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Completed

NCT Number: NCT04473482

Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial

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.

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Key information

Conditions

Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Liver Diseases Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of MAIN-ART Tool as Measured by Recruitment Rates

    Time frame: Up to 6 months

    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.

  2. Feasibility of MAIN-ART Tool as Measured by Retention Rates

    Time frame: Up to 6 months

    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).

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

    Time frame: Up to 1 hour

    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.

Secondary outcomes

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

    Time frame: Baseline and 6 months

    Alcohol use will be defined according to World Health Organization (WHO) risk drinking level. WHO drinking risk levels were derived from patient reports of the number of standard drinks (defined as 0.6 ounces of absolute alcohol) consumed, which were converted to grams of pure alcohol (0.6 ounces = 14 grams). Ranging from abstinence (0 grams) to very high risk (101+ males / 61+ females grams).

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

    Time frame: Up to 6 months

    Alcohol treatment engagement will be defined as at least one visit with formal, external assistance in alcohol cessation or reduction including inpatient rehabilitation services, out patient alcohol cessation programs, engagement in therapy of any kind tailored for alcohol cessation, and engagement in any group therapy or support groups for alcohol cessation including alcoholics anonymous, 12 step facilitation and etc.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Acronym: MAIN-ART

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2020
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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