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Randomized Controlled Trial
. 2011 Sep;37(5):417-25.
doi: 10.3109/00952990.2011.596971.

Design of NIDA CTN Protocol 0047: screening, motivational assessment, referral, and treatment in emergency departments (SMART-ED)

Michael P Bogenschutz  1 , Dennis M Donovan, Bryon Adinoff, Cameron Crandall, Alyssa A Forcehimes, Robert Lindblad, Raul N Mandler, Neal L Oden, Harold I Perl, Robrina Walker
Affiliations
Randomized Controlled Trial

Design of NIDA CTN Protocol 0047: screening, motivational assessment, referral, and treatment in emergency departments (SMART-ED)

Michael P Bogenschutz et al. Am J Drug Alcohol Abuse. 2011 Sep.

Abstract

Background: Medical settings such as emergency departments (EDs) present an opportunity to identify and provide services for individuals with substance use problems who might otherwise never receive any form of assessment, referral, or intervention. Although screening, brief intervention, and referral to treatment models have been extensively studied and are considered effective for individuals with alcohol problems presenting in EDs and other medical settings, the efficacy of such interventions has not been established for drug users presenting in EDs.

Objectives: This article describes the design of a NIDA Clinical Trials Network protocol testing the efficacy of an screening, brief intervention, and referral to treatment model in medical EDs, highlighting considerations that are pertinent to the design of other studies targeting substance use behaviors in medical treatment settings.

Methods: The protocol is described, and critical design decisions are discussed.

Results: Design challenges included defining treatment conditions, study population, and site characteristics; developing the screening process; choosing the primary outcome; balancing brevity and comprehensiveness of assessment; and selecting the strategy for statistical analysis.

Conclusion: Many of the issues arising in the design of this study will be relevant to future studies of interventions for addictions in medical settings.

Scientific significance: Optimal trial design is critical to determining how best to integrate substance abuse interventions into medical care.

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Figures

Figure 1
Figure 1. Study Design
*Allocation to SAR vs. BI-B is concealed until after completion of assessment. **BI-B participants receive informational pamphlet and referral if indicated as part of the Brief Intervention.
Figure 2
Figure 2. Power calculations based on simulations using 4 different analysis strategies

  1. A - Analyze 3-month outcomes only.

  2. B - Analyze change only.

  3. C - Use baseline as a fixed-effect covariate to analyze 3-month outcomes.

  4. D - At trial’s end, calculate the average pre-post correlation within the two treatment groups. If this exceeds 0.5, analyze changes. If it is less than 0.5, analyze 3-mo outcome.

See this image and copyright information in PMC

References

    1. Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA: Journal of the American Medical Association. 2004;291(10):1238–45. - PubMed
    1. Rockett IRH, Putnam SL, Jia H, Chang CF, Smith GS. Unmet substance abuse treatment need, health services utilization, and cost: A population-based emergency department study. Annals of emergency medicine. 2005;45(2):118–27. - PubMed
    1. Rockett IRH, Putnam SL, Jia H, Smith GS. Declared and undeclared substance use among emergency department patients: a population-based study. Addiction. 2006;101(5):706–12. - PubMed
    1. Calle PA, Damen J, De Paepe P, Monsieurs KG, Buylaert WA, Belg AC. A survey on alcohol and illicit drug abuse among emergency department patients. Acta Clinica Belgica. 2006;61(4):188–95. - PubMed
    1. Cherpitel CJ, Ye Y. Drug use and problem drinking associated with primary care and emergency room utilization in the US general population: Data from the 2005 national alcohol survey. Drug and Alcohol Dependence. 2008;97(3):226–30. - PMC - PubMed

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