<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/NCT02191514</url>
  </required_header>
  <id_info>
    <org_study_id>EMS-2014-SV-01</org_study_id>
    <nct_id>NCT02191514</nct_id>
  </id_info>
  <brief_title>Prehospital Management of Stroke Patients by Emergency Medical Services</brief_title>
  <official_title>Prehospital Management of Stroke Patients by Emergency Medical Services - an Evaluation of Emergency Medical Dispatch and Ambulance Personnel.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emergency Medical Services, Capital Region, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Glostrup University Hospital, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>TrygFonden, Denmark</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Emergency Medical Services, Capital Region, Denmark</source>
  <brief_summary>
    <textblock>
      Annually 12.000 people i Denmark suffer from a stroke. Treatment for ischemic stroke is&#xD;
      available, but only 12% of stroke patients receive it.&#xD;
&#xD;
      The treatment is only available within a time frame of 4,5 hours from symptom onset, thus the&#xD;
      Emergency Medical Services (EMS) is essential to fast and effective stroke treatment.&#xD;
&#xD;
      The aim of this study is:&#xD;
&#xD;
        1. To establish the rate of recognition of stroke symptoms by healthcare personnel in the&#xD;
           EMD, ultimately aiming at optimizing performance, and identifying barriers for a fast&#xD;
           and correct EMS-response.&#xD;
&#xD;
        2. To assess prehospital time consumption by ambulance personnel on the scene of a stroke,&#xD;
           create a baseline for future comparison and generate explorative hypotheses for&#xD;
           forthcoming interventions.&#xD;
&#xD;
      The overall aim of this study is, to ensure the best possible prehospital care for all stroke&#xD;
      patients. The study will determine, if the EMD is at a high and international level in&#xD;
      regards to stroke recognition, and if there is a potential to decrease on-scene time. This&#xD;
      will serve as future comparison and have an effect on the structure and future education in&#xD;
      the prehospital services, and potentially improve the outcome after acute ischemic stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Approximately 12.000 strokes occur in Denmark annually. The only evidence based&#xD;
      pharmacological treatment of ischemic stroke is thrombolysis within a time-window of 4.5&#xD;
      hours from symptom onset(1). In 2012, 12% of patients with ischemic stroke in Denmark&#xD;
      received thrombolysis treatment. The probability of a favourable 3-month outcome after stroke&#xD;
      decreases with time from symptom onset to thrombolysis: the onset to needle time(2).&#xD;
      Therefore, it is of the highest importance to identify potential targets for prehospital time&#xD;
      reduction, and thereby reduce delay to definitive care.&#xD;
&#xD;
      Prompt recognition of stroke symptoms by both the EMD and ambulance personnel is a crucial&#xD;
      step, as it provides access to fast track acute stroke services. In this context, the role of&#xD;
      the EMS is essential, as contact to the hospital through EMS opposed to private transport is&#xD;
      correlated to decreased onset-to-door time (3). EMS prenotification of the stroke centre is&#xD;
      correlated to shorter door-to-evaluation time, door-to-needle time and onset-to-needle&#xD;
      time(4). In Denmark EMS prenotification in acute stroke is well established.&#xD;
&#xD;
      According to Danish guidelines for treatment of acute stroke and transient ischaemic attack&#xD;
      (TIA), prehospital diagnosis of stroke is improved by use of validated tests. No such is yet&#xD;
      implemented in the Capital Region of Denmark.&#xD;
&#xD;
      Preliminary data shows that the mean time from the ambulance personnel arrives at the scene&#xD;
      to they start the transport to the hospital (&quot;on scene time&quot;) is 18 minutes in the Capital&#xD;
      Region of Denmark. American guidelines suggest that on-scene-time should be less than 15&#xD;
      minutes in all cases (unless extenuating circumstances or extrication difficulties are&#xD;
      present)(1), however the organisation of stroke care between Scandinavia and USA varies&#xD;
      largely.&#xD;
&#xD;
      The aim of this study is:&#xD;
&#xD;
        1. To establish the rate of recognition of stroke symptoms by healthcare personnel in the&#xD;
           EMD, ultimately aiming at optimizing performance, and identifying barriers for a fast&#xD;
           and correct EMS-response.&#xD;
&#xD;
        2. To assess prehospital time consumption by ambulance personnel on the scene of a stroke,&#xD;
           create a baseline for future comparison and generate explorative hypotheses for&#xD;
           forthcoming interventions.&#xD;
&#xD;
      The study consists of 3 arms:&#xD;
&#xD;
        1. An epidemiological analysis of prospectively collected data from a 2-year period, in&#xD;
           order to establish the rate of identification of stroke symptoms by healthcare personnel&#xD;
           in the EMD.&#xD;
&#xD;
        2. A quantification and statistical analysis of on-scene-time in stroke patients, based on&#xD;
           prospectively collected data from a registration form filled out by the ambulance&#xD;
           personnel after responding to a stroke. The focus of the form is on time spent on&#xD;
           predefined tasks aiming at assessing time consumption on the scene, and generating&#xD;
           explorative hypotheses for forthcoming interventions.&#xD;
&#xD;
        3. Based on EMS data, the investigators will establish a baseline for on-scene-time and&#xD;
           transportation time in patients admitted by fast track stroke service during a 6 months&#xD;
           period, for future comparison and analyse data in conjunction with in-hospital delays.&#xD;
&#xD;
      Method for each arm:&#xD;
&#xD;
        1. The epidemiological analysis is based on prospectively collected data from the Danish&#xD;
           Stroke Registry (DSR) and the National Patient Registry (NPR). In the DSR and NPR,&#xD;
           ICD-10-codes are linked to the Danish personal identification number, a unique number&#xD;
           for every Danish citizen. The investigators shall compare ICD-10 codes from DSR and NPR&#xD;
           with dispatch codes from the EMS database, to determine the amount of diagnosed stroke&#xD;
           patients recognized during the emergency call. The date of the incident report from the&#xD;
           EMS will be matched with the admission date correlated to the discharge ICD-10 code, in&#xD;
           case a patient has been admitted more than once.&#xD;
&#xD;
        2. To quantify and analyse prehospital time consumption, the investigators will develop a&#xD;
           registration form for the ambulance personnel to fill out after responding to a stroke&#xD;
           patient.&#xD;
&#xD;
           This registration form will include registration of time intervals spent on:&#xD;
&#xD;
             -  Clinical tasks; including prior medical history, clinical examination and&#xD;
                measurement of vital parameters&#xD;
&#xD;
             -  Communication in relation to prenotification of the stroke centre&#xD;
&#xD;
             -  Mobilization of the patient and on-scene conditions&#xD;
&#xD;
             -  Patient preparation; including IV-accesses and 12-lead ECG&#xD;
&#xD;
           As well as information regarding:&#xD;
&#xD;
             -  Patient preparation; including IV-accesses and 12-lead ECG&#xD;
&#xD;
             -  Language/communication barriers&#xD;
&#xD;
             -  Specifications of the ambulance (operator, level of education)&#xD;
&#xD;
             -  Patient/relative related conditions&#xD;
&#xD;
             -  Visitation to acute stroke fast track&#xD;
&#xD;
           Statistical analyses:&#xD;
&#xD;
           Poisson regression analyses will be made with over dispersion taken into account, in&#xD;
           order to identify specific time intervals and tasks correlated to extended or decreased&#xD;
           total on-scene-time. This model yields distributions similar to previously collected&#xD;
           data.&#xD;
&#xD;
           A power calculation has been made, based on this distribution and the assumption that a&#xD;
           clinically relevant difference, is defined as any time interval in cases considered as&#xD;
           having a high on-scene-time, (&gt;15 min.) being twice the amount than in cases considered&#xD;
           as having a low on-scene-time (≤15 min.). This has shown an estimated demand of 500&#xD;
           registration forms in order to achieve a power of 0,8 with a 5% two-sided confidence&#xD;
           interval.&#xD;
&#xD;
        3. The establishment of on-scene-times and transportation-times will be made by extracting&#xD;
           specific time points (e.g. ambulance arrival at the scene, departure towards hospital&#xD;
           and arrival at hospital) from the EMS database during a 6 months period, and analysed in&#xD;
           conjunction with data on in-hospital delays.&#xD;
&#xD;
      The stroke centres will provide Danish personal identification numbers for patients referred&#xD;
      to the stroke centres as well as door-to-needle times and treatment decisions in order to&#xD;
      determine if there is a correlation be-tween recognition and treatment decisions in stroke&#xD;
      fast track patients.&#xD;
&#xD;
      As there is no prior comparable registration of this, it is impossible to estimate a&#xD;
      clinically relevant difference in order to make a power calculation and determine the amount&#xD;
      of necessary registrations. Thus it has been decided that a 6-month registration will provide&#xD;
      a reliable baseline. To avoid bias, the registration of this variable, will start after the&#xD;
      end of the registration form period.&#xD;
&#xD;
      The overall aim of this study is, to ensure the best possible prehospital care for all stroke&#xD;
      patients. The study will determine, if the EMD is at a high and international level in&#xD;
      regards to stroke recognition, and if there is a potential to decrease on-scene time. This&#xD;
      will serve as future comparison and have an effect on the structure and future education in&#xD;
      the prehospital services, and potentially improve the outcome after acute ischemic stroke.&#xD;
&#xD;
      Distribution of responsibilities:&#xD;
&#xD;
      Søren Viereck; Medical student, University of Copenhagen; research employee/project manager:&#xD;
      Literature search data analysis, development and evaluation of registration form for&#xD;
      ambulance personnel, first draft of paper (planned 1. author) and fundraising.&#xD;
&#xD;
      Thea Palsgaard Møller; MD; Research fellow, Emergency Medical Services Copenhagen: Data&#xD;
      extraction and supervision on data analysis, critical review of results.&#xD;
&#xD;
      Karl Bang Christensen: Associate Professor, Department of Biostatistics, University of&#xD;
      Copenhagen: Critical review of protocol, supervision on statistical analyses, critical review&#xD;
      of results.&#xD;
&#xD;
      Hanne Christensen; Senior Stroke Neurologist &amp; Associate Professor, MD, PhD, DMSci,&#xD;
      Department of Neurology, Bispebjerg Hospital, University of Copenhagen: Supervision, critical&#xD;
      review of protocol, provision of data, supervision of data-analysis, critical review of&#xD;
      results&#xD;
&#xD;
      Helle Klingenberg Iversen, MD, Senior Stroke Neurologist &amp; associate professor Department of&#xD;
      Neurology, Glostrup Hospital, University of Copenhagen: Supervision, critical review of&#xD;
      protocol, provision of data, supervision of data-analysis, critical review of results.&#xD;
&#xD;
      Freddy Lippert; CEO, Emergency Medical Services in the Capital Region of Denmark; Associate&#xD;
      professor, University of Copenhagen: Supervision, critical review of protocol, provision of&#xD;
      data, supervision of data-analysis, critical review of results and overall clinical and&#xD;
      scientific responsibility,&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>The rate of acute stroke recognized by the EMD during the emergency call (sensitivity).</measure>
    <time_frame>01.01.2012 - 12.31.2013 (up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time from dispatch to ambulance arrival at the scene of accident in stroke fast track patients.</measure>
    <time_frame>Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time on scene by EMS in stroke fast track patients (on-scene-time).</measure>
    <time_frame>Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time from departure from the scene of the accident to arrival at the stroke centre in stroke fast track patients.</measure>
    <time_frame>Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Final diagnoses(ICD-10), in patients with a dispatch code of stroke, but another final diagnosis (false positive).</measure>
    <time_frame>01.01.2012 - 12.31.2013 (up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dispatch codes, in patients with a final diagnosis of acute stroke, but another dispatch code (false negative).</measure>
    <time_frame>01.01.2012 - 12.31.2013 (up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The positive predictive values of stroke recognition by healthcare personnel at the EMD.</measure>
    <time_frame>01.01.2012 - 12.31.2013 (up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients with a final diagnosis of stroke, who accessed the healthcare system through the EMS.</measure>
    <time_frame>01.01.2012 - 12.31.2013 (up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prehospital time compared to in-hospital time in stroke fast track patients.</measure>
    <time_frame>Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recognition of stroke by EMD in relation to treatment decisions in stroke fast track patients</measure>
    <time_frame>Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>On-scene-time in relation to time-point of performing 12-lead ECG</measure>
    <time_frame>Up to 12 months.</time_frame>
    <description>Will the time-point of performing 12-lead ECG (e.g. prior to departure) affect the on-scene-time?</description>
  </other_outcome>
  <other_outcome>
    <measure>On-scene-time in relation to quality of communication during prenotification of the stroke centre.</measure>
    <time_frame>Up to 12 months.</time_frame>
    <description>Will the quality of the communication during prenotification of the stroke centre, affect on-scene time?</description>
  </other_outcome>
  <other_outcome>
    <measure>On-scene-time in relation to ambulance operator</measure>
    <time_frame>Up to 12 months.</time_frame>
    <description>Will it affect on-scene-time, what company that operates the ambulance?</description>
  </other_outcome>
  <other_outcome>
    <measure>On-scene-time in relation to visitation to stroke fast track service</measure>
    <time_frame>Up to 12 months.</time_frame>
    <description>Will it affect the on-scene time, whether or not the patient is visitated to stroke fast track service?</description>
  </other_outcome>
  <other_outcome>
    <measure>On-scene-time in relation time-point of providing IV-accesses</measure>
    <time_frame>Up to 12 months.</time_frame>
    <description>Will the time-point of providing IV-accesses affect the on-scene time?</description>
  </other_outcome>
  <other_outcome>
    <measure>On-scene-time in relation to relatives being on the ambulance</measure>
    <time_frame>Up to 12 months.</time_frame>
    <description>Will it affect on-scene-time if relatives are accompanying the patient in the ambulance?</description>
  </other_outcome>
  <other_outcome>
    <measure>On-scene-time in relation to patients vomiting</measure>
    <time_frame>Up to 12 months.</time_frame>
    <description>Will it affect on-scene-time if a patient vomits?</description>
  </other_outcome>
  <other_outcome>
    <measure>Total on-scene-time in relation to specific time-intervals (se description)</measure>
    <time_frame>Up to 12 months.</time_frame>
    <description>This composite measure will determine if any of the following time-intervals are related to on-scene time.&#xD;
Clinical tasks; including prior medical history, clinical examination and measurement of vital parameters&#xD;
Communication in relation to prenotification of the stroke centre&#xD;
Mobilization of the patient and on-scene conditions&#xD;
Patient preparation; including IV-accesses and 12-lead ECG</description>
  </other_outcome>
  <other_outcome>
    <measure>On-scene-time in relation to ambulance manning</measure>
    <time_frame>Up to 12 months.</time_frame>
    <description>Will it affect on-scene-time, what manning that is on the ambulance?</description>
  </other_outcome>
  <enrollment type="Actual">2653</enrollment>
  <condition>Stroke</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of patients suffering from a stroke in the Capital Region of&#xD;
        Denmark. The Capital Region of Denmark is home to 1,8 mio. people and covers an area of&#xD;
        2.568 km². The regions has 24-hour fast track stroke service divided at 2 hospitals, with&#xD;
        alternate 24-hour shifts.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Part 1.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients are included if registered in Danish Stroke Registry with an ICD-10 code&#xD;
             of stroke (haemorrhagic and ischemic - I61 and I63-64.9), in the National Patient&#xD;
             Registry with an ICD-10 code of TIA (Transient Ischemic Attack - G45.9) or in the&#xD;
             Emergency Medical Services-database with a dispatch code of suspected stroke (A.26.03,&#xD;
             A.26.04) from the 2-year period 01-01-2012 - 12-31-2013.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients are excluded if the Danish personal identification number is not available in&#xD;
             either database. If the patient has been directly referred to the hospital by their&#xD;
             general practitioner without the use of a EMS transport, or they have presented&#xD;
             themselves in the emergency room, they will not be registered in the EMS database.&#xD;
&#xD;
        Part 2.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with suspected stroke where the EMS has been in contact with fast track&#xD;
             stroke service at the stroke centre are included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incomplete forms will be excluded.&#xD;
&#xD;
        Part 3.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with a Danish personal identification number, referred to one of the two&#xD;
             regional stroke centres, during a 6-month period will be included. The 6 month period&#xD;
             will begin after the above mentioned 500 registration form has been collected, to&#xD;
             avoid bias.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Freddy Lippert, MD, CEO</last_name>
    <role>Study Director</role>
    <affiliation>Emergency Medical Services, Capital Region, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>EMS Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <state>Ballerup</state>
        <zip>2750</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.</citation>
    <PMID>23370205</PMID>
  </reference>
  <reference>
    <citation>Lees KR, Bluhmki E, von Kummer R, Brott TG, Toni D, Grotta JC, Albers GW, Kaste M, Marler JR, Hamilton SA, Tilley BC, Davis SM, Donnan GA, Hacke W; ECASS, ATLANTIS, NINDS and EPITHET rt-PA Study Group; Allen K, Mau J, Meier D, del Zoppo G, De Silva DA, Butcher KS, Parsons MW, Barber PA, Levi C, Bladin C, Byrnes G. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet. 2010 May 15;375(9727):1695-703. doi: 10.1016/S0140-6736(10)60491-6.</citation>
    <PMID>20472172</PMID>
  </reference>
  <reference>
    <citation>Tong D, Reeves MJ, Hernandez AF, Zhao X, Olson DM, Fonarow GC, Schwamm LH, Smith EE. Times from symptom onset to hospital arrival in the Get with the Guidelines--Stroke Program 2002 to 2009: temporal trends and implications. Stroke. 2012 Jul;43(7):1912-7. doi: 10.1161/STROKEAHA.111.644963. Epub 2012 Apr 26.</citation>
    <PMID>22539544</PMID>
  </reference>
  <reference>
    <citation>Lin CB, Peterson ED, Smith EE, Saver JL, Liang L, Xian Y, Olson DM, Shah BR, Hernandez AF, Schwamm LH, Fonarow GC. Emergency medical service hospital prenotification is associated with improved evaluation and treatment of acute ischemic stroke. Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):514-22. doi: 10.1161/CIRCOUTCOMES.112.965210. Epub 2012 Jul 10.</citation>
    <PMID>22787065</PMID>
  </reference>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>January 4, 2016</last_update_submitted>
  <last_update_submitted_qc>January 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prehospital</keyword>
  <keyword>EMS</keyword>
  <keyword>EMD</keyword>
  <keyword>Stroke</keyword>
  <keyword>Dispatch</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <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/NCT02191514
org study id: EMS-2014-SV-01
nct id: NCT02191514
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
Annually 12.000 people i Denmark suffer from a stroke. Treatment for ischemic stroke is
      available, but only 12% of stroke patients receive it.

      The treatment is only available within a time frame of 4,5 hours from symptom onset, thus the
      Emergency Medical Services (EMS) is essential to fast and effective stroke treatment.

      The aim of this study is:

        1. To establish the rate of recognition of stroke symptoms by healthcare personnel in the
           EMD, ultimately aiming at optimizing performance, and identifying barriers for a fast
           and correct EMS-response.

        2. To assess prehospital time consumption by ambulance personnel on the scene of a stroke,
           create a baseline for future comparison and generate explorative hypotheses for
           forthcoming interventions.

      The overall aim of this study is, to ensure the best possible prehospital care for all stroke
      patients. The study will determine, if the EMD is at a high and international level in
      regards to stroke recognition, and if there is a potential to decrease on-scene time. This
      will serve as future comparison and have an effect on the structure and future education in
      the prehospital services, and potentially improve the outcome after acute ischemic stroke.
Background:

      Approximately 12.000 strokes occur in Denmark annually. The only evidence based
      pharmacological treatment of ischemic stroke is thrombolysis within a time-window of 4.5
      hours from symptom onset(1). In 2012, 12% of patients with ischemic stroke in Denmark
      received thrombolysis treatment. The probability of a favourable 3-month outcome after stroke
      decreases with time from symptom onset to thrombolysis: the onset to needle time(2).
      Therefore, it is of the highest importance to identify potential targets for prehospital time
      reduction, and thereby reduce delay to definitive care.

      Prompt recognition of stroke symptoms by both the EMD and ambulance personnel is a crucial
      step, as it provides access to fast track acute stroke services. In this context, the role of
      the EMS is essential, as contact to the hospital through EMS opposed to private transport is
      correlated to decreased onset-to-door time (3). EMS prenotification of the stroke centre is
      correlated to shorter door-to-evaluation time, door-to-needle time and onset-to-needle
      time(4). In Denmark EMS prenotification in acute stroke is well established.

      According to Danish guidelines for treatment of acute stroke and transient ischaemic attack
      (TIA), prehospital diagnosis of stroke is improved by use of validated tests. No such is yet
      implemented in the Capital Region of Denmark.

      Preliminary data shows that the mean time from the ambulance personnel arrives at the scene
      to they start the transport to the hospital ("on scene time") is 18 minutes in the Capital
      Region of Denmark. American guidelines suggest that on-scene-time should be less than 15
      minutes in all cases (unless extenuating circumstances or extrication difficulties are
      present)(1), however the organisation of stroke care between Scandinavia and USA varies
      largely.

      The aim of this study is:

        1. To establish the rate of recognition of stroke symptoms by healthcare personnel in the
           EMD, ultimately aiming at optimizing performance, and identifying barriers for a fast
           and correct EMS-response.

        2. To assess prehospital time consumption by ambulance personnel on the scene of a stroke,
           create a baseline for future comparison and generate explorative hypotheses for
           forthcoming interventions.

      The study consists of 3 arms:

        1. An epidemiological analysis of prospectively collected data from a 2-year period, in
           order to establish the rate of identification of stroke symptoms by healthcare personnel
           in the EMD.

        2. A quantification and statistical analysis of on-scene-time in stroke patients, based on
           prospectively collected data from a registration form filled out by the ambulance
           personnel after responding to a stroke. The focus of the form is on time spent on
           predefined tasks aiming at assessing time consumption on the scene, and generating
           explorative hypotheses for forthcoming interventions.

        3. Based on EMS data, the investigators will establish a baseline for on-scene-time and
           transportation time in patients admitted by fast track stroke service during a 6 months
           period, for future comparison and analyse data in conjunction with in-hospital delays.

      Method for each arm:

        1. The epidemiological analysis is based on prospectively collected data from the Danish
           Stroke Registry (DSR) and the National Patient Registry (NPR). In the DSR and NPR,
           ICD-10-codes are linked to the Danish personal identification number, a unique number
           for every Danish citizen. The investigators shall compare ICD-10 codes from DSR and NPR
           with dispatch codes from the EMS database, to determine the amount of diagnosed stroke
           patients recognized during the emergency call. The date of the incident report from the
           EMS will be matched with the admission date correlated to the discharge ICD-10 code, in
           case a patient has been admitted more than once.

        2. To quantify and analyse prehospital time consumption, the investigators will develop a
           registration form for the ambulance personnel to fill out after responding to a stroke
           patient.

           This registration form will include registration of time intervals spent on:

             -  Clinical tasks; including prior medical history, clinical examination and
                measurement of vital parameters

             -  Communication in relation to prenotification of the stroke centre

             -  Mobilization of the patient and on-scene conditions

             -  Patient preparation; including IV-accesses and 12-lead ECG

           As well as information regarding:

             -  Patient preparation; including IV-accesses and 12-lead ECG

             -  Language/communication barriers

             -  Specifications of the ambulance (operator, level of education)

             -  Patient/relative related conditions

             -  Visitation to acute stroke fast track

           Statistical analyses:

           Poisson regression analyses will be made with over dispersion taken into account, in
           order to identify specific time intervals and tasks correlated to extended or decreased
           total on-scene-time. This model yields distributions similar to previously collected
           data.

