NCT02627716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2016

Completed
Last Updated

December 16, 2025

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

July 6, 2015

Last Update Submit

December 8, 2025

Conditions

Schizophrenia

Keywords

Psychiatric advanced directivesJoint crisis planSchizophreniaPrimary care

Outcome Measures

Primary Outcomes (1)

  • incidence of the first psychiatric hospitalisation

    the incidence of the first psychiatric hospitalisation within 18 months following inclusion

    18 months

Secondary Outcomes (11)

  • cumulative time in days of psychiatric hospitalisations

    2 years

  • types of psychiatric hospitalisations

    2 years

  • number of hospitalisations

    2 years

  • number of emergency psychiatric consultations

    2 years

  • clinical assessment by the PANSS scale

    every 6 months during 2 years

  • +6 more secondary outcomes

Study Arms (2)

SOS Intervention Group

EXPERIMENTAL

Subjects benefit from the SOS Plan in addition to the usual follow-ups

Procedure: SOS Plan

Control Group

NO INTERVENTION

Subjects receive no additional intervention (tracking the continuation of psychiatric care according to the standard care terms)

Interventions

SOS PlanPROCEDURE

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.

Also known as: Joint Crisis Plan
SOS Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Refusal to participate in the study
  • Unable to give his or her written consent
  • Patients detained
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital, Brest

Brest, France

Location

University Hospital, Caen

Caen, France

Location

University Hosiptal, Lille

Lille, France

Location

Sainte-Anne Hospital, Paris

Paris, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Guillaume Vaiva

    University Hospiltal Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

December 11, 2015

Study Start

December 5, 2014

Primary Completion

March 10, 2016

Study Completion

March 10, 2016

Last Updated

December 16, 2025

Record last verified: 2020-09

Locations

FR(4)