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

Addiction Science & Clinical Practice

Mary Ann Sevick²  Adam J Gordon⁴  Ada O Youk⁵  Barbara H Hanusa⁴  Kevin L Kraemer³  Monica M DiNardo¹  Andrea L Confer¹  Melissa E Wieland¹  Lauren M Broyles⁴ 

[1]Center for Health Equity Research and Promotion, Veterans Affairs (VA) Pittsburgh Healthcare System, University Drive C (151C), Pittsburgh 15240, PA, USA

[2]Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, 227 East 30th Street, New York 10016, NY, USA

[3]Division of General Internal Medicine, Department of Medicine, School of Medicine, University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh 15213, PA, USA

[4]Veterans Integrated Service Network 4 (VISN4) Mental Illness Research, Education, and Clinical Center, VA Pittsburgh Healthcare System, University Drive C (151C), Pittsburgh 15240, PA, USA

[5]Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA

关键词: Measurement effects;    Assessment reactivity;    Clinical trial;    Brief intervention;    Binge drinking;    Alcohol drinking;    Drinking behavior;    Risk reduction behavior;    Inpatients;   

Others  :  1211525
DOI  :  10.1186/s13722-015-0033-6

 received in 2014-12-31, accepted in 2015-04-22,  发布年份 2015

【 摘 要 】

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 webcite

【 授权许可】

   
2015 Broyles et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

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