Joint Crisis Plan Effectiveness in Preventing Relapses in Schizophrenia and Schizoaffective Disorder (SOS)
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SOS Plan
Sponsored by
About this trial
This is an interventional prevention trial for Schizophrenia focused on measuring Psychiatric advanced directives, Joint crisis plan, Schizophrenia, Primary care
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
Sites / Locations
- University Hospital, BrestRecruiting
- University Hospital, Caen
- University Hosiptal, LilleRecruiting
- Sainte-Anne Hospital, ParisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SOS Intervention Group
Control Group
Arm Description
Subjects benefit from the SOS Plan in addition to the usual follow-ups
Subjects receive no additional intervention (tracking the continuation of psychiatric care according to the standard care terms)
Outcomes
Primary Outcome Measures
incidence of the first psychiatric hospitalisation
the incidence of the first psychiatric hospitalisation within 18 months following inclusion
Secondary Outcome Measures
cumulative time in days of psychiatric hospitalisations
the cumulative time, in days, of psychiatric hospitalisations in the two years following inclusion
types of psychiatric hospitalisations
the types of psychiatric hospitalisation: voluntary (SL) or compulsory (SDT)
number of hospitalisations
the number of hospitalisations for each subject
number of emergency psychiatric consultations
the number of emergency psychiatric consultations
clinical assessment by the PANSS scale
PANSS score (intensity and qualitative aspects of the clinical situation)
patient satisfaction
score at a numeric scale of patient satisfaction
Autonomy Preference Index
decision making-autonomy assessment
Working Alliance Inventory
the working alliance assessment
length of the meeting to develop the SOS Plan
the length of the meeting to develop the SOS Plan in minutes
SF-36 quality of life
quality of life assessment by the SF-36
medical cost
numbers of hospitalisations, of consultations, drugs consummation
Full Information
NCT ID
NCT02627716
First Posted
July 6, 2015
Last Updated
September 10, 2020
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT02627716
Brief Title
Joint Crisis Plan Effectiveness in Preventing Relapses in Schizophrenia and Schizoaffective Disorder
Acronym
SOS
Official Title
Effectiveness of a Joint Crisis Plan (SOS Plan) in Preventing Relapses in Patients Diagnosed With Schizophrenia and Schizoaffective Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 :
the cumulative length of hospitalisations (in days) in the two years following the development of the SOS plan
the type of hospitalisation (voluntary or compulsory)
the number of hospitalisations for a given subject
the number of crisis situations that may require the use of the SOS Plan
the clinical condition of the patient
the patient with the most responses to the SOS Plan in socio-demographic terms
the patient satisfaction in using the SOS Plan
the decisional autonomy during treatment
the quality of the therapeutic alliance
the length of the meeting to develop the SOS Plan
the quality of life
the medico-economic impact
EXECUTION OF PRACTICAL RESEARCH :
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Psychiatric advanced directives, Joint crisis plan, Schizophrenia, Primary care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SOS Intervention Group
Arm Type
Experimental
Arm Description
Subjects benefit from the SOS Plan in addition to the usual follow-ups
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subjects receive no additional intervention (tracking the continuation of psychiatric care according to the standard care terms)
Intervention Type
Procedure
Intervention Name(s)
SOS Plan
Other Intervention Name(s)
Joint Crisis Plan
Intervention Description
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.
Primary Outcome Measure Information:
Title
incidence of the first psychiatric hospitalisation
Description
the incidence of the first psychiatric hospitalisation within 18 months following inclusion
Time Frame
18 months
Secondary Outcome Measure Information:
Title
cumulative time in days of psychiatric hospitalisations
Description
the cumulative time, in days, of psychiatric hospitalisations in the two years following inclusion
Time Frame
2 years
Title
types of psychiatric hospitalisations
Description
the types of psychiatric hospitalisation: voluntary (SL) or compulsory (SDT)
Time Frame
2 years
Title
number of hospitalisations
Description
the number of hospitalisations for each subject
Time Frame
2 years
Title
number of emergency psychiatric consultations
Description
the number of emergency psychiatric consultations
Time Frame
2 years
Title
clinical assessment by the PANSS scale
Description
PANSS score (intensity and qualitative aspects of the clinical situation)
Time Frame
every 6 months during 2 years
Title
patient satisfaction
Description
score at a numeric scale of patient satisfaction
Time Frame
every 6 months during 2 years
Title
Autonomy Preference Index
Description
decision making-autonomy assessment
Time Frame
every 6 months during 2 years
Title
Working Alliance Inventory
Description
the working alliance assessment
Time Frame
every 6 months during 2 years
Title
length of the meeting to develop the SOS Plan
Description
the length of the meeting to develop the SOS Plan in minutes
Time Frame
every 6 months during 2 years
Title
SF-36 quality of life
Description
quality of life assessment by the SF-36
Time Frame
every 6 months during 2 years
Title
medical cost
Description
numbers of hospitalisations, of consultations, drugs consummation
Time Frame
every 6 months during 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elsa MAITRE
Phone
1.45.65.61.21
Ext
+33
Email
e.maitre@ch-sainte-anne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Laure DEMARTY
Email
anne-laure.demarty@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Vaiva
Organizational Affiliation
University Hospiltal Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel WALTER
First Name & Middle Initial & Last Name & Degree
Sofian BERROUIGUET
Facility Name
University Hospital, Caen
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Name
University Hosiptal, Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume VAIVA
Facility Name
Sainte-Anne Hospital, Paris
City
Paris
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Joint Crisis Plan Effectiveness in Preventing Relapses in Schizophrenia and Schizoaffective Disorder
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