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Clinical Trial
. 2013 Sep;36(1):14-24.
doi: 10.1016/j.cct.2013.05.008. Epub 2013 May 22.

The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations

Edwin D Boudreaux  1 , Ivan Miller, Amy B Goldstein, Ashley F Sullivan, Michael H Allen, Anne P Manton, Sarah A Arias, Carlos A Camargo Jr
Affiliations
Clinical Trial

The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations

Edwin D Boudreaux et al. Contemp Clin Trials. 2013 Sep.

Abstract

Background: Due to the concentration of individuals at-risk for suicide, an emergency department visit represents an opportune time for suicide risk screening and intervention.

Purpose: The 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.

Methods: This 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.

Conclusions: While '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.

Keywords: Emergency department; Mental health; Research methods; Suicide.

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Figures

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Figure One: ED-SAFE Study Design
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Figure Two: Screeners
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Figure Three: Personal Safety Plan Template
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Figure Three: Personal Safety Plan Template
See this image and copyright information in PMC

References

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