Improving Kidney Therapy Decision-Making for Older People With Advanced Chronic Kidney Disease (CKD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 326
- 试验地点
- 10
- 主要终点
- Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 12 weeks
研究概览
简要总结
The investigators are conducting a study to see which program better helps older patients with kidney disease choose their treatment. Investigators are also investigating if either program can reduce the number of hospital or emergency room visits in the first 6 months of the study, as well as potentially improve end-of-life care for older adults.
Half of the participants will receive Program A, while the other half will receive Program B. Investigators will compare the two groups to see which participants feel better prepared about their kidney therapy decisions, experience improved end-of-life care, and have fewer emergency room visits and hospital admissions.
Participants in Program A will receive information from the National Kidney Foundation and meet with a kidney therapy educator. Participants in Program B will get information about kidney disease treatment and meet with a decision-support specialist who's an expert in decision-making.
详细描述
Older adults ≥75 years represent the fastest-growing population to initiate dialysis in the US; despite the life-altering effects of dialysis on quality of life, dialysis is often presented as a default without considering patient preferences, prognosis, and alternative options such as conservative kidney management. This study will test the first palliative care intervention for older patients with advanced chronic kidney disease to improve the kidney therapy decision-making process. This research not only has the potential to help thousands of older patients with advanced chronic kidney disease who often have unanswered questions, unmet information needs, and restricted opportunities to share personal treatment preferences with their nephrologists but also has the possibility of creating new models of collaborative care by integrating palliative care into routine nephrology care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research coordinators responsible for administering assessments will remain blinded to the patient's randomization status.
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 75 years old
- •Has advanced kidney disease with kidney function less than 30%
- •Speaks English
- •Has not yet made a dialysis decision
排除标准
- •Has already decided on dialysis or active medical care without dialysis.
- •Has already been seen by a Palliative Care (PC) clinician for kidney-related issues or is enrolled in hospice
- •Currently on dialysis
- •Unable to provide informed consent or complete verbally administered surveys due to health, sensory, or cognitive impairment.
结局指标
主要结局
Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 12 weeks
时间窗: Baseline, 4-6 weeks, and 12 weeks
Determine whether the intervention improves kidney therapy decision-making at 12 weeks by using the Decisional Conflict Scale. Score ranges from 0-100. Lower scores indicate better outcomes.
次要结局
- Changes in patients' well-being at 6 months using the Burden of Kidney Disease Subscale(Base line 6 months)
- Differences in end-of-life care between intervention and control arm(Baseline to 6 months)
- Changes in number of hospital admissions, intensive care admissions, and emergency room visits(Baseline, 6 months)
研究者
Fahad Saeed
Associate Professor
University of Rochester