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

University of Massachusetts, Worcester

Status: Completed

Conditions: Suicide

Treatments: Behavioral: Safety Assessment and Follow-up Telephone Intervention (SAFTI).

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01150994

13420 (Other Identifier)

1U01MH088278-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

see summary above

Enrollment: 1,440 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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1,440 participants in 3 patient groups

Treatment as Usual

No Intervention group

Screening Alone

No Intervention group

Description:

Enhanced screening among ED patients

Safety Assessment and Follow-up Telephone Intervention

Experimental group

Description:

SAFTI: Safety Assessment in the ED combine with a Follow-up Telephone Intervention.

Treatment:

Behavioral: Safety Assessment and Follow-up Telephone Intervention (SAFTI).