Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C

NCT ID: NCT01707030

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2018-06-29

Brief Summary

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.

Detailed Description

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.

Conditions

Hepatitis C; Alcohol Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BAI Arm

Receiving a web-based brief intervention for alcohol problems

Group Type: EXPERIMENTAL

Web-Based Brief Alcohol Intervention

Intervention Type: OTHER

Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.

Usual Care

Intervention Type: OTHER

All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.

Usual Care

In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.

Interventions

Web-Based Brief Alcohol Intervention

Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.

Intervention Type: OTHER

Usual Care

All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith N. Humphreys, PhD MA

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Michael A Cucciare, PhD

Role: PRINCIPAL_INVESTIGATOR

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

Countries

United States

References

Timko C, Schultz NR, Cucciare MA, Vittorio L, Garrison-Diehn C. Retention in medication-assisted treatment for opiate dependence: A systematic review. J Addict Dis. 2016;35(1):22-35. doi: 10.1080/10550887.2016.1100960. Epub 2015 Oct 14.

Reference Type: BACKGROUND

PMID: 26467975 (View on PubMed)

Cucciare MA, Timko C. Bridging the gap between medical settings and specialty addiction treatment. Addiction. 2015 Sep;110(9):1417-9. doi: 10.1111/add.12977. No abstract available.

Reference Type: RESULT

PMID: 26223170 (View on PubMed)

Cucciare MA, Cheung RC, Rongey C. Treating substance use disorders in patients with hepatitis C. Addiction. 2015 Jul;110(7):1057-9. doi: 10.1111/add.12893. Epub 2015 Mar 27. No abstract available.

Reference Type: RESULT

PMID: 25816843 (View on PubMed)

Timko C, Kong C, Vittorio L, Cucciare MA. Screening and brief intervention for unhealthy substance use in patients with chronic medical conditions: a systematic review. J Clin Nurs. 2016 Nov;25(21-22):3131-3143. doi: 10.1111/jocn.13244. Epub 2016 May 3.

Reference Type: RESULT

PMID: 27140392 (View on PubMed)

Cucciare MA, Jamison AL, Combs AS, Joshi G, Cheung RC, Rongey C, Huggins J, Humphreys K. Adapting a computer-delivered brief alcohol intervention for veterans with Hepatitis C. Inform Health Soc Care. 2017 Dec;42(4):378-392. doi: 10.1080/17538157.2016.1255628. Epub 2017 Jan 9.

Reference Type: RESULT

PMID: 28068154 (View on PubMed)

Cucciare MA, Combs AS, Joshi G, Han X, Humphreys K. Computer-delivered brief alcohol intervention for patients with liver disease: a randomized controlled trial. Addiction. 2021 May;116(5):1076-1087. doi: 10.1111/add.15263. Epub 2020 Oct 6.

Reference Type: RESULT

PMID: 32924207 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CRE 12-009

Identifier Type: -

Identifier Source: org_study_id