Alcohol-Related Disorders, Liver Diseases
Conditions
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.
Interventions
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.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of MAIN-ART Tool as Measured by Recruitment Rates | 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. |
| Feasibility of MAIN-ART Tool as Measured by Retention Rates | 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). |
| Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys | 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
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview | 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). |
| 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 3 |
| Overall Study | Lost to Follow-up | 9 | 7 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Routine Care | MAIN-ART Behavior Tool | Total |
|---|---|---|---|
| Age, Continuous | 50.0 years STANDARD_DEVIATION 13.4 | 46.8 years STANDARD_DEVIATION 11.3 | 48.4 years STANDARD_DEVIATION 12.4 |
| Alcohol-Related Liver Disease (ALD) Severity Alcohol related cirrhosis or acute alcohol related hepatitis or both | 20 Participants | 23 Participants | 43 Participants |
| Alcohol-Related Liver Disease (ALD) Severity Alcohol-related Steatosis | 10 Participants | 7 Participants | 17 Participants |
| Cirrhosis Diagnosis Alcohol-Related Liver Disease (ALD), No Cirrhosis | 13 Participants | 10 Participants | 23 Participants |
| Cirrhosis Diagnosis Compensated Cirrhosis | 4 Participants | 3 Participants | 7 Participants |
| Cirrhosis Diagnosis Decompensated Cirrhosis | 13 Participants | 17 Participants | 30 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Native American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown/Declined to Answer | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 27 Participants | 24 Participants | 51 Participants |
| Region of Enrollment United States | 30 Participants | 30 Participants | 60 Participants |
| Self-reported last drink | 61 Days STANDARD_DEVIATION 12.4 | 60 Days STANDARD_DEVIATION 11.2 | 60.5 Days STANDARD_DEVIATION 11.7 |
| Sex/Gender, Customized Gender Female | 15 Participants | 15 Participants | 30 Participants |
| Sex/Gender, Customized Gender Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 3 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: Up to 1 hour
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Clinical Population | Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys | 70 score on a scale |
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.
Time frame: Up to 6 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Population | Feasibility of MAIN-ART Tool as Measured by Recruitment Rates | 60 Participants |
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).
Time frame: Up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Population | Feasibility of MAIN-ART Tool as Measured by Retention Rates | 19 Participants |
| Routine Care | Feasibility of MAIN-ART Tool as Measured by Retention Rates | 19 Participants |
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.
Time frame: Up to 6 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Population | 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 |
| Routine Care | Alcohol Treatment Engagement as Measured by Number of Participants Who Engaged in Any Alcohol Cessation or Reduction Visit as Measured by Self-report. | 4 Participants |
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).
Time frame: Baseline and 6 months
Population: Baseline measure data includes all participants whose data was collected at baseline. The participants at 6 months includes only those who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinical Population | Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview | Baseline | 87 Grams per day | Standard Deviation 192 |
| Clinical Population | Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview | 6 months | 13 Grams per day | Standard Deviation 33 |
| Routine Care | Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview | Baseline | 72 Grams per day | Standard Deviation 191 |
| Routine Care | Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview | 6 months | 29 Grams per day | Standard Deviation 75 |