<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/NCT03783234</url>
  </required_header>
  <id_info>
    <org_study_id>HUS/278/2018</org_study_id>
    <nct_id>NCT03783234</nct_id>
  </id_info>
  <brief_title>Triage Assessment and NEWS-score as Risk Predictor in Older Frailty Adults in the ED</brief_title>
  <official_title>3-level Triage Assessment and National Early Warning Score as Predictor for Mortality, Hospital Admission and ED Readmission for Older Frailty Patients in the ED</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>
      Emergency Department Triage Systems have not been shown to sufficiently recognize frail&#xD;
      elderly patients in need of urgent assessment and care. In this prospective, observational&#xD;
      study the performance of the 3-level triage system and the National Early Warning Score&#xD;
      (NEWS) 2 are assessed (separately and combined) for predicting adverse outcomes in older&#xD;
      frailty patients visiting in the ED. Observational data for this study is gathered as part of&#xD;
      GAOPS - main study (ClinicalTrials.gov Identifier: NCT03751319).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Actual">October 28, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Mortality during the 30 day follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital admission</measure>
    <time_frame>Day 0</time_frame>
    <description>Admission to hospital from the Emergency Department</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU/HDU admission</measure>
    <time_frame>Day 0</time_frame>
    <description>Admission to the Intensive Care Unit or High Dependency Unit from the Emergency Department</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission in the ED</measure>
    <time_frame>Hour 72, Day 30</time_frame>
    <description>Re-visits to the ED after the index-visit</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1711</enrollment>
  <condition>Frailty</condition>
  <condition>Aged</condition>
  <condition>Triage</condition>
  <arm_group>
    <arm_group_label>Older Adult Patients</arm_group_label>
    <description>ED patients age of ≥ 75 who have nurse assessed Clinical Frailty Scale ≥ 4.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Residents of aforementioned counties, aged over 75 years, who attend the Emergency&#xD;
        department and have clinical frailty scale minimum 4.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#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>
  </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 Central Hospital, Jorvi</name>
      <address>
        <city>Espoo</city>
        <zip>02740</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <link>
    <url>https://bmcemergmed.biomedcentral.com/articles/10.1186/s12873-020-00379-y</url>
    <description>Full text</description>
  </link>
  <results_reference>
    <citation>Kemp K, Alakare J, Harjola VP, Strandberg T, Tolonen J, Lehtonen L, Castren M. National Early Warning Score 2 (NEWS2) and 3-level triage scale as risk predictors in frail older adults in the emergency department. BMC Emerg Med. 2020 Oct 28;20(1):83. doi: 10.1186/s12873-020-00379-y.</citation>
    <PMID>33115446</PMID>
  </results_reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>January 29, 2022</last_update_submitted>
  <last_update_submitted_qc>January 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2022</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>
  <keyword>Emergency triage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</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/NCT03783234
org study id: HUS/278/2018
nct id: NCT03783234
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Emergency Department Triage Systems have not been shown to sufficiently recognize frail
      elderly patients in need of urgent assessment and care. In this prospective, observational
      study the performance of the 3-level triage system and the National Early Warning Score
      (NEWS) 2 are assessed (separately and combined) for predicting adverse outcomes in older
      frailty patients visiting in the ED. Observational data for this study is gathered as part of
      GAOPS - main study (ClinicalTrials.gov Identifier: NCT03751319).
observational model: Cohort
time perspective: Prospective
measure: Mortality
time frame: 30 days
description: Mortality during the 30 day follow-up
measure: Hospital admission
time frame: Day 0
description: Admission to hospital from the Emergency Department
measure: ICU/HDU admission
time frame: Day 0
description: Admission to the Intensive Care Unit or High Dependency Unit from the Emergency Department
measure: Readmission in the ED
time frame: Hour 72, Day 30
description: Re-visits to the ED after the index-visit
arm group label: Older Adult Patients
description: ED patients age of ≥ 75 who have nurse assessed Clinical Frailty Scale ≥ 4.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
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://bmcemergmed.biomedcentral.com/articles/10.1186/s12873-020-00379-y
description: Full text
citation: Kemp K, Alakare J, Harjola VP, Strandberg T, Tolonen J, Lehtonen L, Castren M. National Early Warning Score 2 (NEWS2) and 3-level triage scale as risk predictors in frail older adults in the emergency department. BMC Emerg Med. 2020 Oct 28;20(1):83. doi: 10.1186/s12873-020-00379-y.
PMID: 33115446
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: Frailty
sharing ipd: No