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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00911-46 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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The Joint Crisis Plan = SOS Plan is a reference to a particular form of psychiatric advance directive which involves the patient, the healthcare team, their relatives and a third party caregiver as intermediary for the project.
The main objective is to evaluate the effectiveness of the SOS Plan (JCP) in terms of the reduction in hospitalisations within 18 months of its development by comparison to the standard psychiatric care.
Thus, the investigators' proposal is that SOS Plan's are regularly reassessed every 6 months and again where there is an unplanned psychiatric readmission that lasts beyond two weeks.
Single blind multicentre randomised trial with parallel control groups.
Effectiveness study of a psychiatric care strategy.
Single blind multicentre randomised trial with parallel control groups.
2 groups:
OBJECTIVES :
To evaluate the effectiveness of the SOS Plan (JCP) in terms of the reduction in hospitalisations within 18 months of its development by comparison to the standard psychiatric care
To evaluate :
EXECUTION OF PRACTICAL RESEARCH :
The inclusion visit will be completed apart from a period of acute psychiatric decompensation, while the patient is capable of consenting to treatment. The inclusion visit will be completed within a hospital department before the patient is finally released from hospitalisation or during an outpatient follow-up.
This involves placing the patient on the Positive And Negative Syndrome Scale (PANSS) to ensure that the patient's clinical condition allows him to consent to treatment. A score above 95 excludes the patient.
The investigator also outlines the study and schedules visits. The patient then signs both the information letter and informed consent.
A urine pregnancy test will be carried out on women of childbearing age.
Randomisation will be performed by a member of the SOS regional-referral team.
For patients in the SOS Intervention group:
For patients in the control group: tracking the continuation of psychiatric care according to the standard care terms
3 ) Follow-up visits: for the two groups: 4 visits M6, M12, M18, M24 At each visit: meeting with an independent regional SOS assessor blind to allocation.
For both of the groups:
For the SOS Intervention group:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOS Intervention Group | Experimental | Subjects benefit from the SOS Plan in addition to the usual follow-ups |
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| Control Group | No Intervention | Subjects receive no additional intervention (tracking the continuation of psychiatric care according to the standard care terms) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOS Plan | Procedure | It is a customised procedure that involves a meeting (crisis planning meeting) with the patient, their various medical and social referrers and any other person who they may have desired to invite. The booklet outlines four avenues to consider:
Updating the SOS Plan every 6 months in the absence of hospitalisation or after each relapse that leads to an unscheduled psychiatric hospitalisation lasting more than two weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of the first psychiatric hospitalisation | the incidence of the first psychiatric hospitalisation within 18 months following inclusion | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| cumulative time in days of psychiatric hospitalisations | the cumulative time, in days, of psychiatric hospitalisations in the two years following inclusion | 2 years |
| types of psychiatric hospitalisations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume Vaiva | University Hospiltal Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Brest | Brest | France | ||||
| University Hospital, Caen |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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the types of psychiatric hospitalisation: voluntary (SL) or compulsory (SDT)
| 2 years |
| number of hospitalisations | the number of hospitalisations for each subject | 2 years |
| number of emergency psychiatric consultations | the number of emergency psychiatric consultations | 2 years |
| clinical assessment by the PANSS scale | PANSS score (intensity and qualitative aspects of the clinical situation) | every 6 months during 2 years |
| patient satisfaction | score at a numeric scale of patient satisfaction | every 6 months during 2 years |
| Autonomy Preference Index | decision making-autonomy assessment | every 6 months during 2 years |
| Working Alliance Inventory | the working alliance assessment | every 6 months during 2 years |
| length of the meeting to develop the SOS Plan | the length of the meeting to develop the SOS Plan in minutes | every 6 months during 2 years |
| SF-36 quality of life | quality of life assessment by the SF-36 | every 6 months during 2 years |
| medical cost | numbers of hospitalisations, of consultations, drugs consummation | every 6 months during 2 years |
| Caen |
| France |
| University Hosiptal, Lille | Lille | France |
| Sainte-Anne Hospital, Paris | Paris | France |