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The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations
Emergency Medicine Publications and Presentations
  • Edwin D. Boudreaux, University of Massachusetts Medical School
  • Ivan Miller, Brown University
  • Amy B. Goldstein, Brown University
  • Ashley F. Sullivan, Massachusetts General Hospital
  • Michael H. Allen, University of Colorado
  • Anne P. Manton, Cape Cod Hospital
  • Sarah A. Arias, Massachusetts General Hospital
  • Carlos A. Camargo, Jr., Massachusetts General Hospital and Harvard Medical School
UMMS Affiliation
Department of Emergency Medicine
Document Type
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.

Citation: Boudreaux ED, Miller I, Goldstein AB, Sullivan AF, Allen MH, Manton AP, Arias SA, Camargo CA Jr. The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations. Contemp Clin Trials. 2013 Sep;36(1):14-24. doi: 10.1016/j.cct.2013.05.008. Link to article on publisher's site

Related Resources
Link to Article in PubMed
  • Suicide,
  • Research methods,
  • Mental health,
  • Emergency department
PubMed ID
Citation Information
Edwin D. Boudreaux, Ivan Miller, Amy B. Goldstein, Ashley F. Sullivan, et al.. "The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations" Vol. 36 Iss. 1 (2013) ISSN: 1551-7144 (Linking)
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