Clinical trial NCT02627716: Joint Crisis Plan Effectiveness in Preventing Relapses in Schizophrenia and Schizoaffective Disorder
Official title: Effectiveness of a Joint Crisis Plan (SOS Plan) in Preventing Relapses in Patients Diagnosed With Schizophrenia and Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: Psychiatric advanced directives
Joint crisis plan
Schizophrenia
Primary care
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2015-12-11
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: incidence of the first psychiatric hospitalisation
timeFrame: 18 months
Secondary outcomes:
measure: cumulative time in days of psychiatric hospitalisations
timeFrame: 2 years
measure: types of psychiatric hospitalisations
timeFrame: 2 years
measure: number of hospitalisations
timeFrame: 2 years
measure: number of emergency psychiatric consultations
timeFrame: 2 years
measure: clinical assessment by the PANSS scale
timeFrame: every 6 months during 2 years
measure: patient satisfaction
timeFrame: every 6 months during 2 years
measure: Autonomy Preference Index
timeFrame: every 6 months during 2 years
measure: Working Alliance Inventory
timeFrame: every 6 months during 2 years
measure: length of the meeting to develop the SOS Plan
timeFrame: every 6 months during 2 years
measure: SF-36 quality of life
timeFrame: every 6 months during 2 years
measure: medical cost
timeFrame: every 6 months during 2 years
Other outcomes:
Locations:
city: Brest
country: France
facility: University Hospital, Brest
city: Caen
country: France
facility: University Hospital, Caen
city: Lille
country: France
facility: University Hosiptal, Lille
city: Paris
country: France
facility: Sainte-Anne Hospital, Paris
Study officials:
affiliation: University Hospiltal Lille
name: Guillaume Vaiva
role: PRINCIPAL_INVESTIGATOR
References: