Patient-Centered Care and Asian Americans

July 17, 2020 updated by: University of California, San Francisco

A Patient-Centered Intervention to Increase Screening of Hepatitis B and C Among Asian Americans

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

431

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • San Francisco, California, United States, 94110
        • Zuckerberg San Francisco General

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Provider Panel Notification (PPN) Alone
The comparison procedures consist of a panel notification given to providers and an audio-visual presentation on diet and exercise given to patients.
Experimental: Video Doctor, PA + PPN
Video Doctor (VD) and Provider Alert (PA) intervention combined with Provider Panel Notification (PPN)
Behavioral: Video Doctor, PA + PPN
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EHR-documented hepatitis B surface antigen (HBsAg) test
Time Frame: 3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge about hepatitis B virus (HBV) and hepatitis C virus (HCV)
Time Frame: 3 months
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).
3 months

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Collaborators

Patient-Centered Outcomes Research Institute
San Francisco Hep B Free Campaign

Investigators

  • Principal Investigator: Tung T Nguyen, MD, University of California, San Francisco

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 2, 2014

Primary Completion (Actual)

May 28, 2017

Study Completion (Actual)

July 30, 2017

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

May 13, 2014

First Posted (Estimate)

May 15, 2014

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 17, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-11-4615

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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