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| ID | Type | Description | Link |
|---|---|---|---|
| PREPS-22-0042 | Other Grant/Funding Number | French Ministry of Health |
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| Name | Class |
|---|---|
| INSERM ECEVE 1123 | UNKNOWN |
| L'Assistance Publique - Hopitaux de Paris (AP-HP) | UNKNOWN |
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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:
Researchers will compare the QR program intervention with usual practices.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Sectors receiving the WHO QualityRights program |
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| Usual practices | No Intervention | Sectors not receiving the WHO QualityRights program, and maintaining usual practices |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Déborah Sebbane, MD, PhD | GCS-CCOMS & ECEVE 1123 INSERM | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public mental health establishment of Lille Metropole (59G09/G10) | Armentières | 59280 | France | |||
| Public mental health establishment of Lille Metropole (59G20) |
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|
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 |
| Armentières |
| 59280 |
| France |
| Hospital Centre of Erstein | Erstein | 67150 | France |
| Psychotherapeutic Center of Nancy | Laxou | 54520 | France |
| Hospital Centre Drôme Vivarais | Montéléger | 26760 | France |
| Hospital Care Center of Nanterre | Nanterre | 92014 | France |
| Hospital Centre Sainte-Marie Nice | Nice | 06100 | France |
| Hospital Center of Plaisir (78G16) | Plaisir | 78370 | France |
| Hospital Center of Plaisir (78G18) | Plaisir | 78370 | France |
| Hospital Center of Candélie | Pont-du-Casse | 47480 | France |