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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240678
Recruitment Status : Active, not recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Other: Electronic HBV Alert Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8299 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Screening
Official Title: The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B Screening: A Randomized Controlled Trial
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HBV Alert Group Other: Electronic HBV Alert
Electronic HBV Alert deployed in electronic medical charts of at risk patients

No Intervention: Control Group



Primary Outcome Measures :
  1. Serum Hepatitis B surface antigen completion [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. Serum Hepatitis B surface antigen positivity [ Time Frame: up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Exclusion Criteria: Previous HBsAg completion.

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04240678    
Other Study ID Numbers: 8301387
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
Mass Screening
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections