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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01707030
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : September 25, 2019
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C Alcohol Abuse Other: Web-Based Brief Alcohol Intervention Other: Usual Care Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ethanol

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Days of Unhealthy Alcohol Consumption [ Time Frame: Baseline, 3 months, and 6 months ]
    The number of days on which alcohol was consumed beyond recommended levels in the last 30 days.

  2. Change in Drinking Days [ Time Frame: Baseline, 3 months, and 6 months ]
    The number of days on which alcohol was consumed at any level in the last 30 days.


Secondary Outcome Measures :
  1. Change in Drinks Per Drinking Day [ Time Frame: Baseline, 3 months, and 6 months ]
    The number of standard drinks (0.5 ounce ethanol equivalent) consumed on those days that an individual drank in the last 30 days.

  2. Change in Symptoms of Psychological Distress (PHQ-9) [ Time Frame: Baseline, 3 months, and 6 months ]
    Symptoms of psychological distress will be measured using the Patient Health Questionnaire (PHQ-9). The PHQ-9 provides an assessment of depression severity. The minimum value is 0 and the maximum value is 27. Lower scores are better. The reliability, validity, and clinical utility of the PHQ-9 instrument are well-established.

  3. Change in SF-12 Physical Health Composite [ Time Frame: Baseline, 3 months, and 6 months ]
    The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population . The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the physical health component of the SF-12. Scores range from 0-100 and higher scores are better.

  4. Change in Additional Care [ Time Frame: Baseline and 12 months ]
    Total costs in dollars of all VA and non-VA inpatient, outpatient and pharmacy costs.


Other Outcome Measures:
  1. Change in SF-12 Mental Health Composite [ Time Frame: Baseline, 3 months, and 6 months ]
    The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population. The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the mental health component of the SF-12. Scores range from 0-100 and higher scores are better.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707030


Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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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
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol and Statistical Analysis Plan  [PDF] November 1, 2016

More Information
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Publications of Results:

Other Publications:

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01707030    
Other Study ID Numbers: CRE 12-009
First Posted: October 15, 2012    Key Record Dates
Results First Posted: September 25, 2019
Last Update Posted: June 9, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
clinical trial
veteran
substance use disorder
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Alcoholism
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders