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Emergency Department Safety Assessment and Follow-up Evaluation 2 (ED-SAFE-2)

Primary Purpose

Suicide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Planning
A Lean Implementation Strategy
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide focused on measuring Suicide screening in the ED, Safety Planning

Eligibility Criteria

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

Inclusion Criteria:

  • ED patients >18 years old
  • Seen in ED triage

Exclusion Criteria:

  • patients <18 years old
  • not seen in ED triage
  • Adults unable to consent
  • Prisoners

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Other

No Intervention

Arm Label

Baseline

Intervention

Maintenance

Arm Description

Retrospective Chart Reviews will be conducted for the period between the original ED-SAFE and the new study to test the long-term sustainability of nurse administered universal screening implemented in the original study.

Safety Plan Intervention: Clinician training in safety planning, and A Lean Implementation Strategy: The Implementation of the safety planning guided by Lean Combine, this is expected to increase safety planning by clinicians.

Test sustainability of safety planning during the Maintenance phase.

Outcomes

Primary Outcome Measures

Suicide Risk Screening
Consistent with the parent ED-SAFE, a completed suicide screen will be defined as any chart documentation of the presence OR absence of suicidal ideation AND presence or absence of a past suicide attempt (0 = None documented, 1 = Partial (+/- ideation OR attempt noted), 2 = Complete (+/- ideation AND attempt noted). The proportion of general ED patients with a complete screen within each study phase will comprise the primary clinician-level outcome for analyses pertaining to screening (Aim 1). Sensitivity analyses will expand the definition to partial OR complete screens.
Suicide Risk Detection
Using the parent ED-SAFE criteria, a positive screen (i.e., detection) will be defined as any individual who either endorsed active ideation OR reported a lifetime suicide attempt. The proportion of general ED patients with a positive screen within each study phase will comprise the primary patient-level outcome for analyses pertaining to risk detection.
Safety Planning & Suicide Composite
We decided that our primary outcome measure should be a broadly defined composite that reflects the subsequent occurrence of significant suicidal behavior/risk. This measure will be defined as the occurrence of any one of the following: (a) suicide, (b) any ED visit or hospitalization related to suicidal ideation or behavior.

