Comparing Two Approaches for Assessment and Safety Planning With Adults at Risk for Suicide
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 176,000
- 试验地点
- 1
- 主要终点
- Suicide attempt
研究概览
简要总结
The goal of this clinical trial is to learn the best way to provide suicide prevention care to adults receiving outpatient mental health care. The study compares two approaches based on the Zero Suicide Framework: Local Care Continuity and Centralized Care Navigation.
The main questions the study aims to answer are:
- Does adding support from a centralized telehealth care navigation team reduce suicide attempts compared with providing additional tools and support to local mental health clinicians?
- Does the centralized approach help more patients receive recommended suicide prevention care, including safety planning, and connect with follow-up mental health treatment?
- How do patients experience the two approaches, including their ability to cope with difficult situations and their experiences with their mental health care?
Researchers will compare Local Care Continuity, in which suicide prevention care is delivered by patients' local mental health clinicians with additional implementation support, with Centralized Care Navigation, which adds support from a centralized telehealth team of clinicians and care navigators. The researchers expect that Centralized Care Navigation will result in better suicide prevention care, greater connection to follow-up treatment, and fewer suicide attempts than Local Care Continuity.
详细描述
This is a pragmatic, two-arm, parallel, cluster-randomized comparative effectiveness trial evaluating two approaches for delivering systematic suicide prevention care to adults receiving outpatient mental health care. The study is based on the Zero Suicide Framework and addresses an important question for health care systems: whether evidence-based suicide prevention practices can be effectively delivered by patients' existing local mental health clinicians with enhanced implementation support, or whether outcomes can be improved by adding a centralized telehealth team that provides specialized suicide prevention and care navigation services.
Geographic service areas will be randomized to Local Care Continuity or Centralized Care Navigation. Randomization occurs at the geographic service-area level rather than the individual patient level because the interventions are health care delivery approaches that are integrated into routine clinical workflows. The cluster-randomized design also reduces the potential for contamination between the two study approaches within the same service area.
Outcomes for the overall comparative effectiveness trial will primarily be assessed using electronic health record and claims data.
The randomized trial will be supplemented by an observational usual-care cohort from geographic service areas where the two study care pathways have not been implemented. This comparison will provide additional information about outcomes associated with the study approaches relative to ongoing health system quality-improvement efforts.
Finally, the study will examine whether the relative effects of Local Care Continuity and Centralized Care Navigation vary across prespecified patient subgroups. These analyses will help identify whether the effectiveness of the two approaches differs according to patient demographic, socioeconomic, and clinical characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Age 18 years or older
- •Attending an intake or follow-up outpatient mental health visit at a participating Kaiser Permanente Northern California mental health clinic during the study eligibility period
- •Nine months of enrollment in the year prior to index visit, allowing for 1-month gaps
排除标准
- •1) None specified for the overall CE-RCT population
结局指标
主要结局
Suicide attempt
时间窗: From the index outpatient mental health visit through 18 months
Suicide attempts will be identified from EHR and claims data using ICD-10 diagnosis codes for intentional self-harm (X60-X84 and Y87.0). Encounter diagnoses for injury or poisoning with modifiers indicating self-harm intent will be classified as suicide attempts. Fatal and non-fatal suicide attempts occurring during the 18-month follow-up period will be included.
Receipt of a safety plan
时间窗: From the index outpatient mental health visit through 3 months
Receipt of a safety plan will be assessed using text processing of structured and unstructured electronic health record (EHR) documentation. The outcome will indicate whether a patient received a safety plan during the 3-month follow-up period.
Treatment initiation/follow-up
时间窗: From the index outpatient mental health visit through 6 months
Treatment initiation/follow-up will be assessed using EHR data to determine whether a patient attended a subsequent outpatient mental health visit during the 6-month follow-up period.
次要结局
未报告次要终点
研究者
Esti Iturralde
Research Investigator II
Kaiser Permanente