Condition category
Not Applicable
Date applied
04/02/2011
Date assigned
31/03/2011
Last edited
20/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Being on long-term sickness absence involves not only a health risk. People on long-term sickness absence also have an increased risk of losing their jobs and being excluded from the labour market. Many sick-listed persons need help to get out of the difficult situation, so that they can continue to enjoy a meaningful life at work. The Danish National return to work (RTW) program builds on the experience of a number of smaller RTW trials (Danish and foreign). The program includes three approaches that have been shown to have a positive effect on RTW for people on sickness absence: an interdisciplinary assessment of barriers and resources for returning to work, increased coordination between worker, workplace, healthcare and social insurance systems, and early initiation of RTW activities (counselling, education, on-the-job training etc.). The aim of this study is to evaluate the effects of the Danish RTW program (see ISRCTN51445682). The study will test whether the participants in the RTW program have a shorter duration of sickness absence and a faster and more sustainable RTW. We will also test whether the RTW program is cost-effective.

Who can participate?
The participants are working-age adults on long-term sickness absence (at least four weeks) recruited from sickness benefit offices in three Danish municipalities (Copenhagen, Silkeborg and Esbjerg). According to the Danish Sickness Benefit Legislation, all sick-listed persons are categorised into three categories by the municipal sickness benefit offices. The present study includes persons in category 2 (persons who are “not likely to fully return to work within three months, but currently able to participate in RTW activities or gradually return to work”).

What does the study involve?
The three municipalities all have multiple sickness benefit offices, of which some are assigned the intervention while the others proceed with normal sickness absence management. The sickness benefit offices assigned the intervention will establish RTW teams comprising an RTW coordinator (typically an experienced social worker who will receive extensive training), a psychologist and a physiotherapist/occupational therapist; they will also establish a close link to a clinical team comprising a psychiatrist and a medical doctor. The RTW coordinator becomes the focal point for coordination between the relevant stakeholders, including employers, healthcare services, unions and unemployment funds and the RTW team and the clinical team. Data for the evaluation will be obtained from questionnaires, municipal data and national register data.

What are the possible benefits and risks of participating?
Participants will be assigned an RTW coordinator who will be their contact-person throughout the sickness absence period. They will experience a faster and more interdisciplinary assessment process and will receive increased coordination and earlier initiation of RTW activities compared with ordinary sickness benefit management. We expect that these improvements will shorten the average duration of sickness absence and promote a faster and more sustainable RTW.

Where is the study run from?
This study takes place in three municipalities in different parts of Denmark (Copenhagen, Silkeborg and Esbjerg). The main coordination and evaluation will take place at the National Research Centre for the Working Environment in Copenhagen, Denmark.

When is the study starting and how long is it expected to run for?
April 2010 to March 2012

Who is funding the study?
The Danish Prevention Fund and the Danish Ministry of Employment

Who is the main contact?
Dr Otto Mechior Poulsen
Lersø Parkallé 105
2100 Copenhagen
Denmark

Trial website

http://www.arbejdsmiljoforskning.dk/da/projekter/det-store-tta-projekt

Contact information

Type

Scientific

Primary contact

Dr Otto Melchior Poulsen

ORCID ID

Contact details

Lersø Parkallé 105
Copenhagen
2100
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The Danish National Return To Work (RTW) program: a randomised controlled study of a coordinated and multidisciplinary RTW program in three municipalities aiming to reduce the duration of sickness absence and to enable earlier return to work for persons on long-term sick leave

Acronym

Study hypothesis

The overall objective of the intervention is to promote return to work for citizens on long-term sick leave. The main hypothesis is that a coordinated and multidisciplinary RTW program reduces the duration of sickness absence and promotes a faster and more sustainable RTW compared to standard municipal case management.

Specific hypotheses are that the intervention group:
1. Has a shorter duration of sickness absence
2. Is less likely to experience recurrent long-term sickness absence
3. Returns to work (become self-supporting) faster
4. Reports a more positive development in self-rated health, mental and physical health, workability, pain and sleep patterns
5. The coordinated and multidisciplinary RTW program is more cost-effective than standard municipal case management

Ethics approval

The data collection is registered at the Danish Data Protection Agency (www.datatilsynet.dk, ref: 2009-54-08).

The Danish National Committee on Biomedical Research Ethics has in writing confirmed that the intervention does not need their approval. According to the Danish Law, only projects using biological material need approval from the Danish National Committee on Biomedical Research Ethics (http://www.cvk.im.dk/site.aspx?p=513).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Long-term sickness absence

Intervention

The intervention is conducted within the municipalities of Copenhagen, Silkeborg and Esbjerg. These municipalities are selected because they all have geographically separated sickness benefit offices allowing randomisation within the municipality. Randomisation is conducted by social insurance officers using a web-administrated program ('Inquisite') randomly assigning eligible citizens to either a sickness benefit office providing the RTW programme or standard case management. Participants receiving standard case management are designated as controls whereas participants receiving the RTW programme are designated as intervention participants.

