Boudreaux, Edwin DMiller, IvanGoldstein, Amy B.Sullivan, Ashley F.Allen, Michael H.Manton, Anne P.Arias, Sarah A.Camargo, Carlos A. Jr.2022-08-232022-08-232013-09-012014-01-27Boudreaux 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. <a href="http://dx.doi.org/10.1016/j.cct.2013.05.008" target="_blank">Link to article on publisher's site</a>1551-7144 (Linking)10.1016/j.cct.2013.05.00823707435https://hdl.handle.net/20.500.14038/28535BACKGROUND: 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.en-USSuicideResearch methodsMental healthEmergency departmentEmergency MedicinePsychiatric and Mental HealthPsychiatry and PsychologyJournal Articlehttps://escholarship.umassmed.edu/emed_pp/785026607emed_pp/78