A Patient-centered, System-based Approach to Improve Informed Dialysis Choice and Outcomes in Veterans With CKD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 656
- 试验地点
- 2
- 主要终点
- Home Dialysis Use
研究概览
简要总结
This study is intended to correct an important systemic deficit in the care of chronic kidney disease (CKD), VHA's fourth most common healthcare condition with high mortality and healthcare burden. Currently, many Veterans with CKD have poor awareness of their condition. This leads to suboptimal care. The investigators anticipate that the proposed comprehensive pre-end stage renal disease (ESRD) education (CPE) will enhance Veterans' CKD knowledge and their confidence in making an informed selection of an appropriate dialysis modality, and lead to an increase in the use of home dialysis (HoD) - an evidence-based, yet underutilized dialysis modality. Further, this study will allow us to examine whether such Veteran-informed dialysis choice can improve Veteran and health services outcomes. If successful, this study may deliver a ready to roll-out strategy to meet the CKD care needs of the Veterans and reduce VHA healthcare costs.
详细描述
Chronic kidney disease (CKD) is the 4th most common diagnosis among Veterans. Each year, over 13,000 Veterans transition from CKD to end stage renal disease (ESRD), a disease with high mortality and poor health related quality of life (HRQoL). Over 52,000 Veterans with ESRD are currently on dialysis and CKD/ESRD care costs VA over $18 billion per year. The majority of Veterans progressing from CKD to ESRD have limited to no awareness of CKD and its treatment options. This hinders Veterans' informed dialysis selection resulting in a gross underuse (7%) of home dialysis (HoD). As there are no significant differences in mortality among different dialysis modalities, VHA National Kidney Program and professional renal societies advocate informed dialysis selection and greater use of HoD to facilitate improvements in Veterans' post-ESRD clinical and health services utilization outcomes.
Reports from Europe and Canada show that providing comprehensive pre-ESRD patient education (CPE) improves the quality of CKD care and empowers patients to make informed dialysis modality selection. Data further show that informed modality selection substantially corrects the underuse of HoD as desired by the healthcare systems, including VHA.
However, across VHA, many Veterans with CKD are identified too late to benefit from CPE; and even for those identified and under renal care, the availability of CPE is limited. This results in suboptimal pre-ESRD care and preparation, and continued low HoD utilization. Thus, there is an urgent systemic need to provide CPE to all pre-ESRD (stage 4 and 5 CKD) Veterans and study its effectiveness prospectively within the VHA.
This study aims to evaluate the impact of the comprehensive pre-ESRD patient education on high-impact outcomes for Veterans and health services, across a local Veterans Healthcare System (VHS). The investigators will compare the impact of CPE (intervention), delivered either in-person or through telemedicine, with the usual care (control) enhanced by the provision of the self-learning CKD information among Veterans with advanced CKD across the North Florida/South Georgia VHS.
The investigators' study has four aims, consisting of one primary outcome (HoD use) and multiple secondary outcomes, to help us understand the impact of CPE on patients' informed decision making and on important post-ESRD clinical, patient-reported, and health services outcomes.
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
- Single (Outcomes Assessor)
盲法说明
The study compares a comprehensive education with the standard of care. Thus it is not possible to mask investigator, participant or care provider. However, our statistician will assess the outcomes aggregates in a blinded manner.
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
- •Veterans registered to receive healthcare from the NF/SG VHS
- •18 years or older
- •Advanced CKD (stage 4 or 5) and not on dialysis
排除标准
- •Non-English speakers
- •Veterans who are homeless or living in assisted living facilities or nursing homes
- •Veterans with diagnosed dementia
- •Veterans with the life-expectancy less than 6 months
- •Any additional special concerns of a Veteran's provider
研究组 & 干预措施
Comprehensive Pre-ESRD Patient Education (CPE)
These patients will receive CPE for a total of up to 3 session in an intent-to-teach format, either via Face-to-face or telemedicine delivery.
干预措施: Comprehensive Pre-ESRD Patient Education (CPE) (Other)
Enhanced Usual Care
This group will receive usual care. This care will be enhanced by providing them with the freely available education material for the Kidney Disease Education
干预措施: Provision of the freely available resources for Kidney Disease Education (Other)
结局指标
主要结局
Home Dialysis Use
时间窗: 0-48 months
Patient receiving either CPE or Enhanced usual care (EUC) will be followed for the diagnosis of ESRD and initiation of dialysis. The investigators will follow the use of peritoneal dialysis or home hemodialysis at day 90 into the dialysis as the home dialysis (HoD) use primary outcome.
次要结局
- Kidney Disease Knowledge(0-4 weeks)
- confidence in dialysis decision making(0-4 weeks)
- post-ESRD Kidney Disease Quality of life-36(3-48 months)
- Home Dialysis selection(0-4 weeks)
- Satisfaction on Dialysis(3-48 months)