<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/NCT04442880</url>
  </required_header>
  <id_info>
    <org_study_id>PREPS-14-0028</org_study_id>
    <nct_id>NCT04442880</nct_id>
  </id_info>
  <brief_title>Patient Care Pathways Between Ambulatory and Hospital Settings in Mental Health Care</brief_title>
  <acronym>PAPRICA</acronym>
  <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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In France, mental health care is provided by public and private hospitals and is organized&#xD;
      around three main categories of care: ambulatory, full-time and part-time. This wide variety&#xD;
      of treatment methods can lead patients with similar mental disorders to follow different care&#xD;
      pathways. As a result, a patient may have a higher quality of care than others, which would&#xD;
      result in a loss of equity and reduced opportunities for patients.&#xD;
&#xD;
      The primary objective of the study is to identify the organizational factors and the&#xD;
      characteristics of mental health care providers and of the surrounding care provision&#xD;
      associated with the variability in care pathways for mental health care and in their quality.&#xD;
&#xD;
      The primary endpoint is the organizational factors associated with the different typology of&#xD;
      care pathways and with the different levels of quality of care (in a multivariate modelling&#xD;
      allowing an adjustment on the other factors).&#xD;
&#xD;
      In order to do so, a cohort of patients will be constituted using French administrative&#xD;
      databases. Mental health care consumption will be obtained via data from the ambulatory&#xD;
      claims database (SNIIRAM) along with hospital discharge databases for psychiatric care&#xD;
      (RIM-P) and non-psychiatric acute care (PMSI-MCO). These databases will be supplemented by&#xD;
      other linkable databases in order to describe the clinical and socioeconomic characteristics&#xD;
      of the patients and environment, as well as the characteristics of care provision and&#xD;
      available health and social care.&#xD;
&#xD;
      All adult patients with a full-time or part-time admission to one of seven public psychiatric&#xD;
      hospitals participating to the study or admitted to a private psychiatric hospital located on&#xD;
      their health territories will be included in the study. Patients not residing in the health&#xD;
      territory of those hospitals included in the study as well as patients treated exclusively in&#xD;
      ambulatory care settings will be excluded.&#xD;
&#xD;
      Using data from the database and the opinion of key experts, a classification of care&#xD;
      pathways will be established in order to identify the factors associated with the variability&#xD;
      of the pathways and their quality with multinomial logistic regressions.&#xD;
&#xD;
      The identification of factors associated with the variability in care pathways will lead to&#xD;
      recommendations on how to improve the quality of care and the efficiency of the health care&#xD;
      system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In France, mental health care is provided by public and private hospitals and is organized&#xD;
      around three main categories of care: ambulatory, full-time and part-time, each presenting&#xD;
      several types of care (e.g. for full time care: hospitalization or treatment in a therapeutic&#xD;
      apartment). This wide variety of treatment methods is associated with significant variations&#xD;
      in the use of each of them, which can lead patients with similar mental disorders to follow&#xD;
      different care pathways. This suggests that one of them may have a better quality of care&#xD;
      than the others and therefore that the variation in care pathways is associated with a loss&#xD;
      of equity and decreased chances for some patients, as well as a non-optimal use of resources&#xD;
      and inefficiency for the health care system. Several categories of factors are associated&#xD;
      with the variation in care pathways: the clinical and socioeconomic characteristics of&#xD;
      patients, the characteristics of the mental health care providers and those of the health and&#xD;
      health and social care available which can provide care complementary to that of psychiatry,&#xD;
      as well as the characteristics of the environment in terms of living conditions (urban&#xD;
      development and unemployment rate for example).&#xD;
&#xD;
      While it is not possible to act in the short term on the characteristics of patients or of&#xD;
      their living conditions, it seems essential to identify the characteristics of mental health&#xD;
      care providers and of the surrounding care on offer associated with the variation in care&#xD;
      pathways, as they may be subject to reforms to improve the quality of care.&#xD;
&#xD;
      The primary objective of the study is to identify the organizational factors and the&#xD;
      characteristics of mental health care providers and of the surrounding care provision&#xD;
      associated with the variability in care pathways for mental health care and in their quality.&#xD;
&#xD;
      The secondary objectives are:&#xD;
&#xD;
        -  to define a method to elaborate patients' care pathways;&#xD;
&#xD;
        -  to assess the respective quality of each possible pathway;&#xD;
&#xD;
        -  to build a typology of care pathways with similar characteristics;&#xD;
&#xD;
        -  to describe the variability in care pathways and in their associated quality;&#xD;
&#xD;
        -  to identify other factors associated with the variability in care pathways and in their&#xD;
           quality (characteristics of the patients and their environment).&#xD;
&#xD;
      The primary endpoint is the organizational factors associated with the different typology of&#xD;
      care pathways and with the different levels of quality of care (in a multivariate modelling&#xD;
      allowing an adjustment on the other factors).&#xD;
&#xD;
      Secondary endpoints will include:&#xD;
&#xD;
        -  Identification of individualized care pathways&#xD;
&#xD;
        -  Level of quality of each care pathways in ordered classes&#xD;
&#xD;
        -  Typology of similar care pathways, and for each category: proportion of the different&#xD;
           care pathways within this category, proportion in each quality level, intensity,&#xD;
           frequency and diversity of care&#xD;
&#xD;
        -  Clinical and socioeconomic characteristics of patients and of their environment&#xD;
           significantly associated with the different typology of care pathways and with the&#xD;
           different levels of quality of care (in a multivariate modelling allowing an adjustment&#xD;
           to the other factors).&#xD;
&#xD;
      In order to do so, a cohort of patients will be constituted using French administrative&#xD;
      databases. Mental health care consumption will be obtained via data from the ambulatory&#xD;
      claims database (SNIIRAM) along with hospital discharge databases for psychiatric care&#xD;
      (RIM-P) and non-psychiatric acute care (PMSI-MCO). These databases will be supplemented by&#xD;
      other linkable databases in order to describe the clinical and socioeconomic characteristics&#xD;
      of the patients and environment, as well as the characteristics of care provision and&#xD;
      available health and social care.&#xD;
&#xD;
      All adult patients with a full-time or part-time admission to one of seven public psychiatric&#xD;
      hospitals participating to the study or admitted to a private psychiatric hospital located on&#xD;
      their health territories will be included in the study. Patients not residing in the health&#xD;
      territory of those hospitals included in the study as well as patients treated exclusively in&#xD;
      ambulatory care settings will be excluded.&#xD;
&#xD;
      Care pathways will first be constructed with an analysis of state sequences. They will then&#xD;
      be given a quality level: a group of experts will be appointed to define specific criteria to&#xD;
      assess quality. The typology of care pathways will then be constructed via an ascending&#xD;
      hierarchical classification based on a distance calculation taking into account the temporal&#xD;
      ordering of care and descriptive analysis of the groups obtained. Finally, we will identify&#xD;
      factors associated with the variability in care pathways and in their quality using&#xD;
      multinomial logistic regressions.&#xD;
&#xD;
      The identification of factors associated with the variability in care pathways and in their&#xD;
      quality, in particular factors linked to the organization of mental health care and to the&#xD;
      complementary health and health and social care provision, will lead to recommendations on&#xD;
      how to improve the quality of care and the efficiency of the health care system. Ultimately,&#xD;
      this will contribute to the reduction of geographic and social health inequalities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Factors associated with the probability to have a certain type of care pathways with a given quality and similar characteristics</measure>
    <time_frame>24 months</time_frame>
    <description>Results of the multivariate regression analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of specific care pathways, their quality, and analysis of the variations</measure>
    <time_frame>24 months</time_frame>
    <description>Results of the multivariate regression analysis</description>
  </secondary_outcome>
  <enrollment type="Actual">12551</enrollment>
  <condition>Mental Disorder</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients who received full-time or part-time care in one of the 7 public mental&#xD;
        health care facilities participating to the study, as well as patients followed in private&#xD;
        mental health care facilities located in the same health territories&#xD;
&#xD;
        Non-inclusion criteria:&#xD;
&#xD;
          -  Patients not residing in the health territory of one of the 7 public mental health&#xD;
             care establishments included in the study;&#xD;
&#xD;
          -  Patients treated exclusively on an outpatient basis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients who received full-time or part-time care in one of the 7 public&#xD;
             mental health care facilities participating to the study, as well as patients followed&#xD;
             in private mental health care facilities located in the same health territories&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not residing in the health territory of one of the 7 public mental health&#xD;
             care establishments included in the study;&#xD;
&#xD;
          -  Patients treated exclusively on an outpatient basis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Karine CHEVREUL, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mental health, care pathways</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT04442880
org study id: PREPS-14-0028
nct id: NCT04442880
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In France, mental health care is provided by public and private hospitals and is organized
      around three main categories of care: ambulatory, full-time and part-time. This wide variety
      of treatment methods can lead patients with similar mental disorders to follow different care
      pathways. As a result, a patient may have a higher quality of care than others, which would
      result in a loss of equity and reduced opportunities for patients.

