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The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B Screening

Primary Purpose

Hepatitis B

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electronic HBV Alert
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatitis B focused on measuring Mass Screening

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Asian and Pacific Islanders (API) who have not yet received HBsAg testing. API will be identified using a novel algorithm which identifies them using their surname, language preference, country of origin.

-

Exclusion Criteria: Previous HBsAg completion.

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    HBV Alert Group

    Control Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Serum Hepatitis B Surface Antigen Completion
    Number of patients who have completed the HBsAg test

    Secondary Outcome Measures

    Serum Hepatitis B Surface Antigen Positivity
    Number of patients with testing positive for HBsAg

    Full Information

    First Posted
    January 17, 2020
    Last Updated
    August 9, 2021
    Sponsor
    University of California, Davis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04240678
    Brief Title
    The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B Screening
    Official Title
    The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B Screening: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    July 1, 2019 (Actual)
    Study Completion Date
    July 1, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Davis

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Asian and Pacific Islander Americans at risk, but never tested for chronic hepatitis B have been randomized to receive an electronic alert in their electronic medical chart to remind primary care physicians to screen them for chronic hepatitis B.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B
    Keywords
    Mass Screening

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    8299 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HBV Alert Group
    Arm Type
    Experimental
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Electronic HBV Alert
    Intervention Description
    Electronic HBV Alert deployed in electronic medical charts of at risk patients
    Primary Outcome Measure Information:
    Title
    Serum Hepatitis B Surface Antigen Completion
    Description
    Number of patients who have completed the HBsAg test
    Time Frame
    up to 12 months
    Secondary Outcome Measure Information:
    Title
    Serum Hepatitis B Surface Antigen Positivity
    Description
    Number of patients with testing positive for HBsAg
    Time Frame
    up to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Asian and Pacific Islanders (API) who have not yet received HBsAg testing. API will be identified using a novel algorithm which identifies them using their surname, language preference, country of origin. - Exclusion Criteria: Previous HBsAg completion. -

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    33154429
    Citation
    Chak E, Li CS, Chen MS Jr, MacDonald S, Bowlus C. Electronic health record alerts enhance mass screening for chronic hepatitis B. Sci Rep. 2020 Nov 5;10(1):19153. doi: 10.1038/s41598-020-75842-8.
    Results Reference
    derived

    Learn more about this trial

    The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B Screening

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