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Contemp Clin Trials. 2020 Oct;97:106128. doi: 10.1016/j.cct.2020.106128. Epub 2020 Sep 16.

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

Contemporary clinical trials

Federico E Vaca, James Dziura, Fuad Abujarad, Michael V Pantalon, Allen Hsiao, Craig A Field, Gail D'Onofrio

Affiliations

  1. Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: [email protected].
  2. Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: [email protected].
  3. Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: [email protected].
  4. Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: [email protected].
  5. Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America; Yale School of Medicine, Department of Pediatrics, Section of Emergency Medicine, 100 York St, Suite 1F, New Haven, CT 06511, United States of America. Electronic address: [email protected].
  6. University of Texas at El Paso, Latino Alcohol and Health Disparities Research Center (LAHDR), Psychology Building; Rooms 102 and 104, The University of Texas at El Paso, El Paso, TX 79968, United States of America. Electronic address: [email protected].
  7. Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: [email protected].

PMID: 32950400 PMCID: PMC7721867 DOI: 10.1016/j.cct.2020.106128

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.

Copyright © 2020 Elsevier Inc. All rights reserved.

Keywords: Alcohol screening; Behavioral intervention; Digital health; Emergency department; Health disparities; Latino

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