Emergency Department Safety Assessment and Follow-up Evaluation 2
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Hospital, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/8/2019 |
| Start Date: | December 2015 |
| End Date: | June 2020 |
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.
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.
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.
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.
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
We found this trial at
8
sites
Memorial Hospital of Rhode Island Memorial Hospital of Rhode Island is a 294-bed community teaching...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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