NCT04503993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,004

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1.4 years

First QC Date

August 4, 2020

Last Update Submit

May 9, 2022

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Completion of hepatitis B order panel

    Within 1 year after placement of the order

Secondary Outcomes (1)

  • Linkage to care of those found to be infected with hepatitis B

    Within 3 months after a positive HBsAg test

Study Arms (1)

Hepatitis B Healthy Planet Arm

EXPERIMENTAL

This is a single arm study where all patients eligible patients will receive a hepatitis B order set

Other: Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody

Interventions

Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibodyOTHER

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.

Hepatitis B Healthy Planet Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Asian ancestry as determined by ethnicity/race, primary language, surname as recorded in the electronic health record

You may not qualify if:

  • \- previously completed hepatitis B screening tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Hepatitis B Surface Antigens

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Hepatitis B AntigensHepatitis AntigensAntigens, ViralViral ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 7, 2020

Study Start

February 25, 2020

Primary Completion

July 24, 2021

Study Completion

December 31, 2021

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)