Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial

NCT04473482 | Completed Results

• 2 other identifiers: HUM001749465K23AA026333-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine if providing participants with alcohol-related liver disease with tailored alcohol use treatment options is feasible and acceptable in order to increase their engagement with treatment and reduce alcohol use. This is an important area to study to help create ways to increase participants' knowledge about different treatment options as well as increase likelihood of seeking and participating in alcohol use disorder treatments.

Conditions

Alcohol-Related Disorders; Liver Diseases

Outcome Measures

Primary Outcomes (3)

• Feasibility of MAIN-ART Tool as Measured by Recruitment Rates

  Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Study recruitment started on 23 September, 2020 and concluded on 10 January 2022. The results reflect the number and percent of those patients who were approached, were determined to be eligible, and were consented.

  Up to 6 months

• Feasibility of MAIN-ART Tool as Measured by Retention Rates

  Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Retention rate is shown by the number of participants who continued in the study for 6 months, and the percentage that it represents compared to those who began it but did not follow through to the end of the study (6 months).

  Up to 6 months

• Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys

  On the day the participants engage with the MAIN-ART tool, acceptability will be determined by patient-level surveys. The System usability Survey (SUS) consists of 10 questions ranging from 1 (strongly disagree) to 5 (strongly agree). A scoring algorithm which produces a range from 0 to 100 was used. Current literature suggests that a score above 68 for mean SUS is considered "above average." By "intervention," this measure means interaction with the MAIN-ART tool, which occurs only at the participant's initial visit.

  Up to 1 hour

Secondary Outcomes (2)

• Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview

  Baseline and 6 months

• Alcohol Treatment Engagement as Measured by Number of Participants Who Engaged in Any Alcohol Cessation or Reduction Visit as Measured by Self-report.

  Up to 6 months

Study Arms (2)

MAIN-ART Behavior Tool

EXPERIMENTAL

The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching.

Behavioral: Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool

Routine care

NO INTERVENTION

Patients randomized to usual care will receive a pamphlet for alcohol treatment referral to the University of Michigan Addiction Treatment Services, but will receive no further education from the research team.

Interventions

Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool BEHAVIORAL

The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option.

MAIN-ART Behavior Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled at University of Michigan general hepatology clinics or inpatient wards
• Documented diagnosis of alcohol-associated cirrhosis or alcoholic hepatitis or alcohol-related liver disease of any stage
• Drinking of any amount of alcohol within the 6 months prior to recruitment
• No alcohol use treatment within the past 1 month
• Access to a phone for purposes of follow-up

You may not qualify if:

• Active alcohol use treatment
• Undergoing active evaluation for liver transplantation, is listed for liver transplant, or is post-transplantation.
• Is enrolled in the multidisciplinary alcohol-related liver disease clinic at Michigan Medicine

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Mellinger JL, Medley S, Kidwell KM, Asefah H, Winder GS, Fernandez AC, Lok ASF, Blow F. Improving alcohol treatment engagement using integrated behavioral interventions in alcohol-associated liver disease: A randomized pilot trial. Hepatol Commun. 2023 Sep 15;7(10):e0181. doi: 10.1097/HC9.0000000000000181. eCollection 2023 Oct 1.

  PMID: 37708435 DERIVED

MeSH Terms

Conditions

Alcohol-Related Disorders; Liver Diseases

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Jessica Mellinger
• Organization: University of Michigan

jmelling@umich.edu

734-232-0284

Study Officials

• Jessica Mellinger, MD, MSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: September 23, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 30, 2023
• Results First Posted: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)