Suicide Clinical Trial
— ED-SAFE-2Official title:
Emergency Department Safety Assessment and Follow-up Evaluation 2
Verified date | August 2020 |
Source | University of Massachusetts, Worcester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14250 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Hospital | Aurora | Colorado |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Ohio State Univeristy Medical Center | Columbus | Ohio |
United States | University of Arkansas Medical Center | Little Rock | Arkansas |
United States | Marlborough Hospital | Marlborough | Massachusetts |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Memorial Hospital of Rhode Island | Pawtucket | Rhode Island |
United States | Maricopa Medical Center | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Massachusetts, Worcester | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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