Facilitating Anemia Treatment Risk Communication for Patients With Kidney Disease: Decision Aid Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- change in patient understanding of anemia and treatment options
研究概览
简要总结
Anemia is a common complication of chronic kidney disease (CKD). In anemia of chronic kidney disease, patients suffer from low hemoglobin levels, which contribute to feelings of malaise and fatigue. The current accepted practice is often to administer erythropoietin-stimulating agents (ESAs), which act like the body's natural hormones to stimulate the production of red blood cells from bone marrow. Although ESAs are widely used in CKD, recent evidence suggests that they are not as safe as previously thought. In this study, we seek to test a decision aid to be used when a patient visits his or her nephrologist at Vanderbilt. The objective of the decision aid is to reduce patient confusion, improve their satisfaction with their care, improve their knowledge of kidney disease, and ultimately bring more clarity to patients about a controversial but ubiquitous drug.
The decision aid will be about 1 page long and will include questions and information that might help the patient be more active and informed regarding the choice of a course of ESA therapy. We will ask patients to answer questions before and after their clinic visits regarding their satisfaction and confidence in their treatment and their knowledge of kidney disease; we will ask some of the same questions 3 months after the clinic visit. We will compare patients who are counseled using the decision aid to patients who are not. We anticipate total experiment running time to be approximately 5 months to recruit and follow up on all patients.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has Chronic Kidney Disease or End Stage Renal Disease
- •Over 18, under 80 years of age
- •Currently receiving care in the Vanderbilt Nephrology or Dialysis Clinics
- •Receiving ESAs for anemia
- •Speaks and can read English (no previous use of interpreter services)
- •No significant visual impairment documented in medical record
排除标准
- •Diagnosed cognitive disability
- •Stated inability to converse and read fluently in English, or prior use of translation services
- •Poor visual acuity
结局指标
主要结局
change in patient understanding of anemia and treatment options
时间窗: baseline and 3 months
Change from baseline in the following surveys/questionaires at 3 months: * Anemia Knowledge Survey (PAKKD) * Perceived Kidney Self-Management Scale (PKiSMS or PDiSMS for ESRD) * Social Support Measure (MSPSS) * Perceived Efficacy in Patient-Physician Interactions (PEPPI)
次要结局
未报告次要终点
研究者
Kerri Cavanaugh
Assistant Professor
Vanderbilt University
