Health TrialsbyHealthPanel

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

ConditionsAlcohol-related Liver DiseaseLiver Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • ENGAGE-ALD Application (APP)

    Behavioral

    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 single session of the ENGAGE-ALD app.

  • Treatment Facilitation bundle

    Behavioral

    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 identified barriers to alcohol treatment, exploring benefits of and these barriers to alcohol treatment, and performing collaborative goal-setting, among other topics.

  • Enhanced Usual Care

    Behavioral

    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.

Treatment groups

268 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Enhanced usual care (EUC)Experimental treatment 1 intervention
Group B: ENGAGE-ALD application (app)Experimental treatment 1 intervention
Group C: ENGAGE-ALD app then Treatment Facilitation BundleExperimental treatment 2 interventions
Group D: Enhanced usual care then Treatment Facilitation BundleExperimental treatment 2 interventions
Group E: ENGAGE-ALD app then Enhanced usual careExperimental treatment 1 intervention
Group F: Enhanced usual care then Enhanced usual careExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Alcohol treatment engagement

Measured using self-report and defined as any single session (in-person or virtual) of the following: * Professional mental health counselor led 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, Self-Management and Recovery Training (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

Time frame
Baseline and six months

Secondary outcomes

1

Alcohol Use Frequency as Measured by a 30-day alcohol recall calendar method

Time frame
Baseline and six months
2

Percent heavy drinking days (PHDD)

A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women.

Time frame
Six months
3

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
4

Change in Liver health based on liver laboratory values (total bilirubin) for all participants

Time frame
Baseline and six months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henry Ford Health System

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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