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Impact of an Alternative to Incarceration by Housing and Support by Assertive Community Treatment Team for Homeless People With Severe Psychiatric Disorders Referred to Immediate Referral Procedure: AILSI Program (AILSI)

Primary Purpose

Severe Psychiatric Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
alternative to incarceration
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Severe Psychiatric Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At least 18 years old Being defered in immediate appearance to the Public Prosecutor's department of Marseille Being homeless (ETHOS 1 to 8.3) Presenting a diagnosis of a severe psychiatric disorder as defined by DSM-IV-TR Having effective health coverage Having signed an informed consent to participate in the study Having declared to want to stay in the area at least 18 months after inclusion in the study. Exclusion Criteria: Less than 18 years old; Do not have any criteria for ETHOS 1 to 8.3 classification Do not present a diagnosis of a severe psychiatric disorder as defined by DSM-IV-TR Presenting cognitive impairment that limits comprehension, Being under guardianship, Do not have effective health coverage Having refused to participate in the study

Sites / Locations

  • Service Epidémiologie et Economie de la Santé - AP-HMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AILSI

the standard of care

Arm Description

Outcomes

Primary Outcome Measures

Duration of reincarceration, weighted by exposure time

Secondary Outcome Measures

Full Information

First Posted
July 11, 2019
Last Updated
August 29, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT06025006
Brief Title
Impact of an Alternative to Incarceration by Housing and Support by Assertive Community Treatment Team for Homeless People With Severe Psychiatric Disorders Referred to Immediate Referral Procedure: AILSI Program
Acronym
AILSI
Official Title
Impact of an Alternative to Incarceration by Housing and Support by Assertive Community Treatment Team (AILSI Program) for People Who Are Homeless With Severe Psychiatric Disorders and Referred to Immediate Referral Procedure, in Comparison With Usual Services: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
February 2, 2026 (Anticipated)
Study Completion Date
August 2, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
People who are homeless with severe psychiatric disorders have to negotiate discontinuous mental health care pathways including high use of emergency departement and enforced hospitalisation, poor access to ambulatory care, poor access to common rights services and a greater risk of incarceration. In order to reduce morbidity, improve social integration and outpatient care for people with severe psychiatric disorders and multiple factors of social vulnerability, the concept of therapeutic jurisprudence has led to the emergence of mental health courts in Anglo-Saxon nations. These courts aim to condition alternatives to incarceration through community-based intensive care (assertive community treatment-ACT). ACT Teams offer direct access to housing without any prerequisite of treatment or abstinence. This model of community-based intensive care tends to demonstrate medical and legal effectiveness while being associated with greater care acceptability by patients. In France, very little data exists on the subject. Médecins du Monde (NGO), in collaboration with the Public Prosecutor's department of Marseille, proposes the implementation of the AILSI strategy for people who homeless with severe psychiatric disorders and referred to immediate referral procedure. The research unit EA 3279 - CEReSS is in charge of the independent evaluation of this innovative intervention. This is an randomized coontrolled study, with two groups: AILSI group (intervention) and TAU group (usual services). A total of 220 patients will be included (100 in the AILSI group / 120 in the TAU group). The main objective is to evaluate the effectiveness of the innovative program (AILSI) compared to usual services by assessing the duration of reincarceration at 18 months in each group, weighted by exposure time. . Duration of inclusion: 30 months; Duration of follow-up: 18 months; Total duration of the study: 54 months. Both quantitative and qualitative analyses will be conducted to address overall outcomes. Univariate and multivariate analyzes will be performed on the primary outcome as well as the secondary outcomes in order to highlight significant differences between the two groups and to identify predictive factors for improved effectiveness. The analysis will be conducted in accordance with Good Epidemiological Practices, and the final report will be written according to the CONSORT (Consolidated Standards of Reporting Trials) recommendations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Psychiatric Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AILSI
Arm Type
Experimental
Arm Title
the standard of care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
alternative to incarceration
Intervention Description
place of respite with housing plus intensive follow-up
Primary Outcome Measure Information:
Title
Duration of reincarceration, weighted by exposure time
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years old Being defered in immediate appearance to the Public Prosecutor's department of Marseille Being homeless (ETHOS 1 to 8.3) Presenting a diagnosis of a severe psychiatric disorder as defined by DSM-IV-TR Having effective health coverage Having signed an informed consent to participate in the study Having declared to want to stay in the area at least 18 months after inclusion in the study. Exclusion Criteria: Less than 18 years old; Do not have any criteria for ETHOS 1 to 8.3 classification Do not present a diagnosis of a severe psychiatric disorder as defined by DSM-IV-TR Presenting cognitive impairment that limits comprehension, Being under guardianship, Do not have effective health coverage Having refused to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal AUQUIER
Phone
33(0)4 91 38 47 44
Email
pascal.auquier@univ-amu.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Claire MORANDO
Email
claire.morando@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François CREMIEUX
Organizational Affiliation
AP-HM
Official's Role
Study Director
Facility Information:
Facility Name
Service Epidémiologie et Economie de la Santé - AP-HM
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal AUQUIER
Phone
33(0)4 91 38 47 44
Email
pascal.auquier@univ-amu.fr

12. IPD Sharing Statement

Learn more about this trial

Impact of an Alternative to Incarceration by Housing and Support by Assertive Community Treatment Team for Homeless People With Severe Psychiatric Disorders Referred to Immediate Referral Procedure: AILSI Program

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