Psychiatric HospitalizationNCT06250296
Evaluation of a New Recovery-oriented Model of Psychiatric Inpatient Care
An observational study of Psychiatric Hospitalization and Coercion, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
This project will study the effects of a major reorganization of psychiatric inpatient wards. This reorganization will affect many aspects of day-to-day work, with the aim of improving the individualization of care, the integration of relatives and the participation of the patients in treatment planning. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychiatric Hospitalization, Coercion, Recovery
- What is being tested?
- New model of psychiatric inpatient care
- How many people
- 700 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Feb 2024to Oct 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the three participating wards during the study period will be considered for participation. All diagnoses will be included, except for dementia. Patients who are not able to give their written consent to participation and/or with insufficient knowledge of French will be excluded from the study.
Who may be able to join
- Patients hospitalized in one of the three participating wards
Who cannot join
- Incapacity to give informed consent
- Insufficient knowledge of French
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
HUG - Hôpital de Belle-Idée
Thônex, 1226
Alexandre Wullschleger, MD, +41795534904, alexandre.wullschleger@hcuge.ch
About this study
Official title: Evaluation of a New Recovery-oriented Model of Care on Psychiatric Inpatient Wards.
This project will study the effects of a major reorganization of psychiatric inpatient wards. This reorganization will affect many aspects of day-to-day work, with the aim of improving the individualization of care, the integration of relatives and the participation of the patients in treatment planning. This new organization will initially involve a first pilot ward, before being extended to other wards.
The aim of this project is to understand whether this new organization has positive effects on the use of coercive measures, the average length of stay, the improvement in patients' clinical condition, as well as on patient satisfaction, their perception of coercion, the wards' atmosphere on the unit and patients' personal recovery.
All patients admitted to three wards of the Division of adult psychiatry of the Geneva University Hospital aged 18 and over, with a good knowledge of French and being treated for any type of diagnosis except dementia, are invited to take part in the study. They will be assessed at discharge regarding the selected outcomes. The study will last 18 months: during the first 9 months, the new model will be applied on the pilot ward, and the wo other wards will serve as comparison wards. After 9 months, the model will also be applied to these other two wards.
Read the detailed description
The project is designed as a prospective, observational study, supporting the planned reorganization of inpatient care with the implementation of a new recovery-oriented model of care. As part of this reorganization, the new model will be first implemented as a pilot on a first acute psychiatric ward. After nine months, it is planned to be generalized to two comparable other acute wards. These two wards will serve within the current project as a comparison group to assess the effects of the new model.
Patients hospitalized on these three wards will be included in the study over a period of 18 months, covering the initial implementation of the model and its subsequent extension to the other two wards.
Three psychiatric wards of the Division of adult Psychiatry (SPA) will participate in the study. These wards are dedicated to general psychiatric admissions following a sectorization plan and operate with an open-door policy, wherein the wards' doors are uninterruptedly open between 7:30 am. and 11 pm. Patients aged 18 to 65 with all types of diagnosis at the exception of primary substance-abuse disorders and dementia, which are mainly treated in other divisions, are treated on these wards.
All patients admitted to these wards during the study period will be considered for participation. All diagnoses will be included, except for dementia. Patients who are not able to give their written consent to participation and/or with insufficient knowledge of French will be excluded from the trial.
Patient fulfilling the inclusion criteria will be contacted before discharge and offered to participate in the study. They will be informed in writing of the purpose of the study and their written consent will be collected.
Data on coercive measures, length of stay as well as socio-demographic characteristics, diagnosis and admission and discharge HoNOS scores will be extracted from the patients' electronic record.
The assessment of patients' satisfaction, perceived coercion, personal recovery, patients' appraisal of the ward atmosphere, and their perception of care as supporting to their recovery will be carried at discharge using digital questionnaires on the REDCAP platform, using tablets. The planned assessment will take about 30 to 45 minutes.
- Conditions
- Psychiatric Hospitalization, Coercion, Recovery
- Being tested
- New model of psychiatric inpatient care
- Keywords
- psychiatric inpatient care, coercion, recovery, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New model of psychiatric inpatient careOther
The intervention envisages major structural changes in wards, in particular the reorganization of clinical discussion and decision-making spaces, as well as the medical and nursing referral system, and the inclusion of relatives in care:
- Treatment planning involving the patient, with a focus on his or her needs and resources.
- Care by referral teams, present every day of the week, to ensure continuity and consistency of care.
- As few decisions as possible made without the patient, and transparency in decision-making.
- Emphasis on the subjective meaning of illness, beyond symptoms.
- Greater visibility of care planning for patients, who will benefit from weekly agendas
- Closer collaboration with relatives, through open invitations to all clinical discussions, telephone hotlines and meeting times.
- Openness to the network and community care, by promoting communication and exchanges between all stakeholders, and the development of early warning tools such as the joint crisis plan.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | All patients admitted to the ward implementing the foreseen intervention as to February 2024 (pilot phase) Receives: Other: New model of psychiatric inpatient care | |
| Control group | All patients admitted to the two wards implementing the foreseen intervention after the initial pilot phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coercive measures
Number, type and duration of used coercive measures (seclusion or forced medication)
Measured: For each included participant at discharge from hospital, throughout the study (18 months)
Secondary outcomes (9)
Length of stay
Length of hospital stay in days
Measured: For each included participant at discharge from hospital, throughout the study (18 months)
Symptom burden
Burden of symptoms measured at admission and discharge using the Health of Nations Outcome Scale (HoNOS). This scale comprises 12 items rated on a scale from 0 to 4. Final score between 0 and 48. Higher scores indicate higher burden of symptoms.
Measured: For each included participant at discharge from hospital, throughout the study (18 months)
Length of stay under involuntary status
Percentage of hospital stay under involuntary status
Measured: For each included participant at discharge from hospital, throughout the study (18 months)
Personal recovery
Level of personal recovery measured by the Recovery Assessment Scale (RAS-R). The RAS-R comprises 24 items rated on a 5-point Likert scale (1 to 5). The scale is scored by summing the responses for each of the items. total scores range from 24 to 120. Higher scores indicate better recovery.
Measured: For each included participant at discharge from hospital, throughout the study (18 months)
Subjective coercion 1
Level of subjective coercion measured by the Coercion Ladder (CL). The Coercion Ladder is an analog scale ranging from 1 to 10. Higher scores indicate higher levels of perceived coercion.
Measured: For each included participant at discharge from hospital, throughout the study (18 months)
Subjective coercion 2
Level of subjective coercion measured by the Experienced Coercion Scale (ECS). The ECS comprises 15 items rated on a 5-point Likert scale (0-4). Two items (5 and 6) are reverse scored. The average sum score is used for interpretation. Higher scores indicate higher levels of perceived coercion.
Measured: For each included participant at discharge from hospital, throughout the study (18 months)
Ward atmosphere
Quality of the ward atmosphere measured by the Essen Climate Evaluation Schema (EssenCES). The EssenCES comprises 15 items rated on a 5-point Likert scale (0-4). Three subscores are built by adding the items scores following the scoring sheet: Patients' Cohesion, Experienced Safety, Therapeutic Hold. Higher scores indicate a better perceived atmosphere in the three dimensions.
Measured: For each included participant at discharge from hospital, throughout the study (18 months)
Patients' satisfaction
Level of patients' satisfaction measured by the satisfaction questionnaire of the Swiss National Association for Quality Development in Hospitals and Clinics. This questionnaire comprises 6 items, each rated on a 5-Likert scale (1 to 5). The mean of each item score will be used for analysis.
Measured: For each included participant at discharge from hospital, throughout the study (18 months)
Recovery-orientation of services
Patients' perception of the wards' level of Recovery-orientation measured by the Recovery Self-Assessment (RSA). The RSA comprises 32 items rated on a 5-point Likert scale. Total scores range from 32 to 160. Higher scores indicate a better perception of services as supporting for the recovery process.
Measured: For each included participant at discharge from hospital, throughout the study (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start15 Feb 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (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 University Hospital, GenevaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Privée des HUG, IF International Foundation
- Responsible party
- Principal investigator, Alexandre Wullschleger, MD, University Hospital, Geneva
- Investigators
- Alexandre Wullschleger, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250296
- Sponsor's protocol ID
- RP-07-06
- Status last verified
- Jul 2024
- First submitted
- 29 Jan 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Recovery-oriented Model of Care on Psychiatric Inpatient Wards.
- ClinicalTrials.gov ID
- NCT06250296
- Acronym / sponsor ID
- RP-07-06
- Conditions
- Psychiatric Hospitalization, Coercion, Recovery
- Keywords
- psychiatric inpatient care, coercion, recovery, patient satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Fondation Privée des HUG, IF International Foundation
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 9 Feb 2024 (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.
This project will study the effects of a major reorganization of psychiatric inpatient wards. This reorganization will affect many aspects of day-to-day work, with the aim of improving the individualization of care, the integration of relatives and the participation of the patients in treatment planning. This new organization will initially involve a first pilot ward, before being extended to other wards.
The aim of this project is to understand whether this new organization has positive effects on the use of coercive measures, the average length of stay, the improvement in patients' clinical condition, as well as on patient satisfaction, their perception of coercion, the wards' atmosphere on the unit and patients' personal recovery.
All patients admitted to three wards of the Division of adult psychiatry of the Geneva University Hospital aged 18 and over, with a good knowledge of French and being treated for any type of diagnosis except dementia, are invited to take part in the study. They will be assessed at discharge regarding the selected outcomes. The study will last 18 months: during the first 9 months, the new model will be applied on the pilot ward, and the wo other wards will serve as comparison wards. After 9 months, the model will also be applied to these other two wards.
