Results Summary

What was the research about?

Hepatitis B is a disease caused by a virus that attacks and injures the liver. Chronic hepatitis B, or CHB, is hepatitis that lasts more than six months. CHB increases the chance of getting liver cancer and other health problems. Monitoring CHB can help find liver cancer early and reduce complications.

In the United States, Asian Americans are more likely to have CHB than members of other racial and ethnic groups. Asian Americans are also more likely to develop liver cancer and have higher death rates from it. Cultural barriers and lack of access to care may prevent people from getting the care they need.

In this study, the research team tested a program designed for Asian-American patients with CHB to see if it helped patients get recommended care. The program included education and phone access and in-person meetings with patient navigators trained to help patients get care.

What were the results?

Compared with patients who received usual care from their doctors, patients in the program had

  • More recommended doctor visits and blood tests
  • More knowledge about CHB
  • More perceived social support
  • Higher perceived benefits related to the experience of living with CHB, such as learning to be more accepting of things
  • Lower anxiety

The groups did not differ in how satisfied they were with their lives.

Who was in the study?

The study included 532 Asian-American adults with CHB living in Pennsylvania, New York, and New Jersey. Of these, 83 percent identified as Chinese, 10 percent as Korean, and 8 percent as Vietnamese. The average age was 50, and 53 percent were men.

What did the research team do?

The research team assigned patients by chance to take part in the program or receive usual care alone. Patients in the program had three in-person sessions about taking care of CHB. Patients received links to web-based educational programs to review. Patients also received text messages once a week for five weeks about going to the doctor and getting blood tests. Patients could also call or meet in person with patient navigators. Patients received information in their preferred language. Patients receiving usual care alone got follow-up care reminders from their doctors’ office. Patients completed surveys at 6 and 12 months after the start of the study.

Patients, caregivers, healthcare providers like doctors and nurses, and community advocates provided input during the study.

What were the limits of the study?

The study included patients who identified as Chinese, Korean, or Vietnamese. Results may differ for other racial or ethnic groups.

Future research could test the program with patients from other groups at high risk for CHB, such as patients from southeast Asian, Pacific Islander, and African immigrant communities in the United States. Researchers could also see if the effects of the program last more than a year.

How can people use the results?

Doctors can use these results when considering ways to help Asian-American patients with CHB get recommended care.

Final Research Report

View this project's final research report.

More About This Research

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers asked for the researchers’ rationale in choosing a peer navigation intervention to improve patient adherence to monitoring and treatment guidelines. The researchers said they used the Information-Motivation-Behavioral Skills (IMB) Model to guide their adherence intervention and evaluation efforts. The IMB model, first proposed in 1992, gives a framework for how information, motivation, and behavior skills influence health behavior. It has been used as a theoretical basis for behavioral intervention studies. 
  • The reviewers asked for information on the cost and cost effectiveness of the intervention. In general, PCORI research studies cannot include cost-effectiveness analyses. The researchers said they did not have cost data for the study but provided an estimate based on the amount of time required from patient navigators and for clinical support assistance for each patient, plus the training and preparation time required for patient navigators, and the cost of developing online educational modules and text messaging.
  • The reviewers had questions about recruitment, asking why only 52 percent of eligible patients agreed to join the study, what barriers prevented more from participating, the possibility of selection bias, and why the study recruited much more Chinese-American participants than other Asian-American subgroups. The researchers responded that the main reasons patients gave for not participating were not being willing to talk about their hepatitis B disease with a person they did not know and not wanting to disclose their medical information to the research team. The researchers said they did not anticipate the higher proportion of Chinese-American participants and would continue to explore the reasons for the difference in recruitment levels.
  • The reviewers asked about treatment fidelity and the number of participants attending one, two, or all three educational sessions about hepatitis B management. The researchers explained that they only used complete cases–participants attending all three sessions–in their analyses. The researchers also explained that evaluative procedures throughout the study assessed intervention fidelity but did not describe any formal measurement of treatment fidelity.

Conflict of Interest Disclosures

View the COI disclosure form.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers asked for the researchers’ rationale in choosing a peer navigation intervention to improve patient adherence to monitoring and treatment guidelines. The researchers said they used the Information-Motivation-Behavioral Skills (IMB) Model to guide their adherence intervention and evaluation efforts. The IMB model, first proposed in 1992, gives a framework for how information, motivation, and behavior skills influence health behavior. It has been used as a theoretical basis for behavioral intervention studies. 
  • The reviewers asked for information on the cost and cost effectiveness of the intervention. In general, PCORI research studies cannot include cost-effectiveness analyses. The researchers said they did not have cost data for the study but provided an estimate based on the amount of time required from patient navigators and for clinical support assistance for each patient, plus the training and preparation time required for patient navigators, and the cost of developing online educational modules and text messaging.
  • The reviewers had questions about recruitment, asking why only 52 percent of eligible patients agreed to join the study, what barriers prevented more from participating, the possibility of selection bias, and why the study recruited much more Chinese-American participants than other Asian-American subgroups. The researchers responded that the main reasons patients gave for not participating were not being willing to talk about their hepatitis B disease with a person they did not know and not wanting to disclose their medical information to the research team. The researchers said they did not anticipate the higher proportion of Chinese-American participants and would continue to explore the reasons for the difference in recruitment levels.
  • The reviewers asked about treatment fidelity and the number of participants attending one, two, or all three educational sessions about hepatitis B management. The researchers explained that they only used complete cases–participants attending all three sessions–in their analyses. The researchers also explained that evaluative procedures throughout the study assessed intervention fidelity but did not describe any formal measurement of treatment fidelity.

Conflict of Interest Disclosures

Project Information

Grace X. Ma, PhD
Temple University
$1,942,353
10.25302/10.2020.AD.140312613

Key Dates

42 months
September 2014
June 2020
2014
2020

Study Registration Information

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Last updated: October 20, 2021