<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/NCT04497922</url>
  </required_header>
  <id_info>
    <org_study_id>2020P002382</org_study_id>
    <nct_id>NCT04497922</nct_id>
  </id_info>
  <brief_title>Virtual White Boards for Patient Satisfaction</brief_title>
  <official_title>Improving Patient Satisfaction Through Information Display Using Virtual White Boards</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>E-ink corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      Communication with patients on their clinical status is important in delivering care in the&#xD;
      emergency department. During times of high volume or complex patients, there may be lapses in&#xD;
      communicating with patients about their hospital course or plans of action. These&#xD;
      miscommunications may be enhanced during the current COVID-19 pandemic as there is minimized&#xD;
      in-person interaction with patients in order to conserve personal protective equipment and&#xD;
      decrease the risk of disease transmission. This study utilizes a virtual white board to&#xD;
      deliver updates to patients about the status of their emergency department stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ultimate goal of this study is to understand the effect of delivering timely information&#xD;
      about a patient's emergency department course of their satisfaction surrounding the emergency&#xD;
      department stay. The experience of patients in the emergency department has been&#xD;
      significantly altered by the COVID-19 pandemic due to decreased in-person encounters, and the&#xD;
      use of PPE. Delivering information about their clinical course and expected hospital course&#xD;
      is more difficult now given the emphasis on less in-person interaction. In response, the&#xD;
      investigators have deployed in collaboration with e-ink, a virtual e-paper white board that&#xD;
      can be remotely edited to help display pertinent hospital course information to patients in&#xD;
      the emergency department. The investigators will conduct a randomized controlled trial to&#xD;
      understand the effect of deploying these white boards on patient satisfaction in the&#xD;
      emergency department.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 25, 2021</start_date>
  <completion_date type="Anticipated">May 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2021</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>emergency department satisfaction: likert scale</measure>
    <time_frame>30 minutes after disposition decision for patient</time_frame>
    <description>Satisfaction of overall emergency department stay measured by a 1-5 likert scale, hospital developed question on satisfaction (how satisfied were you with your emergency department stay today?)- higher score is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of emergency department stay: likert scale</measure>
    <time_frame>30 minutes after disposition decision for patient</time_frame>
    <description>Quality of information conveyed to participant (rated on 5 point likert scale on questions about quality of waiting time for test results, staff concern, perceived teamwork in the hospital)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preference for virtual white board</measure>
    <time_frame>30 minutes after disposition decision for patient</time_frame>
    <description>Question on preference for virtual white board compared to a standard emergency department room without a white board (1-4 likert scale, with 4 being strongly prefer white board room)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Satisfaction, Patient</condition>
  <condition>Covid19</condition>
  <condition>Emergencies</condition>
  <condition>Satisfaction</condition>
  <condition>Information Disclosure</condition>
  <arm_group>
    <arm_group_label>Treatment as usual in emergency department</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals triaged to a pod in the emergency department without rooms that are fitted with a virtual display screen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual white board</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals triaged to a pod in the emergency department in a room that is fitted with a virtual display screen</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>e-ink screen</intervention_name>
    <description>A virtual display screen developed by e-ink that displays patient status, basic demographics, care team information, pending tests and anticipated disposition</description>
    <arm_group_label>Virtual white board</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <description>Treatment as usual in the emergency department with communication of testing results, imaging and disposition by the primary clinical emergency department team.</description>
    <arm_group_label>Treatment as usual in emergency department</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients in emergency department at Brigham and Women's Hospital&#xD;
&#xD;
          -  Triaged to designated emergency department pods outfitted with virtual white board&#xD;
&#xD;
          -  Expected emergency department stay of at least four hours&#xD;
&#xD;
          -  Able to speak and read english&#xD;
&#xD;
          -  Not primary psychiatric complaint&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically ill or otherwise deemed unable to participate by the study PI and/or&#xD;
