Clinical trial NCT04179877: A Naturalistic Controlled Trial of Individual Placement and Control in Bodø
Official title: A Naturalistic Controlled Trial of Individual Placement and Control in Bodø
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Mental Disorder
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: Nordlandssykehuset HF
name: University of Tromso
name: London School of Economics and Political Science
name: University of Melbourne
name: St George's Healthcare NHS Trust
name: The University of New South Wales
First posted: 2019-11-27
Enrollment: 77000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Naturalistic controlled trial with one municipality (Bodø) as treatment group and 10 similar municipalities without IPS services as controls.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators aim to test the effectiveness of Individual Placement and Support (IPS) on

1. employment,
2. welfare dependency, and
3. public-sector health care utilization.

This is a naturalistic controlled trial, where one municipality (Bodø in Norway) with about 50000 inhabitants get access to IPS services in public sector mental health services during the period 2013-2016. The target group for the intervention is patients with severe mental illness (SMI) in the age group 18-40 at time of treatment. Patients already receiving lifelong disability benefits will be excluded.

The control group will be an average of 10 municipalities in Norway without IPS services.

Data for outcomes will be based on public registries available for research.

Detailed description: The investigators aim test the hypotheses that Individual Placement and Support (IPS) is effective in

1. increasing employment,
2. reducing welfare dependency, and
3. reducing public-sector health care utilization.

This is a naturalistic controlled trial, where one municipality (Bodø in Norway) with about 50000 inhabitants get access to IPS services in public sector mental health services during the period 2013-2016. The follow-up period will last until 2022. The target group for the intervention is patients with severe mental illness (SMI) in the age group 18-40 at time of treatment, with an ambition of 200 received IPS services. The investigators aim to study the effectiveness on the societal (not individual) level, assuming spill-over effects within Bodø municipality as a result of system changes in the treatment municipality (Bodø). Patients already receiving lifelong disability benefits will be excluded. The control group will be 10 similar municipalities in Norway without IPS services and will be chosen on the basis of similarities in economy, demography and geography and collected from publicly available information. Approximately 77000 subjects will be enrolled in this study; 7000 subjects from Bodø municipality and 70000 from the other 10 municipalities (the control group).

Data for outcomes will be based on public registries available for research. Outcome operationalizations are:

1. Employment will be based on registry data from tax records with information both on employment (yes/no and period) and taxable income (NOK).
2. Welfare dependency will be based on registry data including rehabilitation benefits, disability benefits, sickness absence, unemployment benefits, and social benefits. These will be analysed separate and combined, and the main hypothesis will be based on the latter.
3. Health care utilization will be based on data from the Norwegian Patient Register. Data for in-patient and out-patients treatments for mental illness and other (separate analyses) will be used. These will be analysed separate and combined, and the main hypothesis will be based on the first.

The data will be analyzed in two rounds; first in 2019, and a follow-up analysis in 2022. A difference-in-difference approach will be used to measure the effects.

Eligibility criteria: Inclusion Criteria:

* Severe mental illness
* Work assessment allowance

Exclusion Criteria:

* Disability benefit

Primary outcomes:
measure: Long-term welfare dependency
timeFrame: 15 years after implementation of IPS-services in Bodø (intervention municipality)
Secondary outcomes:
measure: Employment rate
timeFrame: 3 years after implementation of IPS-services in Bodø, Norway
measure: Employment rate
timeFrame: 7 years after implementation of IPS-services in Bodø, Norway (intervention municipality)
measure: Welfare dependency rate
timeFrame: 3 years after implementation of IPS-services in Bodø (intervention municipality)
measure: Welfare dependency rate
timeFrame: 7 years after implementation of IPS-services in Bodø (intervention municipality)
measure: Rates of treatments for mental illness
timeFrame: 3 years after implementation of IPS-services in Bodø (intervention municipality)
measure: Rates of treatments for mental illness
timeFrame: 7 years after implementation of IPS-services in Bodø (intervention municipality)
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Nordland Hospital Trust
state: Nordland
Study officials:
affiliation: Norwegian IPH
name: Arnstein Mykletun, Prof PsyD
role: PRINCIPAL_INVESTIGATOR
References: