Psychiatric Hospitalization(PLAID-Care)NCT05136989
Psychiatry and Individual Liberties: a Study of Institutions Characterized by a Reduced Use of Coercion
An observational study of Psychiatric Hospitalization, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Hospitalization
- What is being tested?
- Individual and collective semi-structured interviews, Individual semi-structured interviews with ex-patients and Observations out in the services
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- People who refused to participate to the study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Saint Etienne
Saint-Etienne, 42000
Sébastien SAETTA, MD PhD, (0)477127778 ext. +33, sebastien.saetta@chu-st-etienne.fr
Sébastien SAETTA, MD PhD
About this study
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.
Read the 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.
- Conditions
- Psychiatric Hospitalization
- Being tested
- Individual and collective semi-structured interviews, Individual semi-structured interviews with ex-patients, Observations out in the services
- Keywords
- Psychiatry, Reduction of coercion, Interviews, Observations, Sociology, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual and collective semi-structured interviewsBehavioural
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
Individual semi-structured interviews with ex-patientsBehavioural
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
Observations out in the servicesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Professionals from the seven least coercive facilities | Volunteer professionals selected on the basis of their experience in reducing the use of coercion. Receives: Behavioral: Individual and collective semi-structured interviews; Behavioral: Observations out in the services | |
| Voluntary ex-patients | Voluntary ex-patients who were hospitalized in these establishments in the two years preceding the survey and whose condition is stabilized Receives: Behavioral: Individual semi-structured interviews with ex-patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
understand the history of less coercive institutions
identify and characterize the presence of tools, knowledge, rules, organizational specificities and collaborations in the territories allowing for less recourse to coercion.
Measured: Baseline from 24 months
Secondary outcomes (4)
Analysis of professionals' satisfaction
Analysis interview responses
Measured: Baseline from 24 months
Analysis of ex-patients' satisfaction
Analysis interview responses.
Measured: Baseline from 24 months
Analysis of the impact on care pathway
Analysis interview responses.
Measured: Baseline from 24 months
Analysis of the impact on career paths
Analysis interview responses.
Measured: Baseline from 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Dec 2021
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric HospitalizationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- L'École Nationale des Solidarités, de l'Encadrement et de l'Intervention Sociale (ENSEIS)
- Responsible party
- Sponsor
- Investigators
- Sébastien SAETTA, PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136989
- Sponsor's protocol ID
- IRBN1372021/CHUSTE
- Acronym
- (PLAID-Care)
- Status last verified
- Mar 2024
- First submitted
- 16 Nov 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatry and Individual Liberties: a Study of Institutions Characterized by a Reduced Use of Coercion
- ClinicalTrials.gov ID
- NCT05136989
- Acronym / sponsor ID
- (PLAID-Care) / IRBN1372021/CHUSTE
- Conditions
- Psychiatric Hospitalization
- Keywords
- Psychiatry, Reduction of coercion, Interviews, Observations, Sociology, Nursing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- L'École Nationale des Solidarités, de l'Encadrement et de l'Intervention Sociale (ENSEIS)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Professionals from the seven least coercive facilities | – | Behavioral: Individual and collective semi-structured interviews, Behavioral: Observations out in the servicesVolunteer professionals selected on the basis of their experience in reducing the use of coercion. |
| Voluntary ex-patients | – | Behavioral: Individual semi-structured interviews with ex-patientsVoluntary ex-patients who were hospitalized in these establishments in the two years preceding the survey and whose condition is stabilized |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- People who refused to participate to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual and collective semi-structured interviewsIndividual 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 | Behavioural | Professionals from the seven least coercive facilities |
| Individual semi-structured interviews with ex-patientsIndividual 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 | Behavioural | Voluntary ex-patients |
| Observations out in the servicesObservations 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 | Behavioural | Professionals from the seven least coercive facilities |
Primary outcome
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.
4 secondary outcomes
Analysis of professionals' satisfaction
Time frame: Baseline from 24 months
Analysis of ex-patients' satisfaction
Time frame: Baseline from 24 months
Analysis of the impact on care pathway
Time frame: Baseline from 24 months
Analysis of the impact on career paths
Time frame: Baseline from 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien SAETTA, PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Hospitalization, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sébastien SAETTA, PhD (0477127778, sebastien.saetta@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
understand the history of less coercive institutions (time frame: Baseline from 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.