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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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: April 5, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Hepatitis C
Alcohol Abuse
Other: Web-Based Brief Alcohol Intervention
Other: Usual Care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 340
Study Start Date: March 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BAI Arm
Receiving a web-based brief intervention for alcohol problems
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.
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
Other: Usual Care
All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707030

Contacts
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

Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Keith N Humphreys, PhD MA    650-493-5000 ext 22814    Keith.Humphreys@va.gov   
Principal Investigator: Keith N. Humphreys, PhD MA         
Sub-Investigator: Ramsey C. Cheung, MD         
Sub-Investigator: Ruth C. Cronkite, PhD MS         
San Francisco VA Medical Center, San Francisco, CA Recruiting
San Francisco, California, United States, 94121
Contact: Alex Monto, MD    415-221-4810 ext 2958    alexander.monto@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01707030     History of Changes
Other Study ID Numbers: CRE 12-009 
Study First Received: October 3, 2012
Last Updated: April 5, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
clinical trial
veteran
substance use disorder

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Alcoholism
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2016