Clinical trial NCT05116514: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychotic Episode
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 256
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Rate of patients with recurrence of psychotic episode at least once between groups
timeFrame: 3 years
Secondary outcomes:
measure: Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient
timeFrame: 1 year
measure: Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient
timeFrame: 2 years
measure: Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient
timeFrame: 3 years
measure: Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient
timeFrame: 1 year
measure: Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient
timeFrame: 2 years
measure: Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient
timeFrame: 3 years
measure: Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient
timeFrame: 1 year
measure: Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient
timeFrame: 2 years
measure: Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient
timeFrame: 3 years
measure: Percentage per patient of medical and caregiving appointments honored between groups
timeFrame: Inclusion
measure: Percentage per patient of medical and caregiving appointments honored between groups
timeFrame: 6 months
measure: Percentage per patient of medical and caregiving appointments honored between groups
timeFrame: 1 year
measure: Percentage per patient of medical and caregiving appointments honored between groups
timeFrame: 18 months
measure: Percentage per patient of medical and caregiving appointments honored between groups
timeFrame: 2 years
measure: Percentage per patient of medical and caregiving appointments honored between groups
timeFrame: 2.5 years
measure: Percentage per patient of medical and caregiving appointments honored between groups
timeFrame: 3 years
measure: Type of hospital admission (voluntary versus involuntary) between groups
timeFrame: Inclusion
measure: Type of hospital admission (voluntary versus involuntary) between groups
timeFrame: 6 months
measure: Type of hospital admission (voluntary versus involuntary) between groups
timeFrame: 1 year
measure: Type of hospital admission (voluntary versus involuntary) between groups
timeFrame: 18 months
measure: Type of hospital admission (voluntary versus involuntary) between groups
timeFrame: 2 years
measure: Type of hospital admission (voluntary versus involuntary) between groups
timeFrame: 2.5 years
measure: Type of hospital admission (voluntary versus involuntary) between groups
timeFrame: 3 years
measure: Unscheduled discharge from care between groups
timeFrame: Inclusion
measure: Unscheduled discharge from care between groups
timeFrame: 6 months
measure: Unscheduled discharge from care between groups
timeFrame: 1 year
measure: Unscheduled discharge from care between groups
timeFrame: 18 months
measure: Unscheduled discharge from care between groups
timeFrame: 2 years
measure: Unscheduled discharge from care between groups
timeFrame: 2.5 years
measure: Unscheduled discharge from care between groups
timeFrame: 3 years
measure: Treatment compliance between groups
timeFrame: Inclusion
measure: Treatment compliance between groups
timeFrame: 6 months
measure: Treatment compliance between groups
timeFrame: 1 year
measure: Treatment compliance between groups
timeFrame: 18 months
measure: Treatment compliance between groups
timeFrame: 2 years
measure: Treatment compliance between groups
timeFrame: 2.5 years
measure: Treatment compliance between groups
timeFrame: 3 years
measure: Adherence to treatment
timeFrame: 1 year
measure: Adherence to treatment
timeFrame: 2 years
measure: Adherence to treatment
timeFrame: 3 years
measure: Therapeutic alliance
timeFrame: 1 year
measure: Therapeutic alliance
timeFrame: 2 years
measure: Therapeutic alliance
timeFrame: 3 years
measure: Patient awareness of disorders and of the need for treatment
timeFrame: 1 year
measure: Patient awareness of disorders and of the need for treatment
timeFrame: 2 years
measure: Patient awareness of disorders and of the need for treatment
timeFrame: 3 years
measure: Assessment of addictive comorbidities
timeFrame: Inclusion
measure: Assessment of addictive comorbidities
timeFrame: 3 years
measure: Assessment of tobacco, alcohol and drug use
timeFrame: Every 6 months from inclusion
measure: Evaluation of the clinical impact of the intervention between groups
timeFrame: Every 6 months from inclusion
measure: Psychotic and general symptoms
timeFrame: Every 6 months from inclusion
measure: Depressive symptoms
timeFrame: Every 6 months from inclusion
measure: Self- and hetero-aggressive behaviors
timeFrame: Every 6 months from inclusion
measure: Reported adverse events
timeFrame: Inclusion
measure: Reported adverse events
timeFrame: 6 months
measure: Reported adverse events
timeFrame: 1 year
measure: Reported adverse events
timeFrame: 18 months
measure: Reported adverse events
timeFrame: 2 years
measure: Reported adverse events
timeFrame: 2.5 years
measure: Reported adverse events
timeFrame: 3 years
measure: Current suicidal ideations
timeFrame: Inclusion
measure: Current suicidal ideations
timeFrame: 6 months
measure: Current suicidal ideations
timeFrame: 1 year
measure: Current suicidal ideations
timeFrame: 18 months
measure: Current suicidal ideations
timeFrame: 2 years
measure: Current suicidal ideations
timeFrame: 2.5 years
measure: Current suicidal ideations
timeFrame: 3 years
measure: Assess the impact of the intervention on socio-professional functioning and quality of life
timeFrame: Inclusion
measure: Assess the impact of the intervention on socio-professional functioning and quality of life
timeFrame: 6 months
measure: Assess the impact of the intervention on socio-professional functioning and quality of life
timeFrame: 1 year
measure: Assess the impact of the intervention on socio-professional functioning and quality of life
timeFrame: 18 months
measure: Assess the impact of the intervention on socio-professional functioning and quality of life
timeFrame: 2 years
measure: Assess the impact of the intervention on socio-professional functioning and quality of life
timeFrame: 2.5 years
measure: Assess the impact of the intervention on socio-professional functioning and quality of life
timeFrame: 3 years
measure: Social and occupational functioning
timeFrame: Inclusion
measure: Social and occupational functioning
timeFrame: 6 months
measure: Social and occupational functioning
timeFrame: 1 year
measure: Social and occupational functioning
timeFrame: 18 months
measure: Social and occupational functioning
timeFrame: 2 years
measure: Social and occupational functioning
timeFrame: 2.5 years
measure: Social and occupational functioning
timeFrame: 3 years
measure: Social functioning
timeFrame: Inclusion
measure: Social functioning
timeFrame: 6 months
measure: Social functioning
timeFrame: 1 year
measure: Social functioning
timeFrame: 18 months
measure: Social functioning
timeFrame: 2 years
measure: Social functioning
timeFrame: 2.5 years
measure: Social functioning
timeFrame: 3 years
measure: Psychosocial functioning
timeFrame: Inclusion
measure: Psychosocial functioning
timeFrame: 6 months
measure: Psychosocial functioning
timeFrame: 1 year
measure: Psychosocial functioning
timeFrame: 18 months
measure: Psychosocial functioning
timeFrame: 2 years
measure: Psychosocial functioning
timeFrame: 2.5 years
measure: Psychosocial functioning
timeFrame: 3 years
measure: Functioning
timeFrame: Inclusion
measure: Functioning
timeFrame: 6 months
measure: Functioning
timeFrame: 1 year
measure: Functioning
timeFrame: 18 months
measure: Functioning
timeFrame: 2 years
measure: Functioning
timeFrame: 2.5 years
measure: Functioning
timeFrame: 3 years
measure: Quality of life of users (patient and family)
timeFrame: 1 year
measure: Quality of life of users (patient and family)
timeFrame: 2 years
measure: Quality of life of users (patient and family)
timeFrame: 3 years
measure: Health-related quality of life
timeFrame: 1 year
measure: Health-related quality of life
timeFrame: 2 years
measure: Health-related quality of life
timeFrame: 3 years
measure: Quality of life of relatives
timeFrame: 1 year
measure: Quality of life of relatives
timeFrame: 2 years
measure: Quality of life of relatives
timeFrame: 3 years
measure: Cost-outcome type ratio
timeFrame: 3 years
measure: Cost of care
timeFrame: 3 years
measure: Budget impact analysis between strategies
timeFrame: 3 years
measure: Psychiatric assessment
timeFrame: Inclusion
measure: Psychiatric assessment
timeFrame: 3 years
measure: Patient age
timeFrame: Inclusion
measure: Patient sex
timeFrame: Inclusion
measure: Current patient professional/training situation
timeFrame: Over the study until 3 years
measure: Financial situation
timeFrame: Over the study until 3 years
measure: Care pathways taken by patient
timeFrame: Over the study until 3 years
measure: Duration of non-treated psychosis
timeFrame: Inclusion
measure: Personal and family psychiatric history
