A Naturalistic Controlled Trial of Individual Placement and Control in Bodø
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 77,000
- 试验地点
- 2
- 主要终点
- Long-term welfare dependency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
The control municipalities are unaware of this project, and are thus masked to the study.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe mental illness
- •Work assessment allowance
排除标准
- •Disability benefit
结局指标
主要结局
Long-term welfare dependency
时间窗: 15 years after implementation of IPS-services in Bodø (intervention municipality)
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.
次要结局
- Welfare dependency rate(7 years after implementation of IPS-services in Bodø (intervention municipality))
- Rates of treatments for mental illness(7 years after implementation of IPS-services in Bodø (intervention municipality))
- Employment rate(7 years after implementation of IPS-services in Bodø, Norway (intervention municipality))