Providing Resources to Enhance Patients' Readiness to Make Decisions About Kidney Disease: Partnering to Break the News, Review All Options, Weigh Pros and Cons (PREPARE NOW)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Initiation of self-care dialysis or receipt of transplant
研究概览
简要总结
This study evaluates the effectiveness of patient educational materials (a book and DVD) to help patients with chronic kidney disease make early, shared, and informed decisions about kidney replacement therapy. Half of the participants will receive the educational materials and half will receive usual care from their doctors.
详细描述
The investigators will study the effectiveness of patient educational materials (a book and DVD, called the PREPARED materials) to help patients with chronic kidney disease make early, shared, and informed decisions about kidney replacement therapy. Half of the participants will receive the PREPARED materials and half will receive usual care from their doctors. PREPARED materials feature patients and their families discussing the pros and cons of different treatment options for kidney failure. The investigators will randomly assign patients already under the care of a nephrologist to receive the video and book or to receive their usual nephrology care. They will measure the degree to which patients in either study arm are prepared for kidney failure treatment at follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •18 years or older
- •English speaking
- •Advanced kidney disease defined as an eGFR < 20 mL/min/1.73m2 at their last clinical appointment with their nephrologist
- •Have not initiated a Renal Replacement Therapy
排除标准
- •Cannot speak English
- •Have initiated Renal Replacement Therapy
研究组 & 干预措施
Usual Care
Participants randomized to this arm of the study will receive usual care from their physician.
PREPARED Decision Support
Participants randomized to this arm of the study will receive the PREPARED educational book and video.
干预措施: PREPARED Decision Support (Behavioral)
结局指标
主要结局
Initiation of self-care dialysis or receipt of transplant
时间窗: 90 days after randomization
Among the participants initiating renal replacement therapy (RRT) during follow up, the proportion who initiate self-care dialysis (peritoneal dialysis or home hemodialysis) or receive a transplant.
Use of permanent vascular access
时间窗: 90 days after randomization
Proportion of patients achieving initiation of RRT with a permanent vascular access.
Emergent dialysis initiation
时间窗: 90 days after randomization
Proportion of patients initiating dialysis urgently in the Emergency Room (versus planned initiation).
Transplant evaluations, waiting list placement
时间窗: 90 days after randomization
Proportion of patients achieving receipt of transplant evaluations, or placement on the kidney transplant waiting list prior to initiation.
Blood pressure control at RRT initiation
时间窗: 90 days after randomization
Proportion of patients achieving blood pressure control (systolic blood pressure \<130mmHg and diastolic blood pressure \<80mmHg) at each visit prior to RRT initiation or completion of study follow up.
Anemia management
时间窗: 90 days after randomization
Proportion of patients with anemia treated to recommended levels (hemoglobin 10g/dl to 12g/dl) at each visit prior to RRT initiation or completion of study follow up.
次要结局
未报告次要终点