A System of Safety (SOS)

NCT03104504 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 493756

Last updated 2024-03-12

No results posted yet for this 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

  • 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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03104504 on ClinicalTrials.gov