Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)

This study is currently recruiting participants.
Verified October 2012 by University of Massachusetts, Worcester
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Edwin Boudreaux, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01150994
First received: June 24, 2010
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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)

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01150994

Contacts
Contact: Edwin Boudreaux, PhD 508-334-3817 Edwin.Boudreaux@umassmed.edu

Locations
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            
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Edwin Boudreaux, PhD UMass Medical School
  More Information

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