title: Study design to examine the potential role of assessment reactivity in the Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED) protocol.
abstract: BACKGROUND
  Screening, brief intervention, and referral to treatment (SBIRT) approaches to reducing hazardous alcohol and illicit drug use have been assessed in a variety of health care settings, including primary care, trauma centers, and emergency departments. A major methodological concern in these trials, however, is "assessment reactivity," the hypothesized impact of intensive research assessments to reduce alcohol and drug use and thus mask the purported efficacy of the interventions under scrutiny. Thus, it has been recommended that prospective research designs take assessment reactivity into account. The present article describes the design of the National Institute on Drug Abuse Clinical Trials Network protocol, Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED), which addresses the potential bias of assessment reactivity.
  
  
  METHODS
  The protocol employs a 3-arm design. Following an initial brief screening, individuals identified as positive cases are consented, asked to provide demographic and locator information, and randomly assigned to one of the three conditions: minimal screening only, screening + assessment, or screening + assessment + brief intervention. In a two-stage process, the randomization procedure first reveals whether or not the participant will be in the minimal-screening-only condition. Participants in the other two groups receive a more extensive baseline assessment before it is revealed whether they have been randomized to also receive a brief intervention. Comparing the screening only and screening + assessment conditions will allow determination of the incremental effect of assessment reactivity.
  
  
  CONCLUSIONS
  Assessment reactivity is a potential source of bias that may reduce and/or lead to an underestimation of the purported effectiveness of brief interventions. From a methodological perspective, it needs to be accounted for in research designs. The SMART-ED design offers an approach to minimize assessment reactivity as a potential source of bias. Elucidating the role of assessment reactivity may offer insights into the mechanisms underlying SBIRT as well as suggest clinical options incorporating assessment reactivity as a treatment adjunct. CLINICALTRIALS.GOV IDENTIFIER: NCT01207791.
authors.affiliation: Alcohol & Drug Abuse Institute, University of Washington, 1107 NE 45th Street, Suite 120, Seattle, WA 98105, USA. ddonovan@u.washington.edu
authors.forename: Dennis M
authors.initials: DM
authors.lastname: Donovan
authors.forename: Michael P
authors.initials: MP
authors.lastname: Bogenschutz
authors.forename: Harold
authors.initials: H
authors.lastname: Perl
authors.forename: Alyssa
authors.initials: A
authors.lastname: Forcehimes
authors.forename: Bryon
authors.initials: B
authors.lastname: Adinoff
authors.forename: Raul
authors.initials: R
authors.lastname: Mandler
authors.forename: Neal
authors.initials: N
authors.lastname: Oden
authors.forename: Robrina
authors.initials: R
authors.lastname: Walker
mesh_terms: D000437:Alcoholism / Q000175:diagnosis / Q000628:therapy; D002985:Clinical Protocols; D004636:Emergency Service, Hospital / Q000458:organization & administration*; D006801:Humans; D007258:Informed Consent; D008403:Mass Screening / Q000458:organization & administration; D009042:Motivation; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012017:Referral and Consultation / Q000458:organization & administration; D012107:Research Design; D012959:Socioeconomic Factors; D019966:Substance-Related Disorders / Q000175:diagnosis* / Q000628:therapy*; D014481:United States