• Edwin D Boudreaux, Ivan Miller, Amy B Goldstein, Ashley F Sullivan, Michael H Allen, Anne P Manton, Sarah A Arias, and Carlos A Camargo.
• Department of Emergency Medicine, University of Massachusetts Medical School, Worcester, MA, USA. Edwin.Boudreaux@umassmed.edu
• Contemp Clin Trials. 2013 Sep 1;36(1):14-24.

BackgroundDue to the concentration of individuals at-risk for suicide, an emergency department visit represents an opportune time for suicide risk screening and intervention.PurposeThe Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) uses a quasi-experimental, interrupted time series design to evaluate whether (1) a practical approach to universally screening ED patients for suicide risk leads to improved detection of suicide risk and (2) a multi-component intervention delivered during and after the ED visit improves suicide-related outcomes.MethodsThis paper summarizes the ED-SAFE's study design and methods within the context of considerations relevant to effectiveness research in suicide prevention and pertinent human participants concerns. 1440 suicidal individuals, from 8 general ED's nationally will be enrolled during three sequential phases of data collection (480 individuals/phase): (1) Treatment as Usual; (2) Universal Screening; and (3) Intervention. Data from the three phases will inform two separate evaluations: Screening Outcome (Phases 1 and 2) and Intervention (Phases 2 and 3). Individuals will be followed for 12 months. The primary study outcome is a composite reflecting completed suicide, attempted suicide, aborted or interrupted attempts, and implementation of rescue procedures during an outcome assessment.ConclusionsWhile 'classic' randomized control trials (RCT) are typically selected over quasi-experimental designs, ethical and methodological issues may make an RCT a poor fit for complex interventions in an applied setting, such as the ED. ED-SAFE represents an innovative approach to examining the complex public health issue of suicide prevention through a multi-phase, quasi-experimental design embedded in 'real world' clinical settings.Copyright © 2013 Elsevier Inc. All rights reserved.

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