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.

Centre Hospitalier Universitaire de Nīmes256 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

256

Conditions

Psychotic Episode

Interventions

Eligibility

Sex: ALLMin age: 16 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Locations (6)

CHU de TOULOUSE

Toulouse, Choisir Une Région, France

NOT_YET_RECRUITING

CH Saint Marie Clermont-Ferrand

Clermont-Ferrand, France

NOT_YET_RECRUITING

CHU de Montpellier

Montpellier, France

RECRUITING

CHU Nice

Nice, France

NOT_YET_RECRUITING

CHU de Nîmes

Nîmes, France

RECRUITING

Centre Hospitalier Léon-Jean Grégory

Thuir, France

RECRUITING

Outcomes

Primary Outcomes

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

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.

Time frame: 3 years

Secondary Outcomes

Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

number

Time frame: 1 year

Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

number

Time frame: 2 years

Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

number

Time frame: 3 years

Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient

number

Time frame: 1 year

Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient

number

Time frame: 2 years

Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient

number

Time frame: 3 years

Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient

days/weeks/months

Time frame: 1 year

Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient

days/weeks/months

Time frame: 2 years

Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient

days/weeks/months

Time frame: 3 years

Percentage per patient of medical and caregiving appointments honored between groups

Time frame: Inclusion

Percentage per patient of medical and caregiving appointments honored between groups

Time frame: 6 months

Percentage per patient of medical and caregiving appointments honored between groups

Time frame: 1 year

Percentage per patient of medical and caregiving appointments honored between groups

Time frame: 18 months

Percentage per patient of medical and caregiving appointments honored between groups

Time frame: 2 years

Percentage per patient of medical and caregiving appointments honored between groups

Time frame: 2.5 years

Percentage per patient of medical and caregiving appointments honored between groups

Time frame: 3 years

Type of hospital admission (voluntary versus involuntary) between groups

% voluntary versus involuntary

Time frame: Inclusion

Type of hospital admission (voluntary versus involuntary) between groups

% voluntary versus involuntary

Time frame: 6 months

Type of hospital admission (voluntary versus involuntary) between groups

% voluntary versus involuntary

Time frame: 1 year

Type of hospital admission (voluntary versus involuntary) between groups

% voluntary versus involuntary

Time frame: 18 months

Type of hospital admission (voluntary versus involuntary) between groups

% voluntary versus involuntary

Time frame: 2 years

Type of hospital admission (voluntary versus involuntary) between groups

% voluntary versus involuntary

Time frame: 2.5 years

Type of hospital admission (voluntary versus involuntary) between groups

% voluntary versus involuntary

Time frame: 3 years

Unscheduled discharge from care between groups

Defined by a break in follow-up organized by the referring care team for more than 30 days

Time frame: Inclusion

Unscheduled discharge from care between groups

Defined by a break in follow-up organized by the referring care team for more than 30 days

Time frame: 6 months

Unscheduled discharge from care between groups

Defined by a break in follow-up organized by the referring care team for more than 30 days

Time frame: 1 year

Unscheduled discharge from care between groups

Defined by a break in follow-up organized by the referring care team for more than 30 days

Time frame: 18 months

Unscheduled discharge from care between groups

Defined by a break in follow-up organized by the referring care team for more than 30 days

Time frame: 2 years

Unscheduled discharge from care between groups

Defined by a break in follow-up organized by the referring care team for more than 30 days

Time frame: 2.5 years

Unscheduled discharge from care between groups

Defined by a break in follow-up organized by the referring care team for more than 30 days

Time frame: 3 years

Treatment compliance between groups

item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

Time frame: Inclusion

Treatment compliance between groups

item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

Time frame: 6 months

Treatment compliance between groups

item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

Time frame: 1 year

Treatment compliance between groups

item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

Time frame: 18 months

Treatment compliance between groups

item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

Time frame: 2 years

Treatment compliance between groups

item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

Time frame: 2.5 years

Treatment compliance between groups

item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

Time frame: 3 years

Adherence to treatment

Medication Adherence Rating Scale (MARS, self-administered questionnaire)

Time frame: 1 year

Adherence to treatment

Medication Adherence Rating Scale (MARS, self-administered questionnaire)

Time frame: 2 years

Adherence to treatment

Medication Adherence Rating Scale (MARS, self-administered questionnaire)

Time frame: 3 years

Therapeutic alliance

Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)

Time frame: 1 year

Therapeutic alliance

Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)

Time frame: 2 years

Therapeutic alliance

Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)

