Enhancing Alcohol Treatment Engagement in Associated Liver Disease (ALD) Patients

Official title

Enhancing Alcohol Treatment Engagement in ALD Patients

Overview

The purpose of this trial is to see if providing patients with alcohol-related liver disease with tailored alcohol use treatment options will increase engagement with treatment and correct possible misconceptions.

Detailed description

Eligible participants will be randomized to stage 1 of treatment which consists of a previously pilot-tested behavioral application (app), the ENGAGE-ALD app, consisting of a knowledge improvement module and a preference-sensitive treatment matching module. Those who do not engage in AUD treatment after randomization ('non-responders') will be re-randomized at 3-months and continue on this in stage two if considered a responder (met treatment engagement). Participants that were not considered to have met "treatment engagement" will be re-randomized at 3-months to a Treatment Facilitation bundle consisting of a barriers to treatment survey followed by a health coaching session.

Interventions

• Behavioral ENGAGE-ALD Application (APP)
  Participants randomized to this will complete the app at the time of enrollment. If in-person, will complete the app on a research laptop or iPad. The ENGAGE-ALD app consists of two modules developed based on preliminary data: 1) a misconception correction module and 2) a treatment matching module designed to match patients to participant's preferred form of alcohol treatment based on preferences for 19 different dimensions of alcohol treatment. The intervention will consist of administering a
• Behavioral Treatment Facilitation bundle
  Participants will complete a survey. The module includes motivational interviewing-informed content tailored to address and assist in overcoming barriers. After taking the survey, participants will receive a virtual coaching session (either via phone or online virtual platform). Sessions will focus on identifying participant goals with respect to alcohol use and liver health, providing education on risks of alcohol use to liver health and risks of relapse, reviewing participants individually ide
• Behavioral Enhanced Usual Care
  This group will receive standard hepatology care, and an educational pamphlet defining alcohol treatment resources available within Michigan Medicine and giving information on how participants can access these resources. This information will be given directly to participants that enroll in person or e-mailed to participants or sent via postal mail for those that enroll remotely.

Primary outcome measures

• Alcohol treatment engagement [Time frame: Baseline and six months]

Secondary outcome measures (5)

• Alcohol Use Frequency as Measured by a 30-day alcohol recall calendar method [Time frame: Baseline and six months]
• Percent heavy drinking days (PHDD) [Time frame: Six months]
• Change in Liver health based on liver laboratory values (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase) for all participants [Time frame: Baseline and six months]
• Change in Liver health based on liver laboratory values (total bilirubin) for all participants [Time frame: Baseline and six months]
• Change in Liver health based on The Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis or alcoholic hepatitis [Time frame: Baseline and six months]

Eligibility criteria

Inclusion criteria

• Willingness to comply with all study procedures and availability for the duration of the study
• Willing and able to provide informed consent
• Enrolled at University of Michigan (UM) hepatology clinics or inpatients at UM Hospitals
• Documented diagnosis of alcohol-related liver disease (ALD) (per protocol)
• Recent alcohol use of any amount within the past 6 months as assessed by either patient interview, medical chart review, or positive alcohol biomarker (e.g. blood alcohol level, urinary ethyl glucuronide, urinary ethyl sulfate, or phosphatidylethanol) in the medical record.
• No alcohol use treatment within the past 1 month including, but not limited to:

• Any professionally lead therapy with a mental health counselor (such as, one-on-one therapy, group therapy, couples or family therapy) with a primary aim of alcohol abstinence or reduction in alcohol use.
• Community-based alcohol recovery groups (such as, Alcoholics Anonymous, SMART Recovery, Celebrate Recovery, Refuge Recovery)
• Community-based church support groups primarily focused on alcohol abstinence or reduction in use.
• Residential (inpatient) alcohol treatment
• Intensive outpatient programs
• Any telehealth version of the above options
• Access to a Smartphone or computer for purposes of follow-up. Those who do not have a Smartphone will be provided one along with a calling/data plan at no cost to subject by the study team for the duration of the research stud.
• Ability to speak and comprehend English

Exclusion criteria

• Unable to provide voluntary informed consent for any reason
• Substantially cognitively impaired as evidenced by Westhaven grade 2 or higher hepatic encephalopathy or a score >=10 on the Short Blessed Test for cognitive impairment.
• Unable to read or understand English
• Undergoing active evaluation for liver transplantation, is listed for liver transplant, or is post-transplantation
• Is enrolled in the multidisciplinary ALD clinic at Michigan Medicine
• Any other medical condition or circumstance that precludes safe and meaningful participation in the study
• History of nonadherence to previous clinical or research studies

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Henry Ford Health — Detroit

Identifiers

NCT: NCT06269510 · 17705 · 1R01AA030748-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