<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/NCT03786250</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-AGI-2017-14</org_study_id>
    <nct_id>NCT03786250</nct_id>
  </id_info>
  <brief_title>Comprehensive Geriatric Assessment in an Emergency Department</brief_title>
  <acronym>CGA_ED</acronym>
  <official_title>Comprehensive Geriatric Assessment in Emergency Department. Impact on Health and Patient Flows</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundació Mutuam Conviure</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</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>
      Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency&#xD;
      Departments (ED), higher hospital admissions and more risks for patients arising from the ED&#xD;
      stay. The advantages of developing specific attention to frailty in ED have been highlighted.&#xD;
      The benefits of these approaches are related to patients but also to organizations. The aim&#xD;
      is to present how a Program of Care for Frailty (PCF) in an ED impacts on patient health and&#xD;
      flows.&#xD;
&#xD;
      Objective is to analyze the clinical impact of Comprehensive Geriatric Care (CGA) in the&#xD;
      Emergency Department (ED) and on patient flows Setting: A tertiary, teaching, 550-bed urban&#xD;
      hospital, with 80,000 adult patients/year ED attendances (43%≥65 years). Two periods are&#xD;
      compared: First period (before CGA implantation) del 01/04/2016 - 15/04/2016 and second&#xD;
      period (after) 01/04/2017 - 15/04/2017&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency&#xD;
      Departments (ED), higher hospital admissions and more risks for patients arising from the ED&#xD;
      stay. The advantages of developing specific attention to frailty in ED have been highlighted.&#xD;
      The benefits of these approaches are related to patients but also to organizations. The aim&#xD;
      is to observe how a Program of Care for Frailty (PCF) in an ED impacts on patient health and&#xD;
      flows.&#xD;
&#xD;
      Objective&#xD;
&#xD;
        1. Analyze the clinical impact of Comprehensive Geriatric Care (CGA) in the Emergency&#xD;
           Department (ED).&#xD;
&#xD;
        2. Analyze the impact on patient flows following the implementation of a Comprehensive&#xD;
           Geriatric Assessment in the Emergency Department (ED).&#xD;
&#xD;
      Methods Setting: A tertiary, teaching, 550-bed urban hospital, with 80,000 adult&#xD;
      patients/year ED attendances (43%≥65 years).&#xD;
&#xD;
      First period (before CGA implantation) del 01/04/2016 - 15/04/2016 and second period (after)&#xD;
      01/04/2017 - 15/04/2017 Intervention: In the second period, the AGI was carried out by the&#xD;
      emergency medical teams. It basically consists of care adapted to the special needs of&#xD;
      geriatric patients, with systematic screening of delirium, delirium prevention, early&#xD;
      treatment, pain management with scales adapted to chronicity, conciliation of medication to&#xD;
      discharge from the emergency department, among others A comparison will be made of health&#xD;
      outcomes and patient flows in ED: direct discharge, admission to emergency observation unit,&#xD;
      admission to short stay unit, transfer to intermediate hospital, admission, admission to&#xD;
      critical care area, death, time spent in the Emergency Department (ED) and in intermediate&#xD;
      hospital, mortality during admission at one and six months, re-entry or reconsultation in the&#xD;
      Emergency Department at 30 days and six months will be measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Number of patients with delirium</measure>
    <time_frame>From date of admission until discharge, assessed up to 30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with pain correctly treated</measure>
    <time_frame>From date of admission until discharge, assessed up to 30 days</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Emergencies</condition>
  <condition>Aging</condition>
  <condition>Geriatric Assessment</condition>
  <condition>Patient Discharge</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Geriatric Assessment</intervention_name>
    <description>Systematic screening of delirium, prevention of delirium, early treatment, pain management with scales adapted to chronicity, conciliation of medication to emergency discharge, among others.</description>
    <other_name>CGA</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients older than 65 years, attended in ED during the study periode.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients older than 65 years attended in the ED&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>115 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mireia Puig, PhD</last_name>
      <phone>+34616335291</phone>
      <email>mpuigc@santpau.cat</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Emergency department</keyword>
  <keyword>Older</keyword>
  <keyword>Frailty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03786250
org study id: IIBSP-AGI-2017-14
nct id: NCT03786250
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency
      Departments (ED), higher hospital admissions and more risks for patients arising from the ED
      stay. The advantages of developing specific attention to frailty in ED have been highlighted.
      The benefits of these approaches are related to patients but also to organizations. The aim
      is to present how a Program of Care for Frailty (PCF) in an ED impacts on patient health and
      flows.

      Objective is to analyze the clinical impact of Comprehensive Geriatric Care (CGA) in the
      Emergency Department (ED) and on patient flows Setting: A tertiary, teaching, 550-bed urban
      hospital, with 80,000 adult patients/year ED attendances (43%≥65 years). Two periods are
      compared: First period (before CGA implantation) del 01/04/2016 - 15/04/2016 and second
      period (after) 01/04/2017 - 15/04/2017
Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency
      Departments (ED), higher hospital admissions and more risks for patients arising from the ED
      stay. The advantages of developing specific attention to frailty in ED have been highlighted.
      The benefits of these approaches are related to patients but also to organizations. The aim
      is to observe how a Program of Care for Frailty (PCF) in an ED impacts on patient health and
      flows.

      Objective

        1. Analyze the clinical impact of Comprehensive Geriatric Care (CGA) in the Emergency
           Department (ED).

        2. Analyze the impact on patient flows following the implementation of a Comprehensive
           Geriatric Assessment in the Emergency Department (ED).

      Methods Setting: A tertiary, teaching, 550-bed urban hospital, with 80,000 adult
      patients/year ED attendances (43%≥65 years).

      First period (before CGA implantation) del 01/04/2016 - 15/04/2016 and second period (after)
      01/04/2017 - 15/04/2017 Intervention: In the second period, the AGI was carried out by the
      emergency medical teams. It basically consists of care adapted to the special needs of
      geriatric patients, with systematic screening of delirium, delirium prevention, early
      treatment, pain management with scales adapted to chronicity, conciliation of medication to
      discharge from the emergency department, among others A comparison will be made of health
      outcomes and patient flows in ED: direct discharge, admission to emergency observation unit,
      admission to short stay unit, transfer to intermediate hospital, admission, admission to
      critical care area, death, time spent in the Emergency Department (ED) and in intermediate
      hospital, mortality during admission at one and six months, re-entry or reconsultation in the
      Emergency Department at 30 days and six months will be measured.
observational model: Cohort
time perspective: Retrospective
measure: Number of patients with delirium
time frame: From date of admission until discharge, assessed up to 30 days
measure: Number of patients with pain correctly treated
time frame: From date of admission until discharge, assessed up to 30 days
intervention type: Procedure
intervention name: Geriatric Assessment
description: Systematic screening of delirium, prevention of delirium, early treatment, pain management with scales adapted to chronicity, conciliation of medication to emergency discharge, among others.
other name: CGA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 115 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: Undecided