<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/NCT01692847</url>
  </required_header>
  <id_info>
    <org_study_id>SD-05163-BBN-IGS</org_study_id>
    <secondary_id>12/WA/0050</secondary_id>
    <nct_id>NCT01692847</nct_id>
  </id_info>
  <brief_title>Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes</brief_title>
  <official_title>Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes (VitalCare - Guardian Version 2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Healthcare</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A hospitals manual method of patient monitoring will be implemented in an automated system&#xD;
      and supported by an early patient deterioration detection for timely escalation. The purpose&#xD;
      of this study is to assess if clinical outcomes of patients in Acute Care are significantly&#xD;
      improved by such a system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to assess if the Philips IntelliVue Guardian Solution (IGS) with&#xD;
      all its components can significantly improve clinical outcomes for deteriorating patients on&#xD;
      a general medical ward prior and after referral to the hospitals' Acute Care Team (ACT).&#xD;
      Further, to provide evidence that the Philips IGS assists to increase the efficiency of a&#xD;
      hospital's Early Warning Scoring process (afferent and efferent arm of the escalation&#xD;
      system).&#xD;
&#xD;
      The introduction of such an intelligent automated system offers a unique opportunity to&#xD;
      address the breakdown in the chain of prevention by strengthening the reliability of&#xD;
      calls-for-help to responders through a technical solution with the potential for a more&#xD;
      timely escalation where appropriate.&#xD;
&#xD;
      In this study the hospital's Standard of Care protocol for the monitoring of vital signs&#xD;
      (including timing, vital signs collected and escalation instructions) will be implemented in&#xD;
      a commercially available intelligent automatic monitoring and notification system. No&#xD;
      investigational procedures or devices are associated with this protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of outcome for patients after implementing the IGS</measure>
    <time_frame>15 months</time_frame>
    <description>Does the IGS significantly increase positive outcomes for deteriorating patients after referral to the RRT/ACT as measured by the MAELOR score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Early detection of patient deterioration</measure>
    <time_frame>15 months</time_frame>
    <description>Does the IGS detect patient deterioration earlier and therefore prevent or shorten periods of severe illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily workload for the ward's personnel</measure>
    <time_frame>15 months</time_frame>
    <description>Does the IGS reduce the daily workload related to patient surveillance for the general ward personnel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of satisfaction</measure>
    <time_frame>15 months</time_frame>
    <description>Do Nurses and Doctors express a higher level of satisfaction with the IGS in place than with their current paper-based surveillance.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">678</enrollment>
  <condition>Severe Sepsis</condition>
  <condition>Cardiac Arrest</condition>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>RRT calls prior to IGS use</arm_group_label>
    <description>Patients who triggered ACT/RRT calls prior to the installation of the IGS (Intellivue Guardian System)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RRT calls during IGS use</arm_group_label>
    <description>Patients who triggered ACT/RRT calls after the installation of IGS. All patients on the study ward receive the same care in both groups. The only difference is the system used to collect vital signs and to inform the staff about patient deteriorations. In Group 2, the IGS (FDA approved and CE marked) is the vital signs collection and information system.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators plan to observe a non-probability, convenience sample of patients which&#xD;
        will consist primarily of acutely ill hospitalized adult patients (at least 18 years of&#xD;
        age). Study participants will be recruited from all eligible patients during the enrollment&#xD;
        period who are having vital signs monitoring performed as Standard of Care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients admitted to the study units during the period of data collection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 24h on ward&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian P Subbe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bangor University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ysbyty Gwynedd Hospital</name>
      <address>
        <city>Bangor</city>
        <state>Penrhosgarnedd</state>
        <zip>LL572PW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>April 1, 2016</last_update_submitted>
  <last_update_submitted_qc>April 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>patient deterioration</keyword>
  <keyword>rapid response teams</keyword>
  <keyword>acute care teams</keyword>
  <keyword>early warning scoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Respiratory Insufficiency</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/NCT01692847
org study id: SD-05163-BBN-IGS
secondary id: 12/WA/0050
nct id: NCT01692847
lead sponsor: 
has dmc: Yes
A hospitals manual method of patient monitoring will be implemented in an automated system
      and supported by an early patient deterioration detection for timely escalation. The purpose
      of this study is to assess if clinical outcomes of patients in Acute Care are significantly
      improved by such a system.
The purpose of this study is to assess if the Philips IntelliVue Guardian Solution (IGS) with
      all its components can significantly improve clinical outcomes for deteriorating patients on
      a general medical ward prior and after referral to the hospitals' Acute Care Team (ACT).
      Further, to provide evidence that the Philips IGS assists to increase the efficiency of a
      hospital's Early Warning Scoring process (afferent and efferent arm of the escalation
      system).

      The introduction of such an intelligent automated system offers a unique opportunity to
      address the breakdown in the chain of prevention by strengthening the reliability of
      calls-for-help to responders through a technical solution with the potential for a more
      timely escalation where appropriate.

      In this study the hospital's Standard of Care protocol for the monitoring of vital signs
      (including timing, vital signs collected and escalation instructions) will be implemented in
      a commercially available intelligent automatic monitoring and notification system. No
      investigational procedures or devices are associated with this protocol.
observational model: Cohort
time perspective: Prospective
measure: Improvement of outcome for patients after implementing the IGS
time frame: 15 months
description: Does the IGS significantly increase positive outcomes for deteriorating patients after referral to the RRT/ACT as measured by the MAELOR score
measure: Early detection of patient deterioration
time frame: 15 months
description: Does the IGS detect patient deterioration earlier and therefore prevent or shorten periods of severe illness.
measure: Daily workload for the ward's personnel
time frame: 15 months
description: Does the IGS reduce the daily workload related to patient surveillance for the general ward personnel.
measure: Level of satisfaction
time frame: 15 months
description: Do Nurses and Doctors express a higher level of satisfaction with the IGS in place than with their current paper-based surveillance.
arm group label: RRT calls prior to IGS use
description: Patients who triggered ACT/RRT calls prior to the installation of the IGS (Intellivue Guardian System)
arm group label: RRT calls during IGS use
description: Patients who triggered ACT/RRT calls after the installation of IGS. All patients on the study ward receive the same care in both groups. The only difference is the system used to collect vital signs and to inform the staff about patient deteriorations. In Group 2, the IGS (FDA approved and CE marked) is the vital signs collection and information system.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian P Subbe, MD
role: Principal Investigator
affiliation: Bangor University
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Sepsis
mesh term: Respiratory Insufficiency
sharing ipd: No