Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist (CHECKLISTPEP)

September 18, 2023 updated by: Centre Hospitalier Universitaire de Nīmes

Psychotic disorders are often chronic conditions that lead to impaired functioning, quality of life and social integration. Current research and recommendations for good practice are moving towards early detection and intervention. It is recognized that this leads to better adherence, alliance to care and knowledge of pathology for the patient, especially in young patients. For more than a decade, early intervention services (EIS) are opened in France over an increasingly large territory. Still too few studies assess the impact of these structures in France. These EIS offer a multimodal intervention (social, professional, psychotherapeutic). The intervention of case managers (or care coordinators in french) seems to be the core of EIS. The case manager has a fundamental role in the process of recovery in coordinating each individual's treatment and ensuring continuity of care.

The PEPsy-CM study aims to evaluate the effectiveness on the relapse rate of a 3 year Program for Early Psychosis based on Case Management (PEPsy-CM) compared to TAU in a population of young people with a FEP.

A qualitative evaluation of case management practice in EIS seems essential to assess the impact of case managers under real conditions.

Based on the Australian Good Practice Recommendations (EPICC integrity tools) and the case management practice manuals, the PEPsy-CM check-list questionnaire was developed to evaluate the practice of case management in the EIS in France. This check-list contains different 35 items. The final score between 1(poor) to 5 (good) is established to determine the quality of the case management. Qualitative data are also collected during the interview with the participants.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nîmes, France, 30029
        • Schandrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Professional working in an early intervention center treating first episodes of psychosis

Description

Inclusion Criteria:

  • Professional working in an early intervention center treating first episodes of psychosis
  • Professional involved in the organization/management of the center or practicing case management.

Exclusion Criteria:

  • Professional not working in the early intervention center
  • Professional working in the early intervention center but not having a role in the organization or management of the center or as case manager
  • Professional who does not take charge of people who have had a first psychotic episode

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
conformity to TIDieR checklist in each center and for each case manager interviewed
Time Frame: 1 year
TIDieR checklist Patient - Use of the case management manual (yes or no)
1 year
conformity to TIDieR checklist in each center and for each case manager interviewed
Time Frame: 1 year
TIDieR checklist Patient - Use of specific and validated tools for Psychoeducation (yes or no)
1 year
conformity to TIDieR checklist in each center and for each case manager interviewed
Time Frame: 1 year
TIDieR checklist Patient - Use of an information brochure on First Episode Psychosis (yes or no)
1 year
conformity to TIDieR checklist in each center and for each case manager interviewed
Time Frame: 1 year
TIDieR checklist Patient - Use of specific and validated tools to support families (yes or no)
1 year
conformity to TIDieR checklist in each center and for each case manager interviewed
Time Frame: 1 year
TIDieR checklist Patient - Use of specific and validated tools for Motivational Interviewing (yes or no)
1 year
conformity to TIDieR checklist in each center and for each case manager interviewed
Time Frame: 1 year
TIDieR checklist Patient - Presence of Individualized Therapeutic Plan (ITP) supervision system (yes or no)
1 year
conformity to TIDieR checklist in each center and for each case manager interviewed
Time Frame: 1 year
TIDieR checklist Patient - Use of Individualized Therapeutic Plan (ITP) supervision system (yes or no)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
description of the global organisation of each center
Time Frame: 1 year
Number of staff by trade
1 year
description of their involvement in the early intervention center
Time Frame: 1 year
number of years experience
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

February 17, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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