跳至主要内容
临床试验/NCT06874439
NCT06874439进行中(未招募)不适用

An Evaluation of the WHO QUAlityRights Program

GCS-CCOMS10 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2024年6月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,800
试验地点
10
主要终点
Satisfaction with care

研究概览

简要总结

The World Health Organization's (WHO) QualityRights (QR) program offers assessments and recommendations to help mental health facilities, on a voluntary basis, improve their care practices towards better respect of the rights of service users. The aim of this study is to evaluate the QR program in a French national context.

The main questions it aims to answer are:

  • Does the QR program improve perceived satisfaction with care among mental health service users?
  • What are the implementation procedures of the program?
  • What is its budgetary impact?

Researchers will compare the QR program intervention with usual practices.

详细描述

In France, despite the existence of recommendations and a restrictive legal framework, the use of restraint practices in psychiatry remains widespread, and the duration and conditions of hospitalization do not always guarantee respect for users' rights.

The World Health Organization's (WHO) QualityRights (QR) program offers assessments, called "observations", and recommendations to help mental health facilities, on a voluntary basis, improve their care practices towards better respect of the rights of service users. However, the program has never been evaluated in a French national context.

The WHO QR program, published in 2012 and regularly updated since, aims to improve the quality of care in mental health and related services and promote the rights of people with psychosocial, intellectual and cognitive disabilities.

The reference base for the tools that make up the program is the United Nations Convention on the Rights of Persons with Disabilities (CRPD), ratified by France in 2010. This international convention defines ambitious objectives in terms of respect for rights, some of which are particularly relevant to mental health services. However, the convention does not offer any concrete indications as to how these major international standards are to be applied.

The QR program provides a concrete response to this need, offering observation and training tools not only for mental health services, but more broadly for all those concerned by mental health issues. In particular, the observation methodology is designed to respond to a request for support in changing practices that comes directly from a facility.

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

入排标准

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

入选标准

  • •Adults (18 years or older)
  • •Persons having formulated a non-opposition to participate in the study
  • •Population a (users): Service users of the psychiatric sectors involved in the study hospitalized full-time since at least 3 days in an inpatient unit.
  • •Population b (professionals): Mental health professionals working in the sector since at least 3 months at the time of study participation

排除标准

  • •Persons physically or psychologically unable to participate at the time of the study
  • •Persons subject to a safeguard of justice measure
  • •Persons who do not speak or understand the French language

研究组 & 干预措施

Intervention

Experimental

Sectors receiving the WHO QualityRights program

干预措施: WHO QualityRights program (Other)

Usual practices

No Intervention

Sectors not receiving the WHO QualityRights program, and maintaining usual practices

结局指标

主要结局

Satisfaction with care

时间窗: At baseline, at 1 year, and at 2 years

Service user satisfaction with care score assessed using the Verona Service Satisfaction Scale (VSSS-54F)

次要结局

  • Work-related quality of life(At baseline, at 1 year, and at 2 years)
  • Involuntary psychiatric hospitalisations(At baseline, at 1 year, and at 2 years)
  • Length of stay(At baseline, at 1 year, and at 2 years)
  • Seclusion and restraint(At baseline, at 1 year, and at 2 years)
  • Cost-utility(24 months)
  • Budgetary impact - costs(5 years after hypothetical generalization)
  • Distribution of hospital activity(At baseline, at 1 year, and at 2 years)
  • Cost-effectiveness(24 months)
  • Budgetary impact - QALY(5 years after hypothetical generalization)
  • Budgetary impact - Involuntary psychiatric hospitalizations(5 years after hypothetical generalization)
  • Budgetary impact - Length of stay(5 years after hypothetical generalization)
  • Budgetary impact - Seclusion and restraint(5 years after hypothetical generalization)
  • Implementation(In the 1 year following the last time point)

研究者

发起方
GCS-CCOMS
申办方类型
Other
责任方
Sponsor

研究点 (10)

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