Patient-Centered Care and Asian Americans
Primary Purpose
Hepatitis B, Hepatitis C, Liver Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Doctor, PA + PPN
Sponsored by
About this trial
This is an interventional screening trial for Hepatitis B focused on measuring hepatitis B, hepatitis C, screening, Asian Americans, mobile technology
Eligibility Criteria
Inclusion Criteria:
- ages 18+ years
- identifies as Asian
- Asian American, Chinese, or Vietnamese
- speaks English, Chinese (Cantonese), or Vietnamese
- does not have an electronic health record (EHR)-documented HBV screening test (defined as a hepatitis B surface antigen [HBsAg] test).
- we select Chinese and Vietnamese because those are the 2 most common languages spoken by limited English-proficient Asian Americans
Exclusion Criteria:
- dementia or any conditions precluding understanding informed consent or using a touch screen with audio
Sites / Locations
- Zuckerberg San Francisco General
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Provider Panel Notification (PPN) Alone
Video Doctor, PA + PPN
Arm Description
The comparison procedures consist of a panel notification given to providers and an audio-visual presentation on diet and exercise given to patients.
Video Doctor (VD) and Provider Alert (PA) intervention combined with Provider Panel Notification (PPN)
Outcomes
Primary Outcome Measures
EHR-documented hepatitis B surface antigen (HBsAg) test
The main outcome measure is an EHR-documented hepatitis B surface antigen (HBsAg) test at 3 months post-intervention. We chose screening for hepatitis B because, among adults, particularly immigrants or descendants of immigrants, it is the most important first step in the control of viral hepatitis B and lack of screening remains a significant problem. While many young adult Asian Americans born in the U.S. or who immigrated at a young age may have been vaccinated for hepatitis B as a child or prior to entering college, pre-vaccination testing may not have been done. Given the high rates of infection in their parents and the possibility of vertical transmission, all Asian Americans should be tested for chronic hepatitis B using the HBsAg test. All screening outcomes (test receipt) as well as test ordering by the healthcare providers will be collected from the medical record through the EHRs at 3-month post-intervention.
Secondary Outcome Measures
Knowledge about hepatitis B virus (HBV) and hepatitis C virus (HCV)
Data sources include the self-administered pre-intervention survey via a tablet computer, and the post-intervention phone survey administered by a research assistant, and EHR. All patient surveys will be done in the patient's preferred language (English, Chinese, or Vietnamese). Pre- and post-intervention survey data of secondary outcomes include: Knowledge (awareness of HBV and HCV, screening test, modes of transmission); Self-efficacy (perceived confidence in initiating conversation and request screening test from providers); Patient-Provider Communication Experiences (asked provider for HBV or HCV test, discussed HBV or HCV test with provider, receipt of provider recommendation to get a HBV or HCV test).
Full Information
NCT ID
NCT02139722
First Posted
May 6, 2014
Last Updated
July 17, 2020
Sponsor
University of California, San Francisco
Collaborators
San Francisco Hep B Free Campaign, Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02139722
Brief Title
Patient-Centered Care and Asian Americans
Official Title
A Patient-Centered Intervention to Increase Screening of Hepatitis B and C Among Asian Americans
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2014 (Actual)
Primary Completion Date
May 28, 2017 (Actual)
Study Completion Date
July 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
San Francisco Hep B Free Campaign, Patient-Centered Outcomes Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Liver cancer and hepatitis B are health disparities for Asian Americans, and hepatitis C is a rising problem. Little is known about how to improve the quality of health care Asian Americans receive for viral hepatitis. Technology, specifically mobile applications, can provide a flexible and efficient way to address these challenges. This project seeks to develop, implement, and test an intervention to increase hepatitis B and C screening for Asian Americans in 2 healthcare systems in San Francisco.
The research team will develop, implement, and evaluate the efficacy of an interactive, patient- centered mobile app for use on a tablet computer to increase hepatitis B and C screening among unscreened Asian Americans age 18 and older. The team will use their experience in health promotion to develop the intervention by working with patients, community leaders and advocates, clinical staff, healthcare providers, and healthcare system administrators from a county safety net system and an academic primary care practice in the San Francisco Bay Area. The mobile application will include video clips with a physician (Video Doctor) addressing patient concerns regarding hepatitis B and C screening in the patient's preferred language, English, Chinese, or Vietnamese. A patient who has not been screened for hepatitis B will answer questions about his or her characteristics and preferences using the mobile application. The mobile application will then show 30-60 seconds video clips with messages that address the patient's responses related to hepatitis B screening and that are delivered by an actor playing a physician. Those who are born between 1945 and 1965 also receive messages about hepatitis C screening. At the end, the tablet computer will generate a provider alert to let the treating provider know what the patient's preferences are regarding testing for viral hepatitis.
Once developed, the intervention will then be used in combination with a physician panel notification and tested against physician panel notification only in a randomized controlled trial to see which approach is better in increasing the rate of hepatitis B and C screening. The team will also work with the 2 healthcare system to ensure that the interventions will be practical and easily adopted once the study is over. The findings of this project will greatly expand understanding about how to use technology- based interventions to improve quality of healthcare in diverse patient populations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Hepatitis C, Liver Disease
Keywords
hepatitis B, hepatitis C, screening, Asian Americans, mobile technology
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
431 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Provider Panel Notification (PPN) Alone
Arm Type
No Intervention
Arm Description
The comparison procedures consist of a panel notification given to providers and an audio-visual presentation on diet and exercise given to patients.
Arm Title
Video Doctor, PA + PPN
Arm Type
Experimental
Arm Description
Video Doctor (VD) and Provider Alert (PA) intervention combined with Provider Panel Notification (PPN)
Intervention Type
Behavioral
Intervention Name(s)
Video Doctor, PA + PPN
Intervention Description
The intervention consists of a Video Doctor and Provider Alert. For the Video Doctor, we will develop a series of 30-60 seconds video clips, a branching algorithm, and a mobile application linking the baseline survey to the clips. The Provider Alert is a point-of-care reminder printout generated by the mobile application to facilitate patient-provider communication. The intervention integrates guidelines, literature, guidance from the Systems Model, our prior work, and input from patients and providers.
Primary Outcome Measure Information:
Title
EHR-documented hepatitis B surface antigen (HBsAg) test
Description
The main outcome measure is an EHR-documented hepatitis B surface antigen (HBsAg) test at 3 months post-intervention. We chose screening for hepatitis B because, among adults, particularly immigrants or descendants of immigrants, it is the most important first step in the control of viral hepatitis B and lack of screening remains a significant problem. While many young adult Asian Americans born in the U.S. or who immigrated at a young age may have been vaccinated for hepatitis B as a child or prior to entering college, pre-vaccination testing may not have been done. Given the high rates of infection in their parents and the possibility of vertical transmission, all Asian Americans should be tested for chronic hepatitis B using the HBsAg test. All screening outcomes (test receipt) as well as test ordering by the healthcare providers will be collected from the medical record through the EHRs at 3-month post-intervention.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Knowledge about hepatitis B virus (HBV) and hepatitis C virus (HCV)
Description
Data sources include the self-administered pre-intervention survey via a tablet computer, and the post-intervention phone survey administered by a research assistant, and EHR. All patient surveys will be done in the patient's preferred language (English, Chinese, or Vietnamese). Pre- and post-intervention survey data of secondary outcomes include: Knowledge (awareness of HBV and HCV, screening test, modes of transmission); Self-efficacy (perceived confidence in initiating conversation and request screening test from providers); Patient-Provider Communication Experiences (asked provider for HBV or HCV test, discussed HBV or HCV test with provider, receipt of provider recommendation to get a HBV or HCV test).
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ages 18+ years
identifies as Asian
Asian American, Chinese, or Vietnamese
speaks English, Chinese (Cantonese), or Vietnamese
does not have an electronic health record (EHR)-documented HBV screening test (defined as a hepatitis B surface antigen [HBsAg] test).
we select Chinese and Vietnamese because those are the 2 most common languages spoken by limited English-proficient Asian Americans
Exclusion Criteria:
dementia or any conditions precluding understanding informed consent or using a touch screen with audio
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tung T Nguyen, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34993863
Citation
Khalili M, Kim NJ, Tsoh JY, Walsh JME, Goldman LE, Gildengorin G, Wong C, Tran MT, Yu E, Sharp MT, LeTran VH, Nguyen VV, Nguyen TT. Health Within Reach-a Patient-Centered Intervention to Increase Hepatitis B Screening Among Asian Americans: a Randomized Clinical Trial. J Gen Intern Med. 2022 Oct;37(13):3242-3250. doi: 10.1007/s11606-021-07232-3. Epub 2022 Jan 6.
Results Reference
derived
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Patient-Centered Care and Asian Americans
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