Pilot Randomized-controlled Trial of Integrated Palliative and Nephrology Care Versus Usual Nephrology Care.
2021年10月1日 更新者：NYU Langone Health
A Pilot Randomized-Controlled Study Of The Impact Of Integrated Palliative And Nephrology Care Versus Usual Nephrology Care On Symptom Burden, Quality Of Life And Advance Care Planning In Patients With Chronic Kidney Disease Stage V Not On Dialysis
The objective of this application is to conduct a pilot study testing the impact of integrated nephrology and palliative care versus standard nephrology care on patient-reported outcomes.
This study is a preliminary study designed to determine feasibility of a palliative care study inclusive of kidney disease patients and to look for trends in impact over a 12-week follow-up period.
Measurements will be taken at time one (time of enrollment) and time two (12 weeks).
Our central hypothesis is that integration of palliative care with standard nephrology care in the ambulatory care of patients with a glomerular filtration rate (eGFR) ≤15ml/min/1.73m2
will trend towards improved symptom control, quality of life, and increased documentation of advance care planning when compared to usual nephrology care.
We expect 10-15 patients per arm.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
45
阶段
- 第一阶段早期
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
New York
-
New York、New York、美国、10016
- NYU Langone Health
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age ≥18
- Fluent English speaker
- eGFR≤15 mL/min/1.73m2 (diagnosis of CKD stage V)
- Able to give consent
- Must be followed by a faculty group practice nephrologist
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Diagnosis of dementia
- Non-English speaker
- Have been seen by a palliative care provider prior to study entry
- Pregnant women
- On dialysis or have received a kidney transplant
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm 1
Intervention
|
Monthly ambulatory care visits with the kidney palliative care team in the intervention group for three months. The intervention in this study is addition of a palliative care team to the care team of the subject. This intervention will not change or impact their regular nephrology care. The subjects in the intervention arm will be seen by the palliative care team three times over the 12-week study period (once per month).The intervention will be delivered by a physician trained in both palliative care and nephrology, the PI of the study. |
|
其他：Arm 2
Standard Care
|
Standard nephrology care
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in IPOS-Renal symptom assessment score
大体时间：Baseline, week 12
|
IPOS-Renal is a short measure (11 questions), combining the most common symptoms renal patients experience plus additional items from IPOS on concerns beyond symptoms, such as information needs, practical issues, family anxiety.
The total score reflects symptom burden and can range from zero to 68, where 0 is least symptom burden and 68 is highest symptom burden.
|
Baseline, week 12
|
|
Change in KDQOL-SF 36 Quality of Life Scores
大体时间：Baseline, week 12
|
The KDQOL-36 has five scales, including two generic HRQOL scales from the SF-12 version 1 (12 items total) and three kidney-specific scales (24 items total).
The SF-12 PCS and MCS are scored on a T-score metric (mean=50, SD=10, in the United States general population), with higher scores indicating better HRQOL.
|
Baseline, week 12
|
|
Difference between the number of documented advanced care planning between arms
大体时间：Week 12
|
advanced care planning = health care proxy, Medical Order for Life Sustaining Treatment [MOLST], or a Do Not Resituate form
|
Week 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
retention patients at the end of the study
大体时间：12 weeks
|
12 weeks
|
|
|
percent of returned clinical surveys (IPOS-R and KDQOL-SF 36
大体时间：12 weeks
|
12 weeks
|
|
|
patient satisfaction as rated on the Press Ganey Survey
大体时间：12 weeks
|
Measure satisfaction on a five point scale where "5" is the Top Score.
|
12 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in IPOS-Renal symptom assessment score over time in intervention arm
大体时间：Baseline, 6 weeks, 12 weeks
|
Exploratory end-points include change in symptom burden over time in the intervention arm.
These subjects are expected to have three visits with symptom surveys filled out at each visit.
We hypothesize that symptom burden will improve over time.
|
Baseline, 6 weeks, 12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年7月12日
初级完成 (实际的)
2021年4月26日
研究完成 (实际的)
2021年4月26日
研究注册日期
首次提交
2020年8月18日
首先提交符合 QC 标准的
2020年8月18日
首次发布 (实际的)
2020年8月20日
研究记录更新
最后更新发布 (实际的)
2021年10月5日
上次提交的符合 QC 标准的更新
2021年10月1日
最后验证
2021年10月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health.
Requests may be directed to the PI.
The protocol and statistical analysis plan will be made available on Clinicaltrials.gov
only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.