Effectiveness of a pharmacist-delivered primary care telemedicine intervention to increase access to pharmacotherapy and specialty treatment for alcohol use problems: Protocol for the alcohol telemedicine consult cluster-randomized pragmatic trial.

BACKGROUND: Alcohol use problems are associated with serious medical, mental health and socio-economic consequences. Yet even when patients are identified in healthcare settings, most do not receive treatment, and use of pharmacotherapy is rare. This study will test the effectiveness of the Alcohol Telemedicine Consult (ATC) Service, a novel, personalized telehealth intervention approach for primary care patients with alcohol use problems. METHODS: This cluster-randomized pragmatic trial, supplemented by qualitative interviews, will include adults with a primary care visit between 9/10/21-3/10/23 from 16 primary care clinics at two large urban medical centers within Kaiser Permanente Northern California, a large, integrated healthcare system. Clinics are randomized to the ATC Service (intervention), including alcohol pharmacotherapy and SBIRT (screening, MI (Motivational Interviewing)-based brief intervention and referral to addiction treatment) delivered by clinical pharmacists, or the Usual Care (UC) arm that provides systematic alcohol SBIRT. Primary outcomes include a comparison of the ATC and UC arms on 1) implementation outcomes (alcohol pharmacotherapy prescription rates, specialty addiction treatment referrals); and 2) patient outcomes (medication fills, addiction treatment initiation, alcohol use, healthcare services utilization) over 1.5 years. A general modeling approach will consider clustering of patients/providers, and a random effects model will account for intra-class correlations across patients within providers and across clinics. Qualitative interviews with providers will examine barriers and facilitators to implementation. DISCUSSION: The ATC study examines the effectiveness of a pharmacist-provided telehealth intervention that combines pharmacotherapy and MI-based consultation. If effective, the ATC study could affect treatment models across the spectrum of alcohol use problems. CLINICAL TRIALS REGISTRATION: This study has been registered on ClinicalTrials.gov (NCT05252221).