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

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.

Study Overview

• Status: Unknown
• Conditions: Severe Mental Disorder
• Intervention / Treatment: Behavioral: IPS

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.

• Study Type: Interventional
• Enrollment (Anticipated): 77000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Nordland
    • Bodø, Nordland, Norway, 8092
      • Nordland Hospital Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Severe mental illness
• Work assessment allowance

Exclusion Criteria:

• Disability benefit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Individual placement and support; Group of patients receiving IPS to increase workforce participation.	Behavioral: IPS; Occupational rehabilitation and support Integrated with clinical treatment
NO_INTERVENTION: Control; Group of patients receiving treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 years after implementation of IPS-services in Bodø (intervention municipality)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 years after implementation of IPS-services in Bodø, Norway
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).	7 years after implementation of IPS-services in Bodø, Norway (intervention municipality)
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).	3 years after implementation of IPS-services in Bodø (intervention municipality)
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.	7 years after implementation of IPS-services in Bodø (intervention municipality)
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.	3 years after implementation of IPS-services in Bodø (intervention municipality)
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.	7 years after implementation of IPS-services in Bodø (intervention municipality)

Collaborators and Investigators

• Sponsor: Norwegian Institute of Public Health
• Collaborators: University of Tromso; Nordlandssykehuset HF; University of Melbourne; The University of New South Wales; London School of Economics and Political Science; St George's Healthcare NHS Trust
• Investigators: Principal Investigator: Arnstein Mykletun, Prof PsyD, Norwegian IPH

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2013
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (ACTUAL): November 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: IPSBODO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No