- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05136989
Psychiatry and Individual Liberties: a Study of Institutions Characterized by a Reduced Use of Coercion ((PLAID-Care))
March 8, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
Psychiatric establishments show significant disparities in terms of coercion: while some use it frequently, others use it only exceptionally.
This project aims at a better understanding of the less coercive establishments, which are currently little investigated and whose study may allow to identify the levers of a psychiatry more respectful of individual liberties.
Study Overview
Status
Recruiting
Conditions
Detailed Description
This study aims precisely at understanding the history of less coercive establishments, and at identifying the knowledge as well as the forms of organization, coordination and cooperation that are developed there.
To do so, it will consist of an inventory of establishments and practices based on the analysis of scientific literature, and an intensive study of seven less coercive establishments (four establishments on the French national territory, three establishments in the Auvergne-Rhône-Alpes region).
The study of these institutions and their environment, which mobilizes nursing research and sociology, is based on a methodological approach combining interviews with professionals and users, observations in the institutions and services, a documentary method, and analysis of data from the RIM-P, the SAE, and the institutions' databases.
Study Type
Observational
Enrollment (Estimated)
98
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sébastien SAETTA, PhD
- Phone Number: 0477127778
- Email: sebastien.saetta@chu-st-etienne.fr
Study Contact Backup
- Name: Yvonne QUENUM
- Phone Number: 33 0477127722
- Email: yvonne.quenum@chu-st-etienne.fr
Study Locations
-
-
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Saint-Étienne, France, 42000
- Recruiting
- CHU Saint Etienne
-
Contact:
- Sébastien SAETTA, MD PhD
- Phone Number: +33 (0)477127778
- Email: sebastien.saetta@chu-st-etienne.fr
-
Principal Investigator:
- Sébastien SAETTA, MD PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The research focuses mainly on care and support professionals, administrative and management staff, and users of seven establishments or poles identified as less coercive (three establishments in the Auvergne-Rhône-Alpes region, and four establishments on the national territory).
Description
Inclusion Criteria:
- Professionals who worked in one of the seven establishments identified
- Ex-patients who were hospitalized in these establishments in the two years preceding the survey and whose condition is stabilized
Exclusion Criteria:
- People who refused to participate to the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Professionals from the seven least coercive facilities
Volunteer professionals selected on the basis of their experience in reducing the use of coercion.
|
Individual and collective semi-structured interviews will be performed with professionals to identify levers (practices, knowledge, tools, regulations) which, at the level of services and establishments, enable the development of a policy of less recourse to coercion
Observations will be carried out in the services in order to measure the gap between rhetoric and practice, and to observe the effective implementation of lesser use practices
|
Voluntary ex-patients
Voluntary ex-patients who were hospitalized in these establishments in the two years preceding the survey and whose condition is stabilized
|
Individual semi-structured interviews will be performed with ex-patients in order to gather their experiences in the seven institutions concerned and to better understand the impact of their hospitalization in these institutions on their lives
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
understand the history of less coercive institutions
Time Frame: Baseline from 24 months
|
identify and characterize the presence of tools, knowledge, rules, organizational specificities and collaborations in the territories allowing for less recourse to coercion.
|
Baseline from 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of professionals' satisfaction
Time Frame: Baseline from 24 months
|
Analysis interview responses
|
Baseline from 24 months
|
Analysis of ex-patients' satisfaction
Time Frame: Baseline from 24 months
|
Analysis interview responses.
|
Baseline from 24 months
|
Analysis of the impact on care pathway
Time Frame: Baseline from 24 months
|
Analysis interview responses.
|
Baseline from 24 months
|
Analysis of the impact on career paths
Time Frame: Baseline from 24 months
|
Analysis interview responses.
|
Baseline from 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sébastien SAETTA, PhD, CHU DE SAINT-ETIENNE
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
November 16, 2021
First Submitted That Met QC Criteria
November 16, 2021
First Posted (Actual)
November 30, 2021
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 8, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- IRBN1372021/CHUSTE
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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