A System of Safety (SOS)
NCT03104504 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 493756
Last updated 2024-03-12
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
- Suicide
Interventions
- BEHAVIORAL
-
Suicide Risk Screening
Suicide risk screening will be implemented as the standard of care for all patients who present for treatment.
- BEHAVIORAL
-
Safety Planning
Suicide screen-positive patients who are to be discharged from the hospital will receive personalized safety planning by a mental health clinician or nurse that includes means restriction counseling as a step in the safety plan.
- BEHAVIORAL
-
Care transition facilitation
Include post-acute telephone phone call follow-up to foster engagement with outpatient care and problem solving within 24 hours of discharge
- BEHAVIORAL
-
A Lean Implementation Strategy
The Interventions will be implemented using Lean performance improvement strategies
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH -
University of Massachusetts, Worcester
lead OTHER
Principal Investigators
-
Edwin D Boudreaux, PhD · University of Massachusetts, Worcester
-
Catarina Kiefe, MD, PhD · University of Massachusetts, Worcester
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-01
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
Countries
- United States
Study Locations
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