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

Primary Purpose

Suicide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Assessment and Follow-up Telephone Intervention (SAFTI).
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Suicide focused on measuring Suicide screening among ED patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maricopa Medical Center
  • University of Arkansas Medical Center
  • University of Colorado Hospital
  • Beth Israel Deaconess Medical Center
  • UMass Medical School, Marlborough Hospital
  • University of Nebraska Medical Center
  • Ohio State University Medical Center
  • Memorial Hospital of Rhode Island

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Experimental

Arm Label

Treatment as Usual

Screening Alone

Safety Assessment and Follow-up Telephone Intervention

Arm Description

Enhanced screening among ED patients

SAFTI: Safety Assessment in the ED combine with a Follow-up Telephone Intervention.

Outcomes

Primary Outcome Measures

Percentage of ER patients screened for self harm
Quality of care
Process outcomes (e.g. receipt of safety plan) Involvement in behavioral health treatment
Suicide-related outcomes
Preparatory acts Suicide attempts Completed suicides

Secondary Outcome Measures

Full Information

First Posted
June 24, 2010
Last Updated
March 12, 2019
Sponsor
University of Massachusetts, Worcester
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01150994
Brief Title
Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)
Acronym
ED-SAFE
Official Title
Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
see summary above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Suicide screening among ED patients

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
1440 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Title
Screening Alone
Arm Type
No Intervention
Arm Description
Enhanced screening among ED patients
Arm Title
Safety Assessment and Follow-up Telephone Intervention
Arm Type
Experimental
Arm Description
SAFTI: Safety Assessment in the ED combine with a Follow-up Telephone Intervention.
Intervention Type
Behavioral
Intervention Name(s)
Safety Assessment and Follow-up Telephone Intervention (SAFTI).
Intervention Description
Mental health evaluation in ED, followed by Post-ED counseling
Primary Outcome Measure Information:
Title
Percentage of ER patients screened for self harm
Time Frame
July 2010 - November 2013
Title
Quality of care
Description
Process outcomes (e.g. receipt of safety plan) Involvement in behavioral health treatment
Time Frame
July 2010 - November 2014
Title
Suicide-related outcomes
Description
Preparatory acts Suicide attempts Completed suicides
Time Frame
July 2010 - November 2014

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin Boudreaux, PhD
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Camargo, MD, DrPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ivan Miller III, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maricopa Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
University of Arkansas Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UMass Medical School, Marlborough Hospital
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68195
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Memorial Hospital of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24588679
Citation
Arias SA, Zhang Z, Hillerns C, Sullivan AF, Boudreaux ED, Miller I, Camargo CA. Using structured telephone follow-up assessments to improve suicide-related adverse event detection. Suicide Life Threat Behav. 2014 Oct;44(5):537-47. doi: 10.1111/sltb.12088. Epub 2014 Mar 3.
Results Reference
result
PubMed Identifier
23426881
Citation
Betz ME, Sullivan AF, Manton AP, Espinola JA, Miller I, Camargo CA Jr, Boudreaux ED; ED-SAFE Investigators. Knowledge, attitudes, and practices of emergency department providers in the care of suicidal patients. Depress Anxiety. 2013 Oct;30(10):1005-12. doi: 10.1002/da.22071. Epub 2013 Feb 20.
Results Reference
result
PubMed Identifier
23495002
Citation
Betz ME, Miller M, Barber C, Miller I, Sullivan AF, Camargo CA Jr, Boudreaux ED; ED-SAFE Investigators. Lethal means restriction for suicide prevention: beliefs and behaviors of emergency department providers. Depress Anxiety. 2013 Oct;30(10):1013-20. doi: 10.1002/da.22075. Epub 2013 Mar 14.
Results Reference
result
PubMed Identifier
25726978
Citation
Betz ME, Arias SA, Miller M, Barber C, Espinola JA, Sullivan AF, Manton AP, Miller I, Camargo CA Jr, Boudreaux ED. Change in emergency department providers' beliefs and practices after use of new protocols for suicidal patients. Psychiatr Serv. 2015 Jun;66(6):625-31. doi: 10.1176/appi.ps.201400244. Epub 2015 Mar 1.
Results Reference
result
PubMed Identifier
23707435
Citation
Boudreaux ED, Miller I, Goldstein AB, Sullivan AF, Allen MH, Manton AP, Arias SA, Camargo CA Jr. The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations. Contemp Clin Trials. 2013 Sep;36(1):14-24. doi: 10.1016/j.cct.2013.05.008. Epub 2013 May 22.
Results Reference
result
PubMed Identifier
24033624
Citation
Caterino JM, Sullivan AF, Betz ME, Espinola JA, Miller I, Camargo CA Jr, Boudreaux ED; Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) Investigators. Evaluating current patterns of assessment for self-harm in emergency departments: a multicenter study. Acad Emerg Med. 2013 Aug;20(8):807-15. doi: 10.1111/acem.12188.
Results Reference
result
PubMed Identifier
22554432
Citation
Ting SA, Sullivan AF, Boudreaux ED, Miller I, Camargo CA Jr. Trends in US emergency department visits for attempted suicide and self-inflicted injury, 1993-2008. Gen Hosp Psychiatry. 2012 Sep-Oct;34(5):557-65. doi: 10.1016/j.genhosppsych.2012.03.020. Epub 2012 May 2.
Results Reference
result
PubMed Identifier
22288721
Citation
Ting SA, Sullivan AF, Miller I, Espinola JA, Allen MH, Camargo CA Jr, Boudreaux ED; Emergency Department Safety and Follow-up Evaluation (ED-SAFE) Investigators. Multicenter study of predictors of suicide screening in emergency departments. Acad Emerg Med. 2012 Feb;19(2):239-43. doi: 10.1111/j.1553-2712.2011.01272.x. Epub 2012 Jan 30.
Results Reference
result
PubMed Identifier
32706437
Citation
Brown LA, Boudreaux ED, Arias SA, Miller IW, May AM, Camargo CA Jr, Bryan CJ, Armey MF. C-SSRS performance in emergency department patients at high risk for suicide. Suicide Life Threat Behav. 2020 Dec;50(6):1097-1104. doi: 10.1111/sltb.12657. Epub 2020 Jul 24.
Results Reference
derived
PubMed Identifier
26654691
Citation
Boudreaux ED, Camargo CA Jr, Arias SA, Sullivan AF, Allen MH, Goldstein AB, Manton AP, Espinola JA, Miller IW. Improving Suicide Risk Screening and Detection in the Emergency Department. Am J Prev Med. 2016 Apr;50(4):445-453. doi: 10.1016/j.amepre.2015.09.029. Epub 2015 Dec 4.
Results Reference
derived

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

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