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NCT02453243 · ClinicalTrials.gov registry record · NA
Emergency Department Safety Assessment and Follow-up Evaluation 2
A NA study, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- NA
- Development phase
- 14,250
- Enrollment target
NCT02453243 is a NA study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 14,250 participants.
The verdict
NCT02453243, a NA study, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- NA
- Development phase
- 14,250 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Safety Planning
- BEHAVIORAL A Lean Implementation Strategy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,250 participants |
| Start Date | 2014-01 |
| Est. Completion | 2018-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02453243
The ClinicalTrials.gov registry entry for NCT02453243 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14,250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Massachusetts, Worcester, which has 240 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Safety Planning is the first listed.
NCT02453243 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02453243 about?
NCT02453243 is a clinical study titled "Emergency Department Safety Assessment and Follow-up Evaluation 2". 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 sust...
What is the current status of trial NCT02453243?
This trial is currently completed. It is a NA study. The enrollment target is 14,250 participants. The study started on 2014-01. Estimated completion is 2018-10.
What interventions are being tested in trial NCT02453243?
The interventions under investigation include: Safety Planning (BEHAVIORAL), A Lean Implementation Strategy (BEHAVIORAL).
Who is sponsoring clinical trial NCT02453243?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
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