<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/NCT04428840</url>
  </required_header>
  <id_info>
    <org_study_id>2019/0315</org_study_id>
    <nct_id>NCT04428840</nct_id>
  </id_info>
  <brief_title>Effects of Implementation of a Self-measurement Kiosk in the Emergency Department Waiting Room</brief_title>
  <official_title>Effects of Implementation of Automated Pre-triage Based on a Self-measurement Kiosk With Questionnaire for Patients in the Emergency Department Waiting Room on Triage Time-stamps and Satisfaction of Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spoedopname</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</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>
      In this study the participant will be invited to be seated in the self-measurement kiosk&#xD;
      after registration in the Emergency department. In this kiosk, the participant will be&#xD;
      measuring their own vitals and answering a short questionnaire regarding the reason for&#xD;
      presentation. All these results are displayed on a screen for the triage nurse. Based on the&#xD;
      results, high-risk patients will be highlighted on the screen, so they may be seen faster.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The questionnaire entails questions which would otherwise be asked by the triage nurse,&#xD;
      regarding reason for presentation, fever, pain and and possible allergies. This is done&#xD;
      through a touch-screen.&#xD;
&#xD;
      The vital signs and potential alarm symptoms from the (multilingual) questionnaire are being&#xD;
      displayed with the pain score on a screen in the triage room and at the nurses desk. An&#xD;
      adapted Early Warning Score (aEWS - without respiratory rate) is calculated from the vital&#xD;
      signs. Abnormal results are being highlighted and carried up on the screen to the top&#xD;
      position. This enables the triage nurse to pick up the sicker participants in the waiting&#xD;
      room faster. The measurements are valid, so they do not have to be repeated by the triage&#xD;
      nurse.&#xD;
&#xD;
      Users will be contacted afterwards regarding satisfaction of use&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Patients are randomised in blocks per day regarding use of the kiosk</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Triage time-stamp 1</measure>
    <time_frame>through study completion, average of 1 year</time_frame>
    <description>Shorter time to end of triage process: Time from registration to time of end of triage process (completion of electronic record)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Triage time-stamp 2</measure>
    <time_frame>through study completion, average of 1 year</time_frame>
    <description>Shorter time to beginning of triage process: Time from registration to time of start of triage process (initiation of electronic record)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to see physician</measure>
    <time_frame>through study completion, average 1 year</time_frame>
    <description>Shorter time to see physician: Time from registration to start of medical assessment (first of record of physician care)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">757</enrollment>
  <condition>Emergencies</condition>
  <arm_group>
    <arm_group_label>on-day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of the self-measurement kiosk: measurement of vital signs + completion of short questionnaire</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Off-day</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No use of the self-measurement kiosk</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Self-measurement kiosk</intervention_name>
    <description>Use of the self-measurement kiosk, with results forwarded to the triage nurse screens</description>
    <arm_group_label>on-day</arm_group_label>
    <other_name>BeWell kiosk</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients presenting ambulatory at the Emergency Department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients presenting by ambulance / Emergency Medical Services&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cathelijne Lyphout, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Gent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spoedgevallendienst</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 12, 2019</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Ghent</investigator_affiliation>
    <investigator_full_name>Spoedopname</investigator_full_name>
    <investigator_title>Professor Peter De Paepe</investigator_title>
  </responsible_party>
  <keyword>triage</keyword>
  <keyword>kiosk</keyword>
  <keyword>early warning score</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>No</sharing_ipd>
    <ipd_description>No plan to share - General Data Protection Regulation related</ipd_description>
  </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/NCT04428840
org study id: 2019/0315
nct id: NCT04428840
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study the participant will be invited to be seated in the self-measurement kiosk
      after registration in the Emergency department. In this kiosk, the participant will be
      measuring their own vitals and answering a short questionnaire regarding the reason for
      presentation. All these results are displayed on a screen for the triage nurse. Based on the
      results, high-risk patients will be highlighted on the screen, so they may be seen faster.
The questionnaire entails questions which would otherwise be asked by the triage nurse,
      regarding reason for presentation, fever, pain and and possible allergies. This is done
      through a touch-screen.

      The vital signs and potential alarm symptoms from the (multilingual) questionnaire are being
      displayed with the pain score on a screen in the triage room and at the nurses desk. An
      adapted Early Warning Score (aEWS - without respiratory rate) is calculated from the vital
      signs. Abnormal results are being highlighted and carried up on the screen to the top
      position. This enables the triage nurse to pick up the sicker participants in the waiting
      room faster. The measurements are valid, so they do not have to be repeated by the triage
      nurse.

      Users will be contacted afterwards regarding satisfaction of use
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients are randomised in blocks per day regarding use of the kiosk
primary purpose: Diagnostic
masking: None (Open Label)
measure: Triage time-stamp 1
time frame: through study completion, average of 1 year
description: Shorter time to end of triage process: Time from registration to time of end of triage process (completion of electronic record)
measure: Triage time-stamp 2
time frame: through study completion, average of 1 year
description: Shorter time to beginning of triage process: Time from registration to time of start of triage process (initiation of electronic record)
measure: Time to see physician
time frame: through study completion, average 1 year
description: Shorter time to see physician: Time from registration to start of medical assessment (first of record of physician care)
arm group label: on-day
arm group type: Experimental
description: Use of the self-measurement kiosk: measurement of vital signs + completion of short questionnaire
arm group label: Off-day
arm group type: No Intervention
description: No use of the self-measurement kiosk
intervention type: Device
intervention name: Self-measurement kiosk
description: Use of the self-measurement kiosk, with results forwarded to the triage nurse screens
arm group label: on-day
other name: BeWell kiosk
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cathelijne Lyphout, MSc
role: Principal Investigator
affiliation: UZ Gent
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Ghent
investigator full name: Spoedopname
investigator title: Professor Peter De Paepe
mesh term: Emergencies
sharing ipd: No
ipd description: No plan to share - General Data Protection Regulation related