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A Naturalistic Controlled Trial of Individual Placement and Control in Bodø (IPSBODO)

Primary Purpose

Severe Mental Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
IPS
Sponsored by
Norwegian Institute of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Severe Mental Disorder

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Severe mental illness
  • Work assessment allowance

Exclusion Criteria:

  • Disability benefit

Sites / Locations

  • Nordland Hospital Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Individual placement and support

Control

Arm Description

Group of patients receiving IPS to increase workforce participation.

Group of patients receiving treatment as usual.

Outcomes

Primary Outcome Measures

Long-term welfare dependency
Rates of welfare dependency (rehabilitation benefits, disability benefits, sickness absence, unemployment benefits, and social benefits) in Bodø (intervention municipality) will be compared to rates of welfare dependency in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities) using Norwegian registry data.

Secondary Outcome Measures

Employment rate
Rates of employment in Bodø (intervention municipality) will be compared to employment rates in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities). The measurement tool will be Norwegian registry data from tax records with information both on employment (yes/no and time period) and taxable income (NOK).
Employment rate
Rates of employment in Bodø (intervention municipality) will be compared to employment rates in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities). The measurement tool will be Norwegian registry data from tax records with information both on employment (yes/no and time period) and taxable income (NOK).
Welfare dependency rate
Welfare dependency rates (rehabilitation benefits, disability benefits, sickness absence, unemployment benefits, and social benefits) in Bodø (intervention group/municipality) will be compared to 10 similar municipalities without IPS-services (control groups/municipalities).
Welfare dependency rate
Rates of welfare dependency (rehabilitation benefits, disability benefits, sickness absence, unemployment benefits, and social benefits) in Bodø (intervention municipality) will be compared to rates of welfare dependency in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities) using Norwegian registry data.
Rates of treatments for mental illness
Rates of health care utilization in Bodø (intervention municipality) will be compared to health care utilization rates in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities). Health care utilization will be based on data from the Norwegian Patient Register. We will use data for in-patient and out-patients treatments for mental illness and other (separate analyses), collected from the Norwegian Patient Register as a measurement tool. These will be analysed separate and combined, and the main hypothesis will be based on the first.
Rates of treatments for mental illness
Rates of health care utilization in Bodø (intervention municipality) will be compared to health care utilization rates in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities). Health care utilization will be based on data from the Norwegian Patient Register. We will use data for in-patient and out-patients treatments for mental illness and other (separate analyses), collected from the Norwegian Patient Register as a measurement tool. These will be analysed separate and combined, and the main hypothesis will be based on the first.

Full Information

First Posted
November 30, 2018
Last Updated
November 25, 2019
Sponsor
Norwegian Institute of Public Health
Collaborators
Nordlandssykehuset HF, University of Tromso, London School of Economics and Political Science, University of Melbourne, St George's Healthcare NHS Trust, The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT04179877
Brief Title
A Naturalistic Controlled Trial of Individual Placement and Control in Bodø
Acronym
IPSBODO
Official Title
A Naturalistic Controlled Trial of Individual Placement and Control in Bodø
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian Institute of Public Health
Collaborators
Nordlandssykehuset HF, University of Tromso, London School of Economics and Political Science, University of Melbourne, St George's Healthcare NHS Trust, The University of New South Wales

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators aim to test the effectiveness of Individual Placement and Support (IPS) on employment, welfare dependency, and 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 increasing employment, reducing welfare dependency, and 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: Employment will be based on registry data from tax records with information both on employment (yes/no and period) and taxable income (NOK). 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Mental Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Naturalistic controlled trial with one municipality (Bodø) as treatment group and 10 similar municipalities without IPS services as controls.
Masking
None (Open Label)
Masking Description
The control municipalities are unaware of this project, and are thus masked to the study.
Allocation
Non-Randomized
Enrollment
77000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individual placement and support
Arm Type
Experimental
Arm Description
Group of patients receiving IPS to increase workforce participation.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Group of patients receiving treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
IPS
Intervention Description
Occupational rehabilitation and support Integrated with clinical treatment
Primary Outcome Measure Information:
Title
Long-term welfare dependency
Description
Rates of welfare dependency (rehabilitation benefits, disability benefits, sickness absence, unemployment benefits, and social benefits) in Bodø (intervention municipality) will be compared to rates of welfare dependency in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities) using Norwegian registry data.
Time Frame
15 years after implementation of IPS-services in Bodø (intervention municipality)
Secondary Outcome Measure Information:
Title
Employment rate
Description
Rates of employment in Bodø (intervention municipality) will be compared to employment rates in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities). The measurement tool will be Norwegian registry data from tax records with information both on employment (yes/no and time period) and taxable income (NOK).
Time Frame
3 years after implementation of IPS-services in Bodø, Norway
Title
Employment rate
Description
Rates of employment in Bodø (intervention municipality) will be compared to employment rates in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities). The measurement tool will be Norwegian registry data from tax records with information both on employment (yes/no and time period) and taxable income (NOK).
Time Frame
7 years after implementation of IPS-services in Bodø, Norway (intervention municipality)
Title
Welfare dependency rate
Description
Welfare dependency rates (rehabilitation benefits, disability benefits, sickness absence, unemployment benefits, and social benefits) in Bodø (intervention group/municipality) will be compared to 10 similar municipalities without IPS-services (control groups/municipalities).
Time Frame
3 years after implementation of IPS-services in Bodø (intervention municipality)
Title
Welfare dependency rate
Description
Rates of welfare dependency (rehabilitation benefits, disability benefits, sickness absence, unemployment benefits, and social benefits) in Bodø (intervention municipality) will be compared to rates of welfare dependency in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities) using Norwegian registry data.
Time Frame
7 years after implementation of IPS-services in Bodø (intervention municipality)
Title
Rates of treatments for mental illness
Description
Rates of health care utilization in Bodø (intervention municipality) will be compared to health care utilization rates in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities). Health care utilization will be based on data from the Norwegian Patient Register. We will use data for in-patient and out-patients treatments for mental illness and other (separate analyses), collected from the Norwegian Patient Register as a measurement tool. These will be analysed separate and combined, and the main hypothesis will be based on the first.
Time Frame
3 years after implementation of IPS-services in Bodø (intervention municipality)
Title
Rates of treatments for mental illness
Description
Rates of health care utilization in Bodø (intervention municipality) will be compared to health care utilization rates in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities). Health care utilization will be based on data from the Norwegian Patient Register. We will use data for in-patient and out-patients treatments for mental illness and other (separate analyses), collected from the Norwegian Patient Register as a measurement tool. These will be analysed separate and combined, and the main hypothesis will be based on the first.
Time Frame
7 years after implementation of IPS-services in Bodø (intervention municipality)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe mental illness Work assessment allowance Exclusion Criteria: Disability benefit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnstein Mykletun, Prof PsyD
Organizational Affiliation
Norwegian IPH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nordland Hospital Trust
City
Bodø
State/Province
Nordland
ZIP/Postal Code
8092
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Naturalistic Controlled Trial of Individual Placement and Control in Bodø

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