The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B Screening: A Randomized Controlled Trial
Phase: NA
Conditions: Hepatitis B
Sponsor: University of California, Davis

PROTOCOL TITLE: The Effect of an Electronic Medical Record (EMR) Alert 
on Hepatitis B Screening: A Randomized Controlled Trial. 
 
Page 1 of 8 
 
Revised: June 11, 2015 
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1) Protocol Title 
a) The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B 
Screening: A Randomized Controlled Trial. 
b) May 15, 2019 
2) Author of Protocol: Eric Chak MD, MPH (UC Davis Researcher) 
 
3) IRB Review History: Not Applicable. 
 
4) Objectives: The purpose of this study is to determine the effect of an EMR alert 
released through the UC Davis EMR on Hepatitis B screening. 
 
5) Background 
Chronic hepatitis B is a significant public health problem, which affects Asian 
American/Pacific Islander (API) Americans disproportionately.  Of the CHB-
positive foreign born persons living in the United States in 2009, 58% migrated 
from Asia (Kowdley et al. Hepatology 2012).  Not only are foreign born APIs 
disproportionately infected with HBV, but they also have the highest incidence 
rates of hepatocellular carcinoma (HCC) and HCC-related mortality.  According to 
analysis of the Surveillance Epidemiology and End Results (SEER) database, APIs 
had the highest age-adjusted HCC incidence rates consistently from 1992-2002.  
Hispanics had the second highest HCC incidence rates, but these were 40% lower 
than that of the APIs (El Serag et al. Arch Intern Med 2007).  In the same study, 
APIs were also found to have the highest mortality associated with HCC of all 
groups studied with a relative risk of 3.6 compared to whites. 
 
Despite this, the diagnosis of CHB remains low and only 20-30% of high risk 
individuals are aware of their infection (Cohen et al. J Viral Hepat 2011, Institute of 
Medicine, 2010).  In 2014, the US Preventive Services Task Force placed a Grade B 

PROTOCOL TITLE: The Effect of an Electronic Medical Record (EMR) Alert 
on Hepatitis B Screening: A Randomized Controlled Trial. 
 
Page 2 of 8 
 
Revised: June 11, 2015 
recommendation on screening for Hepatitis B particularly among persons born in 
countries and regions with high prevalence of HBV infection (≥2%) or US born 
persons not vaccinated as infants whose parents were born in very high prevalence 
areas such as sub-Saharan Africa or central and Southeast Asia (LeFevre et al. 
Annals of Internal Medicine, 2014). 
 
This study is part of a larger CDC-funded collaboration to increase screening and 
linkage to care for CHB (Sacramento Collaborative to Advance Testing and Care of 
Hepatitis B-SCrATCH B).  Data from the Thousand Asian American Study at UC 
Davis suggests that the HBV prevalence in Sacramento County is 6%.  Thus, we 
aim to increase HBV screening further with introduction of this EMR alert and to 
measure its effect in a randomized fashion. 
 
6) Inclusion and Exclusion Criteria 
 
Inclusion: 
• Outpatients enrolled in the UC Davis EMR system aged 18 years and older 
with Chinese, Vietnamese, Japanese, Korean, or Indian surnames as 
determined by a peer reviewed listing of the 50 most common surnames 
within each ethnicity (Lauderdale et al. Population Research and Policy 
Review, 2000) 
• Outpatients who have established in the UC Davis Primary Care Network 
• No Hepatitis B surface Antigen (HBsAg) test previously 
• No history of vaccination for HBV previously 
• Primary care physicians (PCP) within the UCD  network entities 
 
Exclusion:  
• Patients outside of this age range 
• Pregnant patients 
• Prisoners 
 
7) Number of Subjects:  We expect that 50% of intervention (EMR alert) patients 
will be tested for hepatitis B and that 20% in the control will be tested.  Therefore, to 
achieve 80% power at the 0.05 significance level (2-sided), 45 patients in each group 
will be needed (90 total). While 90 is the minimum number of patients required to 
show a difference between control and EMR groups, the patient database has the 
potential to randomize 4,000 patients (2,000patients in each arm). This could increase 
the validity of the alert. In addition, 10,000 more patients (5,000 in each arm) will be 
randomized to account patients with Medicare. In sum, 14,000 patients will be in the 
study. The inclusion of additional patients can help to increase the validity of such 
implementation. Physicians of the patients will be part of the study, in which they will 
be informed about the EMR alert study at the end. The number of PCPs involved in 
the study will be determined after the computer randomization of the study patients.   
 

PROTOCOL TITLE: The Effect of an Electronic Medical Record (EMR) Alert 
on Hepatitis B Screening: A Randomized Controlled Trial. 
 
Page 3 of 8 
 
Revised: June 11, 2015 
8) Recruitment Methods 
As mentioned, patients will be identified by EMR search based on their 
surname, previous HBsAg testing status, and previous HBV vaccination 
status.  If they meet criteria for the study, the EMR alert will be released to 
their chart for their primary care provider to view.  No in person recruitment 
will be done. PCPs will be informed at completion of the study about the 
EMR alert study. We will request for a HIPAA waiver of authorization as 
below: 
HIPAA Authorization for Research (check all that apply): 
       
Do you want to request a waiver of authorization?  
☒Yes   
☐ No 
 
If you require a waiver of authorization, the IRB must make determinations to 
approve this waiver. Does the use or disclosure of PHI involve no more than a 
minimal risk to the privacy of the individual based on at least the presence of 
the following: 
 
☒  I confirm that only authorized persons will be granted access to the 
identifiers; identifiers stored on a computers, electronic notebooks, mobile 
devices, data-storage devices will be encrypted and password protected; 
identifiers maintained in paper format will be kept in a locked area with access 
limited to only research staff who require access to conduct the study. 
 
☒  I confirm that I will destroy the identifiers at the earliest opportunity 
consistent with the conduct of the research unless there is a health or research 
justification for retaining the identifiers or as otherwise required by law. 
 
Date or event for when the identifiers will be destroyed: October 31, 2024 
 
☒  I confirm that protected health information from this research will not be 
reused or disclosed to another person or entity, except as required by law, for 
authorized oversight of the research study, or other research for which the use or 
disclosure of PHI would be permitted.   
 
Why will this waiver not adversely affect the privacy rights of the individual?  
Identification of the subjects or their responses will not place them at risk of 
criminal or civil liability or be damaging to the their financial standing, 
employability, insurability, reputation, or be stigmatizing, as appropriate 
protections will be implemented so that risks related to invasion of privacy and 
breach of confidentiality are no greater than minimal risk.  
 
Why do you need this waiver to conduct this research?    

PROTOCOL TITLE: The Effect of an Electronic Medical Record (EMR) Alert 
on Hepatitis B Screening: A Randomized Controlled Trial. 
 
Page 4 of 8 
 
Revised: June 11, 2015 
Patients will be identified as previously aforementioned. The only 
identifying information will be patient MRNs. There will be minimal 
risks for those identified who meet inclusion criteria.   We will be 
activating the alert system-wide in a great number of patients.  For these 
reasons, obtaining HIPAA authorization from subjects would not be 
feasible.   Appropriate precautions will be taken to ensure that the 
privacy rights of those identified will be maintained.  
 
9) Compensation to the Subjects 
 
Patients will not be compensated. 
 
10) 
Study Timelines 
 
We anticipate that we will be able to recruit all 14,000 subjects for the study within 
12 months.  Once the EMR alert is released to a patient’s chart, we will perform 
quarterly EMR data searches to determine if the primary care physician has ordered 
the HBsAg on those patients.  Once a HBsAg test is ordered, the result will be 
recorded and the patient’s participation in the study will end.  If no HBsAg test is 
ordered, we will continue our quarterly EMR data searches to determine if the 
primary care physician orders the HBsAg at subsequent visits.  The post-EMR 
release observation period may last up to 2 years.  If no HBsAg test is ordered at the 
end of 2 year observation, the patient’s participation in the study will end. The 
study will end on October 31, 2024 due to additional participants to allow time for 
data collection, analysis, and manuscript writing. 
 
11) 
Study Endpoints 
 
The study end points will be measurement of an HBsAg level after the EMR alert is 
release to each patients chart.  As mentioned, certain proportion of patients will not 
reach this end point and this will be recorded. 
 
12) 
Procedures Involved 
• A list of patients meeting the eligibility requirements stated above 
will be obtained by searching the UC Davis EMR.  At a given time, 
computerized 1:1 randomization of these patients will occur placing 
them in the intervention or control group.  After randomization, the 
EMR alert will be released in the patients’ charts notifying primary 
care doctors that these patients should be screened for hepatitis B 
with a HBsAg test.  Control group patients will not have the EMR 
alert released in their chart and will undergo “usual care.”  As 
mentioned above (see Study Timelines), we will perform quarterly 

PROTOCOL TITLE: The Effect of an Electronic Medical Record (EMR) Alert 
on Hepatitis B Screening: A Randomized Controlled Trial. 
 
Page 5 of 8 
 
Revised: June 11, 2015 
EMR searches to determine if a HBsAg test was ordered by the 
patient’s primary care physician in response to the EMR alert.  We 
will continue to perform quarterly EMR searches to determine if 
HBsAg tests are ordered at subsequent visits up to 2 years after the 
index visit. 
• The data points that will be collected are MRN, age, sex, number of 
office visits, primary language, insurance type (private, medi-cal, or 
medicare), hepatitis B antigen test result, and date of the hepatitis B 
antigen test. All data points will strip off identifiable information. 
Study ID will be assigned and codes created are the only links to 
identifiable information.  
• Patients who are randomly chosen for this study will be number 
coded. The only link to the patient identifiers will be through a separate 
key code which will be kept on a secure, password-protected computer. 
Anypaper copies of such information will be kept in a locked filing cabinet 
in the division office accessible only to the PI and co-PI. The key code will 
be destroyed once it is confirmed that the data collection is complete.  
 
13) 
Data and/or Specimen Management and Confidentiality 
 
Will data be banked for future use?  
☐ Yes  
 ☒ No  
 
If yes, will the data that are banked be identifiable? 
 
☐ Yes, the data will be identifiable: 
☐ No, the data will be completely anonymous. 
 
☐ No, the data will be stripped of identifiers and coded.  The link to the 
individual’s identity will not be accessible by the research team.   
 
  
Where will the data be stored?   
      
How long will the data be stored?  
      
Who will have access to the data?  
 
Describe the procedures to release data, including: the process to request a 
release, approvals required for release, who can obtain data or specimens, 
and the data to be provided with specimens. 
      

PROTOCOL TITLE: The Effect of an Electronic Medical Record (EMR) Alert 
on Hepatitis B Screening: A Randomized Controlled Trial. 
 
Page 6 of 8 
 
Revised: June 11, 2015 
14) 
Data and/or Specimen Banking: Not applicable. 
 
15) 
Provisions to Monitor the Data to Ensure the Safety of Subjects:  
All data will be stored in a password protected Excel file on a secure 
server and uploaded to REDCap, which is a secure web application, used 
to build and manage online databases specifically for research, 
supported by the CTSC. Only those directly involved in research design, 
data gathering analysis will have access to the database.  
 
 
16) 
Withdrawal of Subjects: A patient will be withdrawn from the study by our 
staff if they fail to make at least one clinic appointment after release of EMR alert 
during the observation period.  This may be due to change or insurance, being lost to 
follow up, or death. 
 
17) 
Risks to Subjects 
This record/data review poses the risk of loss of confidentiality. This risk will be 
minimized by coding of patients’ data and protection of private health information. 
This study will abide by all regulations in place governing the protection of human 
subjects and protected health information. 
 
18) 
Potential Benefits to Subjects 
The direct benefit to subjects is that they may have an increased chance of 
screening for hepatitis B since the EMR alert will be reminding their primary care 
doctors to do so. 
 
19) 
Vulnerable Populations: Not applicable. 
 
20) 
Multi-Site Research: Not applicable. 
 
21) 
Community-Based Participatory Research: Not applicable. 
 
22) 
Sharing of Results with Subjects 
The results will not be shared with the subjects. 
 
23) 
Setting: This project will be conducted solely among UC Davis primary care 
network clinic sites. 
 
24) 
Resources Available 
 
Eric Chak, MD, MPH is an Assistant Professor of Internal Medicine in the 
Division of Gastroenterology and Hepatology.  He is primarily interested in 

PROTOCOL TITLE: The Effect of an Electronic Medical Record (EMR) Alert 
on Hepatitis B Screening: A Randomized Controlled Trial. 
 
Page 7 of 8 
 
Revised: June 11, 2015 
outcomes research in viral hepatitis resulting in several first author 
publications in the field.  Since coming to UC Davis, he has been involved 
in several projects including SCrATCH B and the R21 Biologic Basis of 
Disparities in Liver Cancer Survival Among Asian Americans Study.  He 
will the Principal Investigator of this Study and coordinate the 
randomization of subjects, EMR data searches, and statistical analysis. 
 
Dr. Bowlus is a Professor, Division of Gastroenterology and Hepatology, 
Department of Internal Medicine, UC Davis School of Medicine and the 
Fellowship Director supervising the training of gastroenterologists and 
hepatologists at UC Davis.  Dr. Bowlus serves as the primary hepatologist 
treating patients with hepatitis B in the UC Davis Health System.  He is the 
Principle Investigator for SCrATCH B and the R21 Biologic Basis of 
Disparities in Liver Cancer Survival Among Asian Americans Study and 
will serve as a mentor to Dr. Chak during this study. 
 
Dr. Susan Stewart is an Associate Adjunct Professor in the Division of 
Biostatistics, Department of Public Health Sciences at the University of 
California, Davis School of Medicine as well as the Program Evaluator for 
AANCART and the Director, Biostatistics Core for “Liver Cancer Control 
Interventions for Asian Americans”. Dr. Stewart is a seasoned cancer 
biostatistician having directed a NCI-funded Biostatistics Core in four 
program projects. She has more than 19 years of experience in being 
responsible for the statistical aspects for numerous cancer epidemiology and 
control studies. Her role includes providing advice on study design, data 
analyses, methods for analyzing genetic and lifestyle factors, including 
analyses to assess factors associated with the survival of patients with 
hepatocellular carcinoma.  She  directed the biostatistical work and analyses 
of three interventions to promote hepatitis B testing among Vietnamese, 
Hmong, and Korean Americans. Her role is to provide biostatistical counsel 
and to contribute to data analyses and manuscripts based on this study. 

PROTOCOL TITLE: The Effect of an Electronic Medical Record (EMR) Alert 
on Hepatitis B Screening: A Randomized Controlled Trial. 
 
Page 8 of 8 
 
Revised: June 11, 2015 
 
25) Prior Approvals: Not applicable. 
 
26) Provisions to Protect the Privacy Interests of Subjects: Not applicable. 
 
27) Compensation for Research-Related Injury: Not applicable. 
 
28) Consent Process: 
• We are requesting a waiver of informed consent for this study for the 
following reasons: 
i) The EMR alert is distributed to primary care units across the Sacramento 
area. Thus it is not practical to be present at every or any visit to consent 
the patients. 
ii) Consenting patients to participate in the study prior to EMR alert 
randomization would create bias if the subjects are informed that they are 
selected because they are at risk of hepatitis B. The consent process would 
cause patients to more likely if they are informed and/or they request to be 
tested.  
iii) Patient’s right and welfare will not be violated. They will not be informed 
of the EMR alert study at all. This study will not affect clinical decisions 
made on the subjects.  
• This study is specifically for UCD network clinics and the data will not be 
disclosed to outside of  UCD entities 
• This alert is also for clinical purposes and improve their treatment care 
• The PCPs of the selected study subjects will be informed at end of the study 
about the EMR alert.  No information will be collected on the PCPs 
  
29) Process to Document Consent in Writing: Not applicable. 
 
30) Drugs or Devices: Not applicable.