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

Henry Ford Health

Status: Enrolling

Conditions: Alcohol-related Liver Disease; Liver Diseases

Treatments: Behavioral: ENGAGE-ALD Application (APP); Behavioral: Enhanced Usual Care; Behavioral: Treatment Facilitation bundle

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06269510

1R01AA030748-01 (U.S. NIH Grant/Contract)

17705

Details and patient eligibility

About

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.

Full 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.

Enrollment: 268 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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268 participants in 6 patient groups

Enhanced usual care (EUC)

Experimental group

Description:

Eligible participants randomized will be given this for stage 1 of treatment (three months) and stage 2 (three months) if participants engaged in alcohol treatment during the first stage of treatment.

Treatment:

Behavioral: Enhanced Usual Care

ENGAGE-ALD application (app)

Experimental group

Description:

Eligible participants randomized to this arm will be given this for stage 1 (three months) of treatment and stage 2 (three months) if participants engaged in alcohol treatment during the first stage of treatment.

Treatment:

Behavioral: ENGAGE-ALD Application (APP)

ENGAGE-ALD app then Treatment Facilitation Bundle

Experimental group

Description:

Eligible participants randomized to this arm will be given this for stage 1 of treatment (three months). Participants that are non-responders (did not engage in alcohol treatment) will be re-randomized and assigned to the Treatment Facilitation bundle for stage 2 (three months).

Treatment:

Behavioral: Treatment Facilitation bundle

Behavioral: ENGAGE-ALD Application (APP)

Enhanced usual care then Treatment Facilitation Bundle

Experimental group

Description:

Eligible participants randomized to this arm will be given this for stage 1 of treatment (three months). Participants that are non-responders (did not engage in alcohol treatment) will be re-randomized and assigned to the Treatment Facilitation bundle for stage 2 (three months).

Treatment:

Behavioral: Treatment Facilitation bundle

Behavioral: Enhanced Usual Care

ENGAGE-ALD app then Enhanced usual care

Experimental group

Description:

Eligible participants randomized to this arm will be given this for stage 1 (three months) of treatment. Participants that are non-responders (did not engage in alcohol treatment) will be re-randomized to the EUC arm stage 2 (three months).

Treatment:

Behavioral: ENGAGE-ALD Application (APP)

Enhanced usual care then Enhanced usual care

Experimental group

Description:

Eligible participants randomized to this arm will be given this for stage 1 of treatment (three months). Participants that are non-responders (did not engage in alcohol treatment) will be rerandomized to the Enhanced usual care arm stage 2 (three months).

Treatment:

Behavioral: Enhanced Usual Care