<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/NCT04452695</url>
  </required_header>
  <id_info>
    <org_study_id>2020P000957</org_study_id>
    <nct_id>NCT04452695</nct_id>
  </id_info>
  <brief_title>Acceptability of Telehealth Triage Using Robotic Systems in COVID-19</brief_title>
  <official_title>Acceptability of Telehealth Triage Using Robotic Systems in COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's 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>
      The overall objective of this investigation is to understand the patient response to a&#xD;
      robotic platform used to facilitate telehealth triage in the emergency department during the&#xD;
      COVID-19 pandemic. The COVID-19 pandemic has altered the manner in which emergency department&#xD;
      triage is completed. Attempts at cohorting individuals with potential COVID-19 disease in&#xD;
      order to prevent disease transmission to healthcare workers and minimize the use of personal&#xD;
      protective equipment (PPE) have renewed interest in telemedical solutions as a method to&#xD;
      triage and manage individuals with COVID-19. This investigation deploys a legged robotic&#xD;
      platform to facilitate agile, highly mobile telemedicine to manage COVID-19 patients in the&#xD;
      emergency department. The primary objective is to measure the patient response to interacting&#xD;
      with these systems.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2020</start_date>
  <completion_date type="Actual">August 10, 2020</completion_date>
  <primary_completion_date type="Actual">August 3, 2020</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>Acceptance of robotic telehealth system</measure>
    <time_frame>Immediately after completion of triage</time_frame>
    <description>Quantitative questionnaire on the acceptance of virtual robotic care graded on a likert scale (higher scores better)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Willingness to interact with robotic telehealth system</measure>
    <time_frame>Immediately after completion of triage</time_frame>
    <description>Quantitative questionnaire on the willingness to use this system again based on a likert scale (higher scores better)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction of interacting with a robotic telehealth system</measure>
    <time_frame>Immediately after completion of triage</time_frame>
    <description>Quantitative questionnaire on the user satisfaction with their triage experience (How satisfied were you with your experience interacting with the robotic system today?)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Use of robotic system versus in-person triage</measure>
    <time_frame>Immediately after completion of triage</time_frame>
    <description>Quantitative questionnaire comparing robotic triage process with in-person triage: Do you think your interaction with the robotic system was better, the same or no different than an in-person evaluation?)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>COVID-19</condition>
  <condition>Telemedicine</condition>
  <condition>Robotics</condition>
  <condition>Emergencies</condition>
  <condition>Emerging Infectious Disease</condition>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <description>Patients presenting to the emergency department are triaged using a novel robotic telehealth triage system. Once triage is complete, patients complete a quantitative assessment to measure their acceptance and willingness to interact with the robotic telehealth system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Doctor Spot</intervention_name>
    <description>Robotic platform (Boston Dynamics) controlled by clinician with video interface to facilitate telemedicine triage</description>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Emergency department patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presenting to the emergency department for evaluation&#xD;
&#xD;
          -  &gt; 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Brought to emergency department via ambulance&#xD;
&#xD;
          -  &lt;18 years old&#xD;
&#xD;
          -  non-english speaking&#xD;
&#xD;
          -  in extremis, or unable to participate due to underlying acute medical condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Chai PR, Dadabhoy FZ, Huang HW, Chu JN, Feng A, Le HM, Collins J, da Silva M, Raibert M, Hur C, Boyer EW, Traverso G. Assessment of the Acceptability and Feasibility of Using Mobile Robotic Systems for Patient Evaluation. JAMA Netw Open. 2021 Mar 1;4(3):e210667. doi: 10.1001/jamanetworkopen.2021.0667.</citation>
    <PMID>33662134</PMID>
  </results_reference>
  <results_reference>
    <citation>Huang HW, Chen J, Chai PR, Ehmke C, Rupp P, Dadabhoy FZ, Feng A, Li C, Thomas AJ, da Silva M, Boyer EW, Traverso G. Mobile Robotic Platform for Contactless Vital Sign Monitoring. Cyborg Bionic Syst. 2022;2022:9780497. doi: 10.34133/2022/9780497. Epub 2022 Apr 30.</citation>
    <PMID>35571871</PMID>
  </results_reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>September 16, 2022</last_update_submitted>
  <last_update_submitted_qc>September 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Peter R Chai</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases, Emerging</mesh_term>
    <mesh_term>Emergencies</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/NCT04452695
org study id: 2020P000957
nct id: NCT04452695
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall objective of this investigation is to understand the patient response to a
      robotic platform used to facilitate telehealth triage in the emergency department during the
      COVID-19 pandemic. The COVID-19 pandemic has altered the manner in which emergency department
      triage is completed. Attempts at cohorting individuals with potential COVID-19 disease in
      order to prevent disease transmission to healthcare workers and minimize the use of personal
      protective equipment (PPE) have renewed interest in telemedical solutions as a method to
      triage and manage individuals with COVID-19. This investigation deploys a legged robotic
      platform to facilitate agile, highly mobile telemedicine to manage COVID-19 patients in the
      emergency department. The primary objective is to measure the patient response to interacting
      with these systems.
observational model: Cohort
time perspective: Prospective
measure: Acceptance of robotic telehealth system
time frame: Immediately after completion of triage
description: Quantitative questionnaire on the acceptance of virtual robotic care graded on a likert scale (higher scores better)
measure: Willingness to interact with robotic telehealth system
time frame: Immediately after completion of triage
description: Quantitative questionnaire on the willingness to use this system again based on a likert scale (higher scores better)
measure: Satisfaction of interacting with a robotic telehealth system
time frame: Immediately after completion of triage
description: Quantitative questionnaire on the user satisfaction with their triage experience (How satisfied were you with your experience interacting with the robotic system today?)
measure: Use of robotic system versus in-person triage
time frame: Immediately after completion of triage
description: Quantitative questionnaire comparing robotic triage process with in-person triage: Do you think your interaction with the robotic system was better, the same or no different than an in-person evaluation?)
arm group label: Intervention arm
description: Patients presenting to the emergency department are triaged using a novel robotic telehealth triage system. Once triage is complete, patients complete a quantitative assessment to measure their acceptance and willingness to interact with the robotic telehealth system.
intervention type: Device
intervention name: Doctor Spot
description: Robotic platform (Boston Dynamics) controlled by clinician with video interface to facilitate telemedicine triage
arm group label: Intervention arm
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Chai PR, Dadabhoy FZ, Huang HW, Chu JN, Feng A, Le HM, Collins J, da Silva M, Raibert M, Hur C, Boyer EW, Traverso G. Assessment of the Acceptability and Feasibility of Using Mobile Robotic Systems for Patient Evaluation. JAMA Netw Open. 2021 Mar 1;4(3):e210667. doi: 10.1001/jamanetworkopen.2021.0667.
PMID: 33662134
citation: Huang HW, Chen J, Chai PR, Ehmke C, Rupp P, Dadabhoy FZ, Feng A, Li C, Thomas AJ, da Silva M, Boyer EW, Traverso G. Mobile Robotic Platform for Contactless Vital Sign Monitoring. Cyborg Bionic Syst. 2022;2022:9780497. doi: 10.34133/2022/9780497. Epub 2022 Apr 30.
PMID: 35571871
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Peter R Chai
investigator title: Assistant Professor
mesh term: COVID-19
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Communicable Diseases, Emerging
mesh term: Emergencies
sharing ipd: Undecided