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

August 9, 2021 updated by: University of California, Davis

The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B Screening: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8299

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Experimental: HBV Alert Group
Other: Electronic HBV Alert
Electronic HBV Alert deployed in electronic medical charts of at risk patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Hepatitis B Surface Antigen Completion
Time Frame: up to 12 months
Number of patients who have completed the HBsAg test
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Hepatitis B Surface Antigen Positivity
Time Frame: up to 12 months
Number of patients with testing positive for HBsAg
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 21, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8301387

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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