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Trial record 44 of 517 for:    hepatitis b | Open Studies

Patient-Centered Care and Asian Americans

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of California, San Francisco
Sponsor:
Collaborators:
San Francisco General Hospital
San Francisco Hep B Free Campaign
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02139722
First received: May 6, 2014
Last updated: December 29, 2015
Last verified: December 2015
  Purpose

Liver cancer and hepatitis B are major health disparities for Asian Americans, while hepatitis C is a rising problem. Little is known about how to improve the quality of health care Asian Americans receive in general and for viral hepatitis in particular. Technology, specifically mobile applications, potentially can provide a flexible and efficient way to address these challenges. This proposed project seeks to develop, implement, and test an intervention to increase hepatitis B and C screening for Asian Americans in 2 healthcare systems in the San Francisco Bay Area.

The research team will develop, implement, and evaluate the efficacy of an interactive, patient- centered mobile application for use on a tablet computer to increase the rate of hepatitis B and C screening among unscreened Asian Americans age 18 and older. The team will use their experience from a successful track record 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.


Condition Intervention
Hepatitis B
Hepatitis C
Liver Disease
Behavioral: Video Doctor, PA + PPN

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: A Patient-Centered Intervention to Increase Screening of Hepatitis B and C Among Asian Americans

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • EHR-documented hepatitis B surface antigen (HBsAg) test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 416
Study Start Date: September 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02139722

Contacts
Contact: Tung Nguyen, MD 415-514-8659 tung.nguyen@ucsf.edu
Contact: Ching Wong 415-502-4099 ching.wong@ucsf.edu

Locations
United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Ivy Lau       Ivy.Lau@ucsf.edu   
UCSF Recruiting
San Francisco, California, United States, 94143
Contact: Ching Wong       ching.wong@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
San Francisco General Hospital
San Francisco Hep B Free Campaign
Investigators
Principal Investigator: Tung Nguyen, MD University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02139722     History of Changes
Other Study ID Numbers: AD-11-4615 
Study First Received: May 6, 2014
Last Updated: December 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
hepatitis B
hepatitis C
screening
Asian Americans
mobile technology

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 27, 2016