NCT04240678

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8,299

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

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

January 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 26, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 11, 2021

Status Verified

August 1, 2021

Enrollment Period

3.5 years

First QC Date

January 17, 2020

Results QC Date

February 5, 2021

Last Update Submit

August 9, 2021

Conditions

Hepatitis B

Keywords

Mass Screening

Outcome Measures

Primary Outcomes (1)

  • Serum Hepatitis B Surface Antigen Completion

    Number of patients who have completed the HBsAg test

    up to 12 months

Secondary Outcomes (1)

  • Serum Hepatitis B Surface Antigen Positivity

    up to 12 months

Study Arms (2)

HBV Alert Group

EXPERIMENTAL
Other: Electronic HBV Alert

Control Group

NO INTERVENTION

Interventions

Electronic HBV AlertOTHER

Electronic HBV Alert deployed in electronic medical charts of at risk patients

HBV Alert Group

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 33154429DERIVED

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Eric Chak
Organization
UC Davis Medical Center
echak@ucdavis.edu
916-734-3751

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 27, 2020

Study Start

January 1, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2021

Last Updated

August 11, 2021

Results First Posted

February 26, 2021

Record last verified: 2021-08