The RTW programme combines a RTW coordinator approach with a multidisciplinary approach. Four of the main strategies of the programme are:
1. Early and regular contact with citizens on sick leave
2. Multidisciplinary assessment of sick-listed citizens
3. Improved coordination between relevant stakeholders
4. Tailored rehabilitation including a combination of psychological and physiological counselling with workplace modifications

The program is delivered by a case manager, a RTW team consisting of rehabilitation professionals from physical therapy and psychology, and a clinical unit consisting of a psychiatrist and one of the following medical specialties: occupational health, social medicine or general practice. The program is tailored specifically to meet the need of each participant. Both the control and the intervention group receive a baseline questionnaire at inclusion, a 6-month follow-up questionnaire and are followed-up in a national register of social transfers including sickness benefits.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Duration of sickness absence
2. Time until RTW (becoming self-supporting)
3. Time until reoccurrence of long-term sickness absence (greater than 3 weeks)

Measured from inclusion into the study until end of follow-up

Secondary outcome measures

1. Changes in self-rated health, mental and physical health and mental disorders (SF-12, SCL8-AD) 6 and 12 months after inclusion in the study
2. Changes in workability (single item), pain ('pain intensity', single 10-point Visual Analogue Scale [VAS] scale and 'pain beliefs' - three items modified from Tampera Scale of kinesiophobia), and sleep patterns (Karolinska Sleep Questionnaire) 6 and 12 months after inclusion in the study
3. Municipal sickness benefit expenses, the level of production (earnings) and municipal and central government transfer payment expenses

(Please note, 12-month measure in points 1 and 2 added 14/11/2011. Previously only 6 months)

Overall trial start date

01/04/2010

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Citizens on long-term sickness absence (greater than 4 weeks) registered as a 'category 2 case' (citizens in category 2 are according to Danish legislation guidelines assumed to be unable to return to work within a 3-month period, but to be able to gradually return to work). Citizens of either sex and any age can be included.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Intervention: ~ 3,500; Control: ~ 3,000

Participant exclusion criteria

1. Citizens on sickness absence related to pregnancy
2. Citizens on sickness absence longer than 4 months at inclusion

Recruitment start date

01/04/2010

Recruitment end date

31/03/2012

Locations

Countries of recruitment

Denmark

Trial participating centre

Lersø Parkallé 105
Copenhagen
2100
Denmark

Sponsor information

Organisation

Danish Prevention Fund (Forebyggelsesfonden) (Denmark)

Sponsor details

Landskronagade 33
Copenhagen
2100
Denmark
+45 (0)7220 9260
kontakt@forebyggelsesfonden.dk

Sponsor type

Research organisation

Website

http://www.forebyggelsesfonden.dk/in-english.html

Funders

Funder type

Government

Funder name

Danish Prevention Fund (Forebyggelsesfonden) (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministry of Employment (Beskæftigelsesministeriet) (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22245919
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24577065
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24045856
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26715321

Publication citations

  1. Protocol

    Aust B, Helverskov T, Nielsen MB, Bjorner JB, Rugulies R, Nielsen K, Sørensen OH, Grundtvig G, Andersen MF, Hansen JV, Buchardt HL, Nielsen L, Lund TL, Andersen I, Andersen MH, Clausen AS, Heinesen E, Mortensen OS, Ektor-Andersen J, Ørbæk P, Winzor G, Bültmann U, Poulsen OM, The Danish national return-to-work program--aims, content, and design of the process and effect evaluation., Scand J Work Environ Health, 2012, 38, 2, 120-133, doi: 10.5271/sjweh.3272.

  2. Results

    Nielsen MB, Vinsløv Hansen J, Aust B, Tverborgvik T, Thomsen BL, Bue Bjorner J, Steen Mortensen O, Rugulies R, Winzor G, Orbæk P, Helverskov T, Kristensen N, Melchior Poulsen O, A multisite randomized controlled trial on time to self-support among sickness absence beneficiaries. The Danish national return-to-work programme., Eur J Public Health, 2014, doi: 10.1093/eurpub/cku016.

  3. Results

    Poulsen OM, Aust B, Bjorner JB, Rugulies R, Hansen JV, Tverborgvik T, Winzor G, Mortensen OS, Helverskov T, Orbæk P, Nielsen MB, Effect of the Danish return-to-work program on long-term sickness absence: results from a randomized controlled trial in three municipalities., Scand J Work Environ Health, 2014, 40, 1, 47-56, doi: 10.5271/sjweh.3383.

Additional files

Editorial Notes

20/09/2016: Publication reference added.