Evaluation of a New Recovery-oriented Model of Psychiatric Inpatient Care
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ClinicalTrials.gov Identifier: NCT06250296 |
Recruitment Status :
Not yet recruiting
First Posted : February 9, 2024
Last Update Posted : February 12, 2024
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Tracking Information | |||||
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First Submitted Date | January 29, 2024 | ||||
First Posted Date | February 9, 2024 | ||||
Last Update Posted Date | February 12, 2024 | ||||
Estimated Study Start Date | February 2024 | ||||
Estimated Primary Completion Date | October 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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)
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Evaluation of a New Recovery-oriented Model of Psychiatric Inpatient Care | ||||
Official Title | Evaluation of a New Recovery-oriented Model of Care on Psychiatric Inpatient Wards. | ||||
Brief 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. |
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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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
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. | ||||
Condition |
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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:
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Not yet recruiting | ||||
Estimated Enrollment |
700 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | October 2025 | ||||
Estimated Primary Completion Date | October 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Switzerland | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT06250296 | ||||
Other Study ID Numbers | RP-07-06 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Alexandre Wullschleger, MD, University Hospital, Geneva | ||||
Original Responsible Party | Alexandre Wullschleger, MD, University Hospital, Geneva, MD | ||||
Current Study Sponsor | University Hospital, Geneva | ||||
Original Study Sponsor | Same as current | ||||
Collaborators |
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Investigators |
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PRS Account | University Hospital, Geneva | ||||
Verification Date | February 2024 |