Time frame: 3 years

Patient awareness of disorders and of the need for treatment

Birchwood Insight Scale (BIS, self-administered questionnaire)

Time frame: 1 year

Patient awareness of disorders and of the need for treatment

Birchwood Insight Scale (BIS, self-administered questionnaire)

Time frame: 2 years

Patient awareness of disorders and of the need for treatment

Birchwood Insight Scale (BIS, self-administered questionnaire)

Time frame: 3 years

Assessment of addictive comorbidities

semi-structured clinical interview for DSM (SCID)

Time frame: Inclusion

Assessment of addictive comorbidities

semi-structured clinical interview for DSM (SCID)

Time frame: 3 years

Assessment of tobacco, alcohol and drug use

Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

Time frame: Every 6 months from inclusion

Evaluation of the clinical impact of the intervention between groups

Clinical Global Impression questionnaire (CGI)

Time frame: Every 6 months from inclusion

Psychotic and general symptoms

Positive and Negative Symptom Scale (PANSS)

Time frame: Every 6 months from inclusion

Depressive symptoms

Calgary Depression Scale for Schizophrenia (CDSS)

Time frame: Every 6 months from inclusion

Self- and hetero-aggressive behaviors

according to Health of the Nation Outcome Scales (HoNOS) items 1 and 2

Time frame: Every 6 months from inclusion

Reported adverse events

death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

Time frame: Inclusion

Reported adverse events

death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

Time frame: 6 months

Reported adverse events

death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

Time frame: 1 year

Reported adverse events

death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

Time frame: 18 months

Reported adverse events

death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

Time frame: 2 years

Reported adverse events

death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

Time frame: 2.5 years

Reported adverse events

death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

Time frame: 3 years

Current suicidal ideations

Calgary Depression Scale for Schizophrenia (CDSS)

Time frame: Inclusion

Current suicidal ideations

Calgary Depression Scale for Schizophrenia (CDSS)

Time frame: 6 months

Current suicidal ideations

Calgary Depression Scale for Schizophrenia (CDSS)

Time frame: 1 year

Current suicidal ideations

Calgary Depression Scale for Schizophrenia (CDSS)

Time frame: 18 months

Current suicidal ideations

Calgary Depression Scale for Schizophrenia (CDSS)

Time frame: 2 years

Current suicidal ideations

Calgary Depression Scale for Schizophrenia (CDSS)

Time frame: 2.5 years

Current suicidal ideations

Calgary Depression Scale for Schizophrenia (CDSS)

Time frame: 3 years

Assess the impact of the intervention on socio-professional functioning and quality of life

Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

Time frame: Inclusion

Assess the impact of the intervention on socio-professional functioning and quality of life

Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

Time frame: 6 months

Assess the impact of the intervention on socio-professional functioning and quality of life

Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

Time frame: 1 year

Assess the impact of the intervention on socio-professional functioning and quality of life

Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

Time frame: 18 months

Assess the impact of the intervention on socio-professional functioning and quality of life

Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

Time frame: 2 years

Assess the impact of the intervention on socio-professional functioning and quality of life

Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

Time frame: 2.5 years

Assess the impact of the intervention on socio-professional functioning and quality of life

Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

Time frame: 3 years

Social and occupational functioning

Social and Occupational Functioning Assessment Scale (SOFAS)

Time frame: Inclusion

Social and occupational functioning

Social and Occupational Functioning Assessment Scale (SOFAS)

Time frame: 6 months

Social and occupational functioning

Social and Occupational Functioning Assessment Scale (SOFAS)

Time frame: 1 year

Social and occupational functioning

Social and Occupational Functioning Assessment Scale (SOFAS)

Time frame: 18 months

Social and occupational functioning

Social and Occupational Functioning Assessment Scale (SOFAS)

Time frame: 2 years

Social and occupational functioning

Social and Occupational Functioning Assessment Scale (SOFAS)

Time frame: 2.5 years

Social and occupational functioning

Social and Occupational Functioning Assessment Scale (SOFAS)

