Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) (ED-SAFE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01150994 |
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Recruitment Status :
Active, not recruiting
First Posted : June 25, 2010
Last Update Posted : March 19, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Suicide | Behavioral: Safety Assessment and Follow-up Telephone Intervention (SAFTI). | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1440 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Screening |
| Official Title: | Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) |
| Study Start Date : | July 2010 |
| Estimated Primary Completion Date : | November 2018 |
| Estimated Study Completion Date : | November 2018 |
| Arm | Intervention/treatment |
|---|---|
| No Intervention: Treatment as Usual | |
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No Intervention: Screening Alone
Enhanced screening among ED patients
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Experimental: Safety Assessment and Follow-up Telephone Intervention
SAFTI: Safety Assessment in the ED combine with a Follow-up Telephone Intervention.
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Behavioral: Safety Assessment and Follow-up Telephone Intervention (SAFTI).
Mental health evaluation in ED, followed by Post-ED counseling |
- Percentage of ER patients screened for self harm [ Time Frame: July 2010 - November 2013 ]
- Quality of care [ Time Frame: July 2010 - November 2014 ]
- Process outcomes (e.g. receipt of safety plan)
- Involvement in behavioral health treatment
- Suicide-related outcomes [ Time Frame: July 2010 - November 2014 ]
- Preparatory acts
- Suicide attempts
- Completed suicides
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150994
| United States, Arizona | |
| Maricopa Medical Center | |
| Phoenix, Arizona, United States, 85008 | |
| United States, Arkansas | |
| University of Arkansas Medical Center | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, Colorado | |
| University of Colorado Hospital | |
| Aurora, Colorado, United States, 80045 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| UMass Medical School, Marlborough Hospital | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68195 | |
| United States, Ohio | |
| Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Rhode Island | |
| Memorial Hospital of Rhode Island | |
| Pawtucket, Rhode Island, United States, 02860 | |
| Principal Investigator: | Edwin Boudreaux, PhD | UMass Medical School | |
| Principal Investigator: | Carlos Camargo, MD, DrPH | Massachusetts General Hospital | |
| Principal Investigator: | Ivan Miller III, PhD | Butler Hospital |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Edwin Boudreaux, Study Principal Investigator, University of Massachusetts, Worcester |
| ClinicalTrials.gov Identifier: | NCT01150994 History of Changes |
| Other Study ID Numbers: |
13420 1U01MH088278-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 25, 2010 Key Record Dates |
| Last Update Posted: | March 19, 2018 |
| Last Verified: | March 2018 |
Keywords provided by Edwin Boudreaux, University of Massachusetts, Worcester:
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Suicide screening among ED patients |
Additional relevant MeSH terms:
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Emergencies Suicide Disease Attributes |
Pathologic Processes Self-Injurious Behavior Behavioral Symptoms |