<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/NCT04503369</url>
  </required_header>
  <id_info>
    <org_study_id>ZZSMHP_001_2020</org_study_id>
    <nct_id>NCT04503369</nct_id>
  </id_info>
  <brief_title>Observation of Non-technical Skills in the Pre-hospital Care in the Czech Republic</brief_title>
  <acronym>NTS</acronym>
  <official_title>Observation of Non-technical Skills (e.g. Communication, Team Leader Skills, Teamwork, Situational Awareness Etc.) in the Pre-hospital Care in the Czech Republic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>David Peran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Emergency Medical Services of the Karlovy Vary region, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emergency Medical Services of the Pilsner region, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Emergency Medical Service, Prague</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>
      The aim of the study is to find out if the Emergency Medical Services (EMS) crews are using&#xD;
      the non-technical skills (e.g. communication, decision making, situational awareness etc.) in&#xD;
      the real practice and how well they use them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to find out if the Emergency Medical Services (EMS) crews are using&#xD;
      the non-technical skills (teamwork and team leading, communication, decision making,&#xD;
      situational awareness and task management) in the real practice and how well they use them.&#xD;
      According to the observations of individual crews by field supervisors the use of&#xD;
      non-technical skills will be compared between different groups (e.g. resuscitation, trauma,&#xD;
      medical problems, non-emergency situations etc.). The comparison between the collaborators of&#xD;
      the study is not the subject of the study.&#xD;
&#xD;
      Main hypothesis: The EMS crews are using all of the aspects of non-technical skills&#xD;
      appropriately.&#xD;
&#xD;
      The field supervision is also the limitation of the study because it is done by different&#xD;
      observers / supervisors, the observation therefore might by affected by subjective feelings.&#xD;
      To minimise the subjective view of the situation all of the field supervisors undergo a&#xD;
      uniform training of non-technical skills and how to observe and evaluate them.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>NTS incidence</measure>
    <time_frame>Through study completion, an average of 1 year and until 100 cases from each organization will be collected - 300 observations in total.</time_frame>
    <description>The measurement of non-technical skills usage will be evaluated according to the form developed and published by Cooper et al. (2010) as a Team Emergency Assessment Measure (TEAM) tool based on the Likert scale - Never/Hardly ever (0), Seldom (1), About as often as not (2), Often (3), Always/Nearly always (4).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">359</enrollment>
  <condition>Non-technical Skills</condition>
  <arm_group>
    <arm_group_label>EMS crews</arm_group_label>
    <description>Crews of Emergency Medical Services</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Non-technical skills</intervention_name>
    <description>Teamwork The work of the team consists of information exchange and coordination of all activities performed. In-team communication is always calm and assertive, and team members support each other.&#xD;
Task management With the right planning and preparation of individual activities, the likelihood that all standards of care and best practices will be followed increases.&#xD;
Situational awareness Situational awareness refers primarily to the collection of information, its understanding and, on that basis, prediction of direction into which the situation will develop. Maintaining situational awareness is crucial in order to move towards the right goal.&#xD;
Decision-making With good situational awareness, one is able to keep in mind all information needed to make the correct decision at the right time. In some cases, it is advisable to consult with other team members or to verify their consent to the proposed procedure.&#xD;
Communication Communication is a vital tool when working in a team.</description>
    <arm_group_label>EMS crews</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patient of EMS in participated regions of the Czech Republic where the pre-hospital&#xD;
        care is provided by 2 or more crews and the field supervisor is present.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  EMS called&#xD;
&#xD;
          -  More than 2 crews on the scene&#xD;
&#xD;
          -  Field supervisor present&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - TEAM tool not filled completely&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Peran, DrPH</last_name>
    <role>Study Chair</role>
    <affiliation>Prague Emergency Medical Services</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Roman Sykora, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Emergency Medical Services of the Karlovy Vary Region</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jana Vidunová, MD</last_name>
    <role>Study Director</role>
    <affiliation>Emergency Medical Services of the Pilsner Region</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ivana Krsova, MSc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emergency Medical Services of the Pilsner Region</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaroslav Pekara, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prague Emergency Medical Services</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patrik C Cmorej, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emergency Medical Services of the Usti nad Labem Region</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nikola Brizgalová, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emergency Medical Services of the Karlovy Vary Region</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emergency Medical Services of the Karlovy Vary region</name>
      <address>
        <city>Karlovy Vary</city>
        <zip>36006</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emergency Medical Services of the Pilsner region</name>
      <address>
        <city>Plzen</city>
        <zip>30100</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prague Emergency Medical Services</name>
      <address>
        <city>Praha</city>
        <zip>10100</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <reference>
    <citation>Cooper SJ, Cant RP. Measuring non-technical skills of medical emergency teams: an update on the validity and reliability of the Team Emergency Assessment Measure (TEAM). Resuscitation. 2014 Jan;85(1):31-3. doi: 10.1016/j.resuscitation.2013.08.276. Epub 2013 Sep 12.</citation>
    <PMID>24036193</PMID>
  </reference>
  <reference>
    <citation>Napier F, Davies RP, Baldock C, Stevens H, Lockey AS, Bullock I, Perkins GD. Validation for a scoring system of the ALS cardiac arrest simulation test (CASTest). Resuscitation. 2009 Sep;80(9):1034-8. doi: 10.1016/j.resuscitation.2009.04.043. Epub 2009 Jun 13.</citation>
    <PMID>19525052</PMID>
  </reference>
  <reference>
    <citation>PERAN, D., KUBALOVÁ, J..: Observation of non-technical skills during resuscitation (Sledování netechnických dovedností při resuscitaci) [article in Czech language]. Urgentní medicína: Časopis pro neodkladnou lékařskou péči. Mediprax CB s.r.o., 2017 (4). ISSN 1212-1924.</citation>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Emergency Medical Service, Prague</investigator_affiliation>
    <investigator_full_name>David Peran</investigator_full_name>
    <investigator_title>Head of the Education and Training Centre</investigator_title>
  </responsible_party>
  <keyword>non-technical skills</keyword>
  <keyword>pre-hospital care</keyword>
  <keyword>emergency medical services</keyword>
  <keyword>communication</keyword>
  <keyword>situational awareness</keyword>
  <keyword>task management</keyword>
  <keyword>decision making</keyword>
  <keyword>teamwork</keyword>
  <keyword>team leading</keyword>
  <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/NCT04503369
org study id: ZZSMHP_001_2020
nct id: NCT04503369
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to find out if the Emergency Medical Services (EMS) crews are using
      the non-technical skills (e.g. communication, decision making, situational awareness etc.) in
      the real practice and how well they use them.
The aim of the study is to find out if the Emergency Medical Services (EMS) crews are using
      the non-technical skills (teamwork and team leading, communication, decision making,
      situational awareness and task management) in the real practice and how well they use them.
      According to the observations of individual crews by field supervisors the use of
      non-technical skills will be compared between different groups (e.g. resuscitation, trauma,
      medical problems, non-emergency situations etc.). The comparison between the collaborators of
      the study is not the subject of the study.

      Main hypothesis: The EMS crews are using all of the aspects of non-technical skills
      appropriately.

      The field supervision is also the limitation of the study because it is done by different
      observers / supervisors, the observation therefore might by affected by subjective feelings.
      To minimise the subjective view of the situation all of the field supervisors undergo a
      uniform training of non-technical skills and how to observe and evaluate them.
observational model: Ecologic or Community
time perspective: Prospective
measure: NTS incidence
time frame: Through study completion, an average of 1 year and until 100 cases from each organization will be collected - 300 observations in total.
description: The measurement of non-technical skills usage will be evaluated according to the form developed and published by Cooper et al. (2010) as a Team Emergency Assessment Measure (TEAM) tool based on the Likert scale - Never/Hardly ever (0), Seldom (1), About as often as not (2), Often (3), Always/Nearly always (4).
arm group label: EMS crews
description: Crews of Emergency Medical Services
intervention type: Behavioral
intervention name: Non-technical skills
description: Teamwork The work of the team consists of information exchange and coordination of all activities performed. In-team communication is always calm and assertive, and team members support each other.
Task management With the right planning and preparation of individual activities, the likelihood that all standards of care and best practices will be followed increases.
Situational awareness Situational awareness refers primarily to the collection of information, its understanding and, on that basis, prediction of direction into which the situation will develop. Maintaining situational awareness is crucial in order to move towards the right goal.
Decision-making With good situational awareness, one is able to keep in mind all information needed to make the correct decision at the right time. In some cases, it is advisable to consult with other team members or to verify their consent to the proposed procedure.
Communication Communication is a vital tool when working in a team.
arm group label: EMS crews
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Peran, DrPH
role: Study Chair
affiliation: Prague Emergency Medical Services
last name: Roman Sykora, PhD
role: Study Director
affiliation: Emergency Medical Services of the Karlovy Vary Region
last name: Jana Vidunová, MD
role: Study Director
affiliation: Emergency Medical Services of the Pilsner Region
last name: Ivana Krsova, MSc.
role: Principal Investigator
affiliation: Emergency Medical Services of the Pilsner Region
last name: Jaroslav Pekara, PhD
role: Principal Investigator
affiliation: Prague Emergency Medical Services
last name: Patrik C Cmorej, PhD
role: Principal Investigator
affiliation: Emergency Medical Services of the Usti nad Labem Region
last name: Nikola Brizgalová, DrPH
role: Principal Investigator
affiliation: Emergency Medical Services of the Karlovy Vary Region
facility: 
facility: 
facility: 
country: Czechia
citation: Cooper SJ, Cant RP. Measuring non-technical skills of medical emergency teams: an update on the validity and reliability of the Team Emergency Assessment Measure (TEAM). Resuscitation. 2014 Jan;85(1):31-3. doi: 10.1016/j.resuscitation.2013.08.276. Epub 2013 Sep 12.
PMID: 24036193
citation: Napier F, Davies RP, Baldock C, Stevens H, Lockey AS, Bullock I, Perkins GD. Validation for a scoring system of the ALS cardiac arrest simulation test (CASTest). Resuscitation. 2009 Sep;80(9):1034-8. doi: 10.1016/j.resuscitation.2009.04.043. Epub 2009 Jun 13.
PMID: 19525052
citation: PERAN, D., KUBALOVÁ, J..: Observation of non-technical skills during resuscitation (Sledování netechnických dovedností při resuscitaci) [article in Czech language]. Urgentní medicína: Časopis pro neodkladnou lékařskou péči. Mediprax CB s.r.o., 2017 (4). ISSN 1212-1924.
responsible party type: Sponsor-Investigator
investigator affiliation: Emergency Medical Service, Prague
investigator full name: David Peran
investigator title: Head of the Education and Training Centre
sharing ipd: No