Suicide Clinical Trial
Official title:
Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)
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.
see summary above ;
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