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.
- Conditions
- Psychotic Episode
- Interventions
- Other: Case management
- Registration Number
- NCT05116514
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 256
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The patient or their close relative must have given their free and informed consent and signed the consent form
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The patient must be a member or beneficiary of a health insurance plan
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The patient is available for a 3-year follow-up.
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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.
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Inclusion should be within the first 3 months of care for first episode psychosis in the psychiatric service.
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At the time of inclusion, the psychotic symptomatology observed during the first episode psychosis may still be present or in remission.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Case manager group Case management -
- Primary Outcome Measures
Name Time Method Rate of patients with recurrence of psychotic episode at least once between groups 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 Outcome Measures
Name Time Method Social and occupational functioning 3 years Social and Occupational Functioning Assessment Scale (SOFAS)
Social functioning 3 years Health of the Nation Outcome Scales
Psychosocial functioning 3 years Quality of Life Scale (QLS) - semi-structured interview
Functioning 3 years Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire
Quality of life of users (patient and family) 3 years World Health Organization Quality of Life brief (WHOQOL-brief)
Health-related quality of life 3 years EuroQol-5D 3 level version (EQ-5D-35L)
Quality of life of relatives 3 years caregiver schizophrenia quality of life questionnaire (S-CGQoL)
Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient 3 years number
Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient 3 years number
Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient 3 years days/weeks/months
Percentage per patient of medical and caregiving appointments honored between groups 3 years %
Type of hospital admission (voluntary versus involuntary) between groups 3 years % voluntary versus involuntary
Unscheduled discharge from care between groups 3 years Defined by a break in follow-up organized by the referring care team for more than 30 days
Treatment compliance between groups 3 years item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)
Adherence to treatment 3 years Medication Adherence Rating Scale (MARS, self-administered questionnaire)
Therapeutic alliance 3 years Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)
Patient awareness of disorders and of the need for treatment 3 years Birchwood Insight Scale (BIS, self-administered questionnaire)
Assessment of addictive comorbidities 3 years semi-structured clinical interview for DSM (SCID)
Assessment of tobacco, alcohol and drug use Every 6 months from inclusion Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Evaluation of the clinical impact of the intervention between groups Every 6 months from inclusion Clinical Global Impression questionnaire (CGI)
Psychotic and general symptoms Every 6 months from inclusion Positive and Negative Symptom Scale (PANSS)
Depressive symptoms Every 6 months from inclusion Calgary Depression Scale for Schizophrenia (CDSS)
Self- and hetero-aggressive behaviors Every 6 months from inclusion according to Health of the Nation Outcome Scales (HoNOS) items 1 and 2
Reported adverse events 3 years 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
Current suicidal ideations 3 years Calgary Depression Scale for Schizophrenia (CDSS)
Assess the impact of the intervention on socio-professional functioning and quality of life 3 years Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation
Cost-outcome type ratio 3 years 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
Cost of care 3 years assessed from a community perspective (health care system, out-of-pocket expenses, caregivers)
Budget impact analysis between strategies 3 years National estimates of avoided costs, care consumption and the cost of implementing the system in the two management strategies
Psychiatric assessment 3 years Structured Clinical Interview for DSM
Patient age Inclusion Patient sex Inclusion Current patient professional/training situation Over the study until 3 years working or studying
Financial situation Over the study until 3 years Care pathways taken by patient Over the study until 3 years specialist care sought
Duration of non-treated psychosis Inclusion Interval between start of psychotic symptoms and start of sufficient antipsychotic treatment
Personal and family psychiatric history Inclusion Social and academic function Inclusion Premorbid Adjustment Scale
Medical treatment received Until 3 years Cerebral imagery 2 years Normal/abnormal
IQ profile 2 years Homogenous/heterogenous
IQ 2 years value
BMI 2 years kg/m2
Fasting glycemia 2 years mmol/l
Lipid assessment 2 years Normal/abnormal
Whole blood count 2 years Normal/abnormal
Electrolytes 2 years Normal/abnormal
Neurological exam 2 years Normal/abnormal
Cardiovascular exam 2 years Normal/abnormal
Morphological exam 2 years Normal/abnormal
Hepatic exam 2 years Normal/abnormal
Presence of neurometabolic disease 2 years Yes/no
Electrocardiogram 2 years Normal/abnormal
C-reactive protein 2 years mg/l
thyroid-stimulating hormone 2 years mUI/l
Cortisol 2 years nmol/l
Adverse events 2 years Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other
Non-medical treatment received Until 3 years Psychosocial/psychotherapy interventions
In the experimental group: case management according to good practice guidelines End of follow-up (3 years) EPPIC Model Integrity Tool (80 items with subscores)
In the experimental group: Conformity of case management End of study (5 years) Index of Fidelity to Assertive Community Treatment (16 criteria of conformity for three dimensions)
In the experimental group: conformity to TIDieR checklist in each patient 3 years TIDieR checklist-patient
In the experimental group: conformity to TIDieR checklist in each center Annually until end of study (5 years) Customized TIDieR checklist-center
Satisfaction of patients and their families 3 years Client Satisfaction Questionnaire (CSQ)-8
Satisfaction of participants receiving help from a health coordinator End of follow-up (3 years) 7-item custom questionnaire with free answer section
Trial Locations
- Locations (6)
CHU de TOULOUSE
🇫🇷Toulouse, Choisir une région, France
CH Saint Marie Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
CHU de Montpellier
🇫🇷Montpellier, France
CHU Nice
🇫🇷Nice, France
CHU de Nîmes
🇫🇷Nîmes, France
Centre Hospitalier Léon-Jean Grégory
🇫🇷Thuir, France