Alcohol brief intervention for hospitalized veterans with hazardous drinking: protocol for a 3-arm randomized controlled efficacy trial

BACKGROUND: Various hospital accreditation and quality assurance entities in the United States have approved and endorsed performance measures promoting alcohol brief intervention (BI) for hospitalized individuals who screen positive for unhealthy alcohol use, the spectrum of use ranging from hazardous use to alcohol use disorders. These performance measures have been controversial due to the limited and equivocal evidence for the efficacy of BI among hospitalized individuals. The few BI trials conducted with hospital inpatients vary widely in methodological quality. While the majority of these studies indicate limited to no effects of BI in this population, none have been designed to account for the most pervasive methodological issue in BI studies presumed to drive study findings towards the null: assessment reactivity (AR). METHODS/DESIGN: This is a three-arm, single-site, randomized controlled trial of BI for hospitalized patients at a large academic medical center affiliated with the U.S. Department of Veterans Affairs who use alcohol at hazardous levels but do not have an alcohol use disorder. Participants are randomized to one of three study conditions. Study Arm 1 receives a three-part alcohol BI. Study Arm 2 receives attention control. To account for potential AR, Study Arm 3 receives AC with limited assessment. Primary outcomes will include the number of standard drinks/week and binge drinking episodes reported in the 30-day period prior to a final measurement visit obtained 6 months after hospital discharge. Additional outcomes will include readiness to change drinking behavior and number of adverse consequences of alcohol use. To assess differences in primary outcomes across the three arms, we will use mixed-effects regression models that account for a patient’s repeated measures over the timepoints and clustering within medical units. Intervention implementation will be assessed by: a) review of intervention audio recordings to characterize barriers to intervention fidelity; and b) feasibility of participant recruitment, enrollment, and follow-up. DISCUSSION: The results of this methodologically rigorous trial will provide greater justification for or against the use of BI performance measures in the inpatient setting and inform organizational responses to BI-related hospital accreditation and performance measures. TRIAL REGISTRATION: NCT01602172