Time frame: 3 years

Social functioning

Health of the Nation Outcome Scales

Time frame: Inclusion

Social functioning

Health of the Nation Outcome Scales

Time frame: 6 months

Social functioning

Health of the Nation Outcome Scales

Time frame: 1 year

Social functioning

Health of the Nation Outcome Scales

Time frame: 18 months

Social functioning

Health of the Nation Outcome Scales

Time frame: 2 years

Social functioning

Health of the Nation Outcome Scales

Time frame: 2.5 years

Social functioning

Health of the Nation Outcome Scales

Time frame: 3 years

Psychosocial functioning

Quality of Life Scale (QLS) - semi-structured interview

Time frame: Inclusion

Psychosocial functioning

Quality of Life Scale (QLS) - semi-structured interview

Time frame: 6 months

Psychosocial functioning

Quality of Life Scale (QLS) - semi-structured interview

Time frame: 1 year

Psychosocial functioning

Quality of Life Scale (QLS) - semi-structured interview

Time frame: 18 months

Psychosocial functioning

Quality of Life Scale (QLS) - semi-structured interview

Time frame: 2 years

Psychosocial functioning

Quality of Life Scale (QLS) - semi-structured interview

Time frame: 2.5 years

Psychosocial functioning

Quality of Life Scale (QLS) - semi-structured interview

Time frame: 3 years

Functioning

Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

Time frame: Inclusion

Functioning

Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

Time frame: 6 months

Functioning

Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

Time frame: 1 year

Functioning

Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

Time frame: 18 months

Functioning

Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

Time frame: 2 years

Functioning

Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

Time frame: 2.5 years

Functioning

Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

Time frame: 3 years

Quality of life of users (patient and family)

World Health Organization Quality of Life brief (WHOQOL-brief)

Time frame: 1 year

Quality of life of users (patient and family)

World Health Organization Quality of Life brief (WHOQOL-brief)

Time frame: 2 years

Quality of life of users (patient and family)

World Health Organization Quality of Life brief (WHOQOL-brief)

Time frame: 3 years

Health-related quality of life

EuroQol-5D 3 level version (EQ-5D-35L)

Time frame: 1 year

Health-related quality of life

EuroQol-5D 3 level version (EQ-5D-35L)

Time frame: 2 years

Health-related quality of life

EuroQol-5D 3 level version (EQ-5D-35L)

Time frame: 3 years

Quality of life of relatives

caregiver schizophrenia quality of life questionnaire (S-CGQoL)

Time frame: 1 year

Quality of life of relatives

caregiver schizophrenia quality of life questionnaire (S-CGQoL)

Time frame: 2 years

Quality of life of relatives

caregiver schizophrenia quality of life questionnaire (S-CGQoL)

Time frame: 3 years

Cost-outcome type ratio

the ratio of the difference in costs between the two strategies divided by the difference in QALYs. This ratio measures the cost per life-year gained in full health, i.e. a cost per QALY. This indicator is obtained by weighting the time spent in each health state h by the utility of that health state measured by the EQ-5D

Time frame: 3 years

Cost of care

assessed from a community perspective (health care system, out-of-pocket expenses, caregivers)

Time frame: 3 years

Budget impact analysis between strategies

National estimates of avoided costs, care consumption and the cost of implementing the system in the two management strategies

Time frame: 3 years

Psychiatric assessment

Structured Clinical Interview for DSM

Time frame: Inclusion

Psychiatric assessment

Structured Clinical Interview for DSM

Time frame: 3 years

Patient age

Time frame: Inclusion

Patient sex

Time frame: Inclusion

Current patient professional/training situation

working or studying

Time frame: Over the study until 3 years

Financial situation

Time frame: Over the study until 3 years

Care pathways taken by patient

specialist care sought

Time frame: Over the study until 3 years

Duration of non-treated psychosis

Interval between start of psychotic symptoms and start of sufficient antipsychotic treatment

Time frame: Inclusion

Personal and family psychiatric history

Time frame: Inclusion

Social and academic function

Premorbid Adjustment Scale

Time frame: Inclusion

Medical treatment received

Time frame: Until 3 years

Cerebral imagery

Normal/abnormal

Time frame: Inclusion

Cerebral imagery

Normal/abnormal

Time frame: 1 year

Cerebral imagery

Normal/abnormal

Time frame: 2 years

IQ profile

Homogenous/heterogenous

Time frame: Inclusion

IQ profile

Homogenous/heterogenous

Time frame: 1 year

IQ profile

Homogenous/heterogenous

Time frame: 2 years

value

Time frame: Inclusion

value

Time frame: 1 year

value

Time frame: 2 years

BMI

kg/m2

Time frame: Inclusion

BMI

kg/m2

Time frame: 1 year

BMI

kg/m2

Time frame: 2 years

Fasting glycemia

mmol/l

Time frame: Inclusion

Fasting glycemia

mmol/l

Time frame: 1 year

Fasting glycemia

mmol/l

Time frame: 2 years

Lipid assessment

Normal/abnormal

Time frame: Inclusion

Lipid assessment

Normal/abnormal

Time frame: 1 year

Lipid assessment

Normal/abnormal

Time frame: 2 years

Whole blood count

Normal/abnormal

Time frame: Inclusion

Whole blood count

Normal/abnormal

Time frame: 1 year

Whole blood count

Normal/abnormal

Time frame: 2 years

Electrolytes

Normal/abnormal

Time frame: Inclusion

Electrolytes

Normal/abnormal

Time frame: 1 year

Electrolytes

Normal/abnormal

Time frame: 2 years

Neurological exam

Normal/abnormal

Time frame: Inclusion

Neurological exam

Normal/abnormal

Time frame: 1 year

Neurological exam

Normal/abnormal

Time frame: 2 years

Cardiovascular exam

Normal/abnormal

Time frame: Inclusion

Cardiovascular exam

Normal/abnormal

Time frame: 1 year

Cardiovascular exam

Normal/abnormal

Time frame: 2 years

Morphological exam

Normal/abnormal

Time frame: Inclusion

Morphological exam

Normal/abnormal

Time frame: 1 year

Morphological exam

Normal/abnormal

Time frame: 2 years

Hepatic exam

Normal/abnormal

Time frame: Inclusion

Hepatic exam

Normal/abnormal

Time frame: 1 year

Hepatic exam

Normal/abnormal

Time frame: 2 years

Presence of neurometabolic disease

Yes/no

Time frame: Inclusion

Presence of neurometabolic disease

Yes/no

Time frame: 1 year

Presence of neurometabolic disease

Yes/no

Time frame: 2 years

Electrocardiogram

Normal/abnormal

Time frame: Inclusion

Electrocardiogram

Normal/abnormal

Time frame: 1 year

Electrocardiogram

Normal/abnormal

Time frame: 2 years

C-reactive protein

mg/l

Time frame: Inclusion

C-reactive protein

mg/l

Time frame: 1 year

C-reactive protein

mg/l

Time frame: 2 years

thyroid-stimulating hormone

mUI/l

Time frame: Inclusion

thyroid-stimulating hormone

mUI/l

Time frame: 1 year

thyroid-stimulating hormone

mUI/l

Time frame: 2 years

Cortisol

nmol/l

Time frame: Inclusion

Cortisol

nmol/l

Time frame: 1 year

Cortisol

nmol/l

Time frame: 2 years

Adverse events

Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other

Time frame: Inclusion

Adverse events

Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other

Time frame: 1 year

Adverse events

Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other

Time frame: 2 years

Non-medical treatment received

Psychosocial/psychotherapy interventions

Time frame: Until 3 years

In the experimental group: case management according to good practice guidelines

EPPIC Model Integrity Tool (80 items with subscores)

Time frame: End of follow-up (3 years)

In the experimental group: Conformity of case management

Index of Fidelity to Assertive Community Treatment (16 criteria of conformity for three dimensions)

Time frame: End of study (5 years)

In the experimental group: conformity to TIDieR checklist in each patient

TIDieR checklist-patient

Time frame: Month 3

In the experimental group: conformity to TIDieR checklist in each patient

TIDieR checklist-patient

Time frame: Month 6

In the experimental group: conformity to TIDieR checklist in each patient

TIDieR checklist-patient

Time frame: 1 year

In the experimental group: conformity to TIDieR checklist in each patient

TIDieR checklist-patient

Time frame: 18 Months

In the experimental group: conformity to TIDieR checklist in each patient

TIDieR checklist-patient

Time frame: 2 years

In the experimental group: conformity to TIDieR checklist in each patient

TIDieR checklist-patient

Time frame: 30 Months

In the experimental group: conformity to TIDieR checklist in each patient

TIDieR checklist-patient

Time frame: 3 years

In the experimental group: conformity to TIDieR checklist in each center

Customized TIDieR checklist-center

Time frame: Annually until end of study (5 years)

Satisfaction of patients and their families

Client Satisfaction Questionnaire (CSQ)-8

Time frame: 1 year

Satisfaction of patients and their families

Client Satisfaction Questionnaire (CSQ)-8

Time frame: 2 years

Satisfaction of patients and their families

Client Satisfaction Questionnaire (CSQ)-8

Time frame: 3 years

Satisfaction of participants receiving help from a health coordinator

7-item custom questionnaire with free answer section

Time frame: End of follow-up (3 years)

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.

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts