Adaptive Interventions to Improve Alcohol Treatment Engagement among Alcohol-related Liver Disease Patients

NIH RePORTER · NIH · R01 · $645,878 · view on reporter.nih.gov ↗

Abstract

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.

Key facts

NIH application ID
10875382
Project number
5R01AA030748-02
Recipient
UNIVERSITY OF MICHIGAN AT ANN ARBOR
Principal Investigator
Jessica Leigh Mellinger
Activity code
R01
Funding institute
NIH
Fiscal year
2024
Award amount
$645,878
Award type
5
Project period
2023-07-01 → 2024-07-02