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A System of Safety (SOS) (SOS)

Primary Purpose

Suicide

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suicide Risk Screening
Safety Planning
Care transition facilitation
A Lean Implementation Strategy
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide focused on measuring Suicide Screening, Safety Planning

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Patients >12 years old

Exclusion Criteria:

  • • Patients <12 years old

    • Adults unable to consent
    • Prisoners

Sites / Locations

  • UMass Memorial Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

No Intervention

Intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).
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).
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.
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).
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.
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

Secondary Outcome Measures

Full Information

First Posted
April 3, 2017
Last Updated
September 11, 2023
Sponsor
University of Massachusetts, Worcester
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03104504
Brief Title
A System of Safety (SOS)
Acronym
SOS
Official Title
A System of Safety: Preventing Suicided Through Healthcare System Transformation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The System of Safety (SOS) project will catalyze and expand the investigators existing efforts to transform suicide risk detection and suicide prevention across the UMass Memorial HealthCare system (UMMHC), the largest healthcare system in central Massachusetts representing a catchment area of 1.06 million people. This effort will span emergency department, inpatient, and primary care settings; engage medical and behavioral health clinicians; target adults and children; and support integration and collaboration across the entire system to provide a 360-degree safety net for patients at risk for suicide. Building on our previous and ongoing work, Zero Suicide's Seven Essential Elements of Care (Essential Elements) will be the foundation for an innovative continuous performance improvement (CQI) hub-and-spoke model whereby a central System Hub will work with Local Hubs and Spokes representing each setting and clinical unit. SOS will evolve over three phases. Phase 1 (months 1 - 12) will start with the emergency departments across the four UMMHC hospitals; Phase 2 (months 13 - 30) will extend the efforts to the inpatient medical and psychiatric units; and, Phase 3 (months 31 - 48) will expand to primary care settings. Overall, 39 clinical units will be engaged. Consistent with central CQI tenets and the Zero Suicide model, the investigators will create protocols using best-practice approaches to identifying, assessing, managing, and intervening with suicidal patients while tailoring the approach to the particular clinical unit's unique needs and population. Units will learn from one another through regular collaborative work sessions, retreats, and cross departmental sentinel case reviews of suicides and suicide attempts. Fidelity to key components of the protocols will be measured. The investigators will use a stepped wedge design with cluster randomization of clinical units, stratified by setting. Within each setting (Phase), the study population will consist of all patients seen in any of the clinical units during the pre-specified observation period before (Control) or after (Intervention) the unit's implementation start date. The investigators will follow these estimated 310,000 patients from their 1st encounter with a clinical unit through 6 months after Phase 3 ends (month 54). The investigators Aims assess the effect of SOS on its intervention targets (clinician behaviors) and on patient outcomes, using a system-level analytic strategy. The Specific Aims are: Aim 1: Examine the impact of the SOS intervention on clinician-administered, standardized suicide risk screening and suicide risk identification across settings and clinical units. H1: Likelihood of clinician-administered standardized suicide risk screening (an intervention target) at the time when a patient enters the study will increase monotonically with time since study initiation. H2: Likelihood of suicide risk identification (patient outcome) at the time when a patient enters the study will increase monotonically with time since study initiation. H3: The increasing likelihoods of screening and identification are attributable to SOS implementation. Aim 2: Examine the impact of SOS on suicide related outcomes across settings and clinical units. H4: As SOS is implemented across more settings and clinical units, the likelihood of receiving a best practice suicide prevention intervention by a clinician (intervention target) will increase among newly identified at-risk patients. This includes, but is not limited to, collaborative safety planning, means restriction counseling, and a post-acute care follow-up telephone call within 24 hours of discharge. H5: SOS implementation will decrease the likelihood of suicide, suicide attempt, or suicide-related emergency requiring acute medical attention (patient outcomes) among newly identified at-risk patients. H6: "Dose" of exposure to SOS will mediate the effect of SOS noted in H5. Exploratory Aims: The investigators will also evaluate SOS from different perspectives by: A: Exploring potential moderating and mediating factors, and potential mechanisms of action, such as: EH1: Supportive organizational characteristics (e.g., embedded behavioral services on site, providing regular clinician-level performance feedback) will promote higher adherence to SOS implementation. B: Exploring the population level effect of SOS on a subgroup of UMMHC patients that constitutes an Accountable Care Organization (ACO). For example, the investigators hypothesize that: EH2: Suicide-related outcomes measured at the entire ACO population level (not just those encountering a clinical unit during the study period) will decrease monotonically during the study period (3-month increments). C: Exploring the cost-effectiveness of the SOS intervention compared to usual care. The investigators hypothesize that EH3: The cost of SOS will be < $50,000/ quality-adjusted life year saved, a commonly used threshold.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Suicide Screening, Safety Planning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stepped Wedge Design
Masking
Participant
Allocation
Randomized
Enrollment
310000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Other
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Suicide Risk Screening
Intervention Description
Suicide risk screening will be implemented as the standard of care for all patients who present for treatment.
Intervention Type
Behavioral
Intervention Name(s)
Safety Planning
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Care transition facilitation
Intervention Description
Include post-acute telephone phone call follow-up to foster engagement with outpatient care and problem solving within 24 hours of discharge
Intervention Type
Behavioral
Intervention Name(s)
A Lean Implementation Strategy
Intervention Description
The Interventions will be implemented using Lean performance improvement strategies
Primary Outcome Measure Information:
Title
Standardized suicide risk screening
Description
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).
Time Frame
6 months after the Index ED Visit
Title
Safety planning
Description
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).
Time Frame
6 months after the Index ED Visit
Title
Means restriction counseling
Description
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.
Time Frame
6 months after the Index ED Visit
Title
Care transition facilitation
Description
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).
Time Frame
6 months after the Index ED Visit
Title
Suicide risk identification
Description
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.
Time Frame
6 months after the Index ED Visit
Title
Suicide outcomes
Description
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
Time Frame
6 months after the Index ED Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Patients >12 years old Exclusion Criteria: • Patients <12 years old Adults unable to consent Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin D Boudreaux, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catarina Kiefe, MD, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Memorial Health Care
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A de-identified database from this study, along with associated database documentation (see below), will be made available online three years after the dataset is closed, without cost to researchers and analysts. NIMH will host the dataset on the NIMH Limited Access Dataset website; access and use will be governed by its policies, which can be found at: http://www.nimh.nih.gov/health/trials/datasets/nimh-policy-for-distribution-of-data.shtml.
IPD Sharing Time Frame
Data will be become available in years, length to be determined.
IPD Sharing Access Criteria
See plan description

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A System of Safety (SOS)

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