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

  • STATUS
    Recruiting
  • End date
    Jul 26, 2022
  • participants needed
    210
  • sponsor
    University Hospital, Lille
Updated on 26 January 2021
Investigator
Elsa MAITRE
Primary Contact
University Hospital, Brest (0.4 mi away) Contact
+3 other location
schizoaffective disorder
psychiatric treatment

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.

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

Details
Condition Schizophrenia, Schizophrenia and Schizoaffective Disorders, Schizophrenia and Schizoaffective Disorders (Pediatric), schizophrenia disorders
Treatment SOS Plan
Clinical Study IdentifierNCT02627716
SponsorUniversity Hospital, Lille
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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