<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/NCT02970903</url>
  </required_header>
  <id_info>
    <org_study_id>H16-02361</org_study_id>
    <nct_id>NCT02970903</nct_id>
  </id_info>
  <brief_title>VitalPAD: an Intelligent Monitoring and Communication Device to Optimize Safety in the PICU</brief_title>
  <official_title>VitalPAD: an Intelligent Monitoring and Communication Device to Optimize Safety in the PICU; Project Phases 1 (System Development) and 2 (Prototype Evaluation)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The VitalPAD is a unified, portable and intelligent device that integrates information from&#xD;
      multiple patient monitors, mechanical ventilators, infusion pumps and clinical information&#xD;
      systems on a mobile platform. It will allow nurses, respiratory therapists and physicians to&#xD;
      continuously monitor and coordinate care of critically ill patients.&#xD;
&#xD;
      This study will use a participatory design process to guide the design of an integrated&#xD;
      mobile device, followed by an evaluation of the proposed device in a simulated ICU setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Purpose&#xD;
&#xD;
           Critically ill patients in the intensive care unit (ICU) need constant monitoring by&#xD;
           nurses, respiratory therapists, and physicians. To make decisions and plan therapies,&#xD;
           these clinicians must observe and reconcile a vast array of information originating from&#xD;
           devices located at the bedsides of multiple patients. Their efforts are hindered by:&#xD;
           information being physically limited to the bedside; information overload from the&#xD;
           number of devices and separate displays; lack of integration and interaction between&#xD;
           devices; displays which fail to present information in a way that is easy to understand;&#xD;
           alarm fatigue; lacking historical data or clinical context to support clinical decision&#xD;
           making; difficulty locating a team member for consultation or to provide an extra pair&#xD;
           of hands&#xD;
&#xD;
           This project aims to integrate information from multiple monitoring and therapy devices&#xD;
           (multi-parameter monitor, infusion pumps, mechanical ventilator) onto one application,&#xD;
           the VitalPAD, hosted on a mobile device (tablet or smartphone). The VitalPAD will&#xD;
           process information from multiple bedside monitors in an intelligent decision-support&#xD;
           system, and provide an intuitive display of vital signs information, alerts and&#xD;
           reminders to ICU healthcare team members.&#xD;
&#xD;
           Assigning priority of care and early detection of deterioration of critically ill&#xD;
           patients represents an enormous source of preventable morbidity, mortality and cost.&#xD;
           Enhanced efficiency in patient monitoring can help reduce the time to detection of&#xD;
           critical conditions and improve priority assignment, contributing to enhanced patient&#xD;
           safety.&#xD;
&#xD;
           The goal of this project is to demonstrate that a mobile application (VitalPAD) can&#xD;
           provide dynamic, meaningful, integrated information to intensive care clinicians in&#xD;
           real-time. (also see above)&#xD;
&#xD;
        2. Hypothesis / Aims&#xD;
&#xD;
           Part I - Participatory Design. The participatory design process, as proposed by&#xD;
           Holtzblatt, for system development is a mixed-method approach. The aim is to develop a&#xD;
           prototype that is easy to use, supports decision making, improves awareness of the&#xD;
           patient's condition by ICU healthcare team members, and reduces mental workload.&#xD;
&#xD;
           Part II - Simulation Experiment. The hypothesis is that in simulated ICU scenarios,&#xD;
           critical care physicians, nurses, and respiratory therapists will prioritize the care of&#xD;
           critically ill patients more more rapidly and more accurately with the use of VitalPAD&#xD;
           than without it. Specifically, using VitalPAD to triage 5 patients will be 30 seconds&#xD;
           faster (moderate effect) than performing the same task with the control display.&#xD;
           Expected secondary outcomes are a decrease in mental workload as well as an increase in&#xD;
           situational awareness.&#xD;
&#xD;
        3. Justification This research represents a significant opportunity to enhance patient&#xD;
           safety in ICUs in Canada and elsewhere by directly advancing the conceptual, theoretical&#xD;
           and clinical knowledge required to optimize the use of information in the ICU. It will&#xD;
           leverage advances in mobile computing to provide real time support to healthcare&#xD;
           providers on the move and reduce cognitive demands.&#xD;
&#xD;
           This integrated system aims to enhance performance of the clinicians in real-time,&#xD;
           optimize therapeutic interventions, reduce adverse outcomes and ultimately save lives.&#xD;
           The aim is to provide healthcare team members with a one-stop solution for their patient&#xD;
           monitoring needs, which will improve the way work is done in the ICU and will decrease&#xD;
           worker stress, especially for nurses.&#xD;
&#xD;
        4. Research Design Part I - Participatory design: an inter-professional team of nurses,&#xD;
           physicians, designers, engineers, and human factors experts will follow a user-centered&#xD;
           design process to refine the system requirements, and obtain feedback during the rapid&#xD;
           prototyping phase of prototype development.&#xD;
&#xD;
           In Part II - Simulation Experiment: the prototype device will be evaluated in a&#xD;
           simulated ICU setting using a triaging task. Answer accuracy and time taken to complete&#xD;
           task will be measured. Participants will complete questionnaires (NASA-TLX workload&#xD;
           assessment and a PSSUQ usability evaluation).&#xD;
&#xD;
        5. Statistical Analysis Part I - Participatory design: qualitative methods will be used to&#xD;
           analyze and summarize data. Specific themes will be identified and similar themes&#xD;
           merged. Specific obstacles to usability, design preferences, and opportunities for&#xD;
           information integration will be collated and summarized. In the usability experiment,&#xD;
           error rates and task completion times will be used to detail opportunities for&#xD;
           additional usability improvements.&#xD;
&#xD;
      Part II - Simulation Experiment:&#xD;
&#xD;
        -  Analysis of Response Time. Mixed linear effect modeling will be used to explore the&#xD;
           effects of display, triaging set, and presentation order, and their interactions.&#xD;
           Differences between groups (increase or decrease in time taken to triage) will be&#xD;
           expressed using the nonparametric Hodges-Lehmann estimator and its 95% confidence limit.&#xD;
&#xD;
        -  Analysis of Answer Accuracy. As a secondary outcome, the number of correct responses for&#xD;
           each participant will be recorded. The two proportions will be compared using Fisher's&#xD;
           exact test. False positive and false negative detection rates will be compared.&#xD;
&#xD;
        -  Analysis of Workload Scores. The NASA-TLX scores will be analyzed using two approaches:&#xD;
           a Friedman's ANOVA, a non-parametric version of the ANOVA, of each of the 6 individual&#xD;
           sub-scores to test for individual effects; and an analysis of the weighted composite&#xD;
           score using the same statistical test.&#xD;
&#xD;
        -  Analysis of Usability Questionnaire. The PSSUQ results will be tabulated and specific&#xD;
           problematic usability issues identified. Friedman's ANOVA will be used to test for&#xD;
           individual effects. Feedback provided by the subjects will be screened for improvement&#xD;
           of both user interface and decision support system rules.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    We were unable to secure funding for the triaging experiment. The participatory design process&#xD;
    ran its course as intended.&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 2016</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficiency of priority assignment in triaging task</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Efficiency will be measured by the time it takes clinicians to prioritize 5 patients with/without the aid of the VitalPAD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy of priority assignment in triaging task</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Accuracy will be measured by matching of the participants triage priority ranking with the previously defined expert ranking</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Usability questionnaire: NASA TLX</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>NASA Task Load Index</description>
  </other_outcome>
  <other_outcome>
    <measure>Usability questionnaire: PSSUQ</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Post-Study System Usability Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Usability feedback</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Free-text suggestions to improve prototype device</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Medical Device</condition>
  <condition>User-Computer Interface</condition>
  <condition>Critical Care</condition>
  <condition>Physiologic Monitoring</condition>
  <arm_group>
    <arm_group_label>VitalPAD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using VitalPAD prototype device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using traditional tools (monitors, paper records)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VitalPAD</intervention_name>
    <description>VitalPAD prototype device</description>
    <arm_group_label>VitalPAD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Traditional tools</intervention_name>
    <description>Paper based records, screenshots of monitors and therapy devices</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Staff pediatric critical care physicians, pediatric critical care fellow physicians or&#xD;
             attending physicians, registered pediatric nurses, and respiratory therapists working&#xD;
             in the pediatric ICU at BC Children's Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nursing students and resident physicians are not eligible.&#xD;
&#xD;
          -  For Phase II - Simulation Experiment only: Failure to complete the post-training quiz&#xD;
             after two attempts.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias Görges, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pediatric Anesthesia Research Team, University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>October 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>May 31, 2019</last_update_submitted>
  <last_update_submitted_qc>May 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Matthias Görges, PhD</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <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/NCT02970903
org study id: H16-02361
nct id: NCT02970903
lead sponsor: 
collaborator: 
has dmc: No
The VitalPAD is a unified, portable and intelligent device that integrates information from
      multiple patient monitors, mechanical ventilators, infusion pumps and clinical information
      systems on a mobile platform. It will allow nurses, respiratory therapists and physicians to
      continuously monitor and coordinate care of critically ill patients.

