Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)
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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 ED Safety Assessment and Follow-up Evaluation (EDSAFE) trial. Two inter-related studies will be conducted using a quasi-experimental design appropriate for studying systems-based change. The studies will share three phases of data collection: Treatment as Usual, Screening Alone, and Intervention. During each phase, 472 suicidal patients (1,416 total) will be enrolled and followed using multiple methods for 12 months.
The first study, the Screening Outcome Study, will use data collected during the first two phases (Treatment as Usual and Screening Alone). 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. The second study, the Care-chain Evaluation Study, will use data collected during the last two phases (Screening Alone and Intervention). Primarily, it will evaluate the impact of a multi-component intervention on suicide outcomes. The intervention blends conceptual underpinnings from screening, brief intervention, and referral to treatment (SBIRT) models for health behaviors with empirically grounded strategies for suicide prevention. It will involve (1) Question, Refer, Persuade counseling provided by the treating nurse, (2) incorporation of a Comprehensive Suicide Management Protocol into clinical practice, and (3) post-discharge telephone counseling. Our overarching hypotheses will be tested using a combination of both studies. We predict that screening will improve detection of suicidal ideation, and the intervention will enhance the quality of care and reduce suicide outcomes.
Condition | Intervention | Phase |
---|---|---|
Suicide |
Behavioral: Enhanced screening for suicide ideation and behavior |
Phase 0 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Screening |
Official Title: | Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) |
- Percentage of ER patients screened for self harm [ Time Frame: July 2010 - June 2013 ] [ Designated as safety issue: No ]
Estimated Enrollment: | 1400 |
Study Start Date: | July 2010 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
No Intervention: Treatment as Usual | |
No Intervention: Screening Alone
Enhanced screening among ED patients
|
|
Experimental: Safety Care-chain
ED referral and evaluation followed by post-ED counseling
|
Behavioral: Enhanced screening for suicide ideation and behavior
QPR and mental health evaluation in ED, followed by Post-ED counseling
|
Detailed Description:
see brief summary
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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.
Contact: Edwin Boudreaux, PhD | 508-334-3817 | Edwin.Boudreaux@umassmed.edu |
United States, Arizona | |
Maricopa Medical Center | Recruiting |
Phoenix, Arizona, United States, 85008 | |
Contact: Mary Mulrow, RN,MN 602-344-5058 mary_mulrow@medprodoctors.com | |
Principal Investigator: Frank LoVecchio, DO | |
United States, Arkansas | |
University of Arkansas Medical Center | Recruiting |
Little Rock, Arkansas, United States, 72205 | |
Contact: Cody Burnett 501-686-8586 CABurnett@uams.edu | |
Principal Investigator: Talmage M. Holmes, MPH, PhD | |
United States, Colorado | |
University of Colorado Hospital | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Emily Caldes 303-724-4698 emily.caldes@ucdenver.edu | |
Principal Investigator: Marian Betz, MD, MPH | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Daniel Johnston, RN, BSc 617-754-2332 dsjohnst@bidmc.harvard.edu | |
Principal Investigator: Maura Kennedy, MD, MPH | |
UMass Medical School, Marlborough Hospital | Recruiting |
Worcester, Massachusetts, United States, 01655 | |
Contact: Thomas Bertrand, MPH 508-241-1436 Thomas.Bertrand@umassmed.edu | |
Principal Investigator: Edwin D. Boudreaux, PhD | |
United States, Nebraska | |
University of Nebraska Medical Center | Recruiting |
Omaha, Nebraska, United States, 68195 | |
Contact: Ilir Frrokaj 402-559-6687 ifrrokaj@unmc.edu | |
Principal Investigator: Wesley Zeger, DO | |
United States, Ohio | |
Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Lynn White, MS, CCRP 614-293-5102 Lynn.White@osumc.edu | |
Principal Investigator: Jeffrey Caterino, MD, MD | |
United States, Rhode Island | |
Memorial Hospital of Rhode Island | Recruiting |
Pawtucket, Rhode Island, United States, 02860 | |
Contact: Gretchen Sloane, RN, BSN 401-729-2539 Gretchen_Sloane@mhri.org | |
Principal Investigator: Lisa Uebelacker, PhD |
Principal Investigator: | Edwin Boudreaux, PhD | UMass Medical School |
No publications provided
Responsible Party: | Edwin Boudreaux, Study Principle Investigator, University of Massachusetts, Worcester |
ClinicalTrials.gov Identifier: | NCT01150994 History of Changes |
Other Study ID Numbers: | 13420, 1U01MH088278-01 |
Study First Received: | June 24, 2010 |
Last Updated: | October 11, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Massachusetts, Worcester:
Suicide screening among ED patients |
Additional relevant MeSH terms:
Emergencies Suicide Disease Attributes |
Pathologic Processes Self-Injurious Behavior Behavioral Symptoms |
ClinicalTrials.gov processed this record on October 17, 2012