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.
Professional Abstract
Objective
To determine whether a mobile phone text messaging intervention called PNMI led by patient navigators improves patient adherence to clinical guidelines for monitoring chronic hepatitis B (CHB) infection in Asian-American patients compared with usual care
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 532 Asian-American adults living with CHB infection in the Philadelphia area, New York City, and New Jersey |
| Interventions/ Comparators |
|
| Outcomes |
Primary: adherence to clinical guidelines for monitoring CHB infection Secondary: knowledge about CHB, perceived social support, perceived benefits related to experience of living with CHB, life satisfaction, anxiety |
| Timeframe | 12-month follow-up for primary outcome |
This randomized controlled trial examined whether PNMI improved patient adherence to clinical guidelines for monitoring CHB and other patient-reported outcomes in Asian-American patients compared with usual care. Guidelines recommend that patients see their doctor and undergo blood tests for CHB regularly. Asian Americans are significantly more likely to develop CHB than other US racial and ethnic groups. Asian Americans also have low rates of CHB monitoring, putting them at risk for serious complications from CHB, including liver cancer. Cultural barriers and lack of access to care may prevent Asian Americans from getting the care they need.
The research team randomly assigned patients to receive PNMI or usual care alone. Patients in PNMI attended three in-person educational sessions about managing CHB and received online educational modules to review if desired. Patients also received educational text messages about CHB monitoring and management once a week for five weeks. Patients could meet with patient navigators in person or by phone to get help overcoming barriers to care. Patients received information in their preferred language. For usual care, patients received follow-up care reminders from their doctors’ office.
The study included 532 Asian-American adults with CHB from Pennsylvania, New York, and New Jersey. Of these, 83% identified as Chinese, 10% as Korean, and 8% as Vietnamese. The average age was 50, and 53% were male.
Patients completed surveys at 6 and 12 months after baseline.
Patients, caregivers, healthcare providers, and community advocates helped with refining research questions, designing the study, recruiting patients, and reviewing findings.
Results
Compared with patients who received usual care, patients who received PMNI had significantly
- Higher adherence to clinical guidelines for monitoring CHB, including having a doctor visit for CHB care (91% of patients who received PNMI versus 61% of usual care) and getting a CHB blood test every six months (75% of patients who received PNMI versus 47% of usual care) (p<0.001)
- Greater knowledge about CHB (p<0.001)
- Higher perceived social support (p<0.001)
- Higher perceived benefits related to the experience of living with CHB, such as learning to be more accepting of things (p<0.001)
- Lower levels of anxiety (p=0.03)
The two groups did not differ significantly in life satisfaction.
Limitations
The study only included patients who identified as Chinese, Korean, or Vietnamese. Results may differ for other racial or ethnic groups.
Conclusions and Relevance
In this study, patients who received PMNI showed increased adherence to clinical guidelines for monitoring CHB compared with patients who received usual care. Patients who received PMNI also improved more on most secondary outcomes.
Future Research Needs
Future research could test the intervention with other groups at relatively high risk for CHB, including patients from southeast Asian, Pacific Islander, and African immigrant communities in the United States. Researchers can also test if effects of the intervention are maintained beyond one year.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
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.