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Principal Investigator: Jessica Leigh Mellinger
Organization: UNIVERSITY OF MICHIGAN AT ANN ARBOR
Fiscal Year: 2024
Award: $645,878
Funding agency: National Institute on Alcohol Abuse and Alcoholism
Project Summary
Alcohol-related liver disease (ALD) rates have risen 40% in recent years with mortality rising 3.4% per year
over the last 15 years. Alcohol treatment, even just one session, improves liver disease mortality and liver
function, but only 10-15% of ALD patients engage in treatment after their diagnosis. To date, no interventions
to improve alcohol treatment engagement in ALD patients have been developed. To address this gap, we will
perform a sequential, multiple-assignment, randomized trial (SMART) to evaluate an adaptive intervention
strategy to increase alcohol treatment engagement. Adaptive interventions use specific decision rules tailored
to relevant clinical timepoints in the care of ALD patients to identify early non-responders to the initial
intervention and offer additional interventions to those who need them in order to improve clinical outcomes.
Our specific aims are: 1) To test the efficacy of an adaptive intervention which begins with the Michigan
Alcohol Improvement Network –Alcohol Reduction and Treatment (MAIN-ART) app versus Enhanced Usual
Care on alcohol treatment engagement (primary outcome) and alcohol reduction and liver health (secondary
outcomes); 2) To test the efficacy of the addition of a treatment facilitation bundle for increasing alcohol
treatment engagement among non-responders. Patients (n=268) enrolled in hepatology clinics with all stages
of ALD, past 6-month drinking and no past-month alcohol treatment will be randomized to either the MAIN-ART
app or Enhanced Usual Care. Intervention response at 3 months will be assessed and those who have not
engaged in alcohol treatment in either arm (“non-responders”) will be re-randomized to a second intervention,
the Treatment Facilitation bundle. The Treatment Facilitation bundle will be composed of two parts: 1) an
online barriers elicitation survey to determine patient-specific personal or structural barriers to alcohol
treatment, and 2) a virtual coaching session with an addiction social worker offered after completion of the
barriers survey to help facilitate alcohol treatment engagement by overcoming identified barriers. Outcomes
will be assessed at 3-, 6- and 12-month follow-ups. Exploratory aims are a) to determine the best adaptive
strategy to increase alcohol treatment engagement and b) to evaluate mediators and moderators of
intervention efficacy. The proposed work is innovative, timely, and directly responsive to NIAAA priorities to
improve access to alcohol treatment through barrier reduction and through extension of interventions into
novel, non-addiction clinic settings, such as hepatology clinics (NOT PAR-22-156). Using a novel SMART trial
design, the adaptive interventions developed and tested in this study will leverage the hepatology clinic
environment in an innovative way to increase alcohol treatment engagement for ALD patients and improve
clinical outcomes.
Terms: <21+ years old><Access to Care><Active Follow-up><Address><Adult><Adult Human><Age><Alcohol Chemical Class><Alcohol Drinking><Alcohol consumption><Alcoholic Liver Diseases><Alcohols><Area><Behavior Conditioning Therapy><Behavior Modification><Behavior Therapy><Behavior Treatment><Behavioral Conditioning Therapy><Behavioral Modification><Behavioral Therapy><Behavioral Treatment><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Caring><Clinic><Clinical><Conditioning Therapy><Data><Diagnosis><Drugs><Early identification><Enrollment><Environment><EtOH drinking><EtOH use><Health><Health Services Accessibility><Hepatic Disorder><Hepatology><Improve Access><Intervention><Intervention Strategies><Intervention Trial><Interventional trial><Interview><Life><Liver><Liver Dysfunction><Liver diseases><Mediator><Medical center><Medication><Michigan><NIAAA><National Institute on Alcohol Abuse and Alcoholism><Outcome><Patient Preferences><Patients><Perception><Pharmaceutical Preparations><Randomized><Research><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Self Efficacy><Sequential Multiple Assignment Randomized Trial><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Site><Social Workers><Survey Instrument><Surveys><Testing><Time><Treatment Efficacy><Work><access to alcohol><access to health services><access to services><access to treatment><accessibility to health services><active followup><adaptive intervention><addiction><addictive disorder><adulthood><ages><alcohol abuse therapy><alcohol abuse treatment><alcohol access><alcohol accessibility><alcohol availability><alcohol induced hepatic injury><alcohol induced liver disorder><alcohol induced liver injury><alcohol ingestion><alcohol intake><alcohol prevention><alcohol product use><alcohol related liver disease><alcohol treatment><alcohol use><alcohol-associated liver disease><alcohol-induced hepatic dysfunction><alcohol-induced liver disease><alcohol-induced liver dysfunction><alcohol-mediated liver dysfunction><alcohol-mediated liver injury><alcohol-related liver disease><alcoholic beverage consumption><alcoholic drink intake><alcoholic liver injury><arm><availability of services><behavior intervention><behavioral intervention><care access><care as usual><clinical relevance><clinically relevant><cohort><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><determine efficacy><disease diagnosis><drinking><drug/agent><efficacy analysis><efficacy assessment><efficacy determination><efficacy evaluation><efficacy examination><efficacy testing><enroll><ethanol accessibility><ethanol availability><ethanol consumption><ethanol drinking><ethanol induced hepatic injury><ethanol induced liver disorder><ethanol induced liver injury><ethanol ingestion><ethanol intake><ethanol liver disease><ethanol product use><ethanol use><ethanol-induced hepatic dysfunction><ethanol-induced liver disease><ethanol-induced liver dysfunction><ethanol-mediated liver dysfunction><ethanol-mediated liver injury><evaluate efficacy><examine efficacy><follow up><follow-up><followed up><followup><group intervention><health service access><health services availability><hepatic body system><hepatic disease><hepatic organ system><hepatopathy><improved><innovate><innovation><innovative><intervention efficacy><interventional strategy><liver disorder><liver function><mortality><novel><participant engagement><patient engagement><pilot trial><prevent><prevent alcohol><preventing><preventing alcohol><primary outcome><randomisation><randomization><randomized, clinical trials><randomly assigned><recruit><relapse risk><responders and non-responders><responders from non-responders><responders or non-responders><responders versus non-responders><responders vs non-responders><responders/nonresponders><response><secondary outcome><service availability><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><sex><telehealth><tertiary care><therapeutic efficacy><therapy efficacy><treatment access><treatment as usual><trial design><uptake><usual care><usual care arm><usual care control group><virtual coach>