|- candidate number||1490|
|- NTR Number||NTR292|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||SCION - Study on Cost-effectiveness of IPS regarding Open employment in the Netherlands.|
|- Scientific Title||Effects and Costs of the Individual Placement and Support Program for People with Severe Mental Illness, a Multi-site Randomised Clinical Trial.|
|- hypothesis||1. Clients in IPS will get more competitive jobs, work more hours, and earn more wages than clients in standard services.|
2. IPS will be more cost-effective than standard services in terms of combined medical and non-medical costs.
|- Healt Condition(s) or Problem(s) studied||Mental illness|
|- Inclusion criteria||1. Clients of mental health teams specifically focussed at people with severe mental illness (e.g. diagnosis of a serious mental illness (schizophrenia and schizophrenia-like disorders, bipolar disorder, depression with psychotic features);|
2. Age 18 - 65 years (i.e. age of retirement);
3. Living in the community at baseline (i.e. not hospitalised);
4. Clear interest in competitive;
employment as a short- or long-term goal;
5. No competitive work at inclusion;
6. Willing to give informed consent.
|- Exclusion criteria||N/A|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-sep-2005|
|- planned closingdate||1-okt-2008|
|- Target number of participants||150|
|- Interventions||The study is located at four mental health agencies (mentioned at ‘secondary sponsors’). |
IPS (experimental condition) is integrated within case management teams. These teams (staff patient ratio of 1:20 to 30) deliver comprehensive treatment and care for severely mentally ill clients in their respective catchment areas. An employment specialist (or IPS worker) is added to the team to offer IPS. The employment specialist assists people in getting jobs, offers follow-along support after job placement, and spends most of the time in the community. The employment specialist works in close collaboration with the other team members and attends team meetings.
Clients in the control condition use the same treatment and care facilities. In this condition the mental health staff or a counselor links eligible clients to separate vocational services, based on individual competencies and preferences.
These services range from vocational services offered by the mental health agency (in a separate rehabilitation center), a sheltered workshop and/or reintegration companies. In general these services focus more on getting people ready for competitive employment (by assessment, training, prevocational activities and voluntary jobs) instead of the rapid job search of IPS. The primary difference with IPS is that staff from the these control rehabilitation services are not part of the case management teams.
|- Primary outcome||1. Proportion entering competitive employment during the follow-up period;|
2. Competitive employment is defined as part- or full-time work in competitive job market at prevailing wages with supervision provided by personnel employed by the business and in integrated work settings;
3. In a secondary analysis we will also include subsidized work in regular job settings (including temporary competitive work without loss of benefits rights.
|- Secondary outcome||Vocational: |
1. Hours in competitive employment;
2. Jobs held;
3. Duration of each job in days;
4. Days from baseline to entering first job;
5. Total earnings;
6. Job satisfaction (Indiana Job Satisfaction Scale);
7. Generic work behaviour (Generic Work Behaviour Questionnaire);
9. Days in hospital;
10. Psychiatric symptoms;
11. Global functioning (Global Assessment of Functioning Scale S-D);
13. Quality of life;
14. Costs: based on Client Socio-demographic and Service Receipt Inventory.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. H. Michon |
|- CONTACT for SCIENTIFIC QUERIES||MD. J.J. Wiersma|
|- Sponsor/Initiator ||Trimbos-institute - Netherlands Institute of Mental Health and Addiction, University Medical Center Groningen (UMCG), Rob Giel Research Center (RGOc), Eindhoven Mental Health Care , Groningen Mental Health Care , Adhesie Mental Health Care Midden-Overijssel , Mental Health Care Groep Europoort, Maaskringgroep|
(Source(s) of Monetary or Material Support)
|UWV (Workers Insurance Authority), Trimbos Institute - Netherlands Institute of Mental Health and Addiction, Rob Giel Research centre |
|- Brief summary||Only 10% of people with severe mental illness (SMI) in the Netherlands have competitive employment. |
The Dutch approach to vocational rehabilitation is a cautious one: care providers feel many people with SMI are too symptomatic to work and vocational rehabilitation is focused on pre-vocational training and sheltered work.
In an implementation project experience has been gained with the Individual Placement and Support (IPS) model of vocational rehabilitation. IPS is integrated within mental health services and focuses on rapid job search. Clinical trials of IPS so far show a large increase of clients with SMI getting a paid job (56% versus 20% with standard vocational services).
Although enrolment in IPS itself does not lead to improved clinical outcomes, clients who actually engage in competitive work do experience improvements in self-esteem, and control of symptoms (Bond et al, 2001).
This is a study of the costs and effects of IPS at four sites in the Netherlands. 150 clients will be randomised to IPS or standard vocational services.
Primary outcome measures is the proportion participants entering competitive employment during the 18 month follow-up period. Cost-effectiveness will be assessed, as measured by differences in combined costs per hour of competitive employment gained.
Investigators: J. van Busschbach*, N. van Erp**, H. Kroon**, H. Michon**, A. Niersman*, D. Stant*, J. van Weeghel**; D. Wiersma*
* RGOc - UMC Groningen; **Trimbos Institute
|- Main changes (audit trail)|
|- RECORD||9-sep-2005 - 7-mrt-2006|