NCT06874439

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jun 2024Oct 2027

Study Start

First participant enrolled

June 17, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

December 4, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

February 20, 2025

Last Update Submit

December 3, 2025

Conditions

RecoveryOrganization of Health ServiceMental Health CareMental Health Services

Keywords

User rightsRecovery-oriented practicesMental Health SettingsSatisfaction with careInterventional studyRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • 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

  • Distribution of hospital activity

    At baseline, at 1 year, and at 2 years

  • +8 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Sectors receiving the WHO QualityRights program

Other: WHO QualityRights program

Usual practices

NO INTERVENTION

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

Interventions

WHO QualityRights programOTHER

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: 1. Site preparation 2. On-site observation 3. Restitution of observation report and follow-up

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

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

Armentières, 59280, France

Location

Public mental health establishment of Lille Metropole (59G20)

Armentières, 59280, France

Location

Hospital Centre of Erstein

Erstein, 67150, France

Location

Psychotherapeutic Center of Nancy

Laxou, 54520, France

Location

Hospital Centre Drôme Vivarais

Montéléger, 26760, France

Location

Hospital Care Center of Nanterre

Nanterre, 92014, France

Location

Hospital Centre Sainte-Marie Nice

Nice, 06100, France

Location

Hospital Center of Plaisir (78G16)

Plaisir, 78370, France

Location

Hospital Center of Plaisir (78G18)

Plaisir, 78370, France

Location

Hospital Center of Candélie

Pont-du-Casse, 47480, France

Location

Study Officials

  • Déborah Sebbane, MD, PhD

    GCS-CCOMS & ECEVE 1123 INSERM

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

March 13, 2025

Study Start

June 17, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

December 4, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(10)