Joint Crisis Plan Effectiveness in Preventing Relapses in Schizophrenia and Schizoaffective Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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Single blind multicentre randomised trial with parallel control groups. 2 groups: SOS Intervention Group: benefits from the SOS Plan in addition to the usual follow-ups Control Group: receive no additional intervention (only receive the routine follow-ups) 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 : the cumulative length of hospitalisations (in days) in the two years following the development of the SOS plan the type of hospitalisation (voluntary or compulsory) the number of hospitalisations for a given subject the number of crisis situations that may require the use of the SOS Plan the clinical condition of the patient the patient with the most responses to the SOS Plan in socio-demographic terms the patient satisfaction in using the SOS Plan the decisional autonomy during treatment the quality of the therapeutic alliance the length of the meeting to develop the SOS Plan the quality of life the medico-economic impact 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: Preparatory interview with an SOS regional referrer SOS Plan development meeting in the presence of the patient, the treating psychiatrist, one or more relatives, and an SOS regional referrer 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: Assessment of the clinical condition: placement on the PANSS scale Number of psychiatric hospitalisations, types of hospitalisation, duration of hospitalisation since the last visit Satisfaction assessment (numeric scale), of the therapeutic alliance (WAI), of decision-making autonomy (API), of quality of life (SF-36) For the SOS Intervention group: Updating the SOS Plan after each relapse that leads to an unscheduled psychiatric hospitalisation lasting more than two weeks. Updating the SOS Plan every 6 months in the absence of hospitalisation

Official Title
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Effectiveness of a Joint Crisis Plan (SOS Plan) in Preventing Relapses in Patients Diagnosed With Schizophrenia and Schizoaffective Disorder

Conditions
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Schizophrenia

Intervention / Treatment
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* Procedure: SOS Plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 65 years Diagnosed with schizophrenia or schizoaffective disorder according to criteria specified in DSM Psychiatric inpatient or an outpatient with a specialised framework of psychiatric follow-ups Patient has been hospitalised at least once in a psychiatric department within the previous 2 years Adults under protective measures can be included (guardianship/supervision). Consent will also be sought from the guardian or trusted person. Registered for social security Exclusion Criteria: Refusal to participate in the study Unable to give his or her written consent Patients detained Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOS Intervention Group<br>Subjects benefit from the SOS Plan in addition to the usual follow-ups | Procedure: SOS Plan<br>* 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: Contact details / contact person Treatment and current follow-ups Medical care in the event of a crisis Practical aid in the event of a crisis 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.<br>* Other names: Joint Crisis Plan;|
| No Intervention: Control Group<br>Subjects receive no additional intervention (tracking the continuation of psychiatric care according to the standard care terms) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of the first psychiatric hospitalisation | the incidence of the first psychiatric hospitalisation within 18 months following inclusion | 18 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychiatric advanced directives, Joint crisis plan, Schizophrenia, Primary care