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Coronavirus Disease 2019 (Covid-19) Impact on Alcohol-related Liver Disease Patient Outcomes, Care and Alcohol Use

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ClinicalTrials.gov Identifier: NCT05191446
Recruitment Status : Recruiting
First Posted : January 13, 2022
Last Update Posted : April 27, 2022
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The study consists of a randomized controlled trial evaluating the efficacy and feasibility of a stepped alcohol treatment using telemedicine on unhealthy alcohol use in patients with chronic liver disease receiving care in hepatology practices at three sites. Patients who meet eligibility criteria will be randomized to one of two study arms: 1) Stepped Alcohol Treatment (SAT) or, 2) Usual Care (UC). Participants will be randomized separately by site. SAT includes 3 sessions of motivational interviewing followed by referral to addiction medicine for patients who do not reduce unhealthy drinking. Trial outcome measures will be complete at 6 and 12 months following baseline enrollment.

Condition or disease Intervention/treatment Phase
Liver Diseases Alcohol Use Disorder Behavioral: Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use Other: Usual Care (UC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized trial with patients assigned to an experimental condition or to usual care.
Masking: Single (Outcomes Assessor)
Masking Description: Research assistants completing follow up interviews with participants will be blinded to study condition.
Primary Purpose: Treatment
Official Title: Impact of the Coronavirus 2019 (COVID-19) Pandemic on Patient Outcomes, Telehealth Care Delivery, and Treatment for Unhealthy Alcohol Use in Vulnerable Patients With Advanced Liver Disease Across Two Healthcare Systems
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : January 15, 2024
Estimated Study Completion Date : January 15, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Ethanol

Arm Intervention/treatment
Experimental: Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use
For participants randomized to SAT, consistent with stepped care, treatment will begin with lower intensity services that are stepped up, if necessary, at a predefined time point. Step 1 consists of three motivational interviewing (MI)sessions delivered every 2 weeks. At the 3-month assessment, those with non-response to MI, defined as continued unhealthy alcohol use in the prior 14 days, will be referred to on site physician managed addiction specialty services (Step 2) for higher intensity services.
Behavioral: Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use

Step 1 includes three sessions of motivational interviewing (MI). MI will consist of three video (Zoom) or telephone sessions: an initial 45-minute session, followed by two 20-minute sessions. Treatment is based on "Motivational Interviewing" by Miller and Rollnick, and includes exploring ambivalence about change, reflective listening, expressing empathy, and discussion about change. To support increased motivation to reduce drinking, discussion will center on effects of hazardous drinking on liver disease.

Step 2 includes referral to addiction medicine for participants who do not reduce unhealthy alcohol use. Specialty addiction services include both direct treatment and coordination of addiction care. After an evaluation, the addiction medicine physician may recommend pharmacotherapy (in consultation with hepatology provider if indicated), and/or referral to intensive outpatient, or residential level of care depending on clinical judgement.


Active Comparator: Usual Care (UC)
UC participants will receive their usual services in hepatology. They will also be given publicly available patient education materials regarding risk associated with unhealthy drinking (mail/email or in-person if desired) and will be asked to follow up with their physician should they have questions about information provided in the handouts. UC participants' hepatology provider will be notified if AUDIT-C scores are greater than 3 at baseline. All UC participants will have access to alcohol and other substance use treatment available to patients at their respective sites.
Other: Usual Care (UC)
UC participants will receive their usual services in hepatology. They will also be given publicly available patient education materials regarding risk associated with unhealthy drinking (mail/email or in-person if desired) and will be asked to follow up with their physician should they have questions about information provided in the handouts. UC participants' hepatology provider will be notified if AUDIT-C scores are greater than 3 at baseline. All UC participants will have access to alcohol and other substance use treatment available to patients at their respective sites.




