Patient-Centered Care and Asian Americans

NCT ID: NCT02139722

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

431 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-02

Study Completion Date

2017-07-30

Brief Summary

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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

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Conditions

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Hepatitis B Hepatitis C Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Video Doctor, PA + PPN

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

Group Type EXPERIMENTAL

Video Doctor, PA + PPN

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Francisco Hep B Free Campaign

UNKNOWN

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tung T Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Zuckerberg San Francisco General

San Francisco, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34993863 (View on PubMed)

Other Identifiers

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AD-11-4615

Identifier Type: -

Identifier Source: org_study_id

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