Clinical trial NCT06269510: Enhancing Alcohol Treatment Engagement in Associated Liver Disease (ALD) Patients
Official title: Enhancing Alcohol Treatment Engagement in ALD Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol-related Liver Disease
Liver Diseases
Keywords: Online web application
Engagement
Alcohol use disorder (AUD) treatment
Alcohol-related cirrhosis
SMART trial
Behavioral treatment
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-02-21
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Computer-generated urn randomization will ensure balanced groups based on stage of ALD (advanced ALD and non-advanced ALD) and inpatient versus outpatient status at time of recruitment. Second stage randomization to 3-month intervention conditions will be stratified based on response and non-response status. Urn randomization using stage of ALD and inpatient versus outpatient recruitment will also be used at the second stage randomization. Re-randomization of non-responders will be computerized and stratified by stage of ALD and inpatient vs outpatient status.
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Alcohol treatment engagement
timeFrame: Baseline and six months
Secondary outcomes:
measure: Alcohol Use Frequency as Measured by a 30-day alcohol recall calendar method
timeFrame: Baseline and six months
measure: Percent heavy drinking days (PHDD)
timeFrame: Six months
measure: Change in Liver health based on liver laboratory values (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase) for all participants
timeFrame: Baseline and six months
measure: Change in Liver health based on liver laboratory values (total bilirubin) for all participants
timeFrame: Baseline and six months
measure: Change in Liver health based on The Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis or alcoholic hepatitis
timeFrame: Baseline and six months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jessica Mellinger, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: