<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/NCT02228317</url>
  </required_header>
  <id_info>
    <org_study_id>NRA5</org_study_id>
    <nct_id>NCT02228317</nct_id>
  </id_info>
  <brief_title>Emergency Medical Technician Treat-and-leave Patients Receiving Telemedicine Consultation With Emergency Medical Dispatch Physician - a Controlled Before and After Pilot-study</brief_title>
  <official_title>Emergency Medical Technician Treat-and-leave Patients Receiving Telemedicine Consultation With Emergency Medical Dispatch Physician - a Controlled Before and After Pilot-study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Central Denmark Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A large part of acutely ill patient's access to the health care system starts by calling the&#xD;
      emergency number 1-1-2 and thereby getting in touch with the emergency medical dispatch&#xD;
      center (EMDC). In most cases an ambulance is dispatched and the patient is brought to the&#xD;
      hospital. These patients are not referred by a physician (eg. a GP) and represent an&#xD;
      unselected subpopulation of the acutely ill patients. At present, all non-critically ill&#xD;
      patients not evaluated by a pre-hospital physician are normally be transported to hospital as&#xD;
      category 2 (without activated emergency lightning and sirens).A part of this patient&#xD;
      population, however, is not critically ill and a proportion of these may not need hospital&#xD;
      admittance . Emergency medical technicians (EM) are not allowed to treat - and- leave&#xD;
      patients without a physician's involvement. If the EMT had 24/7 online access to medical&#xD;
      control i.e. in form of a physician present in the EMDC , the number of patients transported&#xD;
      to hospital for assessment may be reduced as well as response times for patients actually&#xD;
      needing ambulance transportation. This could potentially reduce the workload on the whole&#xD;
      healthcare system involved in the management of these patients - thereby potentially reducing&#xD;
      costs.&#xD;
&#xD;
      The objective of this study is to evaluate if a systematic telemedical assessment by an&#xD;
      EMDC-physician of all patients who receive an ambulance but are not critically ill and would&#xD;
      have a category 2 transport to hospital can reduce the number of the patients that are&#xD;
      transported to hospital and save costs and time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Expenses related to EMDC physician vs. savings obtained by avoided admissions</measure>
    <time_frame>Will be assessed at the time of consultation, expected to be presented within 36 months after assessment</time_frame>
    <description>Cost of 24 hour EMDC physician vs. savings obtained by avoided admissions. Calculations of average transport related costs will be provided by the Prehospital Emergency Medical Services Aarhus and average cost of hospitalization for a patient hospitalized 24 hours or less at the emergency dept. will be provided by the Regional Hospital Horsens. The percentage of treat-and-leave patients in the intervention period will be compared to a historical control group represented by the average percentage of treat-and-leave patients for the previous 12 months (August 2013 to August 2014). The savings obtained by avoided admissions will be calculated by multiplying the difference in the proportion of treat and leave patients with the number of patients the previous 12 months who are receiving an ambulance after dialing 112. The EMDC physician related costs will be calculated from the present table of salary for specialist physicians in Denmark.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of avoided hospital admissions</measure>
    <time_frame>Treated-and-left or not will be assessed at the time of consultation, expected to be presented within 36 months of assessment</time_frame>
    <description>Is the difference in percentage of treat-and-leave patients in the intervention period and historical control period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response time for ambulances</measure>
    <time_frame>Is assessed at the time the EMT registers arrival on site, expected to be presented within 36 months of assessment</time_frame>
    <description>Defined as the average response time for ambulances dispatched by EMDC. The average response time is calculated as the time where the emergency medical dispatcher gets an assignment (registered manually by the dispatcher) to the arrival of the ambulance at scene (registered manually by the EMS technician). This definition of response time is predefined politically and is the gold standard for this measurement across dispatch centers in Denmark.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital admission within 3 days</measure>
    <time_frame>Will be assessed at the 72 hours after consultation, expected to be presented within 36 months of assessment</time_frame>
    <description>Percentage of patients where initial hospital admission is avoided, but are admitted to hospital within 72 hours after primary contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time consumption by EMDC physician</measure>
    <time_frame>Will be assessed within 1 minute after end of consultation, expected to be presented within 36 months after assessment</time_frame>
    <description>Registered as the time from receiving phone call or establishing video contact to connection is discontinued</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cause of death</measure>
    <time_frame>Will be assessed as soon as possible after the occurence of death, normally within 24 hours, expected to be presented within 36 months of assessment</time_frame>
    <description>Audit on all patients dying within 30 days of primary contact. Patient's electronic medical record will be assessed by two independent consultant physicians with no relation to EMDC in order to evaluate if death of a treat-and-leave patient can be attributed to treat-and-leave</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's evaluation</measure>
    <time_frame>Will be assessed within 72 hours after end of consultation, expected to be presented within 36 months after assessment</time_frame>
    <description>Patient's evaluation of prehospital care. Telephone survey of all included patients in the intervention period will be conducted within 72 hours after teleconsultation with EMDC-physician</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">774</enrollment>
  <condition>Acutely Ill</condition>
  <condition>Acutely Injured</condition>
  <arm_group>
    <arm_group_label>Telemedicine consultation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EMTs will systematically establish teleconsultation by either telephone or video with the EMDC-physician in all cases of non-critical illness</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telemedicine consultation</intervention_name>
    <description>Telemedicine consultation done by telephone or video</description>
    <arm_group_label>Telemedicine consultation</arm_group_label>
    <other_name>For video consultation iPAD AIR 4G/3G 16 GB will be used.</other_name>
    <other_name>LifeSize ClearSea solution will be used for videoconferencing.</other_name>
    <other_name>4G/3G mobile network.</other_name>
    <other_name>For telephone consultation Nokia C2-01 GSM telephone will be used.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients receiving an emergency ambulance after calling the EMDC Patients who are&#xD;
             going to be admitted to a Hospital in the Central Denmark Region.&#xD;
&#xD;
          -  Patients who are going to be transported as category 2 patients (non-critical illness,&#xD;
             not requiring transport with activated lightning and sirens.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Critically ill patients (Patients who are going to be transported as category 1&#xD;
             patients (critical-illness, requiring immediate transport with activated sirens and&#xD;
             warning lights )&#xD;
&#xD;
          -  Patients who are not supposed to be admitted to a hospital in the Central Denmark&#xD;
             Region&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Prehospital Emergency Medical Services, Aarhus</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200N</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>December 8, 2015</last_update_submitted>
  <last_update_submitted_qc>December 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Emergency Medical Dispatch</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>Emergency Medical Services</keyword>
  <keyword>Pre-hospital</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <!-- 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/NCT02228317
org study id: NRA5
nct id: NCT02228317
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
A large part of acutely ill patient's access to the health care system starts by calling the
      emergency number 1-1-2 and thereby getting in touch with the emergency medical dispatch
      center (EMDC). In most cases an ambulance is dispatched and the patient is brought to the
      hospital. These patients are not referred by a physician (eg. a GP) and represent an
      unselected subpopulation of the acutely ill patients. At present, all non-critically ill
      patients not evaluated by a pre-hospital physician are normally be transported to hospital as
      category 2 (without activated emergency lightning and sirens).A part of this patient
      population, however, is not critically ill and a proportion of these may not need hospital
      admittance . Emergency medical technicians (EM) are not allowed to treat - and- leave
      patients without a physician's involvement. If the EMT had 24/7 online access to medical
      control i.e. in form of a physician present in the EMDC , the number of patients transported
      to hospital for assessment may be reduced as well as response times for patients actually
      needing ambulance transportation. This could potentially reduce the workload on the whole
      healthcare system involved in the management of these patients - thereby potentially reducing
      costs.

      The objective of this study is to evaluate if a systematic telemedical assessment by an
      EMDC-physician of all patients who receive an ambulance but are not critically ill and would
      have a category 2 transport to hospital can reduce the number of the patients that are
      transported to hospital and save costs and time.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Expenses related to EMDC physician vs. savings obtained by avoided admissions
time frame: Will be assessed at the time of consultation, expected to be presented within 36 months after assessment
description: Cost of 24 hour EMDC physician vs. savings obtained by avoided admissions. Calculations of average transport related costs will be provided by the Prehospital Emergency Medical Services Aarhus and average cost of hospitalization for a patient hospitalized 24 hours or less at the emergency dept. will be provided by the Regional Hospital Horsens. The percentage of treat-and-leave patients in the intervention period will be compared to a historical control group represented by the average percentage of treat-and-leave patients for the previous 12 months (August 2013 to August 2014). The savings obtained by avoided admissions will be calculated by multiplying the difference in the proportion of treat and leave patients with the number of patients the previous 12 months who are receiving an ambulance after dialing 112. The EMDC physician related costs will be calculated from the present table of salary for specialist physicians in Denmark.
measure: Percentage of avoided hospital admissions
time frame: Treated-and-left or not will be assessed at the time of consultation, expected to be presented within 36 months of assessment
description: Is the difference in percentage of treat-and-leave patients in the intervention period and historical control period
measure: Response time for ambulances
time frame: Is assessed at the time the EMT registers arrival on site, expected to be presented within 36 months of assessment
description: Defined as the average response time for ambulances dispatched by EMDC. The average response time is calculated as the time where the emergency medical dispatcher gets an assignment (registered manually by the dispatcher) to the arrival of the ambulance at scene (registered manually by the EMS technician). This definition of response time is predefined politically and is the gold standard for this measurement across dispatch centers in Denmark.
measure: Hospital admission within 3 days
time frame: Will be assessed at the 72 hours after consultation, expected to be presented within 36 months of assessment
description: Percentage of patients where initial hospital admission is avoided, but are admitted to hospital within 72 hours after primary contact.
measure: Time consumption by EMDC physician
time frame: Will be assessed within 1 minute after end of consultation, expected to be presented within 36 months after assessment
description: Registered as the time from receiving phone call or establishing video contact to connection is discontinued
measure: Cause of death
time frame: Will be assessed as soon as possible after the occurence of death, normally within 24 hours, expected to be presented within 36 months of assessment
description: Audit on all patients dying within 30 days of primary contact. Patient's electronic medical record will be assessed by two independent consultant physicians with no relation to EMDC in order to evaluate if death of a treat-and-leave patient can be attributed to treat-and-leave
measure: Patient's evaluation
time frame: Will be assessed within 72 hours after end of consultation, expected to be presented within 36 months after assessment
description: Patient's evaluation of prehospital care. Telephone survey of all included patients in the intervention period will be conducted within 72 hours after teleconsultation with EMDC-physician
arm group label: Telemedicine consultation
arm group type: Experimental
description: EMTs will systematically establish teleconsultation by either telephone or video with the EMDC-physician in all cases of non-critical illness
intervention type: Device
intervention name: Telemedicine consultation
description: Telemedicine consultation done by telephone or video
arm group label: Telemedicine consultation
other name: For video consultation iPAD AIR 4G/3G 16 GB will be used.
other name: LifeSize ClearSea solution will be used for videoconferencing.
other name: 4G/3G mobile network.
other name: For telephone consultation Nokia C2-01 GSM telephone will be used.
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Emergencies