Testing a new model of telehealth-delivered treatment for primary care patients with alcohol use disorder: A randomized controlled trial protocol

Erin E Bonar; Jason E Goldstick; Matthew J Rostker; Shayla E Dailey; Alyssa N Augustiniak; Carly Brin; Deborah A Manderachia; Carrie Bourque; Rachel Girard; Lisa Sulkowski; Lewei Allison Lin

doi:10.1016/j.cct.2024.107549

Testing a new model of telehealth-delivered treatment for primary care patients with alcohol use disorder: A randomized controlled trial protocol

Contemp Clin Trials. 2024 Apr 26:142:107549. doi: 10.1016/j.cct.2024.107549. Online ahead of print.

Affiliations

¹ Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA; Michigan Innovations in Addiction Care through Research & Education, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA; Injury Prevention Center, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI 48109, USA. Electronic address: erinbona@med.umich.edu.
² Injury Prevention Center, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI 48109, USA; Department of Emergency Medicine, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI 48109, USA; Department of Health Behavior and Health Education, School of Public Health, University of Michigan, 1415 Washington Heights, Ann Arbor, MI 48109, USA.
³ Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA; Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA.
⁴ Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA; Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA; Center for Clinical Management Research, VA Ann Arbor Healthcare System, North Campus Research Complex, 2800 Plymouth Rd Bldg 16, Ann Arbor, MI 48109, USA.
⁵ Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA; Department of Psychology, University of Rhode Island, 142 Flagg Road, Kingston, RI 02881, USA.
⁶ Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA; Michigan Innovations in Addiction Care through Research & Education, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA; Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA; Center for Clinical Management Research, VA Ann Arbor Healthcare System, North Campus Research Complex, 2800 Plymouth Rd Bldg 16, Ann Arbor, MI 48109, USA.

PMID: 38679140
DOI: 10.1016/j.cct.2024.107549

Abstract

Background: The majority of adults suffering from alcohol use disorders (AUD) do not receive treatment. To address this gap in care, we must develop new models to increase identification, engagement and delivery of accessible and effective treatment. This paper describes the protocol for a randomized controlled trial (RCT) testing a novel telehealth treatment model for primary care patients with untreated AUD.

Methods: We aim to recruit 300 adults across 2 healthcare systems for this two-arm RCT. Participants, initially identified for recruitment based on AUD-related indicators in their electronic health record (EHR), are RCT-eligible if they meet AUD criteria (mild, moderate, severe), report ≥ 3 drinking days/week in past 30 days, and have not received AUD psychotherapy in the past 90 days. Participants are randomized to an intervention or enhanced usual care control (EUC) condition, both individually-delivered. The intervention includes a telephone-delivered motivational interviewing (MI) engagement session and 8 sessions of MI-Cognitive Behavioral Therapy (MI-CBT). EUC involves AUD psychoeducation, advice to reduce drinking and seek treatment, and provision of community resources. Outcomes will be measured at 3-, 6-, and 12-months; primary outcomes include: AUD psychotherapy initiation and engagement (within the study and external community) and alcohol consumption (percent drinking days and heavy drinking days).

Conclusions: This study addresses whether proactive patient identification and engagement and delivery of patient-centered telehealth psychotherapy to patients with untreated AUD is effective in increasing treatment use and improving alcohol outcomes. If effective, this could be a highly scalable model for reducing the public health impact of AUD.

Trial registration: ClinicalTrials.gov # NCT05410561. University of Michigan HUM00204315. Ann Arbor VA IRB #1655886.

Keywords: Alcohol; Alcohol use disorder; Motivational interviewing; Psychotherapy; Telehealth.

Associated data

ClinicalTrials.gov/NCT05410561