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
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
Study objectives	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(s)	Pirkanmaa Hospital District review board, 10/03/2016, ref: R16041
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/06/2018

Eligibility

Participant type(s)	All
Age group	Adult
Sex	All
Target sample size at registration	55000
Key inclusion criteria	All employees of the client organisations of the selected intervention arm occupational health care units will be eligible
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	14/04/2016
Date of final enrolment	01/05/2017

Locations

Countries of recruitment

Finland

Study participating centres

Dextra Pihlajalinna Akaa - Kirkkotori 10

Akaa
37800
Finland

Kamppi

Kampinkuja 2
Helsinki
00100
Finland

Hämeenkyrö

Härkikuja 2
Hämeenkyrö
39100
Finland

Jyväskylä

Cygnaeuksenkatu 8
Jyväskylä
40100
Finland

Mänttä-Vilppula

Koneenhoitajankatu 2
Mänttä
37100
Finland

Nokia

Välikatu 14
Nokia
37100
Finland

Parkano

Parkanontie 48
Parkano
39700
Finland

Pietarsaari

Alholmintie 43
Pietarsaari
68600
Finland

Levi, Sirkka

Levintie 1590
Sirkka
99130
Finland

Kehräsaari

Kehräsaari B, 3.krs
Tampere
33200
Finland

Valkeakoski

Kirjaskatu 7
Valkeakoski
37600
Finland

Munkkivuori

Raumantie 1 a
Helsinki
00350
Finland

Ikaalinen

Vanha Tampereentie 18-20
Ikaalinen
39500
Finland

Kangasala

Kaarninkuja 3
Kangasala
36220
Finland

Kankaanpää

Kuninkaanlähteenkatu 8
Kankaanpää
38700
Finland

Lappeenranta

Kaukaankatu 30
Lappeenranta
53200
Finland

Kuusankoski

Marskinkatu 1
Kuusankoski
45700
Finland

Pieksämäki

Myllykatu 12
Myllykatu
76100
Finland

Rauma

Tikkalantie 6
Rauma
26100
Finland

Vantaa

Teknobulevardi 3-5, D-talo
Vantaa
01530
Finland

Ylöjärvi

Mikkolantie 9
Ylöjärvi
33470
Finland

Jämsä

Sairaalantie 11
Jämsä
42100
Finland

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/03/2020	16/03/2020	Yes	No
Protocol article	protocol	26/07/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/03/2020: Publication reference added.
18/01/2018: The recruitment end date has been updated from 31/12/2017 to 01/05/2017.
31/07/2017: Publication reference added.