A System of Safety (SOS)

NCT03104504 | Completed DMC

• 2 other identifiers: H000114071R01MH112138-01
• Study Type: interventional
• Target: 493,756
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Suicide Screening; Safety Planning

Outcome Measures

Primary Outcomes (6)

• Standardized suicide risk screening

  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).

  6 months after the Index ED Visit

• Safety planning

  A safety plan will be defined as a written document collaboratively developed with the patient identifying steps to take when feeling suicidal. We will code it as 0=None, no documentation of a safety plan, 1=Partial (e.g., some steps but not all completed), or 2=Complete (all six steps completed).

  6 months after the Index ED Visit

• Means restriction counseling

  a step in the Safety Plan Intervention includes means restriction counseling. We will code it as 0=None, no documentation of means restriction counseling, 1=Complete, documentation of means restriction counseling.

  6 months after the Index ED Visit

• 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 (0 = Not completed, 1 = Completed).

  6 months after the Index ED Visit

• Suicide risk identification

  A positive screen (i.e., identification) will be defined as patient endorsement of active ideation OR report of a lifetime suicide attempt. We will also examine ICD-10 codes assigned to each visit within claims data.

  6 months after the Index ED Visit

• Suicide outcomes

  Suicide will be ascertained through MA vital statistics review with the DPH Suicide Prevention Program. We will match definite and suspected suicides against the study population. Suicide attempt will be defined as an ED visit or a hospitalization with: an ICD-10 code (i.e., intentional self-injury) OR Positive suicide attempt on an encounter day per the EHR templated screener. Suicide-related acute healthcare encounter will be defined as a suicide attempt (same criteria as above) OR a ICD-10 code (i.e., suicidal ideation) OR positive screen for suicidal ideation per the EHR templated screener

  6 months after the Index ED Visit

Study Arms (2)

No Intervention

NO INTERVENTION

Baseline Retrospective Chart Reviews that are conducted on subjects for the one year period prior to the implementation of the study will serve as the control.

Intervention

OTHER

The intervention targets will be the following suicide-related clinician behaviors. * suicide risk screening * safety planning * means restriction counseling * Post-acute care follow-up calls A Lean Implementation Strategy: The Implementation of the intervention targets guided by Lean; is expected to increase suicide-related clinician behaviors

Behavioral: Suicide Risk Screening; Behavioral: Safety Planning; Behavioral: Care transition facilitation; Behavioral: A Lean Implementation Strategy

Interventions

Suicide Risk Screening BEHAVIORAL

Suicide risk screening will be implemented as the standard of care for all patients who present for treatment.

Intervention

Safety Planning BEHAVIORAL

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.

Intervention

Care transition facilitation BEHAVIORAL

Include post-acute telephone phone call follow-up to foster engagement with outpatient care and problem solving within 24 hours of discharge

Intervention

A Lean Implementation Strategy BEHAVIORAL

The Interventions will be implemented using Lean performance improvement strategies

Intervention

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>12 years old

You may not qualify if:

• Patients \<12 years old
• Adults unable to consent
• Prisoners

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UMass Memorial Health Care

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Edwin D Boudreaux, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

• Catarina Kiefe, MD, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This was an implementation study that implemented various suicide related best practices into routine care. Data for patients who presented for care were included in the respective phase of the study based on the location and date of presentation. They were not aware they were in a study.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Director of Research

Model Details: Stepped Wedge Design

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 7, 2017
• Study Start: October 1, 2016
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be become available in years, length to be determined.
• Access Criteria: See plan description

Locations

US (1)