NCT02139722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
431

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

3.4 years

First QC Date

May 6, 2014

Last Update Submit

July 17, 2020

Conditions

Keywords

hepatitis Bhepatitis CscreeningAsian Americansmobile technology

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (1)

  • Knowledge about hepatitis B virus (HBV) and hepatitis C virus (HCV)

    3 months

Study Arms (2)

Provider Panel Notification (PPN) Alone

NO INTERVENTION

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, PA + PPN

EXPERIMENTAL

Video Doctor (VD) and Provider Alert (PA) intervention combined with Provider Panel Notification (PPN)

Behavioral: Video Doctor, PA + PPN

Interventions

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.

Video Doctor, PA + PPN

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • dementia or any conditions precluding understanding informed consent or using a touch screen with audio

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zuckerberg San Francisco General

San Francisco, California, 94110, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hepatitis BHepatitis CLiver Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisDigestive System DiseasesFlaviviridae InfectionsRNA Virus Infections

Study Officials

  • Tung T Nguyen, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 15, 2014

Study Start

January 2, 2014

Primary Completion

May 28, 2017

Study Completion

July 30, 2017

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations