<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/NCT03766841</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00031177</org_study_id>
    <nct_id>NCT03766841</nct_id>
  </id_info>
  <brief_title>Avoiding Health Disparities When Collecting Patient Contextual Data for Clinical Care and Pragmatic Research</brief_title>
  <official_title>Avoiding Health Disparities When Collecting Patient Contextual Data for Clinical Care and Pragmatic Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</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>
      To assess whether the routine collection of patient-contextual data improves patient&#xD;
      activation and communication, and can mitigate racial disparities in communication and&#xD;
      engagement, we are inviting patients who have upcoming appointments at the participating&#xD;
      health system to participate in a communication study. Patients will be randomized to having&#xD;
      guided (facilitated) enrollment in a tool that collects patient contextual data, or to usual&#xD;
      care. All patients are invited directly by the health system to use the tool. Statistical&#xD;
      methods will be used to determine the impact of the tool's use on outcomes of interest, as&#xD;
      well as the impact on completion by the use of the facilitated enrollment. The study will&#xD;
      particularly focus on assessing the impact of patient-contextual data and communication on&#xD;
      heath disparities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite Communication Score As Assessed by Communication Assessment Tool, a validated 14-item patient-reported outcome.</measure>
    <time_frame>Post Visit ( 1 week)</time_frame>
    <description>Use of Communication Assessment Tool (CAT), a 14-item instrument that reports patient-views of clinician communication Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007;67: 333-342.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the composite score of the patient activation measure, a validated instrument to assess a patient's engagement and activation in their health issues.</measure>
    <time_frame>Pre/Post Visit (1 week)</time_frame>
    <description>Short form developed by J Hibbard et al on patient activation Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005;40: 1918-1930.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">301</enrollment>
  <condition>Communication</condition>
  <arm_group>
    <arm_group_label>Facilitated Enrollment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be aided in the account creation and usage of a consumer informatics tool to collect and report patient-contextual data within the electronic health record</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will be invited to use the patient contextual data tool as per usual care, but will not receive additional assistance in account creation and usage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Facilitated Enrollment</intervention_name>
    <description>Research coordinator will assist patients in account creation and usage of the tool.</description>
    <arm_group_label>Facilitated Enrollment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 18 or older&#xD;
&#xD;
          -  able to speak and understand English,&#xD;
&#xD;
          -  a patient at a selected Froedtert &amp; Medical College of Wisconson primary care or&#xD;
             internal medicine clinic (i.e., General Internal Medicine On Campus of Milwaukee&#xD;
             Regional Medical Center, Sargeant Health Center, or Tosa Health Center (Plank Road&#xD;
             Clinic) with an upcoming (&gt; 4 weeks away) appointment and at least 1 previous&#xD;
             appointment with the same provider in the previous 12 months.&#xD;
&#xD;
          -  Patients with cognitive impairment (e.g. dementia) are eligible to participate through&#xD;
             the use of proxies who would ordinarily accompany them to appointments and complete&#xD;
             forms or post-visit surveys on their behalf.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minors and non-English speaking patients are not eligible to participate&#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>Bradley H Crotty, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Froedtert &amp; Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>February 2, 2020</last_update_submitted>
  <last_update_submitted_qc>February 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Bradley Crotty</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>consumer informatics</keyword>
  <keyword>communication</keyword>
  <keyword>patient engagement</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 24, 2021</submitted>
    <returned>January 28, 2022</returned>
    <submitted>May 26, 2022</submitted>
    <returned>March 2, 2023</returned>
  </pending_results>
  <!-- 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/NCT03766841
org study id: PRO00031177
nct id: NCT03766841
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess whether the routine collection of patient-contextual data improves patient
      activation and communication, and can mitigate racial disparities in communication and
      engagement, we are inviting patients who have upcoming appointments at the participating
      health system to participate in a communication study. Patients will be randomized to having
      guided (facilitated) enrollment in a tool that collects patient contextual data, or to usual
      care. All patients are invited directly by the health system to use the tool. Statistical
      methods will be used to determine the impact of the tool's use on outcomes of interest, as
      well as the impact on completion by the use of the facilitated enrollment. The study will
      particularly focus on assessing the impact of patient-contextual data and communication on
      heath disparities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: Composite Communication Score As Assessed by Communication Assessment Tool, a validated 14-item patient-reported outcome.
time frame: Post Visit ( 1 week)
description: Use of Communication Assessment Tool (CAT), a 14-item instrument that reports patient-views of clinician communication Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007;67: 333-342.
measure: Change in the composite score of the patient activation measure, a validated instrument to assess a patient's engagement and activation in their health issues.
time frame: Pre/Post Visit (1 week)
description: Short form developed by J Hibbard et al on patient activation Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005;40: 1918-1930.
arm group label: Facilitated Enrollment
arm group type: Experimental
description: Patients will be aided in the account creation and usage of a consumer informatics tool to collect and report patient-contextual data within the electronic health record
arm group label: Usual Care
arm group type: No Intervention
description: Patients will be invited to use the patient contextual data tool as per usual care, but will not receive additional assistance in account creation and usage.
intervention type: Behavioral
intervention name: Facilitated Enrollment
description: Research coordinator will assist patients in account creation and usage of the tool.
arm group label: Facilitated Enrollment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bradley H Crotty, MD MPH
role: Principal Investigator
affiliation: Medical College of Wisconsin
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Bradley Crotty
investigator title: Assistant Professor
sharing ipd: Undecided
submitted: November 24, 2021
returned: January 28, 2022
submitted: May 26, 2022
returned: March 2, 2023