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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01707030
First received: October 3, 2012
Last updated: September 13, 2016
Last verified: September 2016

October 3, 2012
September 13, 2016
March 2015
August 2017   (final data collection date for primary outcome measure)
Days of Unhealthy Alcohol Consumption [ Time Frame: Six months ] [ Designated as safety issue: No ]
This will be an assessment of the number of days on which alcohol was consumed beyond recommended levels.
Same as current
Complete list of historical versions of study NCT01707030 on ClinicalTrials.gov Archive Site
Drinks Per Drinking Day [ Time Frame: Six Months ] [ Designated as safety issue: No ]
This will be an assessment of the number of standard drinks (0.5 ounce ethanol equivalent) consumed on those days that an individual drank.
Same as current
Not Provided
Not Provided
 
Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C
Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • Alcohol Abuse
  • Other: Web-Based Brief Alcohol Intervention
    Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.
  • Other: Usual Care
    All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.
  • Experimental: BAI Arm
    Receiving a web-based brief intervention for alcohol problems
    Interventions:
    • Other: Web-Based Brief Alcohol Intervention
    • Other: Usual Care
  • Active Comparator: 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
    Intervention: Other: Usual Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
December 2017
August 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact: Keith N Humphreys, PhD MA (650) 493-5000 ext 22814 Keith.Humphreys@va.gov
Contact: Ann S Combs, MHA MPH (650) 493-5000 ext 22434 ann.combs@va.gov
United States
 
NCT01707030
CRE 12-009
Yes
No
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Keith N. Humphreys, PhD MA VA Palo Alto Health Care System, Palo Alto, CA
Principal Investigator: Michael A Cucciare, PhD Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
VA Office of Research and Development
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP