<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/NCT03751319</url>
  </required_header>
  <id_info>
    <org_study_id>TYH2018304</org_study_id>
    <secondary_id>HUS1171/2018</secondary_id>
    <nct_id>NCT03751319</nct_id>
  </id_info>
  <brief_title>Geriatric Assessment and Intervention for Older Patients With Frailty in the Emergency Department</brief_title>
  <acronym>GAOPS</acronym>
  <official_title>Geriatric Assessment and Intervention for Older Patients With Frailty in the Emergency Department. Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>City of Espoo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Helsinki</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helsinki University Central Hospital</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>
      Comprehensive Geriatric Assessment (CGA) is an established approach for better detection of&#xD;
      frailty-related problems and includes individualized treatment plan with multi-discipline&#xD;
      supportive and treating measures for the older frailty patients. However, there is limited&#xD;
      evidence of feasibility and efficacy of the CGA when provided in the emergency department&#xD;
      setting.&#xD;
&#xD;
      In the GAOPS-study the efficacy of the CGA in emergency department setting will be studied by&#xD;
      randomized controlled study protocol. We aim to study if the CGA provided in the ED is&#xD;
      feasible, safe and efficient method when added with standard emergency care for older frail&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Actual">July 2, 2021</completion_date>
  <primary_completion_date type="Actual">June 7, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulated Length of Stay</measure>
    <time_frame>Day 365</time_frame>
    <description>Cumulated stay (days) in hospital wards (university hospital and community hospital) including all admissions during the follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Admissions</measure>
    <time_frame>Day 30, Day 365</time_frame>
    <description>Number of admissions to the hospital wards (university hospital and community hospital) during the follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission rate</measure>
    <time_frame>Day 0</time_frame>
    <description>Proportion of admitted patients (university hospital or community hospital ward) from the index ED-visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmissions in the ED</measure>
    <time_frame>Hour 72, Day 30, Day 365</time_frame>
    <description>Re-visits to the ED after the index-visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Living at home</measure>
    <time_frame>Day 365</time_frame>
    <description>Proportion of the patients living at home.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Day 0, Day 365</time_frame>
    <description>Change of the quality of life during one year follow-up using the standardized questionnaire EuroQol EQ-5D-5L. Measured value is the index value defined by the EuroQol group.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Length-of-Stay in the ED</measure>
    <time_frame>Day 0</time_frame>
    <description>Length-of-Stay (h) of the index-visit in the ED</description>
  </other_outcome>
  <other_outcome>
    <measure>Length-of-Stay in the ward</measure>
    <time_frame>Day 365</time_frame>
    <description>Length-of-Stay (d) in the hospital ward of admitted patients from the index-visit in the ED</description>
  </other_outcome>
  <other_outcome>
    <measure>Mortality</measure>
    <time_frame>Day 365</time_frame>
    <description>Mortality during the one-year follow-up.</description>
  </other_outcome>
  <other_outcome>
    <measure>Falls</measure>
    <time_frame>Day 365</time_frame>
    <description>Number of falls which result in new ED visit during the one-year follow-up</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">432</enrollment>
  <condition>Frail Elderly Syndrome</condition>
  <condition>Patient Admission</condition>
  <condition>Hospital Readmission</condition>
  <condition>Length of Stay</condition>
  <condition>Fall</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Standard Emergency Care + CGA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard Care is provided for the acute condition as usual by the ED personnel. Besides the standard care provided by ED personnel, patients are systemically screened and assessed by physician trained for geriatrics or geriatric emergency medicine. Geriatric multi-discipline treatment plan and recommendations are given if suitable for the case.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Emergency Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard Care is provided for the acute condition as usual by the ED personnel.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CGA</intervention_name>
    <description>Comprehensive Geriatric Assessment</description>
    <arm_group_label>Standard Emergency Care + CGA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of minimum 75 years&#xD;
&#xD;
          -  &quot;Clinical Frailty Scale&quot; minimum 4 estimated at the arrival to the ED by nurse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-resident of the counties (City of Espoo, Kirkkonummi, Kauniainen) of the hospital&#xD;
             district.&#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>Veli-Pekka Harjola</last_name>
    <role>Study Director</role>
    <affiliation>Department of Emergency Medicine and Services, Helsinki University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Janne Alakare, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Emergency Medicine and Services, Helsinki University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helsinki University Hospital, Jorvi ED</name>
      <address>
        <city>Espoo</city>
        <state>Uusimaa</state>
        <zip>02740</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <link>
    <url>https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-021-02351-2</url>
    <description>Alakare, J., Kemp, K., Strandberg, T. et al. Systematic geriatric assessment for older patients with frailty in the emergency department: a randomised controlled trial. BMC Geriatr 21, 408 (2021). https://doi.org/10.1186/s12877-021-02351-2</description>
  </link>
  <results_reference>
    <citation>Alakare J, Kemp K, Strandberg T, Castren M, Jakovljevic D, Tolonen J, Harjola VP. Systematic geriatric assessment for older patients with frailty in the emergency department: a randomised controlled trial. BMC Geriatr. 2021 Jul 2;21(1):408. doi: 10.1186/s12877-021-02351-2.</citation>
    <PMID>34215193</PMID>
  </results_reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 18, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>August 4, 2021</last_update_submitted>
  <last_update_submitted_qc>August 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Janne Alakare</investigator_full_name>
    <investigator_title>Senior physician in Emergency Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 27, 2022</submitted>
    <submission_canceled>January 29, 2022</submission_canceled>
    <submitted>January 29, 2022</submitted>
    <returned>April 1, 2022</returned>
  </pending_results>
  <!-- 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/NCT03751319
org study id: TYH2018304
secondary id: HUS1171/2018
nct id: NCT03751319
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comprehensive Geriatric Assessment (CGA) is an established approach for better detection of
      frailty-related problems and includes individualized treatment plan with multi-discipline
      supportive and treating measures for the older frailty patients. However, there is limited
      evidence of feasibility and efficacy of the CGA when provided in the emergency department
      setting.

      In the GAOPS-study the efficacy of the CGA in emergency department setting will be studied by
      randomized controlled study protocol. We aim to study if the CGA provided in the ED is
      feasible, safe and efficient method when added with standard emergency care for older frail
      patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial
primary purpose: Supportive Care
masking: None (Open Label)
measure: Cumulated Length of Stay
time frame: Day 365
description: Cumulated stay (days) in hospital wards (university hospital and community hospital) including all admissions during the follow-up.
measure: Admissions
time frame: Day 30, Day 365
description: Number of admissions to the hospital wards (university hospital and community hospital) during the follow-up.
measure: Admission rate
time frame: Day 0
description: Proportion of admitted patients (university hospital or community hospital ward) from the index ED-visits.
measure: Readmissions in the ED
time frame: Hour 72, Day 30, Day 365
description: Re-visits to the ED after the index-visit.
measure: Living at home
time frame: Day 365
description: Proportion of the patients living at home.
measure: Quality of Life
time frame: Day 0, Day 365
description: Change of the quality of life during one year follow-up using the standardized questionnaire EuroQol EQ-5D-5L. Measured value is the index value defined by the EuroQol group.
measure: Length-of-Stay in the ED
time frame: Day 0
description: Length-of-Stay (h) of the index-visit in the ED
measure: Length-of-Stay in the ward
time frame: Day 365
description: Length-of-Stay (d) in the hospital ward of admitted patients from the index-visit in the ED
measure: Mortality
time frame: Day 365
description: Mortality during the one-year follow-up.
measure: Falls
time frame: Day 365
description: Number of falls which result in new ED visit during the one-year follow-up
arm group label: Standard Emergency Care + CGA
arm group type: Active Comparator
description: Standard Care is provided for the acute condition as usual by the ED personnel. Besides the standard care provided by ED personnel, patients are systemically screened and assessed by physician trained for geriatrics or geriatric emergency medicine. Geriatric multi-discipline treatment plan and recommendations are given if suitable for the case.
arm group label: Standard Emergency Care
arm group type: No Intervention
description: Standard Care is provided for the acute condition as usual by the ED personnel.
intervention type: Other
intervention name: CGA
description: Comprehensive Geriatric Assessment
arm group label: Standard Emergency Care + CGA
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Veli-Pekka Harjola
role: Study Director
affiliation: Department of Emergency Medicine and Services, Helsinki University Hospital
last name: Janne Alakare, MD
role: Principal Investigator
affiliation: Department of Emergency Medicine and Services, Helsinki University Hospital
facility: 
country: Finland
url: https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-021-02351-2
description: Alakare, J., Kemp, K., Strandberg, T. et al. Systematic geriatric assessment for older patients with frailty in the emergency department: a randomised controlled trial. BMC Geriatr 21, 408 (2021). https://doi.org/10.1186/s12877-021-02351-2
citation: Alakare J, Kemp K, Strandberg T, Castren M, Jakovljevic D, Tolonen J, Harjola VP. Systematic geriatric assessment for older patients with frailty in the emergency department: a randomised controlled trial. BMC Geriatr. 2021 Jul 2;21(1):408. doi: 10.1186/s12877-021-02351-2.
PMID: 34215193
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Janne Alakare
investigator title: Senior physician in Emergency Medicine
mesh term: Emergencies
mesh term: Frailty
sharing ipd: No
submitted: January 27, 2022
submission canceled: January 29, 2022
submitted: January 29, 2022
returned: April 1, 2022