Design of NIDA CTN Protocol 0047: Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED)

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.

• brief intervention
• clinical trial
• design
• emergency department
• SBIRT

Acknowledgments

This work was supported by grants from the National Institute on Drug Abuse (U10DA020024, Adinoff, PI; U10DA015833, Bogenschutz, PI; U10DA013714, Donovan, PI). The following individuals made significant contributions to the development of this protocol: Collen Allen, Cindy Claassen, Debbie Drosdick, Andrzej Kosinski, Jeff Sharp, Rose Singh, and Paul Wakim.

Declaration of Interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.

Notes

1 Assuming baseline and 3-month outcomes have the same variance, the variance of change from baseline will be smaller than the variance of the 3-month outcome only if the within-group pre–post correlation exceeds .5.