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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Edwin Boudreaux, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01150994
First received: June 24, 2010
Last updated: November 21, 2014
Last verified: November 2014

June 24, 2010
November 21, 2014
July 2010
November 2015   (final data collection date for primary outcome measure)
  • Percentage of ER patients screened for self harm [ Time Frame: July 2010 - November 2013 ] [ Designated as safety issue: No ]
  • Quality of care [ Time Frame: July 2010 - November 2014 ] [ Designated as safety issue: No ]
    • Process outcomes (e.g. receipt of safety plan)
    • Involvement in behavioral health treatment
  • Suicide-related outcomes [ Time Frame: July 2010 - November 2014 ] [ Designated as safety issue: No ]
    • Preparatory acts
    • Suicide attempts
    • Completed suicides
Percentage of ER patients screened for self harm [ Time Frame: July 2010 - June 2013 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01150994 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)
Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)

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.

see summary above

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Suicide
Behavioral: Safety Assessment and Follow-up Telephone Intervention (SAFTI).
Mental health evaluation in ED, followed by Post-ED counseling
  • 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.
    Intervention: Behavioral: Safety Assessment and Follow-up Telephone Intervention (SAFTI).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1440
November 2015
November 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01150994
13420, 1U01MH088278-01
Yes
Edwin Boudreaux, University of Massachusetts, Worcester
University of Massachusetts, Worcester
National Institute of Mental Health (NIMH)
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
University of Massachusetts, Worcester
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP