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

Suicide Clinical Trial

— ED-SAFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150994
• Other study ID #: 13420
• Secondary ID: 1U01MH088278-01
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: November 2018

Study information

• Verified date: March 2019
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

see summary above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1440
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Suicide

Intervention

Behavioral:
• Safety Assessment and Follow-up Telephone Intervention (SAFTI).
Mental health evaluation in ED, followed by Post-ED counseling

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Ohio State University Medical Center	Columbus	Ohio
United States	University of Arkansas Medical Center	Little Rock	Arkansas
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island
United States	Maricopa Medical Center	Phoenix	Arizona
United States	UMass Medical School, Marlborough Hospital	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (8)

Arias SA, Zhang Z, Hillerns C, Sullivan AF, Boudreaux ED, Miller I, Camargo CA. Using structured telephone follow-up assessments to improve suicide-related adverse event detection. Suicide Life Threat Behav. 2014 Oct;44(5):537-47. doi: 10.1111/sltb.12088. — View Citation

Betz ME, Arias SA, Miller M, Barber C, Espinola JA, Sullivan AF, Manton AP, Miller I, Camargo CA Jr, Boudreaux ED. Change in emergency department providers' beliefs and practices after use of new protocols for suicidal patients. Psychiatr Serv. 2015 Jun;6 — View Citation

Betz ME, Miller M, Barber C, Miller I, Sullivan AF, Camargo CA Jr, Boudreaux ED; ED-SAFE Investigators. Lethal means restriction for suicide prevention: beliefs and behaviors of emergency department providers. Depress Anxiety. 2013 Oct;30(10):1013-20. doi — View Citation

Betz ME, Sullivan AF, Manton AP, Espinola JA, Miller I, Camargo CA Jr, Boudreaux ED; ED-SAFE Investigators. Knowledge, attitudes, and practices of emergency department providers in the care of suicidal patients. Depress Anxiety. 2013 Oct;30(10):1005-12. d — View Citation

Boudreaux ED, Miller I, Goldstein AB, Sullivan AF, Allen MH, Manton AP, Arias SA, Camargo CA Jr. The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations. Contemp Clin Trials. 2013 Sep;36(1):14-24. do — View Citation

Caterino JM, Sullivan AF, Betz ME, Espinola JA, Miller I, Camargo CA Jr, Boudreaux ED; Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) Investigators. Evaluating current patterns of assessment for self-harm in emergency department — View Citation

Ting SA, Sullivan AF, Boudreaux ED, Miller I, Camargo CA Jr. Trends in US emergency department visits for attempted suicide and self-inflicted injury, 1993-2008. Gen Hosp Psychiatry. 2012 Sep-Oct;34(5):557-65. doi: 10.1016/j.genhosppsych.2012.03.020. Epub — View Citation

Ting SA, Sullivan AF, Miller I, Espinola JA, Allen MH, Camargo CA Jr, Boudreaux ED; Emergency Department Safety and Follow-up Evaluation (ED-SAFE) Investigators. Multicenter study of predictors of suicide screening in emergency departments. Acad Emerg Med — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of ER patients screened for self harm		July 2010 - November 2013
Primary	Quality of care	Process outcomes (e.g. receipt of safety plan); Involvement in behavioral health treatment	July 2010 - November 2014
Primary	Suicide-related outcomes	Preparatory acts; Suicide attempts; Completed suicides	July 2010 - November 2014