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临床试验/NCT03989765
NCT03989765已完成不适用

How Can We Reduce The Use Of Compulsion Of People With Severe Mental Illness

University Hospital, Akershus2 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2019年6月25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
900
试验地点
2
主要终点
Change in prevalence rates of involuntary treatment episodes

研究概览

简要总结

There is considerable geographical variation in the rates of compulsion in psychiatric services within as well as between countries. Reducing the use of compulsion of patients with severe mental illness is an expressed policy aim, and also a demand from service user organisations. In Norway, municipalities hold responsibility for primary care and are therefore central to the delivery of services to people with severe mental illness. This indicates a potential for intervening at the municipal level to reduce the use of compulsion where it is high. The Reducing Coercion in Norway study (RECON) will, in collaboration with municipalities with high compulsion rates, develop a municipal-level intervention (Stage 1) that will be implemented in a cluster-RCT (Stage 2) to test if it has effect on compulsion rates.pulsion rates.

详细描述

BACKGROUND:

In Norway, as in other parts of the Western world, there have been concerns about increase in the use of compulsory mental health care for patients with severe mental illness. There is growing public concern, however, despite the explicit instruction from the Norwegian government that health services should reduce the use of compulsion, rates have not decreased. The Reducing Coercion in Norway study (RECON) is designed to develop and test an intervention, at the municipal level, to reduce the use of compulsion.

Most referrals to compulsory treatment come from primary care. In Norway, it is the 400+ municipalities who hold responsibility for primary care. This includes multi-disciplinary municipal mental health teams, substance abuse services, social care and GP services. At the Specialist level, four Regional Health Authorities Commission a number of Health Trusts to deliver specialist mental health care through acute hospitals and District Psychiatric Centres. These centres often collaborate, in different ways, with municipal services.

Municipal service providers are often those in most frequent contact with patients with severe mental illness, and will commonly be those detecting early signs of relapse. Importantly, municipal services (usually GPs or out of hours emergency services) will serve as gatekeepers for involuntary admissions, as they refer to specialist services who then may invoke the Mental Health Act that sanctions compulsion. This suggests a potential for developing strategies within municipal services to intervene early and possibly prevent some episodes of compulsion. Very little research has investigated the role municipal services play in the compulsion or on relevant cross-sectoral collaborations. There is also limited research on out-patient interventions designed to reduce compulsion. A systematic review could only include 15 experimental studies internationally. Joint crisis plans, risk assessments and counselling of staff were identified as promising interventions. However, most studies had insufficient samples or were of too poor quality to draw conclusions. Moreover, all included studies were based in specialist out-patient services.

The 'Six Core Strategies' intervention, developed to reduce seclusion and restraint in psychiatric hospitals, has shown positive effects. The six strategies involved are: structured efforts to improve leadership and organisational change; use of data to inform practice; workforce development; use of seclusion and restraint reduction tools; involvement of peers, and; rigorous debriefing techniques. It has been implemented in six countries, with positive results. No equivalent has been developed for municipal services. Service users and clinicians in Norway have, however, suggested potential strategies for municipal services to impact on compulsion rates. These include crisis plans; structured meetings of patients' networks, spaces for informal contact; key contact persons for patients; improved skills for early detection of relapse and; improved local collaboration. Given the potential role of municipalities for reducing the use of compulsion, it seems clear that further research is needed. RECON takes the Six Core Strategies model as a starting point for developing and testing a municipality-based intervention for reducing the use of compulsion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

The control group will be masked, but it is not possible to mask the intervention group.

入排标准

性别
All
接受健康志愿者

入选标准

  • As we are developing a new intervention, we will target municipalities in the higher 50 percent of rates of involuntary treatment episodes, and of a size that makes it possible to detect effect. To avoid the effect of the national reorganisation of Norwegian municipalities that is currently underway, those municipalities involved in a merging process of their services will not be targeted.
  • Eligible municipalities are those that:
  • Have a population size between 20-50K inhabitants (figures from 2018)
  • Are in the upper half of all municipalities in terms of the rate of involuntary treatment (figures from 2016-17)
  • Are not affected by a merging process

排除标准

  • Municipalities neighbouring another eligible municipality will not be included to prevent contamination should one of them be randomised to the intervention group. The municipality with the lowest rate of involuntary treatment episodes will be removed

结局指标

主要结局

Change in prevalence rates of involuntary treatment episodes

时间窗: 12 months prior to and 12 months after the intervention period has ended

Change in prevalence rates of involuntary treatment episodes per 10K inhabitants over the age of 18. Involuntary treatment episodes will include both inpatient and outpatient episodes of compulsion

次要结局

  • Duration of compulsion(12 months prior to and 12 months during the intervention)
  • Referral rates(12 months prior to and 12 months during the intervention)
  • Referral outcome(12 months prior to and 12 months during the intervention)

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

Jorun Rugkåsa

Senior Researcher

University Hospital, Akershus

研究点 (2)

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