Detailed description
The project is designed as a prospective, observational study, supporting the planned reorganization of inpatient care with the implementation of a new recovery-oriented model of care. As part of this reorganization, the new model will be first implemented as a pilot on a first acute psychiatric ward. After nine months, it is planned to be generalized to two comparable other acute wards. These two wards will serve within the current project as a comparison group to assess the effects of the new model.
Patients hospitalized on these three wards will be included in the study over a period of 18 months, covering the initial implementation of the model and its subsequent extension to the other two wards.
Three psychiatric wards of the Division of adult Psychiatry (SPA) will participate in the study. These wards are dedicated to general psychiatric admissions following a sectorization plan and operate with an open-door policy, wherein the wards' doors are uninterruptedly open between 7:30 am. and 11 pm. Patients aged 18 to 65 with all types of diagnosis at the exception of primary substance-abuse disorders and dementia, which are mainly treated in other divisions, are treated on these wards.
All patients admitted to these wards during the study period will be considered for participation. All diagnoses will be included, except for dementia. Patients who are not able to give their written consent to participation and/or with insufficient knowledge of French will be excluded from the trial.
Patient fulfilling the inclusion criteria will be contacted before discharge and offered to participate in the study. They will be informed in writing of the purpose of the study and their written consent will be collected.
Data on coercive measures, length of stay as well as socio-demographic characteristics, diagnosis and admission and discharge HoNOS scores will be extracted from the patients' electronic record.
The assessment of patients' satisfaction, perceived coercion, personal recovery, patients' appraisal of the ward atmosphere, and their perception of care as supporting to their recovery will be carried at discharge using digital questionnaires on the REDCAP platform, using tablets. The planned assessment will take about 30 to 45 minutes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Other: New model of psychiatric inpatient careAll patients admitted to the ward implementing the foreseen intervention as to February 2024 (pilot phase) |
| Control group | – | –All patients admitted to the two wards implementing the foreseen intervention after the initial pilot phase |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the three participating wards during the study period will be considered for participation. All diagnoses will be included, except for dementia. Patients who are not able to give their written consent to participation and/or with insufficient knowledge of French will be excluded from the study.
Key inclusion criteria (1 listed)
- Patients hospitalized in one of the three participating wards
Key exclusion criteria (2 listed)
- Incapacity to give informed consent
- Insufficient knowledge of French
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 |
|---|---|---|
| New model of psychiatric inpatient careThe intervention envisages major structural changes in wards, in particular the reorganization of clinical discussion and decision-making spaces, as well as the medical and nursing referral system, and the inclusion of relatives in care: * Treatment planning involving the patient, with a focus on his or her needs and resources. * Care by referral teams, present every day of the week, to ensure continuity and consistency of care. * As few decisions as possible made without the patient, and transparency in decision-making. * Emphasis on the subjective meaning of illness, beyond symptoms. * Greater visibility of care planning for patients, who will benefit from weekly agendas * Closer collaboration with relatives, through open invitations to all clinical discussions, telephone hotlines and meeting times. * Openness to the network and community care, by promoting communication and exchanges between all stakeholders, and the development of early warning tools such as the joint crisis plan. | Other | Intervention group |
Primary outcome
Coercive measures
Time frame: For each included participant at discharge from hospital, throughout the study (18 months)
Number, type and duration of used coercive measures (seclusion or forced medication)
9 secondary outcomes
Length of stay
Time frame: For each included participant at discharge from hospital, throughout the study (18 months)
Symptom burden
Time frame: For each included participant at discharge from hospital, throughout the study (18 months)
Length of stay under involuntary status
Time frame: For each included participant at discharge from hospital, throughout the study (18 months)
Personal recovery
Time frame: For each included participant at discharge from hospital, throughout the study (18 months)
Subjective coercion 1
Time frame: For each included participant at discharge from hospital, throughout the study (18 months)
Subjective coercion 2
Time frame: For each included participant at discharge from hospital, throughout the study (18 months)
Ward atmosphere
Time frame: For each included participant at discharge from hospital, throughout the study (18 months)
Patients' satisfaction
Time frame: For each included participant at discharge from hospital, throughout the study (18 months)
Recovery-orientation of services
Time frame: For each included participant at discharge from hospital, throughout the study (18 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Alexandre Wullschleger, MD principal investigator
University Hospital, Geneva
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 and Coercion, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 inclusion and 2 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 3 Jul 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 Switzerland. 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 Alexandre Wullschleger, MD (+41795534904, alexandre.wullschleger@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coercive measures (time frame: For each included participant at discharge from hospital, throughout the study (18 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 3 Jul 2024.