The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations
Department of Emergency Medicine
Emergency Medicine | Psychiatric and Mental Health | Psychiatry and Psychology
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.
Suicide, Research methods, Mental health, Emergency department
DOI of Published Version
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
Contemporary clinical trials
Boudreaux, Edwin D.; Miller, Ivan; Goldstein, Amy B.; Sullivan, Ashley F.; Allen, Michael H.; Manton, Anne P.; Arias, Sarah A.; and Camargo, Carlos A. Jr., "The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations" (2013). Emergency Medicine Publications and Presentations. 78.