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Return to work for workers without a permanent employment contract, sick-listed due to a common mental disorder.


- candidate number13210
- NTR NumberNTR3563
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-aug-2012
- Secondary IDsWC2011-045 METC VUmc
- Public TitleReturn to work for workers without a permanent employment contract, sick-listed due to a common mental disorder.
- Scientific TitleReturn to work for sick-listed workers without a permanent employment contract, sick-listed due to a common mental disorder: A randomized controlled trial.
- ACRONYM
- hypothesisMental health is currently a major challenge facing Western countries. In the working population stress-related disorders, depression and anxiety disorders seem to be most common. Among sick-listed workers, the ones without (relative) permanent employment relationships represent a more vulnerable group, because they have no workplace to return to. To date, little attention has been paid to the development of return-to-work (RTW) interventions for sick-listed workers without a permanent employment contract who experience work limitations due to a common mental disorder (CMD).
Individual placement and support (IPS) is robustly validated by research among people with severe mental disorders. Furthermore, recent studies show that a participatory RTW intervention reduces time to RTW significantly for sick-listed employees with a CMD who have the intention to RTW despite symptoms. Therefore, it seems worthwhile to combine elements of IPS and the participatory RTW program in an integrated care setting. And to investigate the effectiveness of this new construct on the duration until RTW and other forms of participation for workers without a permanent employment contract sick-listed due to a CMD and with the baseline intention to RTW despite symptoms in the Dutch Social Security setting.
- Healt Condition(s) or Problem(s) studiedReturn to work, Mental health complaints, Anxiety disorders, Depression, Sick leave, Temporary agency, Unemployed
- Inclusion criteriaWorkers eligible to participate in this study are temporary agency workers, unemployed workers and workers whose employment contract expires during sickness absence in the working age range (18-64 years), and sick-listed between 6 and 14 weeks, with a CMD as main reason for the sickness benefit claim.
- Exclusion criteriaWorkers will be excluded in case of co-morbidity of such kind that participating in the supportive RTW program is not possible, i.e. (1) in case of a severe psychiatric disorder (mania, psychosis or suicidal), a severe cardiovascular disease or a terminal disease, (2) in case of insufficient proficiency of the Dutch language and/or (3) in case of a conflict with the UWV regarding a sickness benefit claim or a long-term disability claim.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2012
- planned closingdate1-apr-2015
- Target number of participants168
- InterventionsThe intervention will start within two weeks after the first meeting with an insurance physician of the UWV. This first meeting normally takes place when the client is sick-listed between 6 and 14 weeks. The participant will be invited for a second meeting with an insurance physician. The purpose of this meeting is to determine whether the participant is ready to follow the intervention program and to refer the participant to mental health care if necessary. When the participant seems ready to continue the program and if RTW and or other forms of social activities are possible, an introductory interview between the labour expert of the UWV and the participant will be planned. The labour expert stimulates active involvement of both the participant and a RTW coordinator of the UWV in the making of a RTW action plan. The goal of the meeting between the participant and the labour expert is to identify obstacles for RTW from the perspective of the participant. In a separate meeting between the labour expert and the RTW coordinator obstacles for RTW for the participant from the perspective of the RTW coordinator will be identified. Within two weeks after the second meeting with an insurance physician the participant, the RTW coordinator and the labour expert have a joint meeting. A brainstorm session will take place, to think of solutions for the identified obstacles. The end goal of this session is to achieve consensus between the participant and the RTW coordinator about the most suitable and feasible solutions to achieve work resumption and/or to improve social activities. Proposed solutions for RTW will be prioritised and summarised in an RTW action plan, including a concrete work profile. Based on this action plan there will be searched for a suitable job in a competitive workplace. Six weeks after the making of the consensus-based RTW action plan, the labour expert of the UWV contacts the participant and his supervisor to inform whether placement in a temporary workplace has been successful and if everything is satisfactory. Three months after placement in a workplace, the labour expert of the UWV evaluates the program with the participant and the RTW coordinator, and sends a final report to the insurance physician of the worker, describing the process and the outcome of the RTW implementation plan.

