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临床试验/NCT06060535
NCT06060535Enrolling By Invitation不适用

Evaluating Effectiveness and Implementation of a Risk Model for Suicide Prevention Across Health Systems

Kaiser Permanente6 个研究点 分布在 1 个国家目标入组 394,000 人开始时间: 2022年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
394,000
试验地点
6
主要终点
Suicide attempt, 90 days post-index encounter

研究概览

简要总结

The goal of this clinical trial is to evaluate a suicide risk model in patients receiving behavioral health care treatment. The main question it aims to answer is: Does the implementation of the suicide risk model reduce suicide attempts? Researchers will compare the outcomes of patients identified by the model to those in a usual care group.

详细描述

Suicide is a major public health concern in the United States; nearly 50,000 individuals die by suicide annually and almost 1.5 million attempt suicide. To date, identification of individuals at risk for suicide has relied on suicide risk screening practices, including using a variety of self-reported instruments. However, sensitivity of these measures is only moderate; more precise tools for identifying patients at risk for suicide are needed. Suicide risk models, developed by our team, incorporate health records data and historical self-report screening questionnaire responses to improve accuracy of risk prediction. Our models have outperformed traditional clinical screening and similar risk models for adults receiving care in outpatient mental health specialty settings. However, while statistically accurate, they have not been evaluated in real world care; whether the models actually increase identification or result in patients receiving more suicide prevention services, fewer crisis services, or making fewer suicide attempts is unknown. There is substantial clinical interest in implementing suicide risk models but little scientific evidence about the effectiveness of these models in real-world settings compared to standard screening practices alone. Additionally, there is almost no guidance for their implementation in healthcare. The proposed project leverages the NIMH-funded Mental Health Research Network (MHRN), a collaboration of large health systems with established clinical data infrastructure to support multi-site studies. MHRN members Henry Ford Health, Kaiser Permanente Northwest, and HealthPartners will participate in this project and collectively serve >170,000 behavioral health patients per year. The patient populations are diverse, including thousands of individuals with Medicaid and Medicare. Each of these systems has implemented a suicide prevention care model in their behavioral health departments, including robust suicide risk screening and assessment processes. However, none of these systems has implemented a suicide risk identification model. The proposed project includes a pragmatic trial approach with randomization of behavioral health clinics across the three participating health systems. It is innovative because it seeks to implement an MHRN suicide risk model (intervention) into each system's existing suicide prevention care model (usual care) to increase the reach and effectiveness of the suicide prevention care models. Sites will receive implementation planning support based on stakeholder feedback from preliminary studies and deliverables include an implementation planning tool kit to facilitate spread. This high-impact study has important clinical implications as health systems consider whether it makes sense to enhance their existing suicide prevention care models with a suicide risk model. It is timely because many health systems are advancing toward suicide risk model implementation without evidence to support this innovation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18+ years old
  • 1+ visit to a behavioral health clinic at participating sites

排除标准

  • 未提供

结局指标

主要结局

Suicide attempt, 90 days post-index encounter

时间窗: 90 days post-index encounter

The number and proportion of visits followed by any suicide attempt (ICD-10 diagnosis codes) occurring within 90 days of an index visit.

次要结局

  • Evidence-based suicide care(Through study completion, an average of 18 months)
  • Identification(Through study completion, an average of 18 months)
  • Recognition(Through study completion, an average of 18 months)
  • Any 14-day follow-up care in behavioral health(14 days post-index encounter)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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