A Pragmatic Approach to Chronic Kidney Disease Patient Education in the Delta
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Subjects Who Can Choose a Dialysis Modality by the End of the Study.
研究概览
简要总结
Over 350,000 adult Arkansans have chronic kidney disease (CKD) and 9 out of 10 (312,000) of these Arkansans are unaware of having it. A "Know Your Kidney Number" (eGFR) poster (KYKN) campaign is being launched statewide to increase CKD awareness and detection. As awareness increases, the demand for patient education will increase. Educating patients has proven to be effective in delaying CKD progression and establishing optimal renal replacement therapy (RRT) when needed. CKD patient education has historically been provided by nephrology clinicians. Yet most patients are not referred to nephrology until the patient is nearing the need for RRT. Novel pragmatic approaches to reaching and educating patients earlier in their disease state and partnering with a broader pool of clinicians that can provide the education is needed. Most problems related to CKD start when kidney function is ~45 %, earlier education can empower patients to make changes to protect their kidney function earlier and plan for RRT.
University of Arkansas for Medical Sciences (UAMS) developed and copyrighted the "CKD: What You Need to Know" patient education system. Research showed almost 90% of the attendees could choose a modality after either tele-education (TE) or face to face (FTF) education. Home modality choices doubled. Patients were able to make informed choices regardless of the modality of education. Of those starting RRT 47% started on a home modality or received a transplant. This compares to 10% nationally. Both transplant and home dialysis have better outcomes and are less costly compared to in-center hemodialysis.
Harp's Pharmacy has a successful medication therapy management (MTM) program where pharmacists are provided time for patient-centered activities for patients with diabetes (DM), hypertension (HTN), the 2 leading causes for CKD, and heart failure (HF), the leading cause of death in CKD. Thirty six percent of patients with DM will develop CKD and hypertension can be both a cause and an effect of CKD. In this project Harp's Pharmacy will use the MTM infrastructure to add CKD to the program in select pharmacies in the delta. The CKD tools build on and support actions that improve the underlying conditions that are already being addressed. The "CKD: What You Need to Know" tools will be used with patients with known CKD or 2 of the 3 conditions covered by MTM and randomized into 1 of 2 education arms that offer various levels of support or a control arm.
详细描述
Using non-nephrology clinicians to expand access to CKD education earlier in the patient's disease progress is essential. This project will inform how various levels of support provided by pharmacists and staff using nephrology developed tools in self-study models can 1) effect patient's ability to select the End Stage Renal Disease (ESRD) modality (Incenter hemodialysis, home hemodialysis, peritoneal dialysis, no dialysis or do not have enough information to make a choice) to use if or when dialysis is needed 2) identify patient's interest in obtaining a renal transplant and, if so, has a possible donor been identified 3) identify actions they are willing to take to protect their current kidney function using a CKD Action Plan that contains 1 knowledge goal and 10 performance goals based on international guidelines 4) allow comparisons of support time and outcomes for each of the 3 groups. Empowering patients to be proactive partners in their health care, through education and accountability, by choosing both the RRT and performance goals to protect the patient's kidneys is key to improving outcomes. Demonstrating that non-nephrology clinicians can effectively educate and support these patients will provide models that other clinicians can use.
Minorities, especially in rural areas, are less likely to receive most kinds of care including evidence-based practices, home dialysis or transplantation. Developing patient-centered approaches to care such as this project can reduce disparities.
One-on-one outreach to educate, motivate and seek the patient's feedback can strengthen commitment and adherence to medical regimens. Learning what to expect can promote self-management behaviors.
The Arkansas Department of Health (ADH) Southeast (SE) region covers most of the Delta and was selected because the SE region had the poorest outcomes for patients starting RRT. In 2017, new patients were predominately black (61%), less than half had seen a nephrologist prior to starting RRT, only 1.3% had seen a dietitian, most (92.3%) started hemodialysis using a catheter and 2.1% started on home peritoneal dialysis. Only 2.1% had no insurance. This data can be tracked annually to track impact.
The tools being used were developed by a multidisciplinary team of nephrology experts which are limited in the delta. Courses including train the trainer classes for pharmacies and 10 points of Care for CKD for clinicians will be conducted. Collaboration with local providers can both educate and promote community engagement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (any gender)>18 years old
- •Enrolled in Harp's MTM program
- •Has Known CKD or 2 of the 3 conditions covered in MTM (DM, HTN and Heart Failure)
- •Not on dialysis
排除标准
- •unable to read or speak English
- •history of significant cognitive dysfunction unless qualified caregiver is the one being educated
- •not personally independent or without any social support
结局指标
主要结局
Number of Subjects Who Can Choose a Dialysis Modality by the End of the Study.
时间窗: up to 4 months
This primary study aim is to increase the subject's ability to select a dialysis modality. Descriptive statistics will be used to examine the trend in the subjects' ability to choose or not choose a dialysis modality. Descriptive statistics will be used to examine the trend of patients answers based on comparisons of responses on pre and post tests and evaluation form with the options of Incenter Hemodialysis (ICH), Home Hemodialysis (HH), Peritoneal Dialysis (PD), No Dialysis, don't have enough information to make a to make a decision.
Number of Subjects That Choose a Form of Home Dialysis (Home Hemodialysis or Peritoneal Dialysis) by the End of the Study.
时间窗: up to 4 months
This aim is to identify the impact interventions have on the subject's choice of modality (home dialysis versus in-center hemodialysis). Descriptive statistics will be used to examine the trend of patients answers based on comparisons of responses on pre and post tests and evaluation form with the options of Incenter Hemodialysis (ICH), Home Hemodialysis (HH), Peritoneal Dialysis (PD).
Number of Subjects Interested in Kidney Transplant (Pre-test)
时间窗: before implementation of the intervention, average of 1 week
Descriptive statistics will be used to examine the trend in the subjects' level of interest in kidney transplant based on pre-test, post-test and evaluation form answers.
Number of Subjects Interested in Kidney Transplant (Post-test)
时间窗: after the intervention, up to 4 months
Descriptive statistics will be used to examine the trend in the subjects' level of interest in