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Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)

Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01150994
Acronym
ED-SAFE
Enrollment
1440
Registered
2010-06-25
Start date
2010-07-31
Completion date
2018-11-30
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide

Keywords

Suicide screening among ED patients

Brief summary

The NIMH s RFA-Suicide Prevention in Emergency Medicine Departments recognizes the emergency department (ED) as an important setting to increase suicide detection and prevention efforts but observes that evidence-based practice guidelines do not exist. In response, we have designed the Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) trial. The ED-SAFE study will be conducted using a quasi-experimental design appropriate for studying systems-based change. The study consists of two components (Screening Outcome & Intervention Evaluation) and three phases of data collection: Treatment as Usual, Screening Alone, and Intervention. During each phase, 480 suicidal patients (1,440 total) will be enrolled and followed using multiple methods for 12 months. The Screening Outcome Component The Screening Outcome component will use data collected during the Treatment as Usual and Screening Alone phases. Consistent with systems-change principles, when universal screening is incorporated during the Screening Alone phase, it will be completed by the primary nurse as part of routine care. Primarily, it will focus on testing a practical approach to screen ED patients for suicidal ideation and behavior and will assess its impact on suicide detection, process outcomes, and suicide behaviors. Intervention Evaluation Component The Intervention Evaluation component will use data from the Treatment as Usual, Screening Alone, and Intervention Phases. During the Intervention phase, each ED will implement a multi-component, systems-based Intervention called the Safety Assessment and Follow-up Telephone Intervention (SAFTI). The SAFTI will combine elements of: (a) safety planning administered by nursing staff in the ED, and (b) Coping Long Term with Active Suicide Program (CLASP)-ED, a series of up to 7 semi-structured telephone advising calls to the patient and 4 to the significant other over the 12 months after the ED visit. Safety planning will be implemented universally to all suicidal patients, regardless of whether they are ultimately enrolled into the trial, as part of a comprehensive suicide management protocol (e.g., it is a systems-based change). However, for practical and budgetary considerations, the CLASP-ED telephone advising calls will be administered only to participants enrolled into the study. Our overarching hypotheses will be tested using a combination of the Screening Outcome component and the Intervention Evaluation Component. We predict that screening will improve detection of suicidal ideation, and the intervention will enhance the quality of care and reduce suicide outcomes.

Detailed description

see summary above

Interventions

BEHAVIORALSafety Assessment and Follow-up Telephone Intervention (SAFTI).

Mental health evaluation in ED, followed by Post-ED counseling

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Over 18, * Entering care at a hospital ED, * Documented thoughts or behaviors related to self-harm.

Exclusion criteria

* No phone or permanent address, * Does not speak English or Spanish.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of ER patients screened for self harmJuly 2010 - November 2013
Quality of careJuly 2010 - November 2014* Process outcomes (e.g. receipt of safety plan) * Involvement in behavioral health treatment
Suicide-related outcomesJuly 2010 - November 2014* Preparatory acts * Suicide attempts * Completed suicides

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026