xml: <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/NCT06026241</url>
    </required_header>
    <id_info>
      <org_study_id>IRBN1162023/CHUSTE</org_study_id>
      <nct_id>NCT06026241</nct_id>
    </id_info>
    <brief_title>Retrospective Observational Study of Practice Analysis of Care, Paraclinical Exams and Treatments Received by Geriatric Patients Both During the Last Week and the Last 24 Hours of Their Lives.</brief_title>
    <official_title>Retrospective Observational Study of Practice Analysis of Care, Paraclinical Exams and Treatments Received by Geriatric Patients Both During the Last Week and the Last 24 Hours of Their Lives.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Saint Etienne</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>
        End-of-life care is a core topic for geriatricians. One of the key aspects of end-of-life&#xD;
        management is deciding when to discontinue active care measures (for example blood pressure&#xD;
        monitoring, blood tests and X-rays) in favor of exclusive comfort care. In this retrospective&#xD;
        observational study, we looked at the care measures, treatments and paraclinical exams&#xD;
        received by geriatric patients both one week and 24 hours before their death.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This analysis provides information on the differences in geriatric physicians' practices&#xD;
        regarding the anticipation of the end of life, by showing us on average when active care&#xD;
        measures were stopped before death. Secondly, we looked at patient criteria that could&#xD;
        explain a prolongation of active care and a delay in the implementation of exclusive comfort&#xD;
        care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Prevalence of care and treatments received during the last week of life, and during the last 24 hours of life</measure>
      <time_frame>In the last week of life and 24 hours before death</time_frame>
      <description>To measure the prevalence of care (hemodynamic, biological and radiological monitoring), and to evaluate the treatments received during the last week of life, and during the last 24 hours of life of patients hospitalized and who died in a geriatric short-stay ward.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient criteria that may have explained the pursuit of care</measure>
      <time_frame>In the last week of life and 24 hours before death</time_frame>
      <description>Analysis of patient criteria (age, comorbidities, etc.) that may have explained the continuation of care, treatments and paraclinical exams up to the last 24 hours before death.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>End-of-life Care</condition>
    <arm_group>
      <arm_group_label>Patients over 75 who died in geriatrics</arm_group_label>
      <description>Patients over 75 years old who died in the geriatric short-stay departments of Saint-Etienne University Hospital</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Collecting data from the medical record</intervention_name>
      <description>Patient's socio-demographic data (age, gender, residence), comorbidities, cause of death, date and frequency of care measures/treatments/paraclinical exams received before their death.</description>
      <arm_group_label>Patients over 75 who died in geriatrics</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients over 75 years old who died in the geriatric short-stay departments of&#xD;
          Saint-Etienne University Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients over 75 years old who died in a geriatric short-stay department at&#xD;
               Saint-Etienne University Hospital.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients under 75 years old&#xD;
  &#xD;
            -  Patients who died from SARS-Cov2&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>75 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ludovic LAFAIE, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU Saint-Etienne</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ludovic LAFAIE, MD</last_name>
      <phone>(0)477127397</phone>
      <phone_ext>+33</phone_ext>
      <email>ludovic.lafaie@chu-st-etienne.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Solène VALETTE, resident</last_name>
      <phone>(0)670511373</phone>
      <phone_ext>+33</phone_ext>
      <email>solene.valette@hotmail.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHU Saint-Etienne</name>
        <address>
          <city>Saint-Étienne</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Ludovic LAFAIE, MD</last_name>
        <phone>(0)477127397</phone>
        <phone_ext>+33</phone_ext>
        <email>ludovic.lafaie@chu-st-etienne.fr</email>
      </contact>
      <contact_backup>
        <last_name>Solène VALETTE, resident</last_name>
        <phone>(0)670511373</phone>
        <phone_ext>+33</phone_ext>
        <email>solene.valette@hotmail.fr</email>
      </contact_backup>
      <investigator>
        <last_name>Solène VALETTE, resident</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ludovic LAFAIE, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>End of life care</keyword>
    <keyword>Geriatric</keyword>
    <keyword>Death</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Death</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026241
  org study id: IRBN1162023/CHUSTE
  nct id: NCT06026241
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  End-of-life care is a core topic for geriatricians. One of the key aspects of end-of-life
        management is deciding when to discontinue active care measures (for example blood pressure
        monitoring, blood tests and X-rays) in favor of exclusive comfort care. In this retrospective
        observational study, we looked at the care measures, treatments and paraclinical exams
        received by geriatric patients both one week and 24 hours before their death.
  This analysis provides information on the differences in geriatric physicians' practices
        regarding the anticipation of the end of life, by showing us on average when active care
        measures were stopped before death. Secondly, we looked at patient criteria that could
        explain a prolongation of active care and a delay in the implementation of exclusive comfort
        care.
  observational model: Other
  time perspective: Retrospective
  measure: Prevalence of care and treatments received during the last week of life, and during the last 24 hours of life
  time frame: In the last week of life and 24 hours before death
  description: To measure the prevalence of care (hemodynamic, biological and radiological monitoring), and to evaluate the treatments received during the last week of life, and during the last 24 hours of life of patients hospitalized and who died in a geriatric short-stay ward.
  measure: Patient criteria that may have explained the pursuit of care
  time frame: In the last week of life and 24 hours before death
  description: Analysis of patient criteria (age, comorbidities, etc.) that may have explained the continuation of care, treatments and paraclinical exams up to the last 24 hours before death.
  arm group label: Patients over 75 who died in geriatrics
  description: Patients over 75 years old who died in the geriatric short-stay departments of Saint-Etienne University Hospital
  intervention type: Other
  intervention name: Collecting data from the medical record
  description: Patient's socio-demographic data (age, gender, residence), comorbidities, cause of death, date and frequency of care measures/treatments/paraclinical exams received before their death.
  arm group label: Patients over 75 who died in geriatrics
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 75 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ludovic LAFAIE, MD
  role: Principal Investigator
  affiliation: CHU Saint-Etienne
  last name: Ludovic LAFAIE, MD
  phone: (0)477127397
  phone ext: +33
  email: ludovic.lafaie@chu-st-etienne.fr
  last name: Solène VALETTE, resident
  phone: (0)670511373
  phone ext: +33
  email: solene.valette@hotmail.fr
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Death
  sharing ipd: No