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.

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Psychotic Episode

Intervention / Treatment
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* Other: Case management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case manager group<br> | Other: Case management<br>* Regular and personalized follow-up by a case manager using a case management approach, updated every 3 months<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient | number | 1 year | 
| Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient | number | 2 years | 
| Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient | number | 3 years | 
| Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient | number | 1 year | 
| Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient | number | 2 years | 
| Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient | number | 3 years | 
| Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient | days/weeks/months | 1 year | 
| Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient | days/weeks/months | 2 years | 
| Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient | days/weeks/months | 3 years | 
| Percentage per patient of medical and caregiving appointments honored between groups |  | Inclusion | 
| Percentage per patient of medical and caregiving appointments honored between groups |  | 6 months | 
| Percentage per patient of medical and caregiving appointments honored between groups |  | 1 year | 
| Percentage per patient of medical and caregiving appointments honored between groups |  | 18 months | 
| Percentage per patient of medical and caregiving appointments honored between groups |  | 2 years | 
| Percentage per patient of medical and caregiving appointments honored between groups |  | 2.5 years | 
| Percentage per patient of medical and caregiving appointments honored between groups |  | 3 years | 
| Type of hospital admission (voluntary versus involuntary) between groups | % voluntary versus involuntary | Inclusion | 
| Type of hospital admission (voluntary versus involuntary) between groups | % voluntary versus involuntary | 6 months | 
| Type of hospital admission (voluntary versus involuntary) between groups | % voluntary versus involuntary | 1 year | 
| Type of hospital admission (voluntary versus involuntary) between groups | % voluntary versus involuntary | 18 months | 
| Type of hospital admission (voluntary versus involuntary) between groups | % voluntary versus involuntary | 2 years | 
| Type of hospital admission (voluntary versus involuntary) between groups | % voluntary versus involuntary | 2.5 years | 
| Type of hospital admission (voluntary versus involuntary) between groups | % voluntary versus involuntary | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 3 years | 
| Treatment compliance between groups | item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment) | Inclusion | 
| Treatment compliance between groups | item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment) | 6 months | 
| Treatment compliance between groups | item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment) | 1 year | 
| Treatment compliance between groups | item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment) | 18 months | 
| Treatment compliance between groups | item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment) | 2 years | 
| Treatment compliance between groups | item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment) | 2.5 years | 
| Treatment compliance between groups | item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment) | 3 years | 
| Adherence to treatment | Medication Adherence Rating Scale (MARS, self-administered questionnaire) | 1 year | 
| Adherence to treatment | Medication Adherence Rating Scale (MARS, self-administered questionnaire) | 2 years | 
| Adherence to treatment | Medication Adherence Rating Scale (MARS, self-administered questionnaire) | 3 years | 
| Therapeutic alliance | Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire) | 1 year | 
| Therapeutic alliance | Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire) | 2 years | 
| Therapeutic alliance | Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire) | 3 years | 
| Patient awareness of disorders and of the need for treatment | Birchwood Insight Scale (BIS, self-administered questionnaire) | 1 year | 
| Patient awareness of disorders and of the need for treatment | Birchwood Insight Scale (BIS, self-administered questionnaire) | 2 years | 
| Patient awareness of disorders and of the need for treatment | Birchwood Insight Scale (BIS, self-administered questionnaire) | 3 years | 
| Assessment of addictive comorbidities | semi-structured clinical interview for DSM (SCID) | Inclusion | 
| Assessment of addictive comorbidities | semi-structured clinical interview for DSM (SCID) | 3 years | 
| Assessment of tobacco, alcohol and drug use | Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) | Every 6 months from inclusion | 
