title: The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations.
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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Department of Emergency Medicine, University of Massachusetts Medical School, Worcester, MA, USA. Edwin.Boudreaux@umassmed.edu
authors.forename: Edwin D
authors.initials: ED
authors.lastname: Boudreaux
authors.forename: Ivan
authors.initials: I
authors.lastname: Miller
authors.forename: Amy B
authors.initials: AB
authors.lastname: Goldstein
authors.forename: Ashley F
authors.initials: AF
authors.lastname: Sullivan
authors.forename: Michael H
authors.initials: MH
authors.lastname: Allen
authors.forename: Anne P
authors.initials: AP
authors.lastname: Manton
authors.forename: Sarah A
authors.initials: SA
authors.lastname: Arias
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Camargo
mesh_terms: D004636:Emergency Service, Hospital / Q000458:organization & administration*; D006302:Health Services Research / Q000458:organization & administration*; D006801:Humans; D008403:Mass Screening / Q000458:organization & administration*; D001523:Mental Disorders / Q000175:diagnosis* / Q000628:therapy*; D008603:Mental Health; D010043:Outcome and Process Assessment, Health Care; D012107:Research Design; D013405:Suicide / Q000523:psychology; D000092864:Suicide Prevention
keywords: Emergency department; Mental health; Research methods; Suicide