A System of Safety: Preventing Suicided Through Healthcare System Transformation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 493,756
- 试验地点
- 2
- 主要终点
- Standardized suicide risk screening
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients >12 years old
排除标准
- •• Patients <12 years old
- •Adults unable to consent
- •Prisoners
结局指标
主要结局
Standardized suicide risk screening
时间窗: 6 months after the Index ED Visit
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
时间窗: 6 months after the Index ED Visit
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
时间窗: 6 months after the Index ED Visit
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
时间窗: 6 months after the Index ED Visit
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
时间窗: 6 months after the Index ED Visit
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
时间窗: 6 months after the Index ED Visit
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
次要结局
未报告次要终点
研究者
Edwin Boudreaux
Vice Chair, Director of Research
University of Massachusetts, Worcester