- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06250296
Evaluation of a New Recovery-oriented Model of Psychiatric Inpatient Care
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alexandre Wullschleger, MD
- Phone Number: +41795534904
- Email: alexandre.wullschleger@hcuge.ch
Study Locations
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Thônex, Switzerland, 1226
- HUG - Hôpital de Belle-Idée
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Contact:
- Alexandre Wullschleger, MD
- Phone Number: +41795534904
- Email: alexandre.wullschleger@hcuge.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients hospitalized in one of the three participating wards
Exclusion Criteria:
- Incapacity to give informed consent
- Insufficient knowledge of French
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intervention group
All patients admitted to the ward implementing the foreseen intervention as to February 2024 (pilot phase)
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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:
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Control group
All patients admitted to the two wards implementing the foreseen intervention after the initial pilot phase
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coercive measures
Time Frame: For each included participant at discharge from hospital, throughout the study (18 months)
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Number, type and duration of used coercive measures (seclusion or forced medication)
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For each included participant at discharge from hospital, throughout the study (18 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay
Time Frame: For each included participant at discharge from hospital, throughout the study (18 months)
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Length of hospital stay in days
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For each included participant at discharge from hospital, throughout the study (18 months)
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Symptom burden
Time Frame: For each included participant at discharge from hospital, throughout the study (18 months)
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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.
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For each included participant at discharge from hospital, throughout the study (18 months)
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Length of stay under involuntary status
Time Frame: For each included participant at discharge from hospital, throughout the study (18 months)
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Percentage of hospital stay under involuntary status
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For each included participant at discharge from hospital, throughout the study (18 months)
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Personal recovery
Time Frame: For each included participant at discharge from hospital, throughout the study (18 months)
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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.
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For each included participant at discharge from hospital, throughout the study (18 months)
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Subjective coercion 1
Time Frame: For each included participant at discharge from hospital, throughout the study (18 months)
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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.
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For each included participant at discharge from hospital, throughout the study (18 months)
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Subjective coercion 2
Time Frame: For each included participant at discharge from hospital, throughout the study (18 months)
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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.
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For each included participant at discharge from hospital, throughout the study (18 months)
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Ward atmosphere
Time Frame: For each included participant at discharge from hospital, throughout the study (18 months)
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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.
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For each included participant at discharge from hospital, throughout the study (18 months)
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Recovery-orientation of services
Time Frame: For each included participant at discharge from hospital, throughout the study (18 months)
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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.
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For each included participant at discharge from hospital, throughout the study (18 months)
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Patients' satisfaction
Time Frame: For each included participant at discharge from hospital, throughout the study (18 months)
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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.
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For each included participant at discharge from hospital, throughout the study (18 months)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexandre Wullschleger, MD, University Hospital, Geneva
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RP-07-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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