Clinical trial NCT03104504: A System of Safety (SOS)
Official title: A System of Safety: Preventing Suicided Through Healthcare System Transformation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: Suicide Screening
Safety Planning
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-04-07
Enrollment: 493756
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped Wedge Design
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* • Patients \>12 years old

Exclusion Criteria:

* • Patients \<12 years old

  * Adults unable to consent
  * Prisoners

Primary outcomes:
measure: Standardized suicide risk screening
timeFrame: 6 months after the Index ED Visit
measure: Safety planning
timeFrame: 6 months after the Index ED Visit
measure: Means restriction counseling
timeFrame: 6 months after the Index ED Visit
measure: Care transition facilitation
timeFrame: 6 months after the Index ED Visit
measure: Suicide risk identification
timeFrame: 6 months after the Index ED Visit
measure: Suicide outcomes
timeFrame: 6 months after the Index ED Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Health Care
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Edwin D Boudreaux, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Worcester
name: Catarina Kiefe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: