<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/NCT03268967</url>
  </required_header>
  <id_info>
    <org_study_id>113581</org_study_id>
    <secondary_id>113581</secondary_id>
    <nct_id>NCT03268967</nct_id>
  </id_info>
  <brief_title>Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)</brief_title>
  <official_title>Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillerod Hospital, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Holbaek Sygehus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hillerod Hospital, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Admission to the intensive care unit (ICU) is vital for surviving critical illness. An&#xD;
      admission to ICU without having a consistent structure, structured review of the patient and&#xD;
      a solid team organization lead to unclear communication and responsibility. Factors that&#xD;
      correlate with patient acceptance and safety, morbidity and mortality. The hypothesize was&#xD;
      that a structured admission can improve patients safety, reduce delays in treatment, reduce&#xD;
      ICU length of stay, and improve mortality rate. The overall objective was to optimize patient&#xD;
      safety, and effectively use available resources to reduce admission time, delays in treatment&#xD;
      and procedures and mortality by using both quantitative and qualitative methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The quantitative before-data is a one-year observational period prior to the intervention&#xD;
      measured by different perspectives; patients and staff outcomes.&#xD;
&#xD;
      After the intervention, was qualititive data collected from participants, who received&#xD;
      simulation training.&#xD;
&#xD;
      The quantitative after-data is a one-year observational period post-intervention with same&#xD;
      outcomes as before starting the intervention.&#xD;
&#xD;
      Data is already collected registry data from hospital quality assurance board. Data will be&#xD;
      compared before and after with assessor blinded analysis. Missing data will not be replaced&#xD;
      but reported as missing.&#xD;
&#xD;
      The investigators will try to compare the results with data from an approximately comparative&#xD;
      ICU in Denmark due to the implementation of a new patient management system called the Health&#xD;
      Portal.&#xD;
&#xD;
      The statistical analysis plan is based on descriptive and comparative analyses of the group&#xD;
      before and after the trial. The quantitative results are explained in in-depths description&#xD;
      from participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 1, 2014</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Before and after interventional study</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Data analysis</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>ICU length of stay (LOS)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Days admitted at the ICU using registre data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay (LOS)</measure>
    <time_frame>At Hospital discharge within one-year before and after the intervention implementation</time_frame>
    <description>Days admitted to the hospital using registre data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Line Sepsis</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Treatment package of number of the line sepsis after ICU admission covering the number of patients with line sepsis using registre data on Lactat &lt;1 hour, bacteria samples ≤1 hour taken, time between diagnosis of sepsis and taken bacteria samples, time between diagnosis and given antibiotics measured by registre data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilated associated pneumonia (VAP)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Number of VAP measured by registre data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-intubations</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Number of re-intubations measured by registre data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-days Mortality</measure>
    <time_frame>30 days through study completion, an average of 1 year</time_frame>
    <description>30-days mortality rates after ICU discharge measured by registre data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90-days Mortality</measure>
    <time_frame>90 days through study completion, an average of 1 year</time_frame>
    <description>90-days mortality rates after ICU discharge measured by registre data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Staff turn-over</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Staff turn-over before and after the intervention measured by registre data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sick Leave</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Sick leave amongst staff members measured by registre data</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1800</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Structured Admission procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After implementation of a structured admission procedure to all ICU patients inspired by principles of Crisis Resource Management, Closed loop communication, action cards, and staff simulation training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Randomly admission procedure to all ICU patients based on the clinicians' evaluation prior implementation of the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structured admission procedure</intervention_name>
    <description>A structured ICU admission was inspired by principles of Crisis Resource Management and simulation training of ICU staff members. The Principles of Crisis Resource Management consisted of a treatment manual, a learning video, clear precise communication tool based on Identification-Situation-Background-Analysis-Recommendations (ISBAR) and Closed loop, actions cards, and ABCDE-evaluation of the patient including debriefing, and training in the simulation environment.</description>
    <arm_group_label>Structured Admission procedure</arm_group_label>
    <other_name>Standard Care</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ICU admissions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
&#xD;
          -  Drop-out are deaths&#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>Department of Anaestesiology</name>
      <address>
        <city>Holbæk</city>
        <zip>4300</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>March 8, 2018</last_update_submitted>
  <last_update_submitted_qc>March 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hillerod Hospital, Denmark</investigator_affiliation>
    <investigator_full_name>Janet Froulund Jensen</investigator_full_name>
    <investigator_title>PHD, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>intensive care</keyword>
  <keyword>crisis resource management</keyword>
  <keyword>simulation training</keyword>
  <keyword>before and after study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03268967
org study id: 113581
secondary id: 113581
nct id: NCT03268967
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Admission to the intensive care unit (ICU) is vital for surviving critical illness. An
      admission to ICU without having a consistent structure, structured review of the patient and
      a solid team organization lead to unclear communication and responsibility. Factors that
      correlate with patient acceptance and safety, morbidity and mortality. The hypothesize was
      that a structured admission can improve patients safety, reduce delays in treatment, reduce
      ICU length of stay, and improve mortality rate. The overall objective was to optimize patient
      safety, and effectively use available resources to reduce admission time, delays in treatment
      and procedures and mortality by using both quantitative and qualitative methods.
The quantitative before-data is a one-year observational period prior to the intervention
      measured by different perspectives; patients and staff outcomes.

      After the intervention, was qualititive data collected from participants, who received
      simulation training.

      The quantitative after-data is a one-year observational period post-intervention with same
      outcomes as before starting the intervention.

      Data is already collected registry data from hospital quality assurance board. Data will be
      compared before and after with assessor blinded analysis. Missing data will not be replaced
      but reported as missing.

      The investigators will try to compare the results with data from an approximately comparative
      ICU in Denmark due to the implementation of a new patient management system called the Health
      Portal.

      The statistical analysis plan is based on descriptive and comparative analyses of the group
      before and after the trial. The quantitative results are explained in in-depths description
      from participants.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Before and after interventional study
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
masking description: Data analysis
measure: ICU length of stay (LOS)
time frame: through study completion, an average of 1 year
description: Days admitted at the ICU using registre data
measure: Hospital length of stay (LOS)
time frame: At Hospital discharge within one-year before and after the intervention implementation
description: Days admitted to the hospital using registre data
measure: Line Sepsis
time frame: through study completion, an average of 1 year
description: Treatment package of number of the line sepsis after ICU admission covering the number of patients with line sepsis using registre data on Lactat <1 hour, bacteria samples ≤1 hour taken, time between diagnosis of sepsis and taken bacteria samples, time between diagnosis and given antibiotics measured by registre data
measure: Ventilated associated pneumonia (VAP)
time frame: through study completion, an average of 1 year
description: Number of VAP measured by registre data
measure: Re-intubations
time frame: through study completion, an average of 1 year
description: Number of re-intubations measured by registre data
measure: 30-days Mortality
time frame: 30 days through study completion, an average of 1 year
description: 30-days mortality rates after ICU discharge measured by registre data
measure: 90-days Mortality
time frame: 90 days through study completion, an average of 1 year
description: 90-days mortality rates after ICU discharge measured by registre data
measure: Staff turn-over
time frame: through study completion, an average of 1 year
description: Staff turn-over before and after the intervention measured by registre data
measure: Sick Leave
time frame: through study completion, an average of 1 year
description: Sick leave amongst staff members measured by registre data
arm group label: Structured Admission procedure
arm group type: Active Comparator
description: After implementation of a structured admission procedure to all ICU patients inspired by principles of Crisis Resource Management, Closed loop communication, action cards, and staff simulation training
arm group label: Standard Care
arm group type: No Intervention
description: Randomly admission procedure to all ICU patients based on the clinicians' evaluation prior implementation of the intervention.
intervention type: Behavioral
intervention name: Structured admission procedure
description: A structured ICU admission was inspired by principles of Crisis Resource Management and simulation training of ICU staff members. The Principles of Crisis Resource Management consisted of a treatment manual, a learning video, clear precise communication tool based on Identification-Situation-Background-Analysis-Recommendations (ISBAR) and Closed loop, actions cards, and ABCDE-evaluation of the patient including debriefing, and training in the simulation environment.
arm group label: Structured Admission procedure
other name: Standard Care
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hillerod Hospital, Denmark
investigator full name: Janet Froulund Jensen
investigator title: PHD, Principal Investigator
mesh term: Critical Illness
sharing ipd: Undecided