This trial is active, not recruiting.

Condition suicide
Treatment safety assessment and follow-up telephone intervention (safti).
Sponsor University of Massachusetts, Worcester
Collaborator National Institute of Mental Health (NIMH)
Start date July 2010
End date November 2018
Trial size 1440 participants
Trial identifier NCT01150994, 13420, 1U01MH088278-01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking single blind (subject)
Primary purpose screening
(No Intervention)
(No Intervention)
Enhanced screening among ED patients
SAFTI: Safety Assessment in the ED combine with a Follow-up Telephone Intervention.
safety assessment and follow-up telephone intervention (safti).
Mental health evaluation in ED, followed by Post-ED counseling

Primary Outcomes

Percentage of ER patients screened for self harm
time frame: July 2010 - November 2013
Quality of care
time frame: July 2010 - November 2014
Suicide-related outcomes
time frame: July 2010 - November 2014

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)
Principal investigator Edwin Boudreaux, PhD
Description see summary above
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Massachusetts, Worcester.