      This study will use a participatory design process to guide the design of an integrated
      mobile device, followed by an evaluation of the proposed device in a simulated ICU setting.
1. Purpose

           Critically ill patients in the intensive care unit (ICU) need constant monitoring by
           nurses, respiratory therapists, and physicians. To make decisions and plan therapies,
           these clinicians must observe and reconcile a vast array of information originating from
           devices located at the bedsides of multiple patients. Their efforts are hindered by:
           information being physically limited to the bedside; information overload from the
           number of devices and separate displays; lack of integration and interaction between
           devices; displays which fail to present information in a way that is easy to understand;
           alarm fatigue; lacking historical data or clinical context to support clinical decision
           making; difficulty locating a team member for consultation or to provide an extra pair
           of hands

           This project aims to integrate information from multiple monitoring and therapy devices
           (multi-parameter monitor, infusion pumps, mechanical ventilator) onto one application,
           the VitalPAD, hosted on a mobile device (tablet or smartphone). The VitalPAD will
           process information from multiple bedside monitors in an intelligent decision-support
           system, and provide an intuitive display of vital signs information, alerts and
           reminders to ICU healthcare team members.

           Assigning priority of care and early detection of deterioration of critically ill
           patients represents an enormous source of preventable morbidity, mortality and cost.
           Enhanced efficiency in patient monitoring can help reduce the time to detection of
           critical conditions and improve priority assignment, contributing to enhanced patient
           safety.

           The goal of this project is to demonstrate that a mobile application (VitalPAD) can
           provide dynamic, meaningful, integrated information to intensive care clinicians in
           real-time. (also see above)

        2. Hypothesis / Aims

           Part I - Participatory Design. The participatory design process, as proposed by
           Holtzblatt, for system development is a mixed-method approach. The aim is to develop a
           prototype that is easy to use, supports decision making, improves awareness of the
           patient's condition by ICU healthcare team members, and reduces mental workload.

           Part II - Simulation Experiment. The hypothesis is that in simulated ICU scenarios,
           critical care physicians, nurses, and respiratory therapists will prioritize the care of
           critically ill patients more more rapidly and more accurately with the use of VitalPAD
           than without it. Specifically, using VitalPAD to triage 5 patients will be 30 seconds
           faster (moderate effect) than performing the same task with the control display.
           Expected secondary outcomes are a decrease in mental workload as well as an increase in
           situational awareness.

        3. Justification This research represents a significant opportunity to enhance patient
           safety in ICUs in Canada and elsewhere by directly advancing the conceptual, theoretical
           and clinical knowledge required to optimize the use of information in the ICU. It will
           leverage advances in mobile computing to provide real time support to healthcare
           providers on the move and reduce cognitive demands.

           This integrated system aims to enhance performance of the clinicians in real-time,
           optimize therapeutic interventions, reduce adverse outcomes and ultimately save lives.
           The aim is to provide healthcare team members with a one-stop solution for their patient
           monitoring needs, which will improve the way work is done in the ICU and will decrease
           worker stress, especially for nurses.

        4. Research Design Part I - Participatory design: an inter-professional team of nurses,
           physicians, designers, engineers, and human factors experts will follow a user-centered
           design process to refine the system requirements, and obtain feedback during the rapid
           prototyping phase of prototype development.

           In Part II - Simulation Experiment: the prototype device will be evaluated in a
           simulated ICU setting using a triaging task. Answer accuracy and time taken to complete
           task will be measured. Participants will complete questionnaires (NASA-TLX workload
           assessment and a PSSUQ usability evaluation).

        5. Statistical Analysis Part I - Participatory design: qualitative methods will be used to
           analyze and summarize data. Specific themes will be identified and similar themes
           merged. Specific obstacles to usability, design preferences, and opportunities for
           information integration will be collated and summarized. In the usability experiment,
           error rates and task completion times will be used to detail opportunities for
           additional usability improvements.

      Part II - Simulation Experiment:

        -  Analysis of Response Time. Mixed linear effect modeling will be used to explore the
           effects of display, triaging set, and presentation order, and their interactions.
           Differences between groups (increase or decrease in time taken to triage) will be
           expressed using the nonparametric Hodges-Lehmann estimator and its 95% confidence limit.

        -  Analysis of Answer Accuracy. As a secondary outcome, the number of correct responses for
           each participant will be recorded. The two proportions will be compared using Fisher's
           exact test. False positive and false negative detection rates will be compared.

        -  Analysis of Workload Scores. The NASA-TLX scores will be analyzed using two approaches:
           a Friedman's ANOVA, a non-parametric version of the ANOVA, of each of the 6 individual
           sub-scores to test for individual effects; and an analysis of the weighted composite
           score using the same statistical test.

        -  Analysis of Usability Questionnaire. The PSSUQ results will be tabulated and specific
           problematic usability issues identified. Friedman's ANOVA will be used to test for
           individual effects. Feedback provided by the subjects will be screened for improvement
           of both user interface and decision support system rules.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Efficiency of priority assignment in triaging task
time frame: Up to 1 hour
description: Efficiency will be measured by the time it takes clinicians to prioritize 5 patients with/without the aid of the VitalPAD
measure: Accuracy of priority assignment in triaging task
time frame: Up to 1 hour
description: Accuracy will be measured by matching of the participants triage priority ranking with the previously defined expert ranking
measure: Usability questionnaire: NASA TLX
time frame: Up to 1 hour
description: NASA Task Load Index
measure: Usability questionnaire: PSSUQ
time frame: Up to 1 hour
description: Post-Study System Usability Questionnaire
measure: Usability feedback
time frame: Up to 1 hour
description: Free-text suggestions to improve prototype device
arm group label: VitalPAD
arm group type: Experimental
description: Using VitalPAD prototype device
arm group label: Control
arm group type: Active Comparator
description: Using traditional tools (monitors, paper records)
intervention type: Device
intervention name: VitalPAD
description: VitalPAD prototype device
arm group label: VitalPAD
intervention type: Device
intervention name: Traditional tools
description: Paper based records, screenshots of monitors and therapy devices
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Matthias Görges, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Matthias Görges, PhD
investigator title: Principle Investigator
sharing ipd: No