           A power calculation has been made, based on this distribution and the assumption that a
           clinically relevant difference, is defined as any time interval in cases considered as
           having a high on-scene-time, (>15 min.) being twice the amount than in cases considered
           as having a low on-scene-time (≤15 min.). This has shown an estimated demand of 500
           registration forms in order to achieve a power of 0,8 with a 5% two-sided confidence
           interval.

        3. The establishment of on-scene-times and transportation-times will be made by extracting
           specific time points (e.g. ambulance arrival at the scene, departure towards hospital
           and arrival at hospital) from the EMS database during a 6 months period, and analysed in
           conjunction with data on in-hospital delays.

      The stroke centres will provide Danish personal identification numbers for patients referred
      to the stroke centres as well as door-to-needle times and treatment decisions in order to
      determine if there is a correlation be-tween recognition and treatment decisions in stroke
      fast track patients.

      As there is no prior comparable registration of this, it is impossible to estimate a
      clinically relevant difference in order to make a power calculation and determine the amount
      of necessary registrations. Thus it has been decided that a 6-month registration will provide
      a reliable baseline. To avoid bias, the registration of this variable, will start after the
      end of the registration form period.

      The overall aim of this study is, to ensure the best possible prehospital care for all stroke
      patients. The study will determine, if the EMD is at a high and international level in
      regards to stroke recognition, and if there is a potential to decrease on-scene time. This
      will serve as future comparison and have an effect on the structure and future education in
      the prehospital services, and potentially improve the outcome after acute ischemic stroke.

      Distribution of responsibilities:

      Søren Viereck; Medical student, University of Copenhagen; research employee/project manager:
      Literature search data analysis, development and evaluation of registration form for
      ambulance personnel, first draft of paper (planned 1. author) and fundraising.

      Thea Palsgaard Møller; MD; Research fellow, Emergency Medical Services Copenhagen: Data
      extraction and supervision on data analysis, critical review of results.

      Karl Bang Christensen: Associate Professor, Department of Biostatistics, University of
      Copenhagen: Critical review of protocol, supervision on statistical analyses, critical review
      of results.

      Hanne Christensen; Senior Stroke Neurologist & Associate Professor, MD, PhD, DMSci,
      Department of Neurology, Bispebjerg Hospital, University of Copenhagen: Supervision, critical
      review of protocol, provision of data, supervision of data-analysis, critical review of
      results

      Helle Klingenberg Iversen, MD, Senior Stroke Neurologist & associate professor Department of
      Neurology, Glostrup Hospital, University of Copenhagen: Supervision, critical review of
      protocol, provision of data, supervision of data-analysis, critical review of results.

      Freddy Lippert; CEO, Emergency Medical Services in the Capital Region of Denmark; Associate
      professor, University of Copenhagen: Supervision, critical review of protocol, provision of
      data, supervision of data-analysis, critical review of results and overall clinical and
      scientific responsibility,
observational model: Cohort
time perspective: Retrospective
measure: The rate of acute stroke recognized by the EMD during the emergency call (sensitivity).
time frame: 01.01.2012 - 12.31.2013 (up to 24 months)
measure: Time from dispatch to ambulance arrival at the scene of accident in stroke fast track patients.
time frame: Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)
measure: Time on scene by EMS in stroke fast track patients (on-scene-time).
time frame: Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)
measure: Time from departure from the scene of the accident to arrival at the stroke centre in stroke fast track patients.
time frame: Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)
measure: Final diagnoses(ICD-10), in patients with a dispatch code of stroke, but another final diagnosis (false positive).
time frame: 01.01.2012 - 12.31.2013 (up to 24 months)
measure: Dispatch codes, in patients with a final diagnosis of acute stroke, but another dispatch code (false negative).
time frame: 01.01.2012 - 12.31.2013 (up to 24 months)
measure: The positive predictive values of stroke recognition by healthcare personnel at the EMD.
time frame: 01.01.2012 - 12.31.2013 (up to 24 months)
measure: The proportion of patients with a final diagnosis of stroke, who accessed the healthcare system through the EMS.
time frame: 01.01.2012 - 12.31.2013 (up to 24 months)
measure: Prehospital time compared to in-hospital time in stroke fast track patients.
time frame: Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)
measure: Recognition of stroke by EMD in relation to treatment decisions in stroke fast track patients
time frame: Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)
measure: On-scene-time in relation to time-point of performing 12-lead ECG
time frame: Up to 12 months.
description: Will the time-point of performing 12-lead ECG (e.g. prior to departure) affect the on-scene-time?
measure: On-scene-time in relation to quality of communication during prenotification of the stroke centre.
time frame: Up to 12 months.
description: Will the quality of the communication during prenotification of the stroke centre, affect on-scene time?
measure: On-scene-time in relation to ambulance operator
time frame: Up to 12 months.
description: Will it affect on-scene-time, what company that operates the ambulance?
measure: On-scene-time in relation to visitation to stroke fast track service
time frame: Up to 12 months.
description: Will it affect the on-scene time, whether or not the patient is visitated to stroke fast track service?
measure: On-scene-time in relation time-point of providing IV-accesses
time frame: Up to 12 months.
description: Will the time-point of providing IV-accesses affect the on-scene time?
measure: On-scene-time in relation to relatives being on the ambulance
time frame: Up to 12 months.
description: Will it affect on-scene-time if relatives are accompanying the patient in the ambulance?
measure: On-scene-time in relation to patients vomiting
time frame: Up to 12 months.
description: Will it affect on-scene-time if a patient vomits?
measure: Total on-scene-time in relation to specific time-intervals (se description)
time frame: Up to 12 months.
description: This composite measure will determine if any of the following time-intervals are related to on-scene time.
Clinical tasks; including prior medical history, clinical examination and measurement of vital parameters
Communication in relation to prenotification of the stroke centre
Mobilization of the patient and on-scene conditions
Patient preparation; including IV-accesses and 12-lead ECG
measure: On-scene-time in relation to ambulance manning
time frame: Up to 12 months.
description: Will it affect on-scene-time, what manning that is on the ambulance?
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Freddy Lippert, MD, CEO
role: Study Director
affiliation: Emergency Medical Services, Capital Region, Denmark
facility: 
country: Denmark
citation: Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.
PMID: 23370205
citation: Lees KR, Bluhmki E, von Kummer R, Brott TG, Toni D, Grotta JC, Albers GW, Kaste M, Marler JR, Hamilton SA, Tilley BC, Davis SM, Donnan GA, Hacke W; ECASS, ATLANTIS, NINDS and EPITHET rt-PA Study Group; Allen K, Mau J, Meier D, del Zoppo G, De Silva DA, Butcher KS, Parsons MW, Barber PA, Levi C, Bladin C, Byrnes G. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet. 2010 May 15;375(9727):1695-703. doi: 10.1016/S0140-6736(10)60491-6.
PMID: 20472172
citation: Tong D, Reeves MJ, Hernandez AF, Zhao X, Olson DM, Fonarow GC, Schwamm LH, Smith EE. Times from symptom onset to hospital arrival in the Get with the Guidelines--Stroke Program 2002 to 2009: temporal trends and implications. Stroke. 2012 Jul;43(7):1912-7. doi: 10.1161/STROKEAHA.111.644963. Epub 2012 Apr 26.
PMID: 22539544
citation: Lin CB, Peterson ED, Smith EE, Saver JL, Liang L, Xian Y, Olson DM, Shah BR, Hernandez AF, Schwamm LH, Fonarow GC. Emergency medical service hospital prenotification is associated with improved evaluation and treatment of acute ischemic stroke. Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):514-22. doi: 10.1161/CIRCOUTCOMES.112.965210. Epub 2012 Jul 10.
PMID: 22787065
responsible party type: Sponsor
mesh term: Stroke
mesh term: Emergencies