Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial

Liver Diseases Clinical Trial

— MAIN-ART  

Official title:

Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473482
• Other study ID #: HUM00174946
• Secondary ID: 5K23AA026333-02
• Status: Completed
• Phase: N/A
• Start date: September 23, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview	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).	Baseline and 6 months
Secondary	Alcohol Treatment Engagement as Measured by Number of Participants Who Engaged in Any Alcohol Cessation or Reduction Visit as Measured by Self-report.	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.	Up to 6 months