跳至主要内容
临床试验/NCT04655287
NCT04655287已完成不适用

Do Low Rates of Coercion in Catchment Areas Predict Negative Effects for Persons With Severe Mental Disorders? A Register Study From Norway 2015-2017. Part of Reducing Coercion in Norway (ReCoN)

University Hospital, Akershus0 个研究点目标入组 21,759 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21,759
主要终点
Time to death

研究概览

简要总结

Involuntary mental health care is permitted because it is believed to make people with severe mental disorders (SMD) better and prevent them from getting worse or even dying In this study we will investigate whether low levels of coercion in an area is connected with poorer outcomes in Norway. It can be assumed that too little involuntary care might lead to the opposite outcomes to those intended by the Norwegian Mental Health Act.

The same law applies all over Norway, but the rate of involuntary care varies: there is up to five-fold difference between the catchment areas of the 69 Community Mental Health Centers. The investigators will estimate rates of involuntary care and adjust for age, sex, urbanity and area deprivation. The data source is the Norwegian Patients Registry, and all patients in treatment for a severe mental disorder in 2015 and their use of mental health care until 2018 will be followed.

Model 1 follows all patients who were treated for a severe mental disorder in 2015. The model will test whether the rates of involuntary care in the area they live can predict the length of time to death.

Model 2 follows patients with treatment for severe mental disorders that had no episode of involuntary care in 2015. The model will test whether the rate of involuntary care in their area predicts their use of mental health inpatient care in 2016 and 2017.

Model 3 tests how long time patients with severe mental disorders that received only voluntary care in 2015 remain without a period of involuntary care in 2016-17, as a function of the rate of involuntary care in their area in 2015.

Model 4 estimates changes in the total number of patients with severe mental disorders in the catchment area in 2016-17 as a function of time and the rate of involuntary in 2015.

Model 5 tests whether suicide rates for a catchment area varies as a function of its rate of involuntary care. Because suicides are rare, we will observe the variables over longer time periods, using involuntary care rates from 2015 to 2018 and suicide rates for 2015-2019.

The study was evaluated by the Research Ethics Committee (ref 2018/795), who approved use of registry data, and by the Privacy Ombudsman at Akershus University Hospital (ref 2018-090).

详细描述

Involuntary mental health care is permitted because it is believed to make people with severe mental disorders (SMD) better and prevent them from getting worse or even dying. This study concerns whether low levels of coercion in an area is connected with poorer outcomes in Norway. Too little involuntary care could be expected to lead to the opposite outcomes to those intended by the Norwegian Mental Health Act.

The same law applies all over Norway, but the rate of involuntary care varies: there is an up to five-fold difference between the catchment areas of the 69 Community Mental Health Centers (CMHC).

This study will use national register data to test whether areas with low rates of involuntary care shows signs of failing to achieve the patient benefits of involuntary care as intended by the Norwegian Mental Health Act.

Data on involuntary care will be retrieved from the Norwegian Patient Registry (NPR) and combined with data on the general population and demographics from Statistics Norway, to study the hypothesized negative consequences of low rates of involuntary care. All of Norway's 21 Health Trusts and their 69 Community Mental Health Centers that provide specialist services are required to submit to NPR on an annual basis complete data of all service use from their hospitals' electronic patient administrative and clinical systems. The NPR conducts extensive data-quality checks, and publishes completeness data for all variables. The registry implemented a unique patient identifier in 2008, so that a patient's care can be followed across time. From the NPR database, information on all specialist mental health treatment activity for patients with set criteria (in our case diagnosis F20-31 and legal status) during a given time period (here 2015-18) can be extracted.

Both involuntary admissions and outpatient compulsion in the form of community treatment orders (CTO) are envisaged to contribute to the aims of the Mental Health Act, such as protection against harm, improvement, restoration of health, and recovery or cure for the patient. The variable of interest is low use of the combination of these two forms of involuntary care. To our knowledge, there is no established way to calculate a combined measure of inpatient and outpatient involuntary care, and it is not generally established how one form of involuntary care is associated with the other. In Norway, 31% of involuntary admissions continued as a CTO in 2018, and although permitted, CTOs are almost never initiated when the patient lives at home. When a patient is under involuntary admissions or a CTO, the care system has substantial influence and control over their treatment, and medication is a particular focus. Regardless of the form of involuntary care, control over treatment can be continued according to necessity criteria in the law in order to prevent deterioration. For these reasons, the rate of persons affected by involuntary admission and/or CTO per 100 000 capita will be used as an indicator of use of involuntary care in the catchment area and hence, the main covariate.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The person received treatment for ICD-10 codes F20-31 in Norwegian health trusts 2015

排除标准

  • Persons without permanent address in Norway (tourists)
  • For models 2 and 3, patients receiving involuntary mental health care in 2015 is excluded

结局指标

主要结局

Time to death

时间窗: 2015-2017

Time to death for patients with a severe mental disorder in 2015, as a function of the rate of involuntary care for the patient's area of residence in 2015

Mental health inpatient days

时间窗: 2015-2017

Time trends in mental health inpatient days from 2015-2017 for patients with a severe mental disorder but no involuntary care in 2015, as a function of the rate of involuntary care for the patient's area of residence in 2015

Episode of involuntary care

时间窗: 2015-2017

Time to an episode of involuntary care for patients with a severe mental disorder and no involuntary care in 2015, as a function of the rate of involuntary care for the patient's area of residence in 2015

Number of patients with severe mental disorders

时间窗: 2015-2017

Time trends in the rate of severe mental disorders in 69 catchment areas as a function of their rates of involuntary care in 2015-2018

Number of suicides

时间窗: 2015-2019

Standardized rate of suicides in 60 catchment areas in 2015-2019, as a function of rates of involuntary care in 2015-2018

次要结局

未报告次要终点

研究者

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olav Nyttingnes

PostDoctor

University Hospital, Akershus

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