An Evaluation of the WHO QUAlityRights Program (EQUAR)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Recovery; Organization of Health Service; Mental Health Services; Mental Health Care
• Intervention / Treatment: Other: WHO QualityRights program

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.

• Study Type: Interventional
• Enrollment (Estimated): 1800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Armentières, France, 59280
    • Public mental health establishment of Lille Metropole (59G09/G10)
  • Armentières, France, 59280
    • Public mental health establishment of Lille Metropole (59G20)
  • Erstein, France, 67150
    • Hospital Centre of Erstein
  • Laxou, France, 54520
    • Psychotherapeutic Center of Nancy
  • Montéléger, France, 26760
    • Hospital Centre Drôme Vivarais
  • Nanterre, France, 92014
    • Hospital Care Center of Nanterre
  • Nice, France, 06100
    • Hospital Centre Sainte-Marie Nice
  • Plaisir, France, 78370
    • Hospital Center of Plaisir (78G16)
  • Plaisir, France, 78370
    • Hospital Center of Plaisir (78G18)
  • Pont-du-Casse, France, 47480
    • Hospital Center of Candélie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Sectors receiving the WHO QualityRights program	Other: WHO QualityRights program; 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
No Intervention: Usual practices; Sectors not receiving the WHO QualityRights program, and maintaining usual practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with care	Service user satisfaction with care score assessed using the Verona Service Satisfaction Scale (VSSS-54F)	At baseline, at 1 year, and at 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work-related quality of life	Work-related quality of life score for mental health professionals assessed using the SERENAT scale	At baseline, at 1 year, and at 2 years
Involuntary psychiatric hospitalisations	Number of involuntary hospitalizations in the 6 months preceding the time point	At baseline, at 1 year, and at 2 years
Length of stay	Length of stay for each patient in the 6 months preceding the time points	At baseline, at 1 year, and at 2 years
Seclusion and restraint	Number of acts of seclusion and restraint in the 6 months preceding the time points	At baseline, at 1 year, and at 2 years
Distribution of hospital activity	Hospital case load and outpatient service utilization in the 6 months preceding the time points	At baseline, at 1 year, and at 2 years
Cost-utility	Incremental cost-utility ratio in cost per QALY gained (EQ-5D-5L questionnaire)	24 months
Cost-effectiveness	Incremental cost-effectiveness ratio in cost per VSSS-54F score points gained	24 months
Budgetary impact - costs	Costs associated with the generalization of the QR program	5 years after hypothetical generalization
Budgetary impact - QALY	The number of QALYs will be calculated with and without the QR program to assess the gains associated with its generalization.	5 years after hypothetical generalization
Budgetary impact - Involuntary psychiatric hospitalizations	The number of involuntary hospitalizations will be calculated with and without the QR program to assess the gains associated with its generalization.	5 years after hypothetical generalization
Budgetary impact - Length of stay	The length of stay will be calculated with and without the QR program to assess the gains associated with its generalization.	5 years after hypothetical generalization
Budgetary impact - Seclusion and restraint	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.	5 years after hypothetical generalization
Implementation	Qualitative methods will be used through semi-structured interviews conducted with 10 mental health professionals per sector of the intervention group.	In the 1 year following the last time point

Collaborators and Investigators

• Sponsor: GCS-CCOMS
• Collaborators: INSERM ECEVE 1123; L'Assistance Publique - Hopitaux de Paris (AP-HP)
• Investigators: Study Chair: Déborah Sebbane, MD, PhD, GCS-CCOMS & ECEVE 1123 INSERM

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 13, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Satisfaction with care; Interventional study; User rights; Recovery-oriented practices; Mental Health Settings
• Other Study ID Numbers: 2024-A00092-45; PREPS-22-0042 (Other Grant/Funding Number: French Ministry of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No