Better Real-time Information on Documentation of Goals of Care for Engagement in Serious Illness Communication (BRIDGE-SIC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Number of Days in the Hospital
研究概览
简要总结
This is a pragmatic, prospective, randomized clinical trial to test the effectiveness of large language model (LLM)-generated serious illness conversation (SIC) summaries delivered to patients' inpatient and outpatient clinicians at the time of hospital admission on the primary outcome of days in the hospital in the next 90 days.
详细描述
The study will automatically enroll up to 600 DFCI patients with solid tumor cancers admitted to BWH inpatient medical oncology services with a predicted 90-day mortality risk of ≥ 25%. Patients will be randomized 1:1 to intervention vs control arms. The intervention arm will receive LLM-generated SIC summaries sent to their clinical teams, prompting incorporation of patient preferences into care plans. The control arm will receive standard of care. Outcomes will be followed for 90 days post-admission. The study uses a waiver of informed consent and HIPAA authorization due to minimal risk and the need for real-time identification and intervention delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •DFCI Patients, defined as patients who have a DFCI medical record number.
- •Admitted to an inpatient solid tumor medical oncology service at BWH (including beds that are considered to be DFCI beds within BWH)
- •Age ≥ 18 years
- •Mortality prediction ≥ 25%
- •Admitted on a Sunday after 4pm through Friday at 4pm. These time restrictions are necessary for the workflow of this pragmatic pilot trial, as the intervention requires a staff member to send intervention emails during the work week but within <= approximately 18 hours of admission. Accordingly, we will not enroll patients during holiday time periods (e.g., for a Monday holiday, enrollment would start on Monday at 4pm instead of Sunday at 4pm) or on days where staff absences (e.g., illness) preclude enrollment.
排除标准
- •Patients with elective inpatient admissions (typically for planned administration of chemotherapy or other treatments)
结局指标
主要结局
Number of Days in the Hospital
时间窗: 90 days after randomization
The number of days in the hospital is defined as the total number of inpatient days, including days from the index hospitalization and any subsequent hospital admissions during the follow-up period.
次要结局
- Number of Hospital Readmissions(90 days after randomization)
研究者
Alexi A. Wright, MD
Principal Investigator
Dana-Farber Cancer Institute