Successful treatment of alcoholic liver disease (ALD) depends primarily on abstinence from alcohol. Different than addiction treatment where abstinence or even harm reduction may be an eventual goal with less need for immediate adherence, the complete abstinence requirement in this patient population makes it a useful model in which to test new strategies for efficient monitoring of patient behavior. Continuous monitoring of alcohol use by wearable biosensors is possible but to date these devices have not been used in clinical medical settings to monitor adherence to medical directives. For ALD patients such devices could facilitate monitoring of alcohol abstinence providing both patients and clinicians with real-time critical information to develop and adjust alcohol treatment plans. Our R21 proposal targets NIAAA PA 15-301 Alcohol Use Disorders: Behavioral Treatment, Services and Recovery Research soliciting proposals for co-morbid medical and alcohol use disorders specifically proposals using technology to develop and validate assessments capturing real-time data to use in clinical treatment paradigms. We propose a 3 month RCT pilot of alcohol biosensor monitoring (ABM)(WrisTAS-see methods) for patients with decompensated ALD who intend to stop drinking. All participants will wear the ABM device but participants will be randomized to receive either personalized feedback on the data recorded on the device (n=30) or enhanced usual care without feedback on device data (n=30). We will determine whether ABM plus feedback improves outcomes for ALD compared to enhanced usual care and hypothesize ABM feedback will reduce alcohol consumption, improve motivation and self-efficacy for abstinence and improve engagement in treatment. We will also conduct research including quantitative and qualitative data collected from participants and 15 clinical stakeholders (e.g. physicians, nurse practitioners, care coordinators) who will provide opinions on ABM feasibility, acceptability, and usability. Qualitative methods are especially useful for understanding the perceived needs, barriers, and preferences for monitoring alcohol use and are especially required for future translation of this technology into clinical practice. Additionally this study will inform our development of a full scale project by 1) determining the potential for ABM clinical integration 2) identifying barriers to ABM implementation 3) determining long term wearability of ABM devices and 4) determine whether identified patient outcome effect sizes appear clinically meaningful to justify ABM monitoring and evaluation in a full-scale randomized controlled trial in the clinical environment.
Successful treatment of alcoholic liver disease depends primarily on abstinence from alcohol. We propose a randomized clinical trial of alcohol biosensor monitoring for patients with alcoholic liver disease to determine if monitoring with feedback on alcohol use patterns reduces alcohol consumption and improves outcomes.
