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Active, Not Recruiting

NCT Number: NCT06874439

An Evaluation of the WHO QUAlityRights Program

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public mental health establishment of Lille Metropole (59G09/G10), Armentières, France

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About this study

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:

  • Improving work-related quality of life among mental health professionals
  • Decreasing the number of involuntary admissions
  • Reducing the length of full-time hospital stays
  • Reducing the number of acts of seclusion and restraint
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WHO QualityRights program

Other

The WHO's QualityRights program involves an assessment, called observation, of mental health care services by an ephemeral multidisciplinary team, which provides feedback and recommendations for improving care practices. The observation team, trained in the QualityRights (QR) methodology, includes mental health professionals, researchers, legal experts, and management staff from mental health organizations. Each team always incorporates at least one expert by experience and one informal caregiver or family member. Participation in the program is voluntary and initiated at the request of healthcare facilities.

The observation is structured into three stages:

  • Site preparation
  • On-site observation
  • Restitution of observation report and follow-up

Primary outcomes

  1. Satisfaction with care

    Time frame: At baseline, at 1 year, and at 2 years

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

Secondary outcomes

  1. Work-related quality of life

    Time frame: At baseline, at 1 year, and at 2 years

    Work-related quality of life score for mental health professionals assessed using the SERENAT scale

  2. Involuntary psychiatric hospitalisations

    Time frame: At baseline, at 1 year, and at 2 years

    Number of involuntary hospitalizations in the 6 months preceding the time point

  3. Length of stay

    Time frame: At baseline, at 1 year, and at 2 years

    Length of stay for each patient in the 6 months preceding the time points

  4. Seclusion and restraint

    Time frame: At baseline, at 1 year, and at 2 years

    Number of acts of seclusion and restraint in the 6 months preceding the time points

  5. Distribution of hospital activity

    Time frame: At baseline, at 1 year, and at 2 years

    Hospital case load and outpatient service utilization in the 6 months preceding the time points

  6. Cost-utility

    Time frame: 24 months

    Incremental cost-utility ratio in cost per QALY gained (EQ-5D-5L questionnaire)

  7. Cost-effectiveness

    Time frame: 24 months

    Incremental cost-effectiveness ratio in cost per VSSS-54F score points gained

  8. Budgetary impact - costs

    Time frame: 5 years after hypothetical generalization

    Costs associated with the generalization of the QR program

  9. Budgetary impact - QALY

    Time frame: 5 years after hypothetical generalization

    The number of QALYs will be calculated with and without the QR program to assess the gains associated with its generalization.

  10. Budgetary impact - Involuntary psychiatric hospitalizations

    Time frame: 5 years after hypothetical generalization

    The number of involuntary hospitalizations will be calculated with and without the QR program to assess the gains associated with its generalization.

  11. Budgetary impact - Length of stay

    Time frame: 5 years after hypothetical generalization

    The length of stay will be calculated with and without the QR program to assess the gains associated with its generalization.

  12. Budgetary impact - Seclusion and restraint

    Time frame: 5 years after hypothetical generalization

    The number of acts of seclusion and restraint will be calculated with and without the QR program to assess the gains associated with its generalization.

  13. Implementation

    Time frame: In the 1 year following the last time point

    Qualitative methods will be used through semi-structured interviews conducted with 10 mental health professionals per sector of the intervention group.

Sponsors and collaborators

Lead sponsor

GCS-CCOMS

Other

Collaborators

  • INSERM ECEVE 1123
  • L'Assistance Publique - Hopitaux de Paris (AP-HP)

Registry information

Acronym: EQUAR

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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