title: Alcohol brief intervention for hospitalized veterans with hazardous drinking: protocol for a 3-arm randomized controlled efficacy trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT01602172.
authors.affiliation: Center for Health Equity Research and Promotion, Veterans Affairs (VA) Pittsburgh Healthcare System, University Drive C (151C), Pittsburgh, PA, 15240, USA. lauren.broyles@va.gov.|Division of General Internal Medicine, Department of Medicine, School of Medicine, University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA, 15213, USA. lauren.broyles@va.gov.|Veterans Integrated Service Network 4 (VISN4) Mental Illness Research, Education, and Clinical Center, VA Pittsburgh Healthcare System, University Drive C (151C), Pittsburgh, PA, 15240, USA. lauren.broyles@va.gov.
authors.forename: Lauren M
authors.initials: LM
authors.lastname: Broyles
authors.affiliation: Center for Health Equity Research and Promotion, Veterans Affairs (VA) Pittsburgh Healthcare System, University Drive C (151C), Pittsburgh, PA, 15240, USA. melissa.wieland2@va.gov.
authors.forename: Melissa E
authors.initials: ME
authors.lastname: Wieland
authors.affiliation: Center for Health Equity Research and Promotion, Veterans Affairs (VA) Pittsburgh Healthcare System, University Drive C (151C), Pittsburgh, PA, 15240, USA. andrea.confer@va.gov.
authors.forename: Andrea L
authors.initials: AL
authors.lastname: Confer
authors.affiliation: Center for Health Equity Research and Promotion, Veterans Affairs (VA) Pittsburgh Healthcare System, University Drive C (151C), Pittsburgh, PA, 15240, USA. monica.dinardo@va.gov.
authors.forename: Monica M
authors.initials: MM
authors.lastname: DiNardo
authors.affiliation: Division of General Internal Medicine, Department of Medicine, School of Medicine, University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA, 15213, USA. kraemerkl@upmc.edu.
authors.forename: Kevin L
authors.initials: KL
authors.lastname: Kraemer
authors.affiliation: Veterans Integrated Service Network 4 (VISN4) Mental Illness Research, Education, and Clinical Center, VA Pittsburgh Healthcare System, University Drive C (151C), Pittsburgh, PA, 15240, USA. barbara.hanusa@va.gov.
authors.forename: Barbara H
authors.initials: BH
authors.lastname: Hanusa
authors.affiliation: Center for Health Equity Research and Promotion, Veterans Affairs (VA) Pittsburgh Healthcare System, University Drive C (151C), Pittsburgh, PA, 15240, USA. ada.youk@va.gov.|Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA. ada.youk@va.gov.
authors.forename: Ada O
authors.initials: AO
authors.lastname: Youk
authors.affiliation: Center for Health Equity Research and Promotion, Veterans Affairs (VA) Pittsburgh Healthcare System, University Drive C (151C), Pittsburgh, PA, 15240, USA. adam.gordon@va.gov.|Division of General Internal Medicine, Department of Medicine, School of Medicine, University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA, 15213, USA. adam.gordon@va.gov.|Veterans Integrated Service Network 4 (VISN4) Mental Illness Research, Education, and Clinical Center, VA Pittsburgh Healthcare System, University Drive C (151C), Pittsburgh, PA, 15240, USA. adam.gordon@va.gov.
authors.forename: Adam J
authors.initials: AJ
authors.lastname: Gordon
authors.affiliation: Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, 227 East 30th Street, New York, NY, 10016, USA. mary.sevick@nyumc.org.
authors.forename: Mary Ann
authors.initials: MA
authors.lastname: Sevick
mesh_terms: D000328:Adult; D019973:Alcohol-Related Disorders / Q000175:diagnosis* / Q000628:therapy*; D003071:Cognition; D005246:Feedback; D005260:Female; D006787:Hospitals, Veterans / Q000458:organization & administration*; D006801:Humans; D007297:Inpatients; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010353:Patient Education as Topic; D012107:Research Design; D014481:United States