St. Judes-Stanford Comprehensive Support Initiative
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Number of Emergency Department Visits (Chart Review)
研究概览
简要总结
This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management.
详细描述
PRIMARY OBJECTIVES:
I. To reduce acute care utilization by 2-5% for advanced cancer patients by training and deploying health care coaches who help patients and families discuss care goals, virtual modalities, engage in shared-decision-making, and participate in educational activities.
SECONDARY OBJECTIVES:
I. To improve patients' experience of their care. II. Improve patient understanding of advanced care planning. III. To improve the receipt of goal concordant care. IV. To reduce total healthcare costs.
OUTLINE: Patients are randomized to 1 of 2 arms.
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
- •Newly diagnosed patients for the following conditions
- •Colon cancer stage III and IV
- •Rectal cancer stage II, III, IV
- •Glioblastoma multiforme (brain) -- no stage
- •Non-small cell lung cancer stage IIIA, IIIB, IV
- •Small cell lung cancer, limited stage and extensive stage
- •Castration-resistant prostate cancer
- •Head and neck cancer stage III and IV
- •Gastric cancer stage III and IV
- •Esophageal cancer stage III and IV
- •Pancreatic cancer stage II, III, IV
- •Renal cell carcinoma, stage IV
- •Breast cancer, stage IV, if triple negative ER/PR/H2N negative or on systemic chemotherapy
- •Sarcoma, stage IV
- •Bladder carcinoma, stage IV
- •Acute myeloid leukemia
- •Melanoma, stage III and IV
- •Ovarian cancer, stage III and IV
- •High grade myelodysplastic syndrome (MDS)
- •Any patient with recurrent or progressive cancer
- •Patients must have the ability to understand and willingness to sign a written informed consent document
- •Patient must have ongoing oncologic needs and plan to receive all care at the study institution and not already be in hospice or home-care
排除标准
- •Patients must have capacity to consent
- •Pregnant patients are excluded
结局指标
主要结局
Number of Emergency Department Visits (Chart Review)
时间窗: 6 months after patient enrollment
Mean emergency department visits for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of mean numbers of emergency department visits between study arms.
Number of Hospitalization Visits (Chart Review)
时间窗: 6 months after patient enrollment
Mean Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of mean numbers of hospitalizations between the two study arms.
次要结局
- Change in Patient Satisfaction With Care and Decision Making Among Patients Undergoing Health Care Coach Support as Assessed by Consumer Assessment of Healthcare Providers and Systems-G and Patient Satisfaction With Decision Scale(Change in patient satisfaction with care and decision making from baseline to 6 and 12 months)
- Change in Patient Satisfaction With Care Among Patients Undergoing Health Care Coach Support as Assessed by Consumer Assessment of Healthcare Providers and Systems-G.(Change in patient satisfaction with care from baseline to 6 and 12 months)
- Mean Emergency Department Visits (Chart Review)(12 months after patient enrollment)
- Hospitalization Visits (Chart Review)(12 months after patient enrollment)
- Palliative Care Consult (Chart Review)(30 days prior to death)
- Number of Patients With Hospital Use (Chart Review)(30 days prior to death)
- Number of People With Emergency Department Visit (Chart Review)(30 days prior to death)
- Hospice Consult (Chart Review)(30 days prior to death)
研究者
Manali Indravadan Patel
Assistant Professor of Medicine
Stanford University