Terminé

HAPEXIdentification and Validation of Addictology Expert Patients' Fields of Intervention With Inpatients for Addictive Disorders

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Ce qui est testé

Expert patient in addictology

Comportemental
Qui peut participer

Troubles Mentaux

+ Troubles liés aux substances

+ Troubles Induits par Produits Chimiques

De 18 à 99 ans
+8 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude sur les services de santé

Interventionnel
Date de début : juin 2020
Voir le détail du protocole

Résumé

Sponsor principalAssistance Publique - Hôpitaux de Paris
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 19 juin 2020

Date à laquelle le premier participant a commencé l'étude.

1. Targeted population : Major individuals hospitalized in the Department of Addictology and Psychiatry at Bichat Hospital. All participants sign a hospitalization contract upon arrival in which they undertake, among other things, to meet with the EP, within the framework of a system set up in the hospitalization unit since 2015. In order to be able to study the different factors influencing the intervention mechanism, it is decided to take the broadest possible selection criteria in order to remain representative of the heterogeneity of the target population. This is why the investigators have chosen to include all hospitalized patients in the service who agree to meet with an EP, at all socio-economic levels, for withdrawal from any substance regardless of the severity of the addictive disorder, regardless of the previous course of care with or without anxiety and depression symptoms 2. Inclusion criteria : Adults, hospitalized during the period of inclusion of the study in the addictology department at the Bichat-Claude Bernard Hospital in Paris, for withdrawal. Substance use disorder, diagnosed according to the criteria of the DSM-5, i.e. at least 2 diagnostic criteria. Patients who have received information about the research and signed the consent form. 3. Non inclusion criteria : Severe cognitive disorders, i.e. MoCA test < 11, Severe psychiatric disorders assessed using the MINI test (acute psychotic episode, manic or hypomanic episode, severe depression), No understanding of French, Patient under guardianship or curatorship, Patient refusal 4. Study conduct : STEP 1: Preliminary qualitative study * among the first eligible patients in the study to specify the content of EP's intervention, adapted to the inpatient's needs * Individual face-to-face interview, conducted by the principal investigator (PI) , according to the methodology socio-anthropological interviews * The interview will be conducted during the patient's hospitalization, whether the patient has already met with the EP or not. * Number of participants expected is not decided, the PI waiting for the saturation of information as it happens as the interviews progressed * A semi-structured interview grid will be followed * The interviews will be recorded and transcribed in the form of verbatim and then analyzed according to the content analysis technique * This analysis will be supervised by a socio- anthropologist from the research team of Robert Debré * The needs of patients will be produced by this analysis, and will be translated into fields of skills to be addressed during the EP's intervention * End of the study for these first participants STEP 2: Before and after comparative study on inpatients being their own witnesses. This is a study feasibility pilot * Eligible participants will be patients meeting the criteria for judgment and not having not participated in the first part of the study * They will be presented with the study and the collection of the consent at the beginning of hospitalization, before the EP's intervention * After agreement of participation, the initial socio-economic participants' characteristics will be collected on the variable collection notebook * Completion of the first competency assessment hetero-questionnaire before the EP's intervention (main criterion judgment evaluation). This questionnaire will have been constructed based on patient needs expressed in Part 1 * EP's Intervention, with patients hospitalized for withdrawal. These are weekly individual interviews, in room, proposed by the EPs to inpatients. * The second hetero-questionnaire will be proposed to the same patient during his hospitalization, within 48 hours of the EP's intervention (main criterion judgment evaluation) * A follow-up (by telephone or in person) will be carried out at 1 month and then 3 months to estimate the number of patients who have consumed during the hospitalization (frequency, quantity, duration) * End of the study for a patient 5. Inclusion : For the qualitative study, the investigators estimate that the data are saturated between 10 and 20 patients. For the quantitative study, the investigators estimate that there are 10 new patients per month. The investigators hope to include at least half of the target population, meaning 50 participants over the 10 months of the study. In total, for the entire study, an estimate of 70 participants. 6. Statistics analysis : The statistical analysis will be performed using SAS v9.3®. The quantitative variables will be presented as median, interquartile and missing data. The qualitative variables will be presented in terms of frequency, percentage and number of missing data. The initial characteristics of the patients will be presented. The indicators qualitative and quantitative acceptability will also be presented. The median of the results of the competency questionnaires between D0 and H48 will be compared between the group before and after by a Wilcoxon test (no hypothesis on the distribution of this variable). A multivariate analysis will be conducted to identify all the factors influencing the variation in questionnaire responses. This will allow the influence of patient profiles on outcomes to be taken into account.

Titre officielIdentification and Validation of Addictology Expert Patients' Fields of Intervention With Inpatients for Addictive Disorders
NCT04458987
Sponsor principalAssistance Publique - Hôpitaux de Paris
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

69 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Recherche sur les services de santé

Cette étude s'intéresse à la manière dont les soins de santé sont organisés et délivrés, et évalue l'efficacité de différents systèmes ou modèles de prise en charge.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 18 à 99 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Troubles MentauxTroubles liés aux substancesTroubles Induits par Produits Chimiques

Critères

3 critères d'inclusion nécessaires pour participer
Patients hospitalized in the addictology department at the Bichat-Claude Bernard Hospital in Paris, for withdrawal.

Substance use disorder, diagnosed according to the criteria of the DSM-5, i.e. at least 2 diagnostic criteria.

Patients who have received information about the research and signed the consent form.

5 critères d'exclusion empêchent la participation
Severe cognitive impairment i.e. MoCA scale < or = 10

Severe psychiatric conditions assessed using the MINI scale : Acute psychotic episode, Manic or hypomaniacal episode, Severe depression

non comprehension of french

patient Under guardianship or curatorship

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

Un seul groupe d'intervention est désigné dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
before/ after comparison, each patients being its own control

Objectifs de l'étude

Objectifs principaux

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

Département psychiatrie et addictologie Bichat Claude Bernard

Paris, FranceOuvrir Département psychiatrie et addictologie Bichat Claude Bernard dans Google Maps
Terminé1 Centres d'Étude