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Emergency Department Safety Assessment and Follow-up Evaluation 2

Information source: University of Massachusetts, Worcester
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Suicide

Intervention: Safety Planning (Behavioral); A Lean Implementation Strategy (Behavioral)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of Massachusetts, Worcester

Official(s) and/or principal investigator(s):
Edwin D Boudreaux, PhD, Principal Investigator, Affiliation: University of Massachusetts, Worcester

Overall contact:
Edwin D Boudreaux, PhD, Email: Edwin.Boudreaux@umassmed.edu


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 what impact implementing 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, as well as data from the original ED-SAFE study, the ED-SAFE-2 will examine both within and between site differences for existing screening practices and new safety planning procedures. Most of the data collection on outcomes will be done by retrospective chart review. The Safety Plan Intervention will be adopted into routine clinical care for patients who screen positive but are set to be discharged. Each step is presented by the clinician and the responses are recorded on a templated form. After completion of the safety plan, the clinician helps the patient identify the most helpful aspects of the plan, ascertains the likelihood of actually using it, and addresses any potential barriers to use. The patient keeps the safety plan to use as a reminder during times of escalating distress or crisis. A Lean Implementation Strategy will be used to ensure that adoption of the intervention is 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 of 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.

Clinical Details

Official title: Emergency Department Safety Assessment and Follow-up Evaluation 2

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome:

Suicide Risk Screening

Suicide Risk Detection

Safety Planning & Suicide Composite

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Edwin D Boudreaux, PhD, Email: Edwin.Boudreaux@umassmed.edu

Maricopa Medical Center, Pheonix, Arizona 85008, United States; Not yet recruiting
Frank LoVecchio, DO

University of Arkansas Medical Center, Little Rock, Arkansas 72205, United States; Not yet recruiting
Carly Snipes, MD

University of Colorado Hospital, Aurora, Colorado 80045, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Not yet recruiting
Maura Kennedy, MD, MPH

Marlborough Hospital, Marlborough, Massachusetts 01752, United States; Not yet recruiting
Edwin D Boudreaux, PhD

University of Nebraska Medical Center, Omaha, Nebraska 68195, United States; Not yet recruiting
Wesley Zeger, DO

Ohio State Univeristy Medical Center, Columbus, Ohio 43210, United States; Not yet recruiting
Jeffrey Caterino, MD

Memorial Hospital of Rhode Island, Pawtucket, Rhode Island 02860, United States; Not yet recruiting
Lisa Uebelacker, PhD

Additional Information

Starting date: November 2015
Last updated: July 16, 2015

Page last updated: August 23, 2015

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