<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/NCT03228251</url>
  </required_header>
  <id_info>
    <org_study_id>STREAM Trial</org_study_id>
    <nct_id>NCT03228251</nct_id>
  </id_info>
  <brief_title>Simulation-based Training of Rapid Evaluation and Management for Acute Stroke (STREAM) Trial</brief_title>
  <acronym>STREAM</acronym>
  <official_title>Simulation-based Training of Rapid Evaluation and Management for Acute Stroke (STREAM) - Multicentric Prospective Interventional Study for the Improvement of Acute Stroke Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johann Wolfgang Goethe University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stryker Neurovascular</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Johann Wolfgang Goethe University 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>
      Acute stroke care is highly time critical for thrombolysis as well as thrombectomy. In both&#xD;
      scenarios, each minute lost reduces the therapeutic efficacy. Therefore, an optimal&#xD;
      implementation of these effective therapies into daily clinical practice is of utmost&#xD;
      importance for the translation of the evidence from clinical trials into good clinical&#xD;
      outcomes in routine care. In acute stroke therapy, the patient is cared for by an&#xD;
      interdisciplinary team and often has to undergo several handovers between different&#xD;
      caregivers with possible interface problems.&#xD;
&#xD;
      To facilitate a smooth workflow, the investigator developed an interdisciplinary stroke team&#xD;
      algorithm and implemented regular simulation-based team trainings at the investigators&#xD;
      institution. This multimodal intervention markedly improved the &quot;door-to-needle&quot; time for&#xD;
      thrombolysis (time from the patient's arrival in the emergency department to the start of the&#xD;
      tissue plasminogen activator (tPA) infusion) which is the most relevant benchmark parameter&#xD;
      for acute stroke care. The investigators monthly stroke team training had a positive effect&#xD;
      on the perceived degree of safety and staff satisfaction among the employees of the&#xD;
      investigators departments.&#xD;
&#xD;
      The investigator plans to investigate the benefits of the multimodal intervention of a stroke&#xD;
      team algorithm with regular stroke team simulation training in a controlled prospective&#xD;
      pretest-posttest trial design at seven leading stroke centers in Germany. The investigator&#xD;
      hypothesize that the implementation of a stroke team algorithm (defined team, defined tasks)&#xD;
      and regular stroke team training with a focus on efficient team work and communication will&#xD;
      improve process times, patient safety and staff satisfaction.&#xD;
&#xD;
      In the pretest period, the participating seven centers (tertiary care university hospitals&#xD;
      with thrombectomy capacity 24/7/365) record the data of all consecutive patients receiving&#xD;
      thrombolysis and/or thrombectomy during a three month period. Afterwards 3-4 leading&#xD;
      employees of different professional backgrounds (e.g. senior neurologist of the stroke unit,&#xD;
      neurointerventionalist, head nurse of emergency department) will be invited to a joint&#xD;
      &quot;train-the-trainer&quot; seminar at the sponsors institution where the participating centers&#xD;
      present their algorithm to the participants of all seven stroke centers for discussion to&#xD;
      invite suggestions for streamlining and improvement and a train-the-trainer course of stroke&#xD;
      simulation. After the seminar, the principal investigator and stroke team trainer will visit&#xD;
      all centers for one in situ stroke team simulation training and provide teaching materials.&#xD;
      Afterwards, each center will be invited to schedule two additional stroke team trainings a&#xD;
      with stroke team trainer that will be led by e.g. the senior neurologist from the respective&#xD;
      stroke unit with the aim of permanently starting up regular stroke team simulation. In the&#xD;
      posttest period, the participating seven centers again record the data of all consecutive&#xD;
      patients receiving thrombolysis and/or thrombectomy during a three month time period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 11, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Median &quot;door-to-needle&quot; time (median and 25-75 % interquartile range) in a pretest-posttest observation</measure>
    <time_frame>up to 1 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Median thrombectomy process times of patients receiving thrombectomy in a before-after observation</measure>
    <time_frame>up to 2 hours</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety: Hemorrhagic transformation of the infarct on follow-up CT</measure>
    <time_frame>up to 48 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Staff (stroke team) satisfaction</measure>
    <time_frame>up to 6 month</time_frame>
    <description>to recognize an improvement of the staff statisfaction, the members of the stroke Team are asked about their opinion and specific markers for staff satisfaction (investigators pre-designed questionnaire)</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">379</enrollment>
  <condition>Stroke, Thrombolysis, Thrombectomy, Simulation Training, Patient Safety</condition>
  <arm_group>
    <arm_group_label>Observation Group 1</arm_group_label>
    <description>all stroke patients receiving thrombolysis and/or thrombectomy in a time period of three months before stroke team simulation training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation Group 2</arm_group_label>
    <description>all stroke patients receiving thrombolysis and/or thrombectomy in a time period of three months after stroke team simulation training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stroke team simulation training</intervention_name>
    <description>The participating centers identify 3-4 senior staff of different professional backgrounds (e.g. senior neurologist, neurointerventionalist, head nurse) who will design a stroke team algorithm tailored to the local circumstances of the stroke center. The centers will be invited to a joint &quot;train-the-trainer&quot; seminar at the sponsor's institution where they present their algorithm to the participants of all seven stroke centers for discussion to invite suggestions for streamlining and improvement. The teams will be introduced to the concept of simulation-based stroke team training. After the seminar, the principal investigator and the stroke team trainer will visit all centers for one on-site stroke team training and provide teaching materials. Afterwards, each center will be invited to schedule two additional stroke team trainings with the stroke team trainer that will be led by e.g. the senior neurologist from the stroke unit with use of a simulation manikin.</description>
    <arm_group_label>Observation Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Thrombolysis/thrombectomy in one of the seven participating stroke centers following&#xD;
        Emergency Medical Service (EMS) referral. All consecutive patients treated during the two&#xD;
        observation periods will be recorded after obtaining written informed consent from the&#xD;
        patient and/or his/her legal representative. The investigator will not record patients who&#xD;
        suffered an in-hospital stroke or who were referred for thrombectomy by another Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  thrombolysis/thrombectomy in one of the seven participating stroke centers following&#xD;
             EMS referral&#xD;
&#xD;
          -  written informed consent from the patient and/or his/her legal representative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  in-hospital stroke&#xD;
&#xD;
          -  referred for thrombectomy by another Hospital.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Waltraud Pfeilschifter, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johann Wolfgang Goethe University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen</name>
      <address>
        <city>Tübingen</city>
        <state>Baden-Württemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Augsburg</name>
      <address>
        <city>Augsburg</city>
        <zip>86156</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Universitätsmedizin Berlin, Campus Benjamin Franklin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf (UKE)</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinik Köln</name>
      <address>
        <city>Köln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität München, Klinikum Großhadern</name>
      <address>
        <city>München</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>June 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>June 27, 2019</last_update_submitted>
  <last_update_submitted_qc>June 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johann Wolfgang Goethe University Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Waltraud Pfeilschifter</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT03228251
org study id: STREAM Trial
nct id: NCT03228251
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acute stroke care is highly time critical for thrombolysis as well as thrombectomy. In both
      scenarios, each minute lost reduces the therapeutic efficacy. Therefore, an optimal
      implementation of these effective therapies into daily clinical practice is of utmost
      importance for the translation of the evidence from clinical trials into good clinical
      outcomes in routine care. In acute stroke therapy, the patient is cared for by an
      interdisciplinary team and often has to undergo several handovers between different
      caregivers with possible interface problems.

      To facilitate a smooth workflow, the investigator developed an interdisciplinary stroke team
      algorithm and implemented regular simulation-based team trainings at the investigators
      institution. This multimodal intervention markedly improved the "door-to-needle" time for
      thrombolysis (time from the patient's arrival in the emergency department to the start of the
      tissue plasminogen activator (tPA) infusion) which is the most relevant benchmark parameter
      for acute stroke care. The investigators monthly stroke team training had a positive effect
      on the perceived degree of safety and staff satisfaction among the employees of the
      investigators departments.

      The investigator plans to investigate the benefits of the multimodal intervention of a stroke
      team algorithm with regular stroke team simulation training in a controlled prospective
      pretest-posttest trial design at seven leading stroke centers in Germany. The investigator
      hypothesize that the implementation of a stroke team algorithm (defined team, defined tasks)
      and regular stroke team training with a focus on efficient team work and communication will
      improve process times, patient safety and staff satisfaction.

      In the pretest period, the participating seven centers (tertiary care university hospitals
      with thrombectomy capacity 24/7/365) record the data of all consecutive patients receiving
      thrombolysis and/or thrombectomy during a three month period. Afterwards 3-4 leading
      employees of different professional backgrounds (e.g. senior neurologist of the stroke unit,
      neurointerventionalist, head nurse of emergency department) will be invited to a joint
      "train-the-trainer" seminar at the sponsors institution where the participating centers
      present their algorithm to the participants of all seven stroke centers for discussion to
      invite suggestions for streamlining and improvement and a train-the-trainer course of stroke
      simulation. After the seminar, the principal investigator and stroke team trainer will visit
      all centers for one in situ stroke team simulation training and provide teaching materials.
      Afterwards, each center will be invited to schedule two additional stroke team trainings a
      with stroke team trainer that will be led by e.g. the senior neurologist from the respective
      stroke unit with the aim of permanently starting up regular stroke team simulation. In the
      posttest period, the participating seven centers again record the data of all consecutive
      patients receiving thrombolysis and/or thrombectomy during a three month time period.
observational model: Cohort
time perspective: Cross-Sectional
measure: Median "door-to-needle" time (median and 25-75 % interquartile range) in a pretest-posttest observation
time frame: up to 1 hour
measure: Median thrombectomy process times of patients receiving thrombectomy in a before-after observation
time frame: up to 2 hours
measure: Safety: Hemorrhagic transformation of the infarct on follow-up CT
time frame: up to 48 hours
measure: Staff (stroke team) satisfaction
time frame: up to 6 month
description: to recognize an improvement of the staff statisfaction, the members of the stroke Team are asked about their opinion and specific markers for staff satisfaction (investigators pre-designed questionnaire)
arm group label: Observation Group 1
description: all stroke patients receiving thrombolysis and/or thrombectomy in a time period of three months before stroke team simulation training
arm group label: Observation Group 2
description: all stroke patients receiving thrombolysis and/or thrombectomy in a time period of three months after stroke team simulation training
intervention type: Other
intervention name: Stroke team simulation training
description: The participating centers identify 3-4 senior staff of different professional backgrounds (e.g. senior neurologist, neurointerventionalist, head nurse) who will design a stroke team algorithm tailored to the local circumstances of the stroke center. The centers will be invited to a joint "train-the-trainer" seminar at the sponsor's institution where they present their algorithm to the participants of all seven stroke centers for discussion to invite suggestions for streamlining and improvement. The teams will be introduced to the concept of simulation-based stroke team training. After the seminar, the principal investigator and the stroke team trainer will visit all centers for one on-site stroke team training and provide teaching materials. Afterwards, each center will be invited to schedule two additional stroke team trainings with the stroke team trainer that will be led by e.g. the senior neurologist from the stroke unit with use of a simulation manikin.
arm group label: Observation Group 2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Waltraud Pfeilschifter, Prof. Dr.
role: Principal Investigator
affiliation: Johann Wolfgang Goethe University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Johann Wolfgang Goethe University Hospital
investigator full name: Dr. Waltraud Pfeilschifter
investigator title: Prof. Dr. med.
mesh term: Stroke
sharing ipd: No