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.

Psychotic Episode Clinical Trial

— PEPsy-CM  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05116514
• Other study ID #: PREPS/2018/AS-01
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: November 2028

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Aurélie Schandrin
• Phone: 04.66.68.34.26
• Email: aurelie.schandrin[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: November 2028
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Psychotic Episode
• Recurrence

Intervention

Other:
• Case management
Regular and personalized follow-up by a case manager using a "case management" approach, updated every 3 months

Locations

Country	Name	City	State
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	CHU de TOULOUSE	Toulouse	Choisir Une Région

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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