<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/NCT04503993</url>
  </required_header>
  <id_info>
    <org_study_id>1423112</org_study_id>
    <nct_id>NCT04503993</nct_id>
  </id_info>
  <brief_title>Healthy Planet Hepatitis B</brief_title>
  <official_title>Utilizing Electronic Health Systems to Enhance Screening and Linkage to Care for Chronic Hepatitis B</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</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>
      This quality improvement project utilizes Epic Health Planet to increase screening for&#xD;
      chronic hepatitis B through the creation of registries and ordering of hepatitis B laboratory&#xD;
      panels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 24, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Completion of hepatitis B order panel</measure>
    <time_frame>Within 1 year after placement of the order</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Linkage to care of those found to be infected with hepatitis B</measure>
    <time_frame>Within 3 months after a positive HBsAg test</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5004</enrollment>
  <condition>Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Hepatitis B Healthy Planet Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a single arm study where all patients eligible patients will receive a hepatitis B order set</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody</intervention_name>
    <description>The hepatitis B tests are released into the electronic medical charts of at-risk patients who have never been screened for chronic hepatitis B using population health tools.</description>
    <arm_group_label>Hepatitis B Healthy Planet Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Asian ancestry as determined by ethnicity/race, primary language, surname as recorded in&#xD;
        the electronic health record&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - previously completed hepatitis B screening tests&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UC Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>May 9, 2022</last_update_submitted>
  <last_update_submitted_qc>May 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
  </intervention_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/NCT04503993
org study id: 1423112
nct id: NCT04503993
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This quality improvement project utilizes Epic Health Planet to increase screening for
      chronic hepatitis B through the creation of registries and ordering of hepatitis B laboratory
      panels.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Completion of hepatitis B order panel
time frame: Within 1 year after placement of the order
measure: Linkage to care of those found to be infected with hepatitis B
time frame: Within 3 months after a positive HBsAg test
arm group label: Hepatitis B Healthy Planet Arm
arm group type: Experimental
description: This is a single arm study where all patients eligible patients will receive a hepatitis B order set
intervention type: Other
intervention name: Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody
description: The hepatitis B tests are released into the electronic medical charts of at-risk patients who have never been screened for chronic hepatitis B using population health tools.
arm group label: Hepatitis B Healthy Planet Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis
mesh term: Antibodies
mesh term: Immunoglobulins
sharing ipd: No