SuicideED-SAFE-2NCT02453243
Emergency Department Safety Assessment and Follow-up Evaluation 2
A study testing Safety Planning and A Lean Implementation Strategy in people with Suicide, run by University of Massachusetts, Worcester at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- Safety Planning and A Lean Implementation Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,250 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2014to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ED patients >18 years old
- Seen in ED triage
Who cannot join
- patients <18 years old
- not seen in ED triage
- Adults unable to consent
- Prisoners
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Colorado Hospital
Aurora, Colorado, 80045
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Ohio State Univeristy Medical Center
Columbus, Ohio, 43210
University of Arkansas Medical Center
Little Rock, Arkansas, 72205
Marlborough Hospital
Marlborough, Massachusetts, 01752
University of Nebraska Medical Center
Omaha, Nebraska, 68195
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860
Maricopa Medical Center
Phoenix, Arizona, 85008
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Suicide
- Being tested
- Safety Planning, A Lean Implementation Strategy
- Keywords
- Suicide screening in the ED, Safety Planning
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety PlanningBehavioural
Suicide screen-positive patients who are to be discharged from the ED will receive personalized safety planning by a mental health clinician or nurse
A Lean Implementation StrategyBehavioural
The Safety Planning Intervention will be implemented using Lean performance improvement strategies.
Sites will be trained on the Safety Planning Intervention and Lean.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Safety Planning; Behavioral: A Lean Implementation Strategy |
| Maintenance | No intervention | Test sustainability of safety planning during the Maintenance phase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months after the Index ED Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startJan 2014
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Edwin Boudreaux, University of Massachusetts, Worcester
- Investigators
- Edwin D Boudreaux, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453243
- Sponsor's protocol ID
- H000007010
- Other IDs
- R01MH106726
- Acronym
- ED-SAFE-2
- Status last verified
- Aug 2020
- First submitted
- 16 Apr 2015
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Boudreaux ED, Ardelean AJ, Davis-Martin RE, Kelly L, Betz M; ED-SAFE 2 Investigators. Suicide risk among emergency care patients: Exploring incidental risk detection during routine care. Gen Hosp Psychiatry. 2026 Jul-Aug;101:82-92. doi: 10.1016/j.genhosppsych.2026.05.011. Epub 2026 May 17.
PubMed 42214265Boudreaux 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.
PubMed 37195676
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Safety Assessment and Follow-up Evaluation 2
- ClinicalTrials.gov ID
- NCT02453243
- Acronym / sponsor ID
- ED-SAFE-2 / H000007010
- Conditions
- Suicide
- Keywords
- Suicide screening in the ED, Safety Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,250 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2014 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Safety Planning, Behavioral: A Lean Implementation Strategy1. 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. |
| Maintenance | No intervention | –Test sustainability of safety planning during the Maintenance phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ED patients >18 years old
- Seen in ED triage
Key exclusion criteria (4 listed)
- patients <18 years old
- not seen in ED triage
- Adults unable to consent
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety PlanningSuicide screen-positive patients who are to be discharged from the ED will receive personalized safety planning by a mental health clinician or nurse | Behavioural | Intervention |
| A Lean Implementation StrategyThe Safety Planning Intervention will be implemented using Lean performance improvement strategies. Sites will be trained on the Safety Planning Intervention and Lean. | Behavioural | Intervention |
Primary outcome
Suicide Risk Screening
Time frame: up to 4 years
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
Time frame: up to 4 years
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
Time frame: 6 months after the Index ED Visit
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Derived from this study: PubMed 42214265Boudreaux ED, Ardelean AJ, Davis-Martin RE, Kelly L, Betz M; ED-SAFE 2 Investigators. Suicide risk among emergency care patients: Exploring incidental risk detection during routine care. Gen Hosp Psychiatry. 2026 Jul-Aug;101:82-92. doi: 10.1016/j.genhosppsych.2026.05.011. Epub 2026 May 17.
- Derived from this study: PubMed 37195676Boudreaux 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin D Boudreaux, PhD principal investigator
University of Massachusetts, Worcester
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Planning and A Lean Implementation Strategy in people with Suicide, run by University of Massachusetts, Worcester at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide Risk Screening (time frame: up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02453243, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.