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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06250296
Other study ID # RP-07-06
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 2024
Est. completion date October 2025

Study information

Verified date February 2024
Source University Hospital, Geneva
Contact Alexandre Wullschleger, MD
Phone +41795534904
Email alexandre.wullschleger@hcuge.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 700
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients hospitalized in one of the three participating wards Exclusion Criteria: - Incapacity to give informed consent - Insufficient knowledge of French

Study Design


Related Conditions & MeSH terms


Intervention

Other:
New model of psychiatric inpatient care
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.

Locations

Country Name City State
Switzerland HUG - Hôpital de Belle-Idée Thônex

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Geneva Fondation Privée des HUG, IF International Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Coercive measures Number, type and duration of used coercive measures (seclusion or forced medication) For each included participant at discharge from hospital, throughout the study (18 months)
Secondary Length of stay Length of hospital stay in days For each included participant at discharge from hospital, throughout the study (18 months)
Secondary 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. For each included participant at discharge from hospital, throughout the study (18 months)
Secondary Length of stay under involuntary status Percentage of hospital stay under involuntary status For each included participant at discharge from hospital, throughout the study (18 months)
Secondary 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. For each included participant at discharge from hospital, throughout the study (18 months)
Secondary 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. For each included participant at discharge from hospital, throughout the study (18 months)
Secondary 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. For each included participant at discharge from hospital, throughout the study (18 months)
Secondary 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. For each included participant at discharge from hospital, throughout the study (18 months)
Secondary 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. For each included participant at discharge from hospital, throughout the study (18 months)
Secondary 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. For each included participant at discharge from hospital, throughout the study (18 months)
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