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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: Completed NA study of Suicide, sponsored by University of Massachusetts, Worcester.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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).
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 |
What the finished NCT03104504 record still lists
NCT03104504 is an interventional study that assigns participants to a tested intervention. Its 493,756 participants enrollment target places it among the larger protocols in the corpus, above the 1,623-participant average among 92 other Suicide trials with a reported enrollment target (30322% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Suicide
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03104504's enrollment target sits among peer trials
493,756 1st of 92 higher than 92 of 92 other Suicide trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Suicide trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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