Back to resultsHealthy Planet Hepatitis B
Primary Purpose
Hepatitis B
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody
Sponsored by
About this trial
This is an interventional screening trial for Hepatitis B
Eligibility Criteria
Inclusion Criteria:
- Asian ancestry as determined by ethnicity/race, primary language, surname as recorded in the electronic health record
Exclusion Criteria:
- previously completed hepatitis B screening tests
Sites / Locations
- UC Davis Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hepatitis B Healthy Planet Arm
Arm Description
This is a single arm study where all patients eligible patients will receive a hepatitis B order set
Outcomes
Primary Outcome Measures
Completion of hepatitis B order panel
Secondary Outcome Measures
Linkage to care of those found to be infected with hepatitis B
Full Information
NCT ID
NCT04503993
First Posted
August 4, 2020
Last Updated
May 9, 2022
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT04503993
Brief Title
Healthy Planet Hepatitis B
Official Title
Utilizing Electronic Health Systems to Enhance Screening and Linkage to Care for Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
July 24, 2021 (Actual)
Study Completion Date
December 31, 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5004 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hepatitis B Healthy Planet Arm
Arm Type
Experimental
Arm Description
This is a single arm study where all patients eligible patients will receive a hepatitis B order set
Intervention Type
Other
Intervention Name(s)
Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody
Intervention 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.
Primary Outcome Measure Information:
Title
Completion of hepatitis B order panel
Time Frame
Within 1 year after placement of the order
Secondary Outcome Measure Information:
Title
Linkage to care of those found to be infected with hepatitis B
Time Frame
Within 3 months after a positive HBsAg test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Asian ancestry as determined by ethnicity/race, primary language, surname as recorded in the electronic health record
Exclusion Criteria:
- previously completed hepatitis B screening tests
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Healthy Planet Hepatitis B
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