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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA030748-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced usual care (EUC) | Experimental | 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. |
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| ENGAGE-ALD application (app) | Experimental | 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. |
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| ENGAGE-ALD app then Treatment Facilitation Bundle | Experimental | 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). |
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| Enhanced usual care then Treatment Facilitation Bundle | Experimental | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol treatment engagement | Measured using self-report and defined as any single session (in-person or virtual) of the following:
| Baseline and six months |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use Frequency as Measured by a 30-day alcohol recall calendar method | Baseline and six months | |
| 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. |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Melican | Contact | 3138744656 | mmelica1@hfhs.org | |
| Jessica Mellinger, MD | Contact | 3134281536 | jmellin2@hfhs.org |
| Name | Affiliation | Role |
|---|---|---|
| Jessica Mellinger, MD, MSc | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health | Recruiting | Detroit | Michigan | 48202 | United States |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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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.
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| ENGAGE-ALD app then Enhanced usual care | Experimental | 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). |
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| Enhanced usual care then Enhanced usual care | Experimental | 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). |
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| 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. |
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| 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. |
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| Six months |
| Change in Liver health based on liver laboratory values (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase) for all participants | Baseline and six months |
| Change in Liver health based on liver laboratory values (total bilirubin) for all participants | 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 | Minimum MELD score: 6 points. Maximum MELD score: 40 points. Higher scores is considered a worse result. | Baseline and six months |
| D001523 | Mental Disorders |