             treating clinical team.&#xD;
&#xD;
          -  Patients admitted to an inpatient bed but boarding in the emergency department over 10&#xD;
             hours.&#xD;
&#xD;
          -  Previously participated in the study.&#xD;
&#xD;
          -  Has COVID-19 risk flag or confirmed COVID-19 in electronic health record&#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>Peter R Chai, MD MMS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter R Chai, MD</last_name>
    <phone>617-632-5640</phone>
    <email>pchai@bwh.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Guruprasad D Jambaulikar, MBBS MPH</last_name>
    <email>gjambaulikar@bwh.harvard.edu</email>
  </overall_contact_backup>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter R Chai, MD MMS</last_name>
      <phone>617-732-5640</phone>
      <email>pchai@bwh.harvard.edu</email>
    </contact>
    <contact_backup>
      <last_name>Guruprasad D Jambaulikar, MBBS MPH</last_name>
      <email>gjambaulikar@bwh.harvard.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</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>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/NCT04497922
org study id: 2020P002382
nct id: NCT04497922
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Communication with patients on their clinical status is important in delivering care in the
      emergency department. During times of high volume or complex patients, there may be lapses in
      communicating with patients about their hospital course or plans of action. These
      miscommunications may be enhanced during the current COVID-19 pandemic as there is minimized
      in-person interaction with patients in order to conserve personal protective equipment and
      decrease the risk of disease transmission. This study utilizes a virtual white board to
      deliver updates to patients about the status of their emergency department stay.
The ultimate goal of this study is to understand the effect of delivering timely information
      about a patient's emergency department course of their satisfaction surrounding the emergency
      department stay. The experience of patients in the emergency department has been
      significantly altered by the COVID-19 pandemic due to decreased in-person encounters, and the
      use of PPE. Delivering information about their clinical course and expected hospital course
      is more difficult now given the emphasis on less in-person interaction. In response, the
      investigators have deployed in collaboration with e-ink, a virtual e-paper white board that
      can be remotely edited to help display pertinent hospital course information to patients in
      the emergency department. The investigators will conduct a randomized controlled trial to
      understand the effect of deploying these white boards on patient satisfaction in the
      emergency department.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Other
masking: None (Open Label)
measure: emergency department satisfaction: likert scale
time frame: 30 minutes after disposition decision for patient
description: Satisfaction of overall emergency department stay measured by a 1-5 likert scale, hospital developed question on satisfaction (how satisfied were you with your emergency department stay today?)- higher score is better
measure: Quality of emergency department stay: likert scale
time frame: 30 minutes after disposition decision for patient
description: Quality of information conveyed to participant (rated on 5 point likert scale on questions about quality of waiting time for test results, staff concern, perceived teamwork in the hospital)
measure: Preference for virtual white board
time frame: 30 minutes after disposition decision for patient
description: Question on preference for virtual white board compared to a standard emergency department room without a white board (1-4 likert scale, with 4 being strongly prefer white board room)
arm group label: Treatment as usual in emergency department
arm group type: Active Comparator
description: Individuals triaged to a pod in the emergency department without rooms that are fitted with a virtual display screen
arm group label: Virtual white board
arm group type: Experimental
description: Individuals triaged to a pod in the emergency department in a room that is fitted with a virtual display screen
intervention type: Device
intervention name: e-ink screen
description: A virtual display screen developed by e-ink that displays patient status, basic demographics, care team information, pending tests and anticipated disposition
arm group label: Virtual white board
intervention type: Behavioral
intervention name: Treatment as usual
description: Treatment as usual in the emergency department with communication of testing results, imaging and disposition by the primary clinical emergency department team.
arm group label: Treatment as usual in emergency department
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter R Chai, MD MMS
role: Principal Investigator
affiliation: Brigham and Women's Hospital
last name: Peter R Chai, MD
phone: 617-632-5640
email: pchai@bwh.harvard.edu
last name: Guruprasad D Jambaulikar, MBBS MPH
email: gjambaulikar@bwh.harvard.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Peter R Chai
investigator title: Assistant Professor
mesh term: Emergencies
sharing ipd: Undecided