A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
| Status: | Recruiting |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2015 |
| End Date: | December 2017 |
| Contact: | Grace X Ma, PhD |
| Email: | grace.ma@temple.edu |
| Phone: | 2157875434 |
Asian Americans have the highest rates of chronic hepatitis B virus (HBV) infection (CHB) in
the United States.Those with CHB often report that they feel well even though they are at
high risk for complications. Because of the high incidence and prevalence of CHB, patients
at high risk need to be tested every 6 to 12 months for early signs of liver problems.This
study will answer critical questions for Asian Americans with CHB about improving timely
testing. Using a randomization process, 500 of these patients will receive either the
Patient Navigator plus Mobile Phone Text Messaging Intervention (PNMI) or standard care. At
patients' entry into the study, 6 months, and 12 months, information will be
collected.Patient navigators representing Asian cultures will receive a thorough HBV
training. PNMI patients will receive three education sessions and text messages over mobile
phone. Patients, patient advocates, physicians, and Center for Asian Health (CAH) staff will
be active study partners.
Patient Outcomes: The investigators expect to find better health outcomes and lower HBV
health gaps, as measured by the number of patients:
1. getting doctor-recommended tests and care every 6 or 12 months;
2. getting doctor-recommended HBV care;
3. having more HBV knowledge, a better quality of life, social support, and coping skills;
and
4. having fewer barriers and less anxiety.
the United States.Those with CHB often report that they feel well even though they are at
high risk for complications. Because of the high incidence and prevalence of CHB, patients
at high risk need to be tested every 6 to 12 months for early signs of liver problems.This
study will answer critical questions for Asian Americans with CHB about improving timely
testing. Using a randomization process, 500 of these patients will receive either the
Patient Navigator plus Mobile Phone Text Messaging Intervention (PNMI) or standard care. At
patients' entry into the study, 6 months, and 12 months, information will be
collected.Patient navigators representing Asian cultures will receive a thorough HBV
training. PNMI patients will receive three education sessions and text messages over mobile
phone. Patients, patient advocates, physicians, and Center for Asian Health (CAH) staff will
be active study partners.
Patient Outcomes: The investigators expect to find better health outcomes and lower HBV
health gaps, as measured by the number of patients:
1. getting doctor-recommended tests and care every 6 or 12 months;
2. getting doctor-recommended HBV care;
3. having more HBV knowledge, a better quality of life, social support, and coping skills;
and
4. having fewer barriers and less anxiety.
BACKGROUND Asian Americans (AA) have the highest liver cancer mortality rates and highest
prevalence of chronic hepatitis B (HBV) and inadequate care. According to Center for Disease
Control (CDC) over half of 1.4 million chronic HBV (CHB) infections in the US population is
borne by AAs. Approximately 15% - 50% of untreated (CHB patients develop serious hepatic
sequelae during their lifetime that include cirrhosis and hepatocellular carcinoma. The
collective impact represents a significant public health burden. Because CHB often has no
observable early symptoms, patients' adherence to monitoring and care is usually low. For
example, a study indicated that adherence to guidelines at 12 months was 53.3% for alanine
transaminase (ALT) (one of the most useful and low cost tests to assess whether treatment is
needed), 39% for HBV DNA (a direct measure to assess liver damage caused by HBV). A regional
study conducted by Dr. Grace Ma in Chinese CHB patients also found low (40%) patient
adherence to follow up, reporting "feel well". CHB-related liver cancer rates are 6 to 13
times higher for Asian Americans (e.g. Chinese, Korean and Vietnamese) than for Caucasians,
which requires timely monitoring and care. Assessing for alpha-fetoprotein (AFP) (screening
for liver cancer) and alanine transaminase (ALT) (monitoring liver damage) every six months
and conducting an ultrasound every 6-12 months is critical for identifying when to start
treatment, according to CDC.
OBJECTIVES This study addresses a critical need in the AA community to improve the adherence
to monitoring and care for those infected with HBV. The primary aim of this study is to
improve patient adherence to HBV monitoring guidelines. A secondary aim is to increase
knowledge of HBV diagnosis and treatment, quality of life, social support and coping skills,
and decrease barriers to patient adherence. The investigators propose to answer the
question, "For those infected with HBV, will patient navigator (PN)-led plus mobile phone
text messaging intervention be more effective in increasing patient adherence to monitoring
than the standard care?" Ultimately, such an improvement in patient adherence to monitoring
guidelines should reduce delays in timely care and improve 5-year liver cancer survival
rates.
METHODS This is a 2-arm randomized controlled trial with baseline, 6-month, and 12-month
assessments. Our research team including patient advocates and stakeholders proposes to
develop, implement and test the effectiveness of a patient navigator-led intervention plus a
phone-based text messaging intervention versus standard care in primary care clinics serving
underserved Chinese, Korean and Vietnamese patients in Philadelphia and New York City areas.
500 eligible patients aged 18 and older who were tested positive for HBV will be randomized
to PN-led plus mobile phone text messaging intervention or standard care. Bilingually
trained patient navigators will be recruited from our existing patient navigator training
network and receive an intensive training on HBV prevention, diagnosis and treatment
management. The PN-led plus mobile phone text messaging intervention will offer three
education sessions and serve as a liaison with respective clinics. The phone-based, text
messaging will be designed by and for HBV patients who will craft appropriate reminders for
follow up appointments or treatment, educational and motivational messages. In the analyses,
the investigators propose to compare the 6-month and 12-month impact of the interventions
on: 1) adherence to HBV monitoring and treatment guidelines, 2) knowledge of HBV management
and treatment, 3) quality of life, 4) social support, 5) coping skills and 6) patient and
healthcare provider satisfaction.
PATIENT OUTCOMES (PROJECTED) Projected patient outcomes in reducing HBV disparities include:
1) HBV patients who do not need treatment will adhere to HBV management guideline by making
appointments for follow-up tests every 6 per physician requests, 2) HBV patients who need
treatment will follow prescribed treatment including medication, 3) improved knowledge,
quality of life, social support and coping skills; and 4) decreased barriers to adherence to
HBV monitoring and management. Regular monitoring tests can detect the cancer early and lead
to successful treatment for long-term survival.
PATIENT AND STAKEHOLDER ENGAGEMENT This proposed study is built on our 14-year CBPR
partnerships with over 60 primary care providers and community health centers who serve
Chinese, Korean and Vietnamese patients and a pilot HBV patient navigation intervention
among Asian HBV patients. Over the past 14+ years, Center for Asian health has engaged
community members and patient advocates in Community-Based Participatory Research (CBPR).
Stakeholder patient advocates and patient co-investigators will be engaged in every stage of
the research process. Specifically, they will be part of the intervention development team
to participate in orientation for patient navigators and to culturally tailor intervention
sessions. Similarly, they will develop and test text messages. They will also be engaged in
dissemination, taking key roles in reporting results to the community, creating frequently
asked questions and presenting at conferences. Physician and HBV advocacy stakeholders will
have opportunities to participate in developing the interventions, reviewing implementation
and disseminating results as well.
ANTICIPATED IMPACT HBV and liver cancer are the greatest health disparities between Asian
and white Americans. This study will have a significant impact on reducing health
disparities by increasing patient adherence to monitoring guidelines and care to prevent
HBV-related liver diseases and cancer. In addition, overall quality of life and physical,
mental and social well-being will be enhanced for HBV patients. If PN-led plus mobile phone
text messaging intervention prove effective, it has potential for national and global
transportability, hence make substantial contribution toward reducing health disparities
among underserved Asian American immigrants.
prevalence of chronic hepatitis B (HBV) and inadequate care. According to Center for Disease
Control (CDC) over half of 1.4 million chronic HBV (CHB) infections in the US population is
borne by AAs. Approximately 15% - 50% of untreated (CHB patients develop serious hepatic
sequelae during their lifetime that include cirrhosis and hepatocellular carcinoma. The
collective impact represents a significant public health burden. Because CHB often has no
observable early symptoms, patients' adherence to monitoring and care is usually low. For
example, a study indicated that adherence to guidelines at 12 months was 53.3% for alanine
transaminase (ALT) (one of the most useful and low cost tests to assess whether treatment is
needed), 39% for HBV DNA (a direct measure to assess liver damage caused by HBV). A regional
study conducted by Dr. Grace Ma in Chinese CHB patients also found low (40%) patient
adherence to follow up, reporting "feel well". CHB-related liver cancer rates are 6 to 13
times higher for Asian Americans (e.g. Chinese, Korean and Vietnamese) than for Caucasians,
which requires timely monitoring and care. Assessing for alpha-fetoprotein (AFP) (screening
for liver cancer) and alanine transaminase (ALT) (monitoring liver damage) every six months
and conducting an ultrasound every 6-12 months is critical for identifying when to start
treatment, according to CDC.
OBJECTIVES This study addresses a critical need in the AA community to improve the adherence
to monitoring and care for those infected with HBV. The primary aim of this study is to
improve patient adherence to HBV monitoring guidelines. A secondary aim is to increase
knowledge of HBV diagnosis and treatment, quality of life, social support and coping skills,
and decrease barriers to patient adherence. The investigators propose to answer the
question, "For those infected with HBV, will patient navigator (PN)-led plus mobile phone
text messaging intervention be more effective in increasing patient adherence to monitoring
than the standard care?" Ultimately, such an improvement in patient adherence to monitoring
guidelines should reduce delays in timely care and improve 5-year liver cancer survival
rates.
METHODS This is a 2-arm randomized controlled trial with baseline, 6-month, and 12-month
assessments. Our research team including patient advocates and stakeholders proposes to
develop, implement and test the effectiveness of a patient navigator-led intervention plus a
phone-based text messaging intervention versus standard care in primary care clinics serving
underserved Chinese, Korean and Vietnamese patients in Philadelphia and New York City areas.
500 eligible patients aged 18 and older who were tested positive for HBV will be randomized
to PN-led plus mobile phone text messaging intervention or standard care. Bilingually
trained patient navigators will be recruited from our existing patient navigator training
network and receive an intensive training on HBV prevention, diagnosis and treatment
management. The PN-led plus mobile phone text messaging intervention will offer three
education sessions and serve as a liaison with respective clinics. The phone-based, text
messaging will be designed by and for HBV patients who will craft appropriate reminders for
follow up appointments or treatment, educational and motivational messages. In the analyses,
the investigators propose to compare the 6-month and 12-month impact of the interventions
on: 1) adherence to HBV monitoring and treatment guidelines, 2) knowledge of HBV management
and treatment, 3) quality of life, 4) social support, 5) coping skills and 6) patient and
healthcare provider satisfaction.
PATIENT OUTCOMES (PROJECTED) Projected patient outcomes in reducing HBV disparities include:
1) HBV patients who do not need treatment will adhere to HBV management guideline by making
appointments for follow-up tests every 6 per physician requests, 2) HBV patients who need
treatment will follow prescribed treatment including medication, 3) improved knowledge,
quality of life, social support and coping skills; and 4) decreased barriers to adherence to
HBV monitoring and management. Regular monitoring tests can detect the cancer early and lead
to successful treatment for long-term survival.
PATIENT AND STAKEHOLDER ENGAGEMENT This proposed study is built on our 14-year CBPR
partnerships with over 60 primary care providers and community health centers who serve
Chinese, Korean and Vietnamese patients and a pilot HBV patient navigation intervention
among Asian HBV patients. Over the past 14+ years, Center for Asian health has engaged
community members and patient advocates in Community-Based Participatory Research (CBPR).
Stakeholder patient advocates and patient co-investigators will be engaged in every stage of
the research process. Specifically, they will be part of the intervention development team
to participate in orientation for patient navigators and to culturally tailor intervention
sessions. Similarly, they will develop and test text messages. They will also be engaged in
dissemination, taking key roles in reporting results to the community, creating frequently
asked questions and presenting at conferences. Physician and HBV advocacy stakeholders will
have opportunities to participate in developing the interventions, reviewing implementation
and disseminating results as well.
ANTICIPATED IMPACT HBV and liver cancer are the greatest health disparities between Asian
and white Americans. This study will have a significant impact on reducing health
disparities by increasing patient adherence to monitoring guidelines and care to prevent
HBV-related liver diseases and cancer. In addition, overall quality of life and physical,
mental and social well-being will be enhanced for HBV patients. If PN-led plus mobile phone
text messaging intervention prove effective, it has potential for national and global
transportability, hence make substantial contribution toward reducing health disparities
among underserved Asian American immigrants.
Inclusion Criteria:
1. self-identified Chinese, Korean and Vietnamese ethnicity
2. age 18 and above
3. accessible by telephone with text message feature (for text message intervention,
follow up data collection and scheduling purposes),
4. presence in the same geographic study area for a period of one year (to minimize
patient attrition);
5. not enrolled in any chronic HBV adherence management intervention (to prevent a
potential program impact),
6. medically diagnosed chronic HBV infection with positive for hepatitis B surface
antigen (HBsAg) for more than six months, and
7. not had HBV monitoring tests for more than six months.
Exclusion Criteria:
Patients will be excluded from the study for the following conditions:
1. diagnosed with cirrhosis, hepatocellular carcinoma, liver failure and liver cancer
2. concurrent hepatitis C infection, and
3. concurrent HIV infection
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