HAPEXIdentification and Validation of Addictology Expert Patients' Fields of Intervention With Inpatients for Addictive Disorders
Expert patient in addictology
Trastornos Mentales
Estudio de Investigación en servicios de salud
Resumen
Fecha de inicio: 19 de junio de 2020
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 69 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Investigación en Servicios de Salud
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 99 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Département psychiatrie et addictologie Bichat Claude Bernard
Paris, FranceAbrir Département psychiatrie et addictologie Bichat Claude Bernard en Google Maps