Emergency Department Safety Assessment and Follow-up Evaluation 2

NCT02453243 | Completed DMC

• 2 other identifiers: H000007010R01MH106726
• Study Type: interventional
• Target: 14,250
• Locations: 1 country
• Sites: 8

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.

Conditions

Suicide

Keywords

Suicide screening in the ED; Safety Planning

Outcome Measures

Primary Outcomes (3)

• 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.

  up to 4 years

• 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.

  up to 4 years

• 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.

  6 months after the Index ED Visit

Study Arms (3)

Baseline

NO INTERVENTION

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.

Intervention

OTHER

1. Safety Plan Intervention: Clinician training in safety planning, and 2. A Lean Implementation Strategy: The Implementation of the safety planning guided by Lean Combine, this is expected to increase safety planning by clinicians.

Behavioral: Safety Planning; Behavioral: A Lean Implementation Strategy

Maintenance

NO INTERVENTION

Test sustainability of safety planning during the Maintenance phase.

Interventions

Safety Planning BEHAVIORAL

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

A Lean Implementation Strategy BEHAVIORAL

The Safety Planning Intervention will be implemented using Lean performance improvement strategies. Sites will be trained on the Safety Planning Intervention and Lean.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (8)

Maricopa Medical Center

Phoenix, Arizona, 85008, United States

Location

University of Arkansas Medical Center

Little Rock, Arkansas, 72205, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Marlborough Hospital

Marlborough, Massachusetts, 01752, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68195, United States

Location

Ohio State Univeristy Medical Center

Columbus, Ohio, 43210, United States

Location

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

Related Publications (1)

• Boudreaux ED, Larkin C, Vallejo Sefair A, Ma Y, Li YF, Ibrahim AF, Zeger W, Brown GK, Pelletier L, Miller I; ED-SAFE 2 Investigators. Effect of an Emergency Department Process Improvement Package on Suicide Prevention: The ED-SAFE 2 Cluster Randomized Clinical Trial. JAMA Psychiatry. 2023 Jul 1;80(7):665-674. doi: 10.1001/jamapsychiatry.2023.1304.

  PMID: 37195676 DERIVED

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Edwin D Boudreaux, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Director of Research

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: May 25, 2015
• Study Start: January 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)