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

Schizophrenia Clinical Trial

— SOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02627716
• Other study ID #: 2014_04
• Secondary ID: 2014-A00911-46
• Status: Recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: July 2022

Study information

• Verified date: September 2020
• Source: University Hospital, Lille
• Contact: Elsa MAITRE
• Phone: 1.45.65.61.21
• Email: e.maitre[@]ch-sainte-anne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: July 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital, Brest	Brest
France	University Hospital, Caen	Caen
France	University Hosiptal, Lille	Lille
France	Sainte-Anne Hospital, Paris	Paris

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of the first psychiatric hospitalisation	the incidence of the first psychiatric hospitalisation within 18 months following inclusion	18 months
Secondary	cumulative time in days of psychiatric hospitalisations	the cumulative time, in days, of psychiatric hospitalisations in the two years following inclusion	2 years
Secondary	types of psychiatric hospitalisations	the types of psychiatric hospitalisation: voluntary (SL) or compulsory (SDT)	2 years
Secondary	number of hospitalisations	the number of hospitalisations for each subject	2 years
Secondary	number of emergency psychiatric consultations	the number of emergency psychiatric consultations	2 years
Secondary	clinical assessment by the PANSS scale	PANSS score (intensity and qualitative aspects of the clinical situation)	every 6 months during 2 years
Secondary	patient satisfaction	score at a numeric scale of patient satisfaction	every 6 months during 2 years
Secondary	Autonomy Preference Index	decision making-autonomy assessment	every 6 months during 2 years
Secondary	Working Alliance Inventory	the working alliance assessment	every 6 months during 2 years
Secondary	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
Secondary	SF-36 quality of life	quality of life assessment by the SF-36	every 6 months during 2 years
Secondary	medical cost	numbers of hospitalisations, of consultations, drugs consummation	every 6 months during 2 years