The emergency department safety assessment and follow-up evaluation (ED-SAFE): method and design considerations

Boudreaux, Edwin D.; Miller, Ivan; Goldstein, Amy B.; Sullivan, Ashley F.; Allen, Michael H.; Manton, Anne P.; Arias, Sarah A.; Camargo, Carlos A.

doi:10.1016/j.cct.2013.05.008

Cited by 113Suicide and Self-Harm StudiesEmergency and Acute Care StudiesHealth Policy Implementation Science

The emergency department safety assessment and follow-up evaluation (ED-SAFE): method and design considerations

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Boudreaux, Edwin D., Miller, Ivan, Goldstein, Amy B., Sullivan, Ashley F., Allen, Michael H., Manton, Anne P., Arias, Sarah A., Camargo, Carlos A.·2013·Contemporary Clinical Trials

DOI 10.1016/j.cct.2013.05.008PMC PMC3979300

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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.

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ED-SAFE 1 found that common continuous quality improvement methods made it possible to raise suicide screening to about 85% of adults across eight varied emergency departments.
“using common continuous quality improvement (CQI) strategies, it was feasible to increase suicide screening to reach, on average, 85% of the adult ED population across eight diverse EDs”
From Emergency department safety assessment and follow-up evaluation 2: an implementation trial to improve suicide prevention. (2020) · cites this paper as [9]

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Authors: Boudreaux, E. D., Miller, I., Goldstein, A. B., Sullivan, A. F., Allen, M. H., Manton, A. P., Arias, S. A., & Camargo, C. A.
Affiliations: University of Massachusetts Chan Medical School (US)
Butler Hospital (US)
National Institutes of Health (US)
Massachusetts General Hospital (US)
VA Rocky Mountain Network (US)
Cape Cod Hospital (US)
Corresponding author: Boudreaux, Edwin D.
ORCID: Boudreaux, Edwin D.
Goldstein, Amy B.
Sullivan, Ashley F.
Arias, Sarah A.
Camargo, Carlos A.
Venue: Contemporary Clinical Trials
Publisher: Elsevier BV
Published: 2013-09
Volume: 36
Issue: 1
Pages: 14-24
ISSN: 1551-7144 (ISSN-L)
DOI: 10.1016/j.cct.2013.05.008
PMC: PMC3979300
OpenAlex: W2024562192
Cited by: 113
References: 25
Citations by year: 2026: 7 · 2025: 12 · 2024: 10 · 2023: 10 · 2022: 5 · 2021: 5 · 2020: 11 · 2019: 9 · 2018: 10 · 2017: 15 · 2016: 8 · 2015: 6 · 2014: 5
FWCI: 7.05
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Contemporary Clinical Trials (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
The Journal of the American Medical Association (JAMA) Network (American Medical Association) (submittedVersion)
Funders: National Institute of Mental Health (U01MH088278)
Topics: Social Sciences › Psychology › Clinical Psychology › Suicide and Self-Harm Studies
Health Sciences › Medicine › Emergency Medicine › Emergency and Acute Care Studies
Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Keywords: suicide risk screening, emergency department, universal screening, suicide prevention, complex interventions, interrupted time series design, quasi-experimental design, suicide attempts, suicide mortality, follow-up evaluation
MeSH terms: Suicide Prevention, Mental Disorders, Emergency Service, Hospital, Health Services Research, Humans, Mass Screening, Mental Health, Outcome and Process Assessment, Health Care, Research Design, Suicide

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The emergency department safety assessment and follow-up evaluation (ED-SAFE): method and design considerations

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