      The primary objective of the study is to identify the organizational factors and the
      characteristics of mental health care providers and of the surrounding care provision
      associated with the variability in care pathways for mental health care and in their quality.

      The primary endpoint is the organizational factors associated with the different typology of
      care pathways and with the different levels of quality of care (in a multivariate modelling
      allowing an adjustment on the other factors).

      In order to do so, a cohort of patients will be constituted using French administrative
      databases. Mental health care consumption will be obtained via data from the ambulatory
      claims database (SNIIRAM) along with hospital discharge databases for psychiatric care
      (RIM-P) and non-psychiatric acute care (PMSI-MCO). These databases will be supplemented by
      other linkable databases in order to describe the clinical and socioeconomic characteristics
      of the patients and environment, as well as the characteristics of care provision and
      available health and social care.

      All adult patients with a full-time or part-time admission to one of seven public psychiatric
      hospitals participating to the study or admitted to a private psychiatric hospital located on
      their health territories will be included in the study. Patients not residing in the health
      territory of those hospitals included in the study as well as patients treated exclusively in
      ambulatory care settings will be excluded.

      Using data from the database and the opinion of key experts, a classification of care
      pathways will be established in order to identify the factors associated with the variability
      of the pathways and their quality with multinomial logistic regressions.

      The identification of factors associated with the variability in care pathways will lead to
      recommendations on how to improve the quality of care and the efficiency of the health care
      system.
In France, mental health care is provided by public and private hospitals and is organized
      around three main categories of care: ambulatory, full-time and part-time, each presenting
      several types of care (e.g. for full time care: hospitalization or treatment in a therapeutic
      apartment). This wide variety of treatment methods is associated with significant variations
      in the use of each of them, which can lead patients with similar mental disorders to follow
      different care pathways. This suggests that one of them may have a better quality of care
      than the others and therefore that the variation in care pathways is associated with a loss
      of equity and decreased chances for some patients, as well as a non-optimal use of resources
      and inefficiency for the health care system. Several categories of factors are associated
      with the variation in care pathways: the clinical and socioeconomic characteristics of
      patients, the characteristics of the mental health care providers and those of the health and
      health and social care available which can provide care complementary to that of psychiatry,
      as well as the characteristics of the environment in terms of living conditions (urban
      development and unemployment rate for example).

      While it is not possible to act in the short term on the characteristics of patients or of
      their living conditions, it seems essential to identify the characteristics of mental health
      care providers and of the surrounding care on offer associated with the variation in care
      pathways, as they may be subject to reforms to improve the quality of care.

      The primary objective of the study is to identify the organizational factors and the
      characteristics of mental health care providers and of the surrounding care provision
      associated with the variability in care pathways for mental health care and in their quality.

      The secondary objectives are:

        -  to define a method to elaborate patients' care pathways;

        -  to assess the respective quality of each possible pathway;

        -  to build a typology of care pathways with similar characteristics;

        -  to describe the variability in care pathways and in their associated quality;

        -  to identify other factors associated with the variability in care pathways and in their
           quality (characteristics of the patients and their environment).

      The primary endpoint is the organizational factors associated with the different typology of
      care pathways and with the different levels of quality of care (in a multivariate modelling
      allowing an adjustment on the other factors).

      Secondary endpoints will include:

        -  Identification of individualized care pathways

        -  Level of quality of each care pathways in ordered classes

        -  Typology of similar care pathways, and for each category: proportion of the different
           care pathways within this category, proportion in each quality level, intensity,
           frequency and diversity of care

        -  Clinical and socioeconomic characteristics of patients and of their environment
           significantly associated with the different typology of care pathways and with the
           different levels of quality of care (in a multivariate modelling allowing an adjustment
           to the other factors).

      In order to do so, a cohort of patients will be constituted using French administrative
      databases. Mental health care consumption will be obtained via data from the ambulatory
      claims database (SNIIRAM) along with hospital discharge databases for psychiatric care
      (RIM-P) and non-psychiatric acute care (PMSI-MCO). These databases will be supplemented by
      other linkable databases in order to describe the clinical and socioeconomic characteristics
      of the patients and environment, as well as the characteristics of care provision and
      available health and social care.

      All adult patients with a full-time or part-time admission to one of seven public psychiatric
      hospitals participating to the study or admitted to a private psychiatric hospital located on
      their health territories will be included in the study. Patients not residing in the health
      territory of those hospitals included in the study as well as patients treated exclusively in
      ambulatory care settings will be excluded.

      Care pathways will first be constructed with an analysis of state sequences. They will then
      be given a quality level: a group of experts will be appointed to define specific criteria to
      assess quality. The typology of care pathways will then be constructed via an ascending
      hierarchical classification based on a distance calculation taking into account the temporal
      ordering of care and descriptive analysis of the groups obtained. Finally, we will identify
      factors associated with the variability in care pathways and in their quality using
      multinomial logistic regressions.

      The identification of factors associated with the variability in care pathways and in their
      quality, in particular factors linked to the organization of mental health care and to the
      complementary health and health and social care provision, will lead to recommendations on
      how to improve the quality of care and the efficiency of the health care system. Ultimately,
      this will contribute to the reduction of geographic and social health inequalities.
observational model: Cohort
time perspective: Retrospective
measure: Factors associated with the probability to have a certain type of care pathways with a given quality and similar characteristics
time frame: 24 months
description: Results of the multivariate regression analysis
measure: Identification of specific care pathways, their quality, and analysis of the variations
time frame: 24 months
description: Results of the multivariate regression analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Karine CHEVREUL, MD, PhD
role: Study Chair
affiliation: Assistance Publique - Hôpitaux de Paris
responsible party type: Sponsor
mesh term: Mental Disorders