Joint Crisis Plan Effectiveness in Preventing Relapses in Schizophrenia and Schizoaffective Disorder
- Conditions
- Schizophrenia
- Interventions
- Procedure: SOS Plan
- Registration Number
- NCT02627716
- Lead Sponsor
- University Hospital, Lille
- Brief Summary
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
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 :
1. the cumulative length of hospitalisations (in days) in the two years following the development of the SOS plan
2. the type of hospitalisation (voluntary or compulsory)
3. the number of hospitalisations for a given subject
4. the number of crisis situations that may require the use of the SOS Plan
5. the clinical condition of the patient
6. the patient with the most responses to the SOS Plan in socio-demographic terms
7. the patient satisfaction in using the SOS Plan
8. the decisional autonomy during treatment
9. the quality of the therapeutic alliance
10. the length of the meeting to develop the SOS Plan
11. the quality of life
12. the medico-economic impact
EXECUTION OF PRACTICAL RESEARCH :
1. 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.
2. 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 210
- 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
- Refusal to participate in the study
- Unable to give his or her written consent
- Patients detained
- Pregnant or lactating women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOS Intervention Group SOS Plan Subjects benefit from the SOS Plan in addition to the usual follow-ups
- Primary Outcome Measures
Name Time Method incidence of the first psychiatric hospitalisation 18 months the incidence of the first psychiatric hospitalisation within 18 months following inclusion
- Secondary Outcome Measures
Name Time Method types of psychiatric hospitalisations 2 years the types of psychiatric hospitalisation: voluntary (SL) or compulsory (SDT)
cumulative time in days of psychiatric hospitalisations 2 years the cumulative time, in days, of psychiatric hospitalisations in the two years following inclusion
number of hospitalisations 2 years the number of hospitalisations for each subject
number of emergency psychiatric consultations 2 years the number of emergency psychiatric consultations
clinical assessment by the PANSS scale every 6 months during 2 years PANSS score (intensity and qualitative aspects of the clinical situation)
Working Alliance Inventory every 6 months during 2 years the working alliance assessment
length of the meeting to develop the SOS Plan every 6 months during 2 years the length of the meeting to develop the SOS Plan in minutes
SF-36 quality of life every 6 months during 2 years quality of life assessment by the SF-36
medical cost every 6 months during 2 years numbers of hospitalisations, of consultations, drugs consummation
Autonomy Preference Index every 6 months during 2 years decision making-autonomy assessment
patient satisfaction every 6 months during 2 years score at a numeric scale of patient satisfaction
Trial Locations
- Locations (4)
University Hospital, Caen
🇫🇷Caen, France
Sainte-Anne Hospital, Paris
🇫🇷Paris, France
University Hospital, Brest
🇫🇷Brest, France
University Hosiptal, Lille
🇫🇷Lille, France