Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation
2021年1月11日 更新者：University of North Carolina, Chapel Hill
Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation: a Pilot Study
More than 80% of individuals in the U.S. start maintenance hemodialysis (HD) with a central venous catheter, despite substantial evidence that starting HD with an arteriovenous (AV) access improves quality of life, lowers mortality, and decreases healthcare costs. Health system- and patient-level barriers contribute to low rates of AV access creation prior to HD initiation. Evidence-based, pre-dialysis interventions to improve these low rates and associated clinical outcomes are lacking.
A Vascular Access Navigation and Education Quality Improvement Program will be implemented in the Geisinger Danville, PA chronic kidney disease clinic. Individuals who choose to participate in a research sub-study of the program will complete questionnaires to assess their vascular access care knowledge and confidence before and after participation in the quality improvement program.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
46
阶段
- 不适用
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
-
-
Pennsylvania
-
Danville、Pennsylvania、美国、17822
- Geisinger Danville Nephrology Clinic
-
-
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
Patients:
- Receive care at the Geisinger Danville Nephrology Clinic
- Age ≥ 18 years
- eGFR ≤ 25 mL/min/1.73 m and 2-year kidney failure risk score >10% based on kidney failure risk equation, or nephrologist recommendation for vascular access
- Participation in the Vascular Access Navigation and Education Quality Improvement Program
Providers: Professional involved in dialysis vascular access care (e.g., nephrologist, surgeon, kidney disease clinic nurse, etc.) at Geisinger in Danville, PA
Exclusion Criteria
Patients:
- Too far into the vascular access creation process to benefit from the intervention (e.g. completed vascular access surgery appointment or has a surgery appointment scheduled within the next 4 weeks),
- Inability to consent, or
- Inability to complete interviews in English
Providers: None
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：卫生服务研究
- 分配：不适用
- 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：Vascular access quality improvement program participants
All participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program.
|
A Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic.
Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program.
|
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 |
|---|---|---|
|
Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation
大体时间：Pre- and post-intervention, a total of up to 7 months
|
Patient confidence in ability to navigate the vascular access creation process.
Measured using 3 team-developed confidence questions (score range: 1-10).
Higher scores reflect higher confidence in navigating vascular access care.
|
Pre- and post-intervention, a total of up to 7 months
|
|
Mean Scores of a Questionnaire Evaluating Patient Confidence in Self-managing Kidney Disease Pre- to Post-program Implementation
大体时间：Pre- and post-intervention, a total of up to 7 months
|
Patient confidence in ability to self-manage kidney disease.
Measured using a modified version of the 8-item Perceived Kidney Disease Self-Management Scale (score range: 8-40).
Higher scores reflect higher confidence in self-management of patient's kidney disease.
|
Pre- and post-intervention, a total of up to 7 months
|
|
Mean Scores of a Questionnaire Evaluating Patient Vascular Access Knowledge Pre- to Post-program Implementation
大体时间：Pre- and post-intervention, a total of up to 7 months
|
Patient vascular access care knowledge.
Measured using 8 team-developed knowledge questions (score range: 0-10).
Higher scores reflect higher knowledge of vascular access.
|
Pre- and post-intervention, a total of up to 7 months
|
|
Mean Scores of a Questionnaire Evaluating Provider Confidence Supporting Patients Through the Vascular Access Care Process Pre- to Post-program Implementation
大体时间：Pre- and post-intervention, a total of up to 7 months
|
Provider confidence in ability to help patients navigate the vascular access creation process.
Measured using 11 team-developed confidence questions (score range: 1-10).
Higher scores reflect higher confidence supporting patients through the vascular access care process.
|
Pre- and post-intervention, a total of up to 7 months
|
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。
合作者
调查人员
- 首席研究员：Jennifer Flythe, MD, MPH、University of North Carolina, Chapel Hill
- 首席研究员：Jamie Green, MD, MS、Geisinger Clinic
- 首席研究员：Ebony Boulware, MD, MPH、Duke University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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)
2019年7月30日
初级完成 (实际的)
2020年4月30日
研究完成 (实际的)
2020年6月22日
研究注册日期
首次提交
2019年6月26日
首先提交符合 QC 标准的
2019年7月23日
首次发布 (实际的)
2019年7月25日
研究记录更新
最后更新发布 (实际的)
2021年1月28日
上次提交的符合 QC 标准的更新
2021年1月11日
最后验证
2020年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 18-1912
- 1R21DK116115 (美国 NIH 拨款/合同)
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 data generated in this study are protected under data use agreements among Geisinger, Duke University, and the University of North Carolina at Chapel Hill.
We cannot directly share the source data without written approval from these institutions.
If scientists are interested in accessing de-identified study data, we will work with all institutions to obtain the necessary data use agreement modifications.
IPD 共享时间框架
Starting 6 months after publication, pending data use agreement modifications.
IPD 共享访问标准
Principal Investigators will review all requests for data, per data use agreement modifications.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
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.