<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04458987</url>
  </required_header>
  <id_info>
    <org_study_id>APHP190489</org_study_id>
    <nct_id>NCT04458987</nct_id>
  </id_info>
  <brief_title>Addictology Expert Patients' Fields of Intervention</brief_title>
  <acronym>HAPEX</acronym>
  <official_title>Identification and Validation of Addictology Expert Patients' Fields of Intervention With Inpatients for Addictive Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although there are many publications concerning the benefit of the interventions of the&#xD;
      self-help movements and peer health mediators in psychiatry, no studies have described the&#xD;
      intervention specific to patients with expertise in addictology (EP), nor evaluated their&#xD;
      effectiveness.&#xD;
&#xD;
      The objective of this study is twofold: identify and define the fields of intervention of EPs&#xD;
      adapted to the specific needs of addictology patients. And validate, through a pilot study,&#xD;
      the intermediate effectiveness of EP intervention. This EP intervention will be built on the&#xD;
      areas of expertise defined in the first step. Intermediate effectiveness will be measured by&#xD;
      patients' ability to manage their addiction. The first part of the study will consist of a&#xD;
      preliminary qualitative patient-centered study to clarify patients' needs and expectations&#xD;
      regarding the content of the EPs' intervention into a one addictology service of the&#xD;
      university hospital of Bichat, Paris, France. This will make it possible to translate these&#xD;
      needs into fields of expertise to address during the EPs' intervention and will result in the&#xD;
      creation of a hetero-questionnaire. The second part of the study will consist of a&#xD;
      before-and-after comparative study on inpatients who are their own controls based on the&#xD;
      hetero-questionnaire constructed through the qualitative study.&#xD;
&#xD;
      This study will identify the main EP's intervention fields in addictology in which EP are&#xD;
      more relevant to patients. Thus, their inpatient interventions can be validated and improved,&#xD;
      and better carried by addiction professionals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Targeted population : Major individuals hospitalized in the Department of Addictology&#xD;
           and Psychiatry at Bichat Hospital. All participants sign a hospitalization contract upon&#xD;
           arrival in which they undertake, among other things, to meet with the EP, within the&#xD;
           framework of a system set up in the hospitalization unit since 2015. In order to be able&#xD;
           to study the different factors influencing the intervention mechanism, it is decided to&#xD;
           take the broadest possible selection criteria in order to remain representative of the&#xD;
           heterogeneity of the target population. This is why the investigators have chosen to&#xD;
           include all hospitalized patients in the service who agree to meet with an EP, at all&#xD;
           socio-economic levels, for withdrawal from any substance regardless of the severity of&#xD;
           the addictive disorder, regardless of the previous course of care with or without&#xD;
           anxiety and depression symptoms&#xD;
&#xD;
        2. Inclusion criteria : Adults, hospitalized during the period of inclusion of the study in&#xD;
           the addictology department at the Bichat-Claude Bernard Hospital in Paris, for&#xD;
           withdrawal. Substance use disorder, diagnosed according to the criteria of the DSM-5,&#xD;
           i.e. at least 2 diagnostic criteria. Patients who have received information about the&#xD;
           research and signed the consent form.&#xD;
&#xD;
        3. Non inclusion criteria : Severe cognitive disorders, i.e. MoCA test &lt; 11, Severe&#xD;
           psychiatric disorders assessed using the MINI test (acute psychotic episode, manic or&#xD;
           hypomanic episode, severe depression), No understanding of French, Patient under&#xD;
           guardianship or curatorship, Patient refusal&#xD;
&#xD;
        4. Study conduct : STEP 1: Preliminary qualitative study&#xD;
&#xD;
             -  among the first eligible patients in the study to specify the content of EP's&#xD;
                intervention, adapted to the inpatient's needs&#xD;
&#xD;
             -  Individual face-to-face interview, conducted by the principal investigator (PI) ,&#xD;
                according to the methodology socio-anthropological interviews&#xD;
&#xD;
             -  The interview will be conducted during the patient's hospitalization, whether the&#xD;
                patient has already met with the EP or not.&#xD;
&#xD;
             -  Number of participants expected is not decided, the PI waiting for the saturation&#xD;
                of information as it happens as the interviews progressed&#xD;
&#xD;
             -  A semi-structured interview grid will be followed&#xD;
&#xD;
             -  The interviews will be recorded and transcribed in the form of verbatim and then&#xD;
                analyzed according to the content analysis technique&#xD;
&#xD;
             -  This analysis will be supervised by a socio- anthropologist from the research team&#xD;
                of Robert Debré&#xD;
&#xD;
             -  The needs of patients will be produced by this analysis, and will be translated&#xD;
                into fields of skills to be addressed during the EP's intervention&#xD;
&#xD;
             -  End of the study for these first participants&#xD;
&#xD;
           STEP 2: Before and after comparative study on inpatients being their own witnesses. This&#xD;
           is a study feasibility pilot&#xD;
&#xD;
             -  Eligible participants will be patients meeting the criteria for judgment and not&#xD;
                having not participated in the first part of the study&#xD;
&#xD;
             -  They will be presented with the study and the collection of the consent at the&#xD;
                beginning of hospitalization, before the EP's intervention&#xD;
&#xD;
             -  After agreement of participation, the initial socio-economic participants'&#xD;
                characteristics will be collected on the variable collection notebook&#xD;
&#xD;
             -  Completion of the first competency assessment hetero-questionnaire before the EP's&#xD;
                intervention (main criterion judgment evaluation). This questionnaire will have&#xD;
                been constructed based on patient needs expressed in Part 1&#xD;
&#xD;
             -  EP's Intervention, with patients hospitalized for withdrawal. These are weekly&#xD;
                individual interviews, in room, proposed by the EPs to inpatients.&#xD;
&#xD;
             -  The second hetero-questionnaire will be proposed to the same patient during his&#xD;
                hospitalization, within 48 hours of the EP's intervention (main criterion judgment&#xD;
                evaluation)&#xD;
&#xD;
             -  A follow-up (by telephone or in person) will be carried out at 1 month and then 3&#xD;
                months to estimate the number of patients who have consumed during the&#xD;
                hospitalization (frequency, quantity, duration)&#xD;
&#xD;
             -  End of the study for a patient&#xD;
&#xD;
        5. Inclusion : For the qualitative study, the investigators estimate that the data are&#xD;
           saturated between 10 and 20 patients. For the quantitative study, the investigators&#xD;
           estimate that there are 10 new patients per month. The investigators hope to include at&#xD;
           least half of the target population, meaning 50 participants over the 10 months of the&#xD;
           study. In total, for the entire study, an estimate of 70 participants.&#xD;
&#xD;
        6. Statistics analysis : The statistical analysis will be performed using SAS v9.3®. The&#xD;
           quantitative variables will be presented as median, interquartile and missing data. The&#xD;
           qualitative variables will be presented in terms of frequency, percentage and number of&#xD;
           missing data. The initial characteristics of the patients will be presented. The&#xD;
           indicators qualitative and quantitative acceptability will also be presented. The median&#xD;
           of the results of the competency questionnaires between D0 and H48 will be compared&#xD;
           between the group before and after by a Wilcoxon test (no hypothesis on the distribution&#xD;
           of this variable). A multivariate analysis will be conducted to identify all the factors&#xD;
           influencing the variation in questionnaire responses. This will allow the influence of&#xD;
           patient profiles on outcomes to be taken into account.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Actual">May 19, 2021</completion_date>
  <primary_completion_date type="Actual">May 19, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>patients hospitalized for addiction withdrawal in the addiction service of the university hospital Bichat, Paris, France</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>median of the difference of the score of the competency questionnaires between D0 and H48 will be compared between the group before and the group after</measure>
    <time_frame>48 hours</time_frame>
    <description>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. This will be measured by a hetero-questionnaire, created by the first part of the study, evaluating the skills acquired by patients before and after this intervention. As this is a new scale created thanks to the forst part of the study, the investigators don't know what will be the minimum, the maximum or/and the relation between the score and the outcome</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Substance-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Expert patient in addictology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>before/ after comparison, each patients being its own control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Expert patient in addictology</intervention_name>
    <description>EP's Intervention, with patients hospitalized for addiction withdrawal. These are weekly individual interviews, in room, proposed by the EPs to inpatients.&#xD;
The content of the intervention will be defined trough the results of step one of the study.</description>
    <arm_group_label>Expert patient in addictology</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients hospitalized in the addictology department at the Bichat-Claude Bernard&#xD;
             Hospital in Paris, for withdrawal.&#xD;
&#xD;
          -  Substance use disorder, diagnosed according to the criteria of the DSM-5, i.e. at&#xD;
             least 2 diagnostic criteria.&#xD;
&#xD;
          -  Patients who have received information about the research and signed the consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive impairment i.e. MoCA scale &lt; or = 10&#xD;
&#xD;
          -  Severe psychiatric conditions assessed using the MINI scale : Acute psychotic episode,&#xD;
             Manic or hypomaniacal episode, Severe depression&#xD;
&#xD;
          -  non comprehension of french&#xD;
&#xD;
          -  patient Under guardianship or curatorship&#xD;
&#xD;
          -  patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chanaëlle OBADIA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aurélie BOURMAUD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Département psychiatrie et addictologie Bichat Claude Bernard</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>October 15, 2021</last_update_submitted>
  <last_update_submitted_qc>October 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>expert patients</keyword>
  <keyword>addictology</keyword>
  <keyword>withdrawal</keyword>
  <keyword>addiction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04458987
org study id: APHP190489
nct id: NCT04458987
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: patients hospitalized for addiction withdrawal in the addiction service of the university hospital Bichat, Paris, France
primary purpose: Health Services Research
masking: None (Open Label)
measure: median of the difference of the score of the competency questionnaires between D0 and H48 will be compared between the group before and the group after
time frame: 48 hours
description: 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. This will be measured by a hetero-questionnaire, created by the first part of the study, evaluating the skills acquired by patients before and after this intervention. As this is a new scale created thanks to the forst part of the study, the investigators don't know what will be the minimum, the maximum or/and the relation between the score and the outcome
arm group label: Expert patient in addictology
arm group type: Experimental
description: before/ after comparison, each patients being its own control
intervention type: Behavioral
intervention name: Expert patient in addictology
description: EP's Intervention, with patients hospitalized for addiction withdrawal. These are weekly individual interviews, in room, proposed by the EPs to inpatients.
The content of the intervention will be defined trough the results of step one of the study.
arm group label: Expert patient in addictology
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Chanaëlle OBADIA, MD
role: Principal Investigator
affiliation: APHP
last name: Aurélie BOURMAUD, PhD
role: Study Director
affiliation: APHP
facility: 
country: France
responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: No