During the whole process a strong collaboration, communication and coordination between all key players in OHC and mental health care will be promoted.
- Primary outcomeDuration until sustainable first return to work: The duration in calendar days from the day of enrolment until first sustainable return to work, i.e. return to work in regular paid work for at least 28 consecutive (calendar) days.
- Secondary outcome1. Duration of sickness benefit period;
2. Severity of mental disorder symptoms;
3. Perceived health status;
4. Quality of life;
5. Attitude;
6. Social influence and self-Efficacy (ASE) determinants;
7. Work status;
8. Work limitations;
9. Direct and indirect costs.
- Timepoints1. Baseline (T0);
2. 6 months follow-up (T1);
3. 12 months follow-up (T2);
4. 18 months follow-up (T3).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Han J.R. Anema
- CONTACT for SCIENTIFIC QUERIESDr. Han J.R. Anema
- Sponsor/Initiator VU University Medical Center, EMGO+ Institute, Department of Public and Occupational Health
- Funding
(Source(s) of Monetary or Material Support)
UWV (Workers Insurance Authority)
- PublicationsN/A
- Brief summaryThe main study objective is to evaluate the cost-effectiveness of a new participatory supportive RTW program for sick-listed workers without a permanent employment contract sick-listed due to a CMD and with the baseline intention to RTW despite symptoms on the duration until sustainable first return to work and other forms of participation, compared to care as usual. The study design consists of a randomised controlled trial (RCT) with a follow-up of 18 months. Workers eligible to participate in this study are workers without a permanent employment contract in the working age range (18-64 years) and sick-listed between 6 and 14 weeks, with a CMD as main reason for the sickness benefit claim.
- Main changes (audit trail)Inclusion criteria: Workers eligible to participate in this study are temporary agency workers, unemployed workers and workers whose employment contract ended during sickness absence in the working age range (18-64 years), and sick-listed between 2 and 14 weeks, with a CMD as main reason for the sickness benefit claim.

Startdate: March 1, 2013

End date: September 1, 2015

Participants: 172

Interventions: Within two weeks after the randomization is performed and the sick-listed worker has been allocated to the intervention group, The participatory supportive RTW program starts with an examination of the sickness benefit claim by a RTW coordinator and a medical assessment by an insurance physician of the Social Security Agency (SSA), conform usual OHC. A strong collaboration and communication between the insurance physician, the GP and mental health care specialists is required. Therefore, the insurance physician contacts the caregivers of the sick-listed workers right after the first medical assessment by telephone to make sure that no conflicting advices will be given to the participant and to agree upon treatment and RTW options. When the participant seems ready to continue the program and if RTW and or other forms of social activities are possible, an interview between a labour expert of the SSA and the participant will be planned. The labour expert stimulates active involvement of both the participant and the RTW coordinator in the making of a RTW action plan. The goal of the meeting between the participant and the labour expert is to identify obstacles for RTW from the perspective of the participant. In a separate meeting between the labour expert and the RTW coordinator obstacles for RTW for the participant from the perspective of the RTW coordinator will be identified. Within two weeks after the meeting with the insurance physician the participant, the RTW coordinator and the labour expert have a joint meeting. A brainstorm session will take place, to think of solutions for the identified obstacles. The end goal of this session is to achieve consensus between the participant and the RTW coordinator about the most suitable and feasible solutions to achieve work resumption and/or to improve social activities. Proposed solutions for RTW will be prioritised and summarised in a RTW action plan, including a concrete work profile. Based on this action plan there will be searched for a suitable job in a competitive workplace. The sick-listed worker will be supported in the searching for a suitable workplace by a rehabilitation agency. Four weeks after the making of the consensus-based RTW action plan, the RTW coordinator contacts the participant and the case manager of the rehabilitation agency by telephone to inform whether placement in a workplace has been successful and if everything is satisfactory. The RTW coordinator evaluates together with the sick-listed worker which actions have been undertaken so far to overcome barriers for RTW. If necessary, the action plan for RTW is adapted to new circumstances. The RTW coordinator summarizes findings in a final report.

Timepoints:
1. Baseline (T0);
2. 3 months follow-up (T1);
3. 6 months follow-up (T2);
4. 9 months follow-up (T3);
5. 12 months follow-up (T4)
- RECORD7-aug-2012 - 19-aug-2013


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