Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C
Status: | Completed |
---|---|
Conditions: | Psychiatric, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/31/2018 |
Start Date: | March 1, 2015 |
End Date: | June 29, 2018 |
Many people who are infected with Hepatitis C misuse alcohol, which is even more dangerous
for them than it is for a non-infected person. In this VA study, such individuals will be
screened and given feedback on their drinking using an Internet-based program which has been
shown to reduce drinking in other populations. The research team will evaluate whether the
program helps Veterans drink less over time and thereby improve their health.
for them than it is for a non-infected person. In this VA study, such individuals will be
screened and given feedback on their drinking using an Internet-based program which has been
shown to reduce drinking in other populations. The research team will evaluate whether the
program helps Veterans drink less over time and thereby improve their health.
As many as 80% of Veterans with the hepatitis C virus (HCV) engage in harmful drinking. This
is a major health challenge given that even light and moderate alcohol consumption can worsen
the course and consequences of HCV and can be a barrier to receiving antiviral therapy. In
response, the VA Uniform Mental Health Services Package has made it a priority that HCV and
other ambulatory clinics provide evidence-based mental health services to all Veterans
engaging in harmful drinking within two week (but preferably the same day as the clinic
visit). The investigators' CREATE partners, the VA Office of Mental Health Services, VA
Operations (10N), and the VA Office of Public Health, are strongly committed to achieving
this standard throughout the Veterans Health Administration (VHA). However, the cost and
organizational challenges to meeting this mandate in HCV clinics are enormous, but may be
surmountable through the use of self-directed technology that minimizes demands on scarce
staff time.
The primary objective of this study is to implement and evaluate a web-based brief alcohol
intervention (BAI) for treating Veterans with HCV and seeking care at two VA HCV clinics -
Veterans Affairs Palo Alto Health Care System (VAPAHCS) and San Francisco Veterans Affairs
Medical Center (SFVAMC). This study will have three aims: First (Aim 1), the investigators
plan to assess patient, provider, and system factors that may impact the initial adoption of
this intervention in two VA HCV clinics. These data will result in the development of a
protocol for the initial implementation of the web-based BAI at the investigators' two study
sites. A secondary aim will involve obtaining patient and provider feedback on an existing
web-based BAI (see www.bmi-aft.org, VA Intranet Only) to help inform its redesign for use
with this population. Second (Aim 2), the investigators will implement and examine the
effectiveness of a web-based BAI in two HCV clinics to reduce alcohol consumption in Veterans
with HCV at three- and six-months post-treatment. Third (Aim 3), the investigators will
conduct a budget impact analysis to estimate the short-term costs (1-3 years) of adoption and
diffusion of the web-based BAI and the trajectory of health care spending for study
participants.
This mixed-methods study will utilize qualitative and quantitative methods to achieve its
three primary aims. To address aim 1, qualitative interviews will be used to collect data
that will inform the initial implementation and re-versioning of a web-based BAI for use in
two HCV clinics located at the Palo Alto and San Francisco. To address aim 2, the
investigators will use a randomized, hybrid (type 1) design with patient level clinical
outcome data and formative evaluation data collected to examine the effectiveness of the
web-based BAI. "Hybrid" designs also integrate formative evaluation into experimental designs
to identify factors that impact the effectiveness of implementation efforts. Formative
evaluation (e.g., site visits, clinic observation, and interviews with staff and patients)
will be used to improve the adoption of the web-based BAI at both sites and to provide
evidence-based guidance to the investigators' CREATE operational partners for nationwide
implementation. To address aim 3, the investigators will conduct a budget impact analysis to
estimate the short-term costs (1-3 years) of adoption and diffusion of the web-based BAI and
the trajectory of health care spending for study participants. The investigators plan to
collect several types of utilization data, including outpatient, inpatient, and pharmacy
utilization, and calculate total dollars.
is a major health challenge given that even light and moderate alcohol consumption can worsen
the course and consequences of HCV and can be a barrier to receiving antiviral therapy. In
response, the VA Uniform Mental Health Services Package has made it a priority that HCV and
other ambulatory clinics provide evidence-based mental health services to all Veterans
engaging in harmful drinking within two week (but preferably the same day as the clinic
visit). The investigators' CREATE partners, the VA Office of Mental Health Services, VA
Operations (10N), and the VA Office of Public Health, are strongly committed to achieving
this standard throughout the Veterans Health Administration (VHA). However, the cost and
organizational challenges to meeting this mandate in HCV clinics are enormous, but may be
surmountable through the use of self-directed technology that minimizes demands on scarce
staff time.
The primary objective of this study is to implement and evaluate a web-based brief alcohol
intervention (BAI) for treating Veterans with HCV and seeking care at two VA HCV clinics -
Veterans Affairs Palo Alto Health Care System (VAPAHCS) and San Francisco Veterans Affairs
Medical Center (SFVAMC). This study will have three aims: First (Aim 1), the investigators
plan to assess patient, provider, and system factors that may impact the initial adoption of
this intervention in two VA HCV clinics. These data will result in the development of a
protocol for the initial implementation of the web-based BAI at the investigators' two study
sites. A secondary aim will involve obtaining patient and provider feedback on an existing
web-based BAI (see www.bmi-aft.org, VA Intranet Only) to help inform its redesign for use
with this population. Second (Aim 2), the investigators will implement and examine the
effectiveness of a web-based BAI in two HCV clinics to reduce alcohol consumption in Veterans
with HCV at three- and six-months post-treatment. Third (Aim 3), the investigators will
conduct a budget impact analysis to estimate the short-term costs (1-3 years) of adoption and
diffusion of the web-based BAI and the trajectory of health care spending for study
participants.
This mixed-methods study will utilize qualitative and quantitative methods to achieve its
three primary aims. To address aim 1, qualitative interviews will be used to collect data
that will inform the initial implementation and re-versioning of a web-based BAI for use in
two HCV clinics located at the Palo Alto and San Francisco. To address aim 2, the
investigators will use a randomized, hybrid (type 1) design with patient level clinical
outcome data and formative evaluation data collected to examine the effectiveness of the
web-based BAI. "Hybrid" designs also integrate formative evaluation into experimental designs
to identify factors that impact the effectiveness of implementation efforts. Formative
evaluation (e.g., site visits, clinic observation, and interviews with staff and patients)
will be used to improve the adoption of the web-based BAI at both sites and to provide
evidence-based guidance to the investigators' CREATE operational partners for nationwide
implementation. To address aim 3, the investigators will conduct a budget impact analysis to
estimate the short-term costs (1-3 years) of adoption and diffusion of the web-based BAI and
the trajectory of health care spending for study participants. The investigators plan to
collect several types of utilization data, including outpatient, inpatient, and pharmacy
utilization, and calculate total dollars.
Inclusion Criteria:
- Must be a US military veteran.
- Over the age of 17 with liver disease.
- Must be receiving care at a VA liver clinic.
Exclusion Criteria:
- Those with no current or historical use of alcohol.
We found this trial at
2
sites
San Francisco, California 94121
Phone: 415-221-4810
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Palo Alto, California 94304
Principal Investigator: Keith N. Humphreys, PhD MA
Phone: 650-493-5000
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