Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
Primary Outcome Measures
- Change in Days of Unhealthy Alcohol Consumption [Baseline, 3 months, and 6 months]
The number of days on which alcohol was consumed beyond recommended levels in the last 30 days.
- Change in Drinking Days [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
- Change in Drinks Per Drinking Day [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.
- Change in Symptoms of Psychological Distress (PHQ-9) [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.
- Change in SF-12 Physical Health Composite [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.
- Change in Additional Care [Baseline and 12 months]
Total costs in dollars of all VA and non-VA inpatient, outpatient and pharmacy costs.
Other Outcome Measures
- Change in SF-12 Mental Health Composite [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
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | United States | 94304-1290 |
| 2 | San Francisco VA Medical Center, San Francisco, CA | San Francisco | California | United States | 94121 |
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
Study Documents (Full-Text)
More Information
Publications
- CRE 12-009
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Web-Based BAI Arm | Usual Care Arm |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 67 | 71 |
| COMPLETED | 56 | 54 |
| NOT COMPLETED | 11 | 17 |
Baseline Characteristics
| Arm/Group Title | Intervention: Computer-Based Brief Alcohol Intervention | Control: Treatment as Usual | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Total of all reporting groups |
| Overall Participants | 67 | 71 | 138 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
42
62.7%
|
40
56.3%
|
82
59.4%
|
| >=65 years |
25
37.3%
|
31
43.7%
|
56
40.6%
|
| Age (years) [Median (Standard Deviation) ] | |||
| Median (Standard Deviation) [years] |
64
(8.682)
|
63
(7.212)
|
63.5
(8.023)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5
7.5%
|
0
0%
|
5
3.6%
|
| Male |
62
92.5%
|
71
100%
|
133
96.4%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Asian and/or Pacific Islander |
2
3%
|
1
1.4%
|
3
2.2%
|
| Black/African Amerian |
21
31.3%
|
20
28.2%
|
41
29.7%
|
| White/Caucasion, not of Hispanic origin |
25
37.3%
|
28
39.4%
|
53
38.4%
|
| Hispanic |
9
13.4%
|
15
21.1%
|
24
17.4%
|
| Other |
6
9%
|
6
8.5%
|
12
8.7%
|
| Declined to State/Unknown |
1
1.5%
|
1
1.4%
|
2
1.4%
|
| American Indian or Alaskan Native |
3
4.5%
|
0
0%
|
3
2.2%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
67
100%
|
71
100%
|
138
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | BAI Arm | Usual Care |
|---|---|---|
| Arm/Group Description | 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. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on 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 Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems. |
| Measure Participants | 67 | 70 |
| Baseline Days of Unhealthy Alcohol Consumption |
5.46
(9.24)
|
7.16
(10.66)
|
| 3-mo Days of Unhealthy Alcohol Consumption |
2.72
(6.69)
|
5.56
(10.68)
|
| 6-mo Days of Unhealthy Alcohol Consumption |
2.29
(6.37)
|
4.78
(9.91)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Intervention: Web Based BAI | Control: Usual Care |
|---|---|---|
| Arm/Group Description | 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. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on 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 Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems. |
| Measure Participants | 67 | 71 |
| Baseline drinking days |
9.39
(10.44)
|
12.41
(11.47)
|
| 3-mo drinking days |
5.20
(8.09)
|
7.77
(10.78)
|
| 6-mo drinking days |
4.61
(7.66)
|
8.26
(10.67)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Intervention: Web Based BAI | Control: Usual Care |
|---|---|---|
| Arm/Group Description | 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. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on 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 Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems. |
| Measure Participants | 67 | 71 |
| Baseline Drinks per Drinking Day |
3.57
(3.90)
|
3.72
(3.69)
|
| 3-mo Drinks per Drinking Day |
2.29
(2.47)
|
2.17
(2.17)
|
| 6-mo Drinks per Drinking Day |
1.98
(2.85)
|
1.87
(1.90)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Intervention: Web Based BAI | Control: Usual Care |
|---|---|---|
| Arm/Group Description | 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. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on 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 Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems. |
| Measure Participants | 67 | 71 |
| Baseline PHQ-9 |
6.00
(5.70)
|
6.68
(5.67)
|
| 3-mo PHQ-9 |
6.03
(5.65)
|
6.91
(6.86)
|
| 6-mo PHQ-9 |
5.57
(5.07)
|
7.44
(7.48)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Intervention: Web Based BAI | Control: Usual Care |
|---|---|---|
| Arm/Group Description | 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. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on 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 Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems. |
| Measure Participants | 67 | 71 |
| Baseline SF-12 Health |
40.43
(12.20)
|
40.49
(11.43)
|
| 3mo SF-12 Health |
39.92
(12.25)
|
41.59
(12.30)
|
| 6mo SF-12 Health |
42.21
(10.43)
|
40.75
(12.45)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| These are the same individuals enrolled in the clinical trial from whom the primary outcomes were assessed. |
| Arm/Group Title | Web-Based BAI Arm | Usual Care Arm |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 53 | 54 |
| Mean (Standard Error) [US Dollars] |
42412
(5381)
|
51667
(8611)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Intervention: Web Based BAI | Control: Usual Care |
|---|---|---|
| Arm/Group Description | 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. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on 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 Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems. |
| Measure Participants | 67 | 71 |
| Baseline SF-12 Mental Health |
49.10
(12.72)
|
48.91
(11.87)
|
| 3mo SF-12 Mental Health |
50.83
(9.94)
|
49.25
(11.62)
|
| 6 mo SF-12 Mental Health |
50.63
(10.59)
|
48.51
(12.77)
|
Adverse Events
| Time Frame | Adverse event data were collected for 4 years. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Intervention: Web-Based BAI Arm | Control: Usual Care Arm | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| Intervention: Web-Based BAI Arm | Control: Usual Care Arm | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/67 (1.5%) | 1/71 (1.4%) | ||
Serious Adverse Events |
||||
| Intervention: Web-Based BAI Arm | Control: Usual Care Arm | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/67 (1.5%) | 1/71 (1.4%) | ||
| General disorders | ||||
| Death | 1/67 (1.5%) | 1 | 0/71 (0%) | 0 |
| Renal and urinary disorders | ||||
| Death | 0/67 (0%) | 0 | 1/71 (1.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Intervention: Web-Based BAI Arm | Control: Usual Care Arm | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/67 (0%) | 0/71 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Micheal Cucciare |
|---|---|
| Organization | Department of Veterans Affairs |
| Phone | 501-257-1068 |
| Michael.Cucciare@va.gov |
- CRE 12-009