| Evaluation of the clinical impact of the intervention between groups | Clinical Global Impression questionnaire (CGI) | Every 6 months from inclusion | 
| Psychotic and general symptoms | Positive and Negative Symptom Scale (PANSS) | Every 6 months from inclusion | 
| Depressive symptoms | Calgary Depression Scale for Schizophrenia (CDSS) | Every 6 months from inclusion | 
| Self- and hetero-aggressive behaviors | according to Health of the Nation Outcome Scales (HoNOS) items 1 and 2 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 3 years | 
| Current suicidal ideations | Calgary Depression Scale for Schizophrenia (CDSS) | Inclusion | 
| Current suicidal ideations | Calgary Depression Scale for Schizophrenia (CDSS) | 6 months | 
| Current suicidal ideations | Calgary Depression Scale for Schizophrenia (CDSS) | 1 year | 
| Current suicidal ideations | Calgary Depression Scale for Schizophrenia (CDSS) | 18 months | 
| Current suicidal ideations | Calgary Depression Scale for Schizophrenia (CDSS) | 2 years | 
| Current suicidal ideations | Calgary Depression Scale for Schizophrenia (CDSS) | 2.5 years | 
| Current suicidal ideations | Calgary Depression Scale for Schizophrenia (CDSS) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 3 years | 
| Social and occupational functioning | Social and Occupational Functioning Assessment Scale (SOFAS) | Inclusion | 
| Social and occupational functioning | Social and Occupational Functioning Assessment Scale (SOFAS) | 6 months | 
| Social and occupational functioning | Social and Occupational Functioning Assessment Scale (SOFAS) | 1 year | 
| Social and occupational functioning | Social and Occupational Functioning Assessment Scale (SOFAS) | 18 months | 
| Social and occupational functioning | Social and Occupational Functioning Assessment Scale (SOFAS) | 2 years | 
| Social and occupational functioning | Social and Occupational Functioning Assessment Scale (SOFAS) | 2.5 years | 
| Social and occupational functioning | Social and Occupational Functioning Assessment Scale (SOFAS) | 3 years | 
| Social functioning | Health of the Nation Outcome Scales | Inclusion | 
| Social functioning | Health of the Nation Outcome Scales | 6 months | 
| Social functioning | Health of the Nation Outcome Scales | 1 year | 
| Social functioning | Health of the Nation Outcome Scales | 18 months | 
| Social functioning | Health of the Nation Outcome Scales | 2 years | 
| Social functioning | Health of the Nation Outcome Scales | 2.5 years | 
| Social functioning | Health of the Nation Outcome Scales | 3 years | 
| Psychosocial functioning | Quality of Life Scale (QLS) - semi-structured interview | Inclusion | 
| Psychosocial functioning | Quality of Life Scale (QLS) - semi-structured interview | 6 months | 
| Psychosocial functioning | Quality of Life Scale (QLS) - semi-structured interview | 1 year | 
| Psychosocial functioning | Quality of Life Scale (QLS) - semi-structured interview | 18 months | 
| Psychosocial functioning | Quality of Life Scale (QLS) - semi-structured interview | 2 years | 
| Psychosocial functioning | Quality of Life Scale (QLS) - semi-structured interview | 2.5 years | 
| Psychosocial functioning | Quality of Life Scale (QLS) - semi-structured interview | 3 years | 
| Functioning | Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire | Inclusion | 
| Functioning | Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire | 6 months | 
| Functioning | Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire | 1 year | 
| Functioning | Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire | 18 months | 
| Functioning | Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire | 2 years | 
| Functioning | Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire | 2.5 years | 
| Functioning | Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire | 3 years | 
| Quality of life of users (patient and family) | World Health Organization Quality of Life brief (WHOQOL-brief) | 1 year | 
| Quality of life of users (patient and family) | World Health Organization Quality of Life brief (WHOQOL-brief) | 2 years | 
| Quality of life of users (patient and family) | World Health Organization Quality of Life brief (WHOQOL-brief) | 3 years | 
| Health-related quality of life | EuroQol-5D 3 level version (EQ-5D-35L) | 1 year | 
| Health-related quality of life | EuroQol-5D 3 level version (EQ-5D-35L) | 2 years | 
| Health-related quality of life | EuroQol-5D 3 level version (EQ-5D-35L) | 3 years | 
| Quality of life of relatives | caregiver schizophrenia quality of life questionnaire (S-CGQoL) | 1 year | 
| Quality of life of relatives | caregiver schizophrenia quality of life questionnaire (S-CGQoL) | 2 years | 
| Quality of life of relatives | caregiver schizophrenia quality of life questionnaire (S-CGQoL) | 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 | 3 years | 
| Cost of care | assessed from a community perspective (health care system, out-of-pocket expenses, caregivers) | 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 | 3 years | 
| Psychiatric assessment | Structured Clinical Interview for DSM | Inclusion | 
| Psychiatric assessment | Structured Clinical Interview for DSM | 3 years | 
| Patient age |  | Inclusion | 
| Patient sex |  | Inclusion | 
| Current patient professional/training situation | working or studying | Over the study until 3 years | 
| Financial situation |  | Over the study until 3 years | 
| Care pathways taken by patient | specialist care sought | Over the study until 3 years | 
| Duration of non-treated psychosis | Interval between start of psychotic symptoms and start of sufficient antipsychotic treatment | Inclusion | 
| Personal and family psychiatric history |  | Inclusion | 
| Social and academic function | Premorbid Adjustment Scale | Inclusion | 
| Medical treatment received |  | Until 3 years | 
| Cerebral imagery | Normal/abnormal | Inclusion | 
| Cerebral imagery | Normal/abnormal | 1 year | 
| Cerebral imagery | Normal/abnormal | 2 years | 
| IQ profile | Homogenous/heterogenous | Inclusion | 
| IQ profile | Homogenous/heterogenous | 1 year | 
| IQ profile | Homogenous/heterogenous | 2 years | 
| IQ | value | Inclusion | 
| IQ | value | 1 year | 
| IQ | value | 2 years | 
| BMI | kg/m2 | Inclusion | 
| BMI | kg/m2 | 1 year | 
| BMI | kg/m2 | 2 years | 
| Fasting glycemia | mmol/l | Inclusion | 
| Fasting glycemia | mmol/l | 1 year | 
| Fasting glycemia | mmol/l | 2 years | 
| Lipid assessment | Normal/abnormal | Inclusion | 
| Lipid assessment | Normal/abnormal | 1 year | 
| Lipid assessment | Normal/abnormal | 2 years | 
| Whole blood count | Normal/abnormal | Inclusion | 
| Whole blood count | Normal/abnormal | 1 year | 
| Whole blood count | Normal/abnormal | 2 years | 
| Electrolytes | Normal/abnormal | Inclusion | 
| Electrolytes | Normal/abnormal | 1 year | 
| Electrolytes | Normal/abnormal | 2 years | 
| Neurological exam | Normal/abnormal | Inclusion | 
| Neurological exam | Normal/abnormal | 1 year | 
| Neurological exam | Normal/abnormal | 2 years | 
| Cardiovascular exam | Normal/abnormal | Inclusion | 
| Cardiovascular exam | Normal/abnormal | 1 year | 
| Cardiovascular exam | Normal/abnormal | 2 years | 
| Morphological exam | Normal/abnormal | Inclusion | 
| Morphological exam | Normal/abnormal | 1 year | 
| Morphological exam | Normal/abnormal | 2 years | 
| Hepatic exam | Normal/abnormal | Inclusion | 
| Hepatic exam | Normal/abnormal | 1 year | 
| Hepatic exam | Normal/abnormal | 2 years | 
| Presence of neurometabolic disease | Yes/no | Inclusion | 
| Presence of neurometabolic disease | Yes/no | 1 year | 
| Presence of neurometabolic disease | Yes/no | 2 years | 
| Electrocardiogram | Normal/abnormal | Inclusion | 
| Electrocardiogram | Normal/abnormal | 1 year | 
| Electrocardiogram | Normal/abnormal | 2 years | 
| C-reactive protein | mg/l | Inclusion | 
| C-reactive protein | mg/l | 1 year | 
| C-reactive protein | mg/l | 2 years | 
| thyroid-stimulating hormone | mUI/l | Inclusion | 
| thyroid-stimulating hormone | mUI/l | 1 year | 
| thyroid-stimulating hormone | mUI/l | 2 years | 
| Cortisol | nmol/l | Inclusion | 
| Cortisol | nmol/l | 1 year | 
| Cortisol | nmol/l | 2 years | 
| Adverse events | Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other | Inclusion | 
| Adverse events | Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other | 1 year | 
| Adverse events | Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other | 2 years | 
| Non-medical treatment received | Psychosocial/psychotherapy interventions | Until 3 years | 
| In the experimental group: case management according to good practice guidelines | EPPIC Model Integrity Tool (80 items with subscores) | 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) | End of study (5 years) | 
| In the experimental group: conformity to TIDieR checklist in each patient | TIDieR checklist-patient | Month 3 | 
| In the experimental group: conformity to TIDieR checklist in each patient | TIDieR checklist-patient | Month 6 | 
| In the experimental group: conformity to TIDieR checklist in each patient | TIDieR checklist-patient | 1 year | 
| In the experimental group: conformity to TIDieR checklist in each patient | TIDieR checklist-patient | 18 Months | 
| In the experimental group: conformity to TIDieR checklist in each patient | TIDieR checklist-patient | 2 years | 
| In the experimental group: conformity to TIDieR checklist in each patient | TIDieR checklist-patient | 30 Months | 
| In the experimental group: conformity to TIDieR checklist in each patient | TIDieR checklist-patient | 3 years | 
| In the experimental group: conformity to TIDieR checklist in each center | Customized TIDieR checklist-center | Annually until end of study (5 years) | 
| Satisfaction of patients and their families | Client Satisfaction Questionnaire (CSQ)-8 | 1 year | 
| Satisfaction of patients and their families | Client Satisfaction Questionnaire (CSQ)-8 | 2 years | 
| Satisfaction of patients and their families | Client Satisfaction Questionnaire (CSQ)-8 | 3 years | 
| Satisfaction of participants receiving help from a health coordinator | 7-item custom questionnaire with free answer section | End of follow-up (3 years) |