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

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Procedure: SOS Plan

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

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France
    • University Hospital, Brest
  • Caen, France
    • University Hospital, Caen
  • Lille, France
    • University Hosiptal, Lille
  • Paris, France
    • Sainte-Anne Hospital, Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOS Intervention Group; Subjects benefit from the SOS Plan in addition to the usual follow-ups	Procedure: SOS Plan; 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.; Other Names: Joint Crisis Plan
No Intervention: Control Group; Subjects receive no additional intervention (tracking the continuation of psychiatric care according to the standard care terms)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Guillaume Vaiva, University Hospiltal Lille

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2014
• Primary Completion (Actual): March 10, 2016
• Study Completion (Actual): March 10, 2016

Study Registration Dates

• First Submitted: July 6, 2015
• First Submitted That Met QC Criteria: December 8, 2015
• First Posted (Estimated): December 11, 2015

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Schizophrenia; Primary care; Psychiatric advanced directives; Joint crisis plan
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: 2014_04; 2014-A00911-46 (Other Identifier: ID-RCB number, ANSM)