Secondary Outcome Measures

Full Information

First Posted
April 16, 2015
Last Updated
August 6, 2020
Sponsor
University of Massachusetts, Worcester
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02453243
Brief Title
Emergency Department Safety Assessment and Follow-up Evaluation 2
Acronym
ED-SAFE-2
Official Title
Emergency Department Safety Assessment and Follow-up Evaluation 2
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 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
Many patients at risk for suicide are discharged from the ED with little or no intervention. Evidence-based suicide prevention interventions, like universal screening and safety planning should be adopted in clinical practice to help prevent suicidal behavior. This study will test the long-term sustainability of the nurse administered universal screening implemented in the original ED-SAFE study. Also, the investigators will test the impact of a new personalized Safety Planning Intervention guided by Lean has on suicide composite outcomes. The ED-SAFE-2 will use a stepped wedge design where the original eight ED-SAFE sites will collect quantitative and qualitative data during the three phases: Baseline, Implementation, and Maintenance. Using this data, the ED-SAFE-2 will examine both within and between site differences for existing screening practices and new care processes, including safety planning. Most of the data collection on outcomes will be done by retrospective chart review. A Lean Implementation Strategy will be used to ensure that adoption of improved care processes are fully supported vertically and horizontally within the organization, infrastructure is built that supports the efforts, and that the protocols fit naturally within roles, responsibilities, and clinical flow. Consistent with the RFA's emphasis, the intervention target will be the clinician's behavior, including, at minimum, screening and safety planning. All emergency mental health and nursing personnel at the sites will be trained on safety planning, and Lean will be used to help ensure the safety planning is being implemented properly and consistently. The mechanisms of action of the combination of the safety planning training and Lean will be studied, allowing the team to establish both the effect the intervention has on the intervention target but also on the mechanisms of action comprised of departmental culture change and infrastructure support.
Detailed Description
Suicide risk is much more prevalent among general emergency department (ED) patients than in the general community but this risk often goes undetected, especially among patients presenting with non-psychiatric complaints. By definition, universal screening is the only way to identify occult risk among patients presenting for non-psychiatric complaints. Until recently, however, little was known about how to implement universal screening in a clinical ED setting or whether doing so had any effect on detecting risk. The ED-SAFE has shown that it is feasible to implement universal screening and that the screening increases detection of suicide risk. Simply identifying risk is not sufficient; efforts must be taken to mitigate risk and prevent suicidal behavior. However, many studies have shown that even those patients identified as having clinically significant risk are often discharged home without receiving any kind of active intervention during the ED visit, with many not even receiving a psychiatric evaluation.1-3 Brief interventions that are a good fit for the ED are needed. One such intervention has received strong research support and has already been accepted as a best practice in the United States Department of Veterans Affairs: Safety Planning Intervention.4 This intervention, however, has not been adopted in civilian EDs and little is known about how to effectively implement it, and whether doing so impacts suicide-related outcomes. This study will address the following specific aims: Aim 1: Test the long-term sustainability of nurse administered universal screening implemented in the original study across two new time periods. (a) The first is the period between the original ED-SAFE and the new study (ED-SAFE-2), which represents an ecologically valid "natural" state without any grant support, hereafter referred to as Baseline. (b) The second is the Maintenance phase of the new study, which will represent a time period spanning a minimum of four years after screening was initially implemented. • Primary hypothesis: Sites that sustained high screening rates (intervention target) will sustain improved suicide risk detection (patient outcome) during each time period examined. Sustained screening practices will be mediated through ED organizational characteristics and enabling infrastructure (mechanisms of action). Aim 2: Test the impact of implementing the new personalized Safety Planning Intervention for patients with suicide risk who are discharged from the ED. • Primary hypotheses: Clinician training in safety planning, combined with implementation guided by Lean, is expected to increase safety planning by clinicians (intervention target), which will result in reduced suicide and suicide-related acute healthcare in the 6-months post-visit (suicide composite outcome). This will be more likely in sites with organizational characteristics and infrastructure that supports safety planning (mechanisms of action). Aim 3: Test sustainability of safety planning during the Maintenance phase. • Primary hypotheses: Sustained safety planning will result in sustained reductions in the suicide composite outcome. Sustained safety planning will be mediated by strong organizational characteristics and a robust enabling infrastructure supporting safety planning.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
14250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline
Arm Type
No Intervention
Arm Description
Retrospective Chart Reviews will be conducted for the period between the original ED-SAFE and the new study to test the long-term sustainability of nurse administered universal screening implemented in the original study.
Arm Title
Intervention
Arm Type
Other
Arm Description
Safety Plan Intervention: Clinician training in safety planning, and A Lean Implementation Strategy: The Implementation of the safety planning guided by Lean Combine, this is expected to increase safety planning by clinicians.
Arm Title
Maintenance
Arm Type
No Intervention
Arm Description
Test sustainability of safety planning during the Maintenance phase.
Intervention Type
Behavioral
Intervention Name(s)
Safety Planning
Intervention Description
Suicide screen-positive patients who are to be discharged from the ED will receive personalized safety planning by a mental health clinician or nurse
Intervention Type
Behavioral
Intervention Name(s)
A Lean Implementation Strategy
Intervention Description
The Safety Planning Intervention will be implemented using Lean performance improvement strategies. Sites will be trained on the Safety Planning Intervention and Lean.
Primary Outcome Measure Information:
Title
Suicide Risk Screening
Description
Consistent with the parent ED-SAFE, a completed suicide screen will be defined as any chart documentation of the presence OR absence of suicidal ideation AND presence or absence of a past suicide attempt (0 = None documented, 1 = Partial (+/- ideation OR attempt noted), 2 = Complete (+/- ideation AND attempt noted). The proportion of general ED patients with a complete screen within each study phase will comprise the primary clinician-level outcome for analyses pertaining to screening (Aim 1). Sensitivity analyses will expand the definition to partial OR complete screens.
Time Frame
up to 4 years
Title
Suicide Risk Detection
Description
Using the parent ED-SAFE criteria, a positive screen (i.e., detection) will be defined as any individual who either endorsed active ideation OR reported a lifetime suicide attempt. The proportion of general ED patients with a positive screen within each study phase will comprise the primary patient-level outcome for analyses pertaining to risk detection.
Time Frame
up to 4 years
Title
Safety Planning & Suicide Composite
Description
We decided that our primary outcome measure should be a broadly defined composite that reflects the subsequent occurrence of significant suicidal behavior/risk. This measure will be defined as the occurrence of any one of the following: (a) suicide, (b) any ED visit or hospitalization related to suicidal ideation or behavior.
Time Frame
6 months after the Index ED Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ED patients >18 years old Seen in ED triage Exclusion Criteria: patients <18 years old not seen in ED triage Adults unable to consent Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin D Boudreaux, PhD
Organizational Affiliation
University of Massachusetts, Worcester
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
Marlborough Hospital
City
Marlborough
State/Province
Massachusetts
ZIP/Postal Code
01752
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 Univeristy 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

Plan to Share IPD
No

Learn more about this trial

Emergency Department Safety Assessment and Follow-up Evaluation 2

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