Patient-Centered Care and Asian Americans

• ClinicalTrials.gov Identifier: NCT02139722
• Recruitment Status: Completed
• First Posted: May 15, 2014
• Last Update Posted: July 21, 2020
• Sponsor: University of California, San Francisco
• Collaborators: San Francisco Hep B Free Campaign; Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: May 6, 2014
• First Posted Date: May 15, 2014
• Last Update Posted Date: July 21, 2020
• Actual Study Start Date: January 2, 2014
• Actual Primary Completion Date: May 28, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 13, 2014)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 13, 2014)

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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Screening

Condition

• Hepatitis B
• Hepatitis C
• Liver Disease

Intervention

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.

Study Arms

• 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)
  Intervention: Behavioral: Video Doctor, PA + PPN

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 5, 2017): 431
• Original Estimated Enrollment (submitted: May 13, 2014): 416
• Actual Study Completion Date: July 30, 2017
• Actual Primary Completion Date: May 28, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02139722
• Other Study ID Numbers: AD-11-4615
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of California, San Francisco
• Study Sponsor: University of California, San Francisco

Collaborators

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

Investigators

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

• PRS Account: University of California, San Francisco
• Verification Date: July 2020