A Stepped-Wedge Cluster Randomized Trial Using Machine-Generated Mortality Estimates and Behavioral Nudges to Promote Advance Care Planning Discussion Among Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change in the proportion of patients with a documented serious illness conversation (SIC)
研究概览
简要总结
This study will use a stepped-wedge cluster randomized trial to evaluate the effect of a health system initiative using machine learning algorithms and behavioral nudges to prompt oncologists to have serious illness conversations with patients at high-risk of short-term mortality.
详细描述
Patients with cancer often undergo costly therapy and acute care utilization that is discordant with their wishes, particularly at the end of life. Early serious illness conversations (SIC) improve goal-concordant care, and accurate prognostication is critical to inform the timing and content of these discussions. This study will use a stepped-wedge, cluster randomized trial to evaluate the effect of a health system initiative using machine learning algorithms and behavioral nudges to prompt oncologists to have serious illness conversations with patients at high-risk of short-term mortality. Oncology practices will be randomly assigned in sequential four-week blocks to receive the intervention.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The principal study investigator and data analyst will not have knowledge of when the practices are randomized to the intervention.
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
- •Care for adults with cancer at the following clinics at Perelman Center for Advanced Medicine
- •Breast Oncology
- •Gastrointestinal Oncology
- •Genitourinary Oncology
- •Melanoma and Central Nervous System Oncology
- •Thoracic / Head and Neck Oncology
- •Care for adults with cancer at the Pennsylvania Hospital Oncology clinic
排除标准
- •Providers who care for only patients with benign hematologic disorders
- •Providers who see only genetic consults
- •Providers who see less than 12 high-risk patients in either the pre- or post- intervention periods
- •Visits for patients with lung cancer who are enrolled in an ongoing palliative care clinical trial that may lead to more SICs
- •Patient visits that are for oncology genetics consults (such patients may still be included if they see their primary oncologist during the trial)
- •Providers who have not undergone serious illness conversation program training (SIC)
结局指标
主要结局
Change in the proportion of patients with a documented serious illness conversation (SIC)
时间窗: 16 weeks
The change in the proportion of patients that have an outpatient oncology visit with documentation of a serious illness conversation (SIC)
次要结局
- Change in the proportion of patients with a documented advanced care planning including follow-up(40 weeks)
- Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm including follow-up(40 weeks)
- Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm(16 weeks)
- Change in the proportion of patients with a documented advanced care planning(16 weeks)
- Change in the proportion of patients with a documented serious illness conversation (SIC) including follow-up(40 weeks)