Evaluating Alcohol Use in Alcoholic Liver Disease
Study Details
Study Description
Brief Summary
This prospective, analytic observational study will investigate alcohol recidivism in patients with alcoholic liver disease. All adult subjects presenting with alcoholic liver disease are considered for inclusion. Subjects able to give consent are included.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is a longitudinal observational study. Subjects with a diagnosis of alcoholic liver disease (acute alcoholic hepatitis or alcoholic cirrhosis) who present to Weill Cornell Medical Center or Columbia University Medical Center New York Presbyterian Hospital or the Gastroenterology and Hepatology Clinic will be invited to join this study, which entails a survey at baseline and follow-up at 3, 6, 9, 12, 15, and 18 months and then at 2, 5, and 10 years. Follow-up will consist of a chart review, a phone or in person interview, and most recent clinic visit interview for alcohol recidivism. The clinical providers will be blinded to the survey results.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| alcohol liver disease Patients with alcohol liver disease consenting to participate in the study will be administered an initial survey at inclusion and then follow-up surveys at 3, 6, 9, 12, 15, and 18 month intervals and then 2, 5, and 10 years. There is no intervention cohort, all enrolled will complete the same surveys. Recidivism will be measured by responses to survey questions, clinical interviews documented in the chart, and urine ethnyl glucuronide or blood ethanol testing. |
Other: survey
surveys will be administered at inclusion and follow-ups
|
Outcome Measures
Primary Outcome Measures
- alcohol recidivism assessed by questionnaire [6 months]
Follow-up questionnaires will be administered at 6 months assessing for alcohol use
- alcohol recidivism assessed by clinical interview [6 months]
Follow-up interviews will be conducted at 6 months assessing for alcohol use
- alcohol recidivism assessed by urine ethyl glucuronide [6 months]
Follow-up urine testing may be conducted at 6 months assessing for alcohol use
- alcohol recidivism assessed by blood [6 months]
Follow-up blood testing may be conducted at 6 months assessing for alcohol use
Secondary Outcome Measures
- alcohol recidivism assessed by questionnaire [after 6 months]
Follow-up questionnaires will be administered after 6 months assessing for alcohol use
- alcohol recidivism assessed by clinical interview [after 6 months]
Follow-up clinical interviews will be conducted after 6 months assessing for alcohol use
- alcohol recidivism assessed by urine ethyl glucuronide [after 6 months]
Follow-up urine testing may be conducted after 6 months assessing for alcohol use
- alcohol recidivism assessed by blood [after 6 months]
Follow-up blood testing may be conducted after 6 months assessing for alcohol use
Eligibility Criteria
Criteria
Inclusion Criteria:
- alcoholic liver disease able to consent
Exclusion Criteria:
- without alcoholic liver disease unable to consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Nicole T Shen
Investigators
- Principal Investigator: Robert S Brown, MD, MPH, New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1601016922