Suicide Clinical Trial
— ED-SAFEOfficial title:
Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)
Verified date | March 2019 |
Source | University of Massachusetts, Worcester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Massachusetts, Worcester | National Institute of Mental Health (NIMH) |
United States,
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
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 |
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