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

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
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Edwin Boudreaux, University of Massachusetts, Worcester

Study Description
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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 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

Detailed Description:
see summary above
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Treatment as Usual
No Intervention: Screening Alone
Enhanced screening among ED patients
Experimental: Safety Assessment and Follow-up Telephone Intervention
SAFTI: Safety Assessment in the ED combine with a Follow-up Telephone Intervention.
 Behavioral: Safety Assessment and Follow-up Telephone Intervention (SAFTI).
Mental health evaluation in ED, followed by Post-ED counseling


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of ER patients screened for self harm [ Time Frame: July 2010 - November 2013 ]
  2. Quality of care [ Time Frame: July 2010 - November 2014 ]
    • Process outcomes (e.g. receipt of safety plan)
    • Involvement in behavioral health treatment

  3. Suicide-related outcomes [ Time Frame: July 2010 - November 2014 ]
    • Preparatory acts
    • Suicide attempts
    • Completed suicides


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
University of Massachusetts, Worcester
National Institute of Mental Health (NIMH)
Investigators
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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
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Edwin Boudreaux, Study Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01150994    
Other Study ID Numbers: 13420
1U01MH088278-01 ( U.S. NIH Grant/Contract )
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Keywords provided by Edwin Boudreaux, University of Massachusetts, Worcester:
Suicide screening among ED patients
Additional relevant MeSH terms:
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Emergencies
Suicide
Disease Attributes
 Pathologic Processes
Self-Injurious Behavior
Behavioral Symptoms