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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAI Arm | Experimental | Receiving a web-based brief intervention for alcohol problems |
|
| Usual Care | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-Based Brief Alcohol Intervention | Other | Participants report their alcohol use and problems on line and receive feedback comparing them to national norms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Days of Unhealthy Alcohol Consumption | The number of days on which alcohol was consumed beyond recommended levels in the last 30 days. | Baseline, 3 months, and 6 months |
| Change in Drinking Days | The number of days on which alcohol was consumed at any level in the last 30 days. | Baseline, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months, and 6 months |
| Change in Symptoms of Psychological Distress (PHQ-9) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SF-12 Mental 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 mental health component of the SF-12. Scores range from 0-100 and higher scores are better. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1290 | United States | ||
| San Francisco VA Medical Center, San Francisco, CA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26467975 | Background | 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. | |
| 26223170 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Web-Based BAI Arm | Receiving a web-based brief intervention for alcohol problems Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms. |
| FG001 | Usual Care Arm | 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 Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention: Computer-Based Brief Alcohol Intervention | Receiving a web-based brief intervention for alcohol problems Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms. Intervention participants will also receive usual care. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Days of Unhealthy Alcohol Consumption | The number of days on which alcohol was consumed beyond recommended levels in the last 30 days. | Not all participants were able to complete all follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups. | Posted | Mean | Standard Deviation | Unhealthy drinking days in last 30 | Baseline, 3 months, and 6 months |
|
Adverse event data were collected for 4 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention: Web-Based BAI Arm | Receiving a web-based brief intervention for alcohol problems Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | Intervention: Unable to pinpoint cause of death at time of entry as participant had multiple disorders which could have caused death. Control: Renal Disease |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Micheal Cucciare | Department of Veterans Affairs | 501-257-1068 | Michael.Cucciare@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2016 | May 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000437 | Alcoholism |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D008722 | Methods |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008919 | Investigative Techniques |
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| Usual Care | Other | All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems. |
|
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. |
| Baseline, 3 months, and 6 months |
| 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. | Baseline, 3 months, and 6 months |
| Change in Additional Care | Total costs in dollars of all VA and non-VA inpatient, outpatient and pharmacy costs. | Baseline and 12 months |
| Baseline, 3 months, and 6 months |
| San Francisco |
| California |
| 94121 |
| United States |
| 25816843 | Result | 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. |
| 27140392 | Result | 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. |
| 28068154 | Result | 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. |
| 32924207 | Result | 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. |
| Lost to Follow-up |
|
| BG001 | Control: Treatment as Usual | 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 Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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 Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems. |
|
|
| Primary | Change in Drinking Days | The number of days on which alcohol was consumed at any level in the last 30 days. | Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups. | Posted | Mean | Standard Deviation | Number of drinking days in last 30 | Baseline, 3 months, and 6 months |
|
|
|
| Secondary | 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. | Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups. | Posted | Mean | Standard Deviation | Drinks per Drinking Day | Baseline, 3 months, and 6 months |
|
|
|
| Secondary | 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. | Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, and 6 months |
|
|
|
| Secondary | 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. | Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, and 6 months |
|
|
|
| Secondary | Change in Additional Care | Total costs in dollars of all VA and non-VA inpatient, outpatient and pharmacy costs. | These are the same individuals enrolled in the clinical trial from whom the primary outcomes were assessed. | Posted | Mean | Standard Error | US Dollars | Baseline and 12 months |
|
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|
| Other Pre-specified | Change in SF-12 Mental 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 mental health component of the SF-12. Scores range from 0-100 and higher scores are better. | Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, and 6 months |
|
|
|
| 1 |
| 67 |
| 1 |
| 67 |
| 0 |
| 67 |
| EG001 | Control: Usual Care Arm | 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 Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems. | 1 | 71 | 1 | 71 | 0 | 71 |
|
| Death | Renal and urinary disorders | Non-systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| 3-mo drinking days |
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| 6-mo drinking days |
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| 3-mo Drinks per Drinking Day |
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| 6-mo Drinks per Drinking Day |
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| 3-mo PHQ-9 |
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| 6-mo PHQ-9 |
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| 3mo SF-12 Health |
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| 6mo SF-12 Health |
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| 3mo SF-12 Mental Health |
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| 6 mo SF-12 Mental Health |
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