Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode. Randomized, Open-label, Multicenter Controlled Study With Blinded Evaluation.

Centre Hospitalier Universitaire de Nīmes6 sites in 1 country256 target enrollmentSeptember 27, 2021

ConditionsPsychotic Episode

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Psychotic Episode
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 256
Locations: 6
Primary Endpoint: Rate of patients with recurrence of psychotic episode at least once between groups
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study investigators hypothesize that the intervention of case managers specifically trained in case management of early psychosis will change the paradigm of care of a first psychotic episode from the current organization of the care system. Indeed, the creation of specific services for emerging psychotic disorders cannot easily be generalized throughout the country and requires specific funding. The intervention of case managers according to the recommendations of good practices will make it possible to propose the fundamental principles of early intervention to young patients and their families on a large scale throughout the territory, namely: personalized and proactive accompaniment, psycho-education of the pathology and treatments, involvement and support of the families, and support for socio-professional reintegration

Registry

clinicaltrials.gov

Start Date

September 27, 2021

End Date

November 1, 2028

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient or their close relative must have given their free and informed consent and signed the consent form
•The patient must be a member or beneficiary of a health insurance plan
•The patient is available for a 3-year follow-up.
•Patient is managed in a psychiatric service (consultation or hospitalization) for a first episode psychosis defined by:
•Presence of positive psychotic symptoms (delusion(s) and/or hallucination(s) and/or conceptual disorganization) evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion ;
•Never having taken a neuroleptic treatment with antipsychotic aim (except for an antipsychotic treatment started for the current episode for example by the general practitioner before being referred to psychiatry);
•A disorder meeting the DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder greater than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder greater than 7 days, other specific or nonspecific schizophrenic spectrum disorder or other psychotic disorder, bipolar I or II disorder with congruent and non-mood congruent psychotic features, bipolar disorder with congruent and non-mood congruent psychotic features induced by a substance, major depressive disorder with congruent and non-mood congruent psychotic features.
•Inclusion should be within the first 3 months of care for first episode psychosis in the psychiatric service.
•At the time of inclusion, the psychotic symptomatology observed during the first episode psychosis may still be present or in remission.

Exclusion Criteria

•The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
•The subject, or one of the parents for minor patients, refuses to sign the consent
•It is impossible to give the subject informed information
•The patient is under safeguard of justice or state guardianship
•The patients has an IQ less than or equal to 55
•The patient has a first psychotic episode linked to a psychotic problem triggered by a medication of other medical condition
•The patient is pregnant or breastfeeding

Outcomes

Primary Outcomes

Rate of patients with recurrence of psychotic episode at least once between groups

Time Frame: 3 years

Recurrence of the psychotic episode will be defined as psychiatric hospitalization with a diagnosis of psychotic disorder and/or the presence of positive psychotic symptoms according to the Positive and Negative Symptom Scale (PANSS) ≥ 4 for item P1 (delusions) and/or P2 (conceptual disorganization) and/or P3 (hallucination)) over a period of at least one week.

Secondary Outcomes

Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient(3 years)
Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient(3 years)
Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient(3 years)
Percentage per patient of medical and caregiving appointments honored between groups(3 years)
Type of hospital admission (voluntary versus involuntary) between groups(3 years)
Unscheduled discharge from care between groups(3 years)
Treatment compliance between groups(3 years)
Adherence to treatment(3 years)
Therapeutic alliance(3 years)
Patient awareness of disorders and of the need for treatment(3 years)
Assessment of addictive comorbidities(3 years)
Assessment of tobacco, alcohol and drug use(Every 6 months from inclusion)
Evaluation of the clinical impact of the intervention between groups(Every 6 months from inclusion)
Psychotic and general symptoms(Every 6 months from inclusion)
Depressive symptoms(Every 6 months from inclusion)
Self- and hetero-aggressive behaviors(Every 6 months from inclusion)
Reported adverse events(3 years)
Current suicidal ideations(3 years)
Assess the impact of the intervention on socio-professional functioning and quality of life(3 years)
Social and occupational functioning(3 years)
Social functioning(3 years)
Psychosocial functioning(3 years)
Functioning(3 years)
Quality of life of users (patient and family)(3 years)
Health-related quality of life(3 years)
Quality of life of relatives(3 years)
Cost-outcome type ratio(3 years)
Cost of care(3 years)
Budget impact analysis between strategies(3 years)
Psychiatric assessment(3 years)
Patient age(Inclusion)
Patient sex(Inclusion)
Current patient professional/training situation(Over the study until 3 years)
Financial situation(Over the study until 3 years)
Care pathways taken by patient(Over the study until 3 years)
Duration of non-treated psychosis(Inclusion)
Personal and family psychiatric history(Inclusion)
Social and academic function(Inclusion)
Medical treatment received(Until 3 years)
Cerebral imagery(2 years)
IQ profile(2 years)
IQ(2 years)
BMI(2 years)
Fasting glycemia(2 years)
Lipid assessment(2 years)
Whole blood count(2 years)
Electrolytes(2 years)
Neurological exam(2 years)
Cardiovascular exam(2 years)
Morphological exam(2 years)
Hepatic exam(2 years)
Presence of neurometabolic disease(2 years)
Electrocardiogram(2 years)
C-reactive protein(2 years)
thyroid-stimulating hormone(2 years)
Cortisol(2 years)
Adverse events(2 years)
Non-medical treatment received(Until 3 years)
In the experimental group: case management according to good practice guidelines(End of follow-up (3 years))
In the experimental group: Conformity of case management(End of study (5 years))
In the experimental group: conformity to TIDieR checklist in each patient(3 years)
In the experimental group: conformity to TIDieR checklist in each center(Annually until end of study (5 years))
Satisfaction of patients and their families(3 years)
Satisfaction of participants receiving help from a health coordinator(End of follow-up (3 years))