Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)
This trial is active, not recruiting.
|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|
|Phoenix, AZ||Maricopa Medical Center||no longer recruiting|
|Little Rock, AR||University of Arkansas Medical Center||no longer recruiting|
|Aurora, CO||University of Colorado Hospital||no longer recruiting|
|Boston, MA||Beth Israel Deaconess Medical Center||no longer recruiting|
|Worcester, MA||UMass Medical School, Marlborough Hospital||no longer recruiting|
|Omaha, NE||University of Nebraska Medical Center||no longer recruiting|
|Columbus, OH||Ohio State University Medical Center||no longer recruiting|
|Pawtucket, RI||Memorial Hospital of Rhode Island||no longer recruiting|
|Intervention model||single group assignment|
|Masking||single blind (subject)|
Percentage of ER patients screened for self harm
time frame: July 2010 - November 2013
Quality of care
time frame: July 2010 - November 2014
time frame: July 2010 - November 2014
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.
|Official title||Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)|
|Principal investigator||Edwin Boudreaux, PhD|
|Description||see summary above|
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