Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04458987 |
Other study ID # |
APHP190489 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 19, 2020 |
Est. completion date |
May 19, 2021 |
Study information
Verified date |
October 2020 |
Source |
Assistance Publique - Hôpitaux de Paris |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Although there are many publications concerning the benefit of the interventions of the
self-help movements and peer health mediators in psychiatry, no studies have described the
intervention specific to patients with expertise in addictology (EP), nor evaluated their
effectiveness.
The objective of this study is twofold: identify and define the fields of intervention of EPs
adapted to the specific needs of addictology patients. And validate, through a pilot study,
the intermediate effectiveness of EP intervention. This EP intervention will be built on the
areas of expertise defined in the first step. Intermediate effectiveness will be measured by
patients' ability to manage their addiction. The first part of the study will consist of a
preliminary qualitative patient-centered study to clarify patients' needs and expectations
regarding the content of the EPs' intervention into a one addictology service of the
university hospital of Bichat, Paris, France. This will make it possible to translate these
needs into fields of expertise to address during the EPs' intervention and will result in the
creation of a hetero-questionnaire. The second part of the study will consist of a
before-and-after comparative study on inpatients who are their own controls based on the
hetero-questionnaire constructed through the qualitative study.
This study will identify the main EP's intervention fields in addictology in which EP are
more relevant to patients. Thus, their inpatient interventions can be validated and improved,
and better carried by addiction professionals.
Description:
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.