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NCT03104504 · ClinicalTrials.gov registry record · NA
A System of Safety (SOS)
A NA study of Suicide, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- NA
- Development phase
- 493,756
- Enrollment target
- 1
- Study location
NCT03104504 is a NA study of Suicide that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 493,756 participants, above the 1,623-participant average among 92 other Suicide trials with a reported enrollment target (30322% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03104504, a NA study of Suicide, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- NA
- Development phase
- 493,756 participants
- Enrollment target
- 1
- Study location
Study Summary
SOS will identify evidence based best practices consistent with Zero Suicide's six specific recommended clinical actions (A.2.) and use them to develop standardized clinical protocols for each care setting, clinical unit, population serviced, and clinical discipline. Using Lean CQI, the investigators will tailor, implement, and improve adherence to these protocols. To support feasibility, SOS will use a phased roll out and a hub-and-spoke design. The intervention targets will be suicide-related clinician behaviors. The investigators will aspire to adopt best practices and measure all six recommended performance elements; however, for feasibility, the research evaluation will focus on suicide risk screening, safety planning, means restriction counseling, and post-acute care follow-up calls. The primary patient outcomes will be suicide risk identification, suicide, suicide attempts, and suicide-related emergencies requiring acute care. The investigators will examine potential mechanisms of action and moderators, and conduct a cost effectiveness analysis of SOS versus usual care. The investigators will employ a stepped wedge design and follow individuals for 6 to 54 months. Outcomes, clinician behaviors, and other variables will be gathered through: (1) EHR data extraction, (2) claims data from UMMHC and the MA All Payer Claims Database, (3) random medical chart abstractions, (4) MA state vital statistics and National Death Index (NDI), (5) clinician surveys, (6) Lean evaluations and process observations, and (7) patient fidelity interviews. Data will be analyzed using generalized linear mixed models.
Conditions Studied
Interventions
- BEHAVIORAL Safety Planning
- BEHAVIORAL Suicide Risk Screening
- BEHAVIORAL Care transition facilitation
- BEHAVIORAL A Lean Implementation Strategy
Study Locations (1)
Massachusetts
- UMass Memorial Health Care - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 493,756 participants |
| Start Date | 2016-10-01 |
| Est. Completion | 2023-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03104504
The ClinicalTrials.gov registry entry for NCT03104504 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 493,756 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,623-participant average among 92 other Suicide trials with a reported enrollment target (30322% higher). The listed sponsor is University of Massachusetts, Worcester, which has 240 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Suicide appearing as the primary indexed condition, and to 4 interventions - of which Safety Planning is the first listed.
NCT03104504 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03104504 about?
NCT03104504 is a clinical study titled "A System of Safety (SOS)". SOS will identify evidence based best practices consistent with Zero Suicide's six specific recommended clinical actions (A.2.) and use them to develop standardized clinical protocols for each care setting, clinical unit, population serviced, and clinical discipline. Using Lean CQI, the investigator...
What is the current status of trial NCT03104504?
This trial is currently completed. It is a NA study. The enrollment target is 493,756 participants. The study started on 2016-10-01. Estimated completion is 2023-12-31.
What conditions does trial NCT03104504 study?
This clinical trial studies the following conditions: Suicide.
What interventions are being tested in trial NCT03104504?
The interventions under investigation include: Safety Planning (BEHAVIORAL), Suicide Risk Screening (BEHAVIORAL), Care transition facilitation (BEHAVIORAL), A Lean Implementation Strategy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03104504?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03104504 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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