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
People on long-term sickness absence have an increased risk of losing their jobs and being excluded from the labour market. Many of these people need help to get out of this situation, so that they can continue to enjoy a meaningful life at work.
The Danish National RTW-program includes three approaches that have been shown to have positive effect on return to work (RTW) for people on sickness absence:
1. Assessment of barriers and resources for returning to work
2. Increased coordination between worker, workplace, health care and social insurance systems
3. Early initiation of RTW-activities (counselling, education, on-the-job-training etc.)
The aims of the study are:
To improve municipal sickness benefit management
To evaluate the implementation process both from the beneficiaries, the RTW-teams and the external stakeholders point of views
The economic burden of this approach compared to normal sickness benefit management
The effects on the participants’ sickness absence duration, sustainability of RTW and on a range of secondary outcomes (sleep pattern, general health, workability etc.)

Who can participate?
Working-age adults on long-term sickness absence (at least four weeks).

What does the study involve?
The 22 municipalities involved in the project established RTW-teams comprising an RTW-coordinator (typically an experienced social worker who received extensive training), a psychologist and a physiotherapist/occupational therapist. The RTW teams established close links with psychiatrists and medical doctors. The RTW-coordinators then became the focal point for coordination between the relevant stakeholders, including employers, health care services, unions and unemployment funds and the RTW-team and the clinical unit. Data for the evaluation was obtained by questionnaires, focus-group interviews, individual interviews, municipal data and national register-data.

What are the possible benefits and risks of participating?
These improvements will hopefully reduce the average duration of sickness absence, provide a faster and more sustainable RTW and a positive development in health, sleep and workability for the participants. There are no known risks associated with taking part in this study.

Where is the study run from?
National Research Centre for the Working Environment, 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
nfa@arbejdsmiljoforskning.dk

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
+45 (0)3916 5200
nfa@arbejdsmiljoforskning.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The Danish National RTW program: a stratified cluster controlled study of a coordinated and multidisciplinary return to work program in 22 municipalities aiming to reduce the duration of sickness absence and to enable earlier return to work for citizens on long-term sick leave

Acronym

Study hypothesis

The overall objective of the intervention is to promote return to work (RTW) 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, and
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

Stratified cluster controlled study

Primary study design

Interventional

Secondary study design

Cluster randomised 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

Current interventions as of 14/09/2011:
The municipalities were assigned to the control and intervention group using a stratified allocation procedure. The initial selection of municipalities was based on applications from 45 municipalities. All applications were assessed for quality and feasibility of implementation plans resulting in a total of 33 municipalities. Further, two municipalities were selected a prior due to the possibility of strong study designs (randomization of individuals and cluster allocation of sickness benefit offices within the sickness benefit offices).
All municipalities were grouped in distinct strata based on their size, socio-economic profile and organisation of the RTW-programme. Finally a stratified cluster selection was performed resulting in 13 municipalities in the intervention group and 9 municipalities (representing 12 offices) in the control group. All control municipalities were offered the intervention after the end of the study. After one year the control municipalities became intervention municipalities. Three of the municipalities are also part of an individual RCT-study (see www.controlled-trials.com/ISRCTN43004323).

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 work place 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 six months follow-up questionnaire and are followed-up in a national register of social transfers including sickness benefits.

Previous interventions:
The municipalities were assigned to the control and intervention group using a stratified allocation procedure. The initial selection of municipalities was based on applications from 43 municipalities. All applications were assessed for quality and feasibility of implementation plans resulting in a total of 33 municipalities. These municipalities were grouped in distinct strata based on their size, socio-economic profile and organisation of the RTW-programme. Finally a stratified cluster selection was performed resulting in 11 municipalities (representing 14 offices) in the intervention group and 8 municipalities (representing 12 offices) in the control group. All control municipalities were offered the intervention after the end of the study.

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) six and twelve 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' - 3 items modified from Tampera Scale of kinesiophobia), and sleep patterns (Karolinska Sleep Questionnaire) six and twelve 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, twelve month measure in points 1 and 2 added 14/11/2011. Previously only six)

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 three months 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

Adult

Gender

Both

Target number of participants

Intervention: approx 12,600: Control: approx 6,900

Participant exclusion criteria

1. Citizens on sickness absence related to pregnancy
2. Citizens on sickness absence longer than four 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://forebyggelsesfonden.dk

Funders

Funder type

Government

Funder name

Danish Prevention Fund (Forebyggelsesfonden) (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Beskæftigelsesministeriet

Alternative name(s)

Ministry of Employment, Danish Ministry of Employment

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Denmark

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
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.

Additional files

Editorial Notes

20/09/2016: Publication reference added. 14/11/2011: The following changes were made to the trial record: 1. Both public and scientific titles were updated from '11 municipalities' to '22 municipalities'. 2. The overall trial end date was changed from 31/03/2011 to 31/03/2012. 3. The target number of participants was changed from "Intervention: approx 5,000: Control: approx 3,700" to "Intervention: approx 12,600: Control: approx 6,900".