Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients

Abstract

We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). In an effort to surmount known ED-based alcohol screening, brief intervention, and referral to treatment process barriers, while addressing racial/ethnic alcohol-related health disparities among Latino groups, this trial will purposively use a digital health tool and seek enrollment of English and/or Spanish speaking self-identified adult Latino ED patients. Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish). The primary outcome will be the number of binge drinking days assessed using the 28-day timeline followback method at 12 months post-randomization. Secondary outcomes will include mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school. A sample size of 820 is necessary to provide 80% power to detect a 1.14 difference between AB-CASI and SC in the primary outcome. Showing efficacy of this promising bilingual ED-based brief intervention tool in Latino patients has the potential to widely and efficiently expand prevention efforts and facilitate meaningful contact with specialized treatment services.