Clinical trial NCT06874439: An Evaluation of the WHO QUAlityRights Program
Official title: An Evaluation of the WHO QUAlityRights Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Recovery
Organization of Health Service
Mental Health Care
Mental Health Services
Keywords: User rights
Recovery-oriented practices
Mental Health Settings
Satisfaction with care
Interventional study
Randomized controlled trial
Lead sponsor: GCS-CCOMS
Sponsor class: OTHER
Collaborators: name: INSERM ECEVE 1123
name: L'Assistance Publique - Hopitaux de Paris (AP-HP)
First posted: 2025-03-13
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

The WHO Collaborating Centre in Lille is mandated by the WHO to roll out this program in France and other French-speaking countries. It is expected that the QualityRights approach will act as a lever for change in the organization of services, providing a multidisciplinary perspective on users' rights and recovery-oriented practices.

The primary research objective is to evaluate the effectiveness of the QR program on the perceived satisfaction with care of mental health service users.

The secondary research objectives concern:

A. Evaluating the effectiveness of the QR program on:

1. Improving work-related quality of life among mental health professionals
2. Decreasing the number of involuntary admissions
3. Reducing the length of full-time hospital stays
4. Reducing the number of acts of seclusion and restraint
5. The distribution of clinical activity in favour of ambulatory activity

B. Evaluating the efficiency and the budgetary impact of the QR program.

C. Conducting an implementation study to understand the appropriation of the recommendations by professionals and management following the introduction of the QR program by exploring the representations linked to the QR program and respect for users' rights among mental health professionals.

This research involves an effectiveness study, supplemented by an implementation study based on a qualitative methodology, and an economic evaluation.

The effectiveness study is a cluster randomized trial designed to compare the effectiveness of the QR program intervention versus usual practices on user satisfaction. The cluster is defined at the level of the psychiatric sector (the public psychiatric care entity organizing the mental health care of a population within a pre-specified geographical and demographic area in France, to meet local needs). 10 psychiatric sectors are participating, randomized into two groups: the intervention group receiving the QR program and the control group maintaining their usual practices.

Data will be collected in both groups at baseline, and during follow-up at 1 and 2 years. The implementation study and the economic evaluation will be carried out in the intervention group after the effectiveness study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Satisfaction with care
timeFrame: At baseline, at 1 year, and at 2 years
Secondary outcomes:
measure: Work-related quality of life
timeFrame: At baseline, at 1 year, and at 2 years
measure: Involuntary psychiatric hospitalisations
timeFrame: At baseline, at 1 year, and at 2 years
measure: Length of stay
timeFrame: At baseline, at 1 year, and at 2 years
measure: Seclusion and restraint
timeFrame: At baseline, at 1 year, and at 2 years
measure: Distribution of hospital activity
timeFrame: At baseline, at 1 year, and at 2 years
measure: Cost-utility
timeFrame: 24 months
measure: Cost-effectiveness
timeFrame: 24 months
measure: Budgetary impact - costs
timeFrame: 5 years after hypothetical generalization
measure: Budgetary impact - QALY
timeFrame: 5 years after hypothetical generalization
measure: Budgetary impact - Involuntary psychiatric hospitalizations
timeFrame: 5 years after hypothetical generalization
measure: Budgetary impact - Length of stay
timeFrame: 5 years after hypothetical generalization
measure: Budgetary impact - Seclusion and restraint
timeFrame: 5 years after hypothetical generalization
measure: Implementation
timeFrame: In the 1 year following the last time point
Other outcomes:
Locations:
city: Armentières
country: France
facility: Public mental health establishment of Lille Metropole (59G09/G10)
city: Armentières
country: France
facility: Public mental health establishment of Lille Metropole (59G20)
city: Erstein
country: France
facility: Hospital Centre of Erstein
city: Laxou
country: France
facility: Psychotherapeutic Center of Nancy
city: Montéléger
country: France
facility: Hospital Centre Drôme Vivarais
city: Nanterre
country: France
facility: Hospital Care Center of Nanterre
city: Nice
country: France
facility: Hospital Centre Sainte-Marie Nice
city: Plaisir
country: France
facility: Hospital Center of Plaisir (78G16)
city: Plaisir
country: France
facility: Hospital Center of Plaisir (78G18)
city: Pont-du-Casse
country: France
facility: Hospital Center of Candélie
Study officials:
affiliation: GCS-CCOMS & ECEVE 1123 INSERM
name: Déborah Sebbane, MD, PhD
role: STUDY_CHAIR
References: