Joint Crisis Plan Effectiveness in Preventing Relapses in Schizophrenia and Schizoaffective Disorder (SOS)

University Hospital, Lille

Status: Unknown

Conditions: Schizophrenia

Treatments: Procedure: SOS Plan

Study type: Interventional

Funder types: Other

Identifiers

NCT02627716

2014-A00911-46 (Other Identifier)

2014_04

Details and patient eligibility

About

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.

Full 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

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups

SOS Intervention Group

Experimental group

Description:

Subjects benefit from the SOS Plan in addition to the usual follow-ups

Treatment:

Procedure: SOS Plan

Control Group

No Intervention group

Description:

Subjects receive no additional intervention (tracking the continuation of psychiatric care according to the standard care terms)