timeFrame: Inclusion
measure: Social and academic function
timeFrame: Inclusion
measure: Medical treatment received
timeFrame: Until 3 years
measure: Cerebral imagery
timeFrame: Inclusion
measure: Cerebral imagery
timeFrame: 1 year
measure: Cerebral imagery
timeFrame: 2 years
measure: IQ profile
timeFrame: Inclusion
measure: IQ profile
timeFrame: 1 year
measure: IQ profile
timeFrame: 2 years
measure: IQ
timeFrame: Inclusion
measure: IQ
timeFrame: 1 year
measure: IQ
timeFrame: 2 years
measure: BMI
timeFrame: Inclusion
measure: BMI
timeFrame: 1 year
measure: BMI
timeFrame: 2 years
measure: Fasting glycemia
timeFrame: Inclusion
measure: Fasting glycemia
timeFrame: 1 year
measure: Fasting glycemia
timeFrame: 2 years
measure: Lipid assessment
timeFrame: Inclusion
measure: Lipid assessment
timeFrame: 1 year
measure: Lipid assessment
timeFrame: 2 years
measure: Whole blood count
timeFrame: Inclusion
measure: Whole blood count
timeFrame: 1 year
measure: Whole blood count
timeFrame: 2 years
measure: Electrolytes
timeFrame: Inclusion
measure: Electrolytes
timeFrame: 1 year
measure: Electrolytes
timeFrame: 2 years
measure: Neurological exam
timeFrame: Inclusion
measure: Neurological exam
timeFrame: 1 year
measure: Neurological exam
timeFrame: 2 years
measure: Cardiovascular exam
timeFrame: Inclusion
measure: Cardiovascular exam
timeFrame: 1 year
measure: Cardiovascular exam
timeFrame: 2 years
measure: Morphological exam
timeFrame: Inclusion
measure: Morphological exam
timeFrame: 1 year
measure: Morphological exam
timeFrame: 2 years
measure: Hepatic exam
timeFrame: Inclusion
measure: Hepatic exam
timeFrame: 1 year
measure: Hepatic exam
timeFrame: 2 years
measure: Presence of neurometabolic disease
timeFrame: Inclusion
measure: Presence of neurometabolic disease
timeFrame: 1 year
measure: Presence of neurometabolic disease
timeFrame: 2 years
measure: Electrocardiogram
timeFrame: Inclusion
measure: Electrocardiogram
timeFrame: 1 year
measure: Electrocardiogram
timeFrame: 2 years
measure: C-reactive protein
timeFrame: Inclusion
measure: C-reactive protein
timeFrame: 1 year
measure: C-reactive protein
timeFrame: 2 years
measure: thyroid-stimulating hormone
timeFrame: Inclusion
measure: thyroid-stimulating hormone
timeFrame: 1 year
measure: thyroid-stimulating hormone
timeFrame: 2 years
measure: Cortisol
timeFrame: Inclusion
measure: Cortisol
timeFrame: 1 year
measure: Cortisol
timeFrame: 2 years
measure: Adverse events
timeFrame: Inclusion
measure: Adverse events
timeFrame: 1 year
measure: Adverse events
timeFrame: 2 years
measure: Non-medical treatment received
timeFrame: Until 3 years
measure: In the experimental group: case management according to good practice guidelines
timeFrame: End of follow-up (3 years)
measure: In the experimental group: Conformity of case management
timeFrame: End of study (5 years)
measure: In the experimental group: conformity to TIDieR checklist in each patient
timeFrame: Month 3
measure: In the experimental group: conformity to TIDieR checklist in each patient
timeFrame: Month 6
measure: In the experimental group: conformity to TIDieR checklist in each patient
timeFrame: 1 year
measure: In the experimental group: conformity to TIDieR checklist in each patient
timeFrame: 18 Months
measure: In the experimental group: conformity to TIDieR checklist in each patient
timeFrame: 2 years
measure: In the experimental group: conformity to TIDieR checklist in each patient
timeFrame: 30 Months
measure: In the experimental group: conformity to TIDieR checklist in each patient
timeFrame: 3 years
measure: In the experimental group: conformity to TIDieR checklist in each center
timeFrame: Annually until end of study (5 years)
measure: Satisfaction of patients and their families
timeFrame: 1 year
measure: Satisfaction of patients and their families
timeFrame: 2 years
measure: Satisfaction of patients and their families
timeFrame: 3 years
measure: Satisfaction of participants receiving help from a health coordinator
timeFrame: End of follow-up (3 years)
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de TOULOUSE
state: Choisir une région
city: Clermont-Ferrand
country: France
facility: CH Saint Marie Clermont-Ferrand
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nice
country: France
facility: CHU Nice
city: Nîmes
country: France
facility: CHU de Nîmes
city: Thuir
country: France
facility: Centre Hospitalier Léon-Jean Grégory
Study officials:
affiliation: CHU Nimes
name: Aurélie Schandrin
role: PRINCIPAL_INVESTIGATOR
References: