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

Primary Purpose

Hepatitis C, Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-Based Brief Alcohol Intervention
Usual Care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring clinical trial, veteran, substance use disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CA
  • San Francisco VA Medical Center, San Francisco, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BAI Arm

Usual Care

Arm Description

Receiving a web-based brief intervention for alcohol problems

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

Outcomes

Primary Outcome Measures

Change in Days of Unhealthy Alcohol Consumption
The number of days on which alcohol was consumed beyond recommended levels in the last 30 days.
Change in Drinking Days
The number of days on which alcohol was consumed at any level in the last 30 days.

Secondary Outcome Measures

Change in Drinks Per Drinking Day
The number of standard drinks (0.5 ounce ethanol equivalent) consumed on those days that an individual drank in the last 30 days.
Change in Symptoms of Psychological Distress (PHQ-9)
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.
Change in SF-12 Physical Health Composite
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.
Change in Additional Care
Total costs in dollars of all VA and non-VA inpatient, outpatient and pharmacy costs.

Full Information

First Posted
October 3, 2012
Last Updated
May 26, 2020
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01707030
Brief Title
Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C
Official Title
Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
June 29, 2018 (Actual)
Study Completion Date
June 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Alcohol Abuse
Keywords
clinical trial, veteran, substance use disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAI Arm
Arm Type
Experimental
Arm Description
Receiving a web-based brief intervention for alcohol problems
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Web-Based Brief Alcohol Intervention
Intervention Description
Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.
Primary Outcome Measure Information:
Title
Change in Days of Unhealthy Alcohol Consumption
Description
The number of days on which alcohol was consumed beyond recommended levels in the last 30 days.
Time Frame
Baseline, 3 months, and 6 months
Title
Change in Drinking Days
Description
The number of days on which alcohol was consumed at any level in the last 30 days.
Time Frame
Baseline, 3 months, and 6 months
Secondary Outcome Measure Information:
Title
Change in Drinks Per Drinking Day
Description
The number of standard drinks (0.5 ounce ethanol equivalent) consumed on those days that an individual drank in the last 30 days.
Time Frame
Baseline, 3 months, and 6 months
Title
Change in Symptoms of Psychological Distress (PHQ-9)
Description
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.
Time Frame
Baseline, 3 months, and 6 months
Title
Change in SF-12 Physical Health Composite
Description
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.
Time Frame
Baseline, 3 months, and 6 months
Title
Change in Additional Care
Description
Total costs in dollars of all VA and non-VA inpatient, outpatient and pharmacy costs.
Time Frame
Baseline and 12 months
Other Pre-specified Outcome Measures:
Title
Change in SF-12 Mental Health Composite
Description
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.
Time Frame
Baseline, 3 months, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith N. Humphreys, PhD MA
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael A Cucciare, PhD
Organizational Affiliation
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States
Facility Name
San Francisco VA Medical Center, San Francisco, CA
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26467975
Citation
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.
Results Reference
background
PubMed Identifier
26223170
Citation
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.
Results Reference
result
PubMed Identifier
25816843
Citation
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.
Results Reference
result
PubMed Identifier
27140392
Citation
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.
Results Reference
result
PubMed Identifier
28068154
Citation
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.
Results Reference
result

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

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