Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)
| Tracking Information | |||||
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| First Received Date ICMJE | June 24, 2010 | ||||
| Last Updated Date | April 7, 2013 | ||||
| Start Date ICMJE | July 2010 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percentage of ER patients screened for self harm [ Time Frame: July 2010 - November 2013 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Percentage of ER patients screened for self harm [ Time Frame: July 2010 - June 2013 ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01150994 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) | ||||
| Official Title ICMJE | Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) | ||||
| Brief 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 Screening Alone and Intervention Phases, with conditional post-hoc and exploratory analyses using the Treatment as Usual phase. 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. |
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| Detailed Description | see summary above |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Screening |
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| Condition ICMJE | Suicide | ||||
| Intervention ICMJE | Behavioral: Safety Assessment and Follow-up Telephone Intervention (SAFTI).
Mental health evaluation in ED, followed by Post-ED counseling |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1400 | ||||
| Estimated Completion Date | November 2013 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01150994 | ||||
| Other Study ID Numbers ICMJE | 13420, 1U01MH088278-01 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Edwin Boudreaux, University of Massachusetts, Worcester | ||||
| Study Sponsor ICMJE | University of Massachusetts, Worcester | ||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Massachusetts, Worcester | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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