Back to resultsMichigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial (MAIN-ART)
Primary Purpose
Alcohol-Related Disorders, Liver Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol-Related Disorders
Eligibility Criteria
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
Sites / Locations
- The University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MAIN-ART Behavior Tool
Routine care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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).
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.
Secondary Outcome Measures
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).
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.
Full Information
NCT ID
NCT04473482
First Posted
July 13, 2020
Last Updated
August 7, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT04473482
Brief Title
Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial
Acronym
MAIN-ART
Official Title
Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Related Disorders, Liver Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MAIN-ART Behavior Tool
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of MAIN-ART Tool as Measured by Recruitment Rates
Description
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.
Time Frame
Up to 6 months
Title
Feasibility of MAIN-ART Tool as Measured by Retention Rates
Description
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).
Time Frame
Up to 6 months
Title
Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys
Description
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.
Time Frame
Up to 1 hour
Secondary Outcome Measure Information:
Title
Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview
Description
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).
Time Frame
Baseline and 6 months
Title
Alcohol Treatment Engagement as Measured by Number of Participants Who Engaged in Any Alcohol Cessation or Reduction Visit as Measured by Self-report.
Description
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.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Mellinger, MD, MSc
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial
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