Trial Outcomes & Findings for Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial (NCT NCT04473482)
NCT ID: NCT04473482
Last Updated: 2023-08-30
Results Overview
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.
COMPLETED
NA
60 participants
Up to 6 months
2023-08-30
Participant Flow
Participant milestones
| Measure |
MAIN-ART Behavior Tool
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.
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.
|
Routine Care
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
3-month Post Intervention Phone Call
|
22
|
27
|
|
Overall Study
6-month Post Intervention Phone Call
|
19
|
19
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
| Measure |
MAIN-ART Behavior Tool
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.
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.
|
Routine Care
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.
|
|---|---|---|
|
Overall Study
Death
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial
Baseline characteristics by cohort
| Measure |
MAIN-ART Behavior Tool
n=30 Participants
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.
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.
|
Routine Care
n=30 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
46.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown/Declined to Answer
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Alcohol-Related Liver Disease (ALD) Severity
Alcohol related cirrhosis or acute alcohol related hepatitis or both
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Alcohol-Related Liver Disease (ALD) Severity
Alcohol-related Steatosis
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Cirrhosis Diagnosis
Compensated Cirrhosis
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Cirrhosis Diagnosis
Decompensated Cirrhosis
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Cirrhosis Diagnosis
Alcohol-Related Liver Disease (ALD), No Cirrhosis
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Self-reported last drink
|
60 Days
STANDARD_DEVIATION 11.2 • n=5 Participants
|
61 Days
STANDARD_DEVIATION 12.4 • n=7 Participants
|
60.5 Days
STANDARD_DEVIATION 11.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: This population is prior to consent and includes the patients who were ultimately excluded due to not meeting study criteria, cancellation, not showing up to appointments, being unreachable via phone, or for declining participation in the study.
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.
Outcome measures
| Measure |
Clinical Population
n=276 Participants
Patients in hepatology and the University of Michigan Hospital's inpatient ward who were approached about possible participation in this study.
|
Routine Care
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.
|
|---|---|---|
|
Feasibility of MAIN-ART Tool as Measured by Recruitment Rates
|
60 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 6 monthsFeasibility 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).
Outcome measures
| Measure |
Clinical Population
n=30 Participants
Patients in hepatology and the University of Michigan Hospital's inpatient ward who were approached about possible participation in this study.
|
Routine Care
n=30 Participants
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.
|
|---|---|---|
|
Feasibility of MAIN-ART Tool as Measured by Retention Rates
|
19 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Up to 1 hourPopulation: Only subjects randomized to the intervention MAIN-ART behavioral tool were assessed in the intervention group. Because this intervention was given at the initial visit, all participants who were randomized to the MAIN-ART tool arm are available for analysis.
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.
Outcome measures
| Measure |
Clinical Population
n=30 Participants
Patients in hepatology and the University of Michigan Hospital's inpatient ward who were approached about possible participation in this study.
|
Routine Care
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.
|
|---|---|---|
|
Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys
|
70 score on a scale
Interval 47.5 to 95.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Baseline measure data includes all participants whose data was collected at baseline. The participants at 6 months includes only those who completed the study.
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).
Outcome measures
| Measure |
Clinical Population
n=30 Participants
Patients in hepatology and the University of Michigan Hospital's inpatient ward who were approached about possible participation in this study.
|
Routine Care
n=30 Participants
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.
|
|---|---|---|
|
Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview
Baseline
|
87 Grams per day
Standard Deviation 192
|
72 Grams per day
Standard Deviation 191
|
|
Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview
6 months
|
13 Grams per day
Standard Deviation 33
|
29 Grams per day
Standard Deviation 75
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: All participants involved in the initial use of the MAIN-ART tool or who received routine care are analyzed to evaluate what percent engaged with alcohol treatment by the end of the study.
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.
Outcome measures
| Measure |
Clinical Population
n=30 Participants
Patients in hepatology and the University of Michigan Hospital's inpatient ward who were approached about possible participation in this study.
|
Routine Care
n=30 Participants
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.
|
|---|---|---|
|
Alcohol Treatment Engagement as Measured by Number of Participants Who Engaged in Any Alcohol Cessation or Reduction Visit as Measured by Self-report.
|
8 Participants
|
4 Participants
|
Adverse Events
Routine Care
MAIN-ART Behavior Tool
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place