Primary Outcome Measures :
  1. Change in alcohol use [ Time Frame: 6 months after enrollment ]
    Less than moderate alcohol use in the prior 14 days at month 6 follow-up. Alcohol use survey questions will assess usual drinking frequency (days per week) and typical number of standard drinks consumed, in order to compute average number of drinks per week; and number of days of hazardous drinking (5+ drinks for men and, and 4+ drinks per women) in the past 30 days, using the Timeline Followback Method.


Secondary Outcome Measures :
  1. Alcohol use cessation [ Time Frame: 6 and 12 months after enrollment ]
    Alcohol use will be assessed at 6 months and 12 months following enrollment, using the Timeline Followback Method.

  2. Drinks per week [ Time Frame: 6 and 12 months after enrollment ]
    Alcohol use will be assessed at 6 months and 12 months following enrollment, using the Timeline Followback Method.

  3. Liver-related outcomes [ Time Frame: 6 and 12 months after enrollment ]
    Worsening liver function tests, new or worsening hepatic decompensation or new diagnosis of cirrhosis in those without advanced CLD, number of hospitalizations, Child-Pugh (A, B, and C) and Model of End stage Liver Disease (MELD) labs will be captured using electronic medical record data.



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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:

  1. Men and women age ≥ 18 years.
  2. Diagnosis of chronic liver disease (CLD).
  3. Unhealthy alcohol use, defined as more than moderate amount of alcohol use within the prior 30 days by National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria defined as on average more than 1 drink/day (7 drinks per week) for women and more than 2 drinks per day (14 drinks per week) for men, or on average at least one heavy drinking day (4+ drinks in a day for women and 5+ for men) per week in the prior 30 days. A standard drink is ~14 g of alcohol.
  4. Ability to access a telephone or a digital device (i.e., computer, tablet or smart phone).

Exclusion criteria:

  1. Severe medical or psychiatric conditions or evidence of acute alcohol intoxication preventing participation in the study
  2. Are currently enrolled in formal treatment for unhealthy alcohol use, excluding self or mutual-help groups (e.g., Alcoholics Anonymous).
  3. Women who are pregnant or breastfeeding or unwilling to use birth control.
  4. Language preference other than English or Spanish.
  5. Unwilling or unable to provide informed consent.

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): NCT05191446


Contacts
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Contact: Mandana Khalili, M.D. 628-206-4766 mandana.khalili@ucsf.edu

Locations
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United States, California
University of california San Francisco Enrolling by invitation
San Francisco, California, United States, 94110
Zuckerberg San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Mandana Khalili       mandana.khalili@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Mandana Khalili, M.D. University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05191446    
Other Study ID Numbers: 20-33076
R01AA029312 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study will comply with NOT-AA-19-020, "Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)." NIAAA requires studies that include human subjects to submit de-identified data into the NIAAA data repository (NIAAADA), a NIAAA data repository hosted and managed by the National Institute of Mental Health (NIMH) Data Archive (NDA), in order to enable widespread data sharing. Key measurement domains include quality of life, patient satisfaction with care, use of telemedicine, health literacy measures, alcohol use, anxiety, depression, and use of health services. The investigators will obtain Informed Consent that allows for broad sharing of the research subjects' de-identified data and will follow all other necessary procedures as described in our Data Sharing and Archiving Plan.
Supporting Materials: Study Protocol
Time Frame: The study team will submit data on or before the NDA submission due dates (April 1 and October 1 each year) in accordance with the applicable Data Sharing Terms and Conditions of award. The team will perform quality assurance (QA)/quality control (QC) checks on data within 4 months after the submission due dates and address any issues identified by the NDA. The study team will run the required NIAAADA data validation tool at least one time per month once data collection begins. Duration of availability will follow NIAAADA criteria.
Access Criteria: Access criteria will follow NIAAADA guidelines. The study team will Share data in accordance with the default NIAAADA data sharing schedule in accordance with the applicable Data Sharing Terms and Conditions of award.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Alcoholism
Alcohol Drinking
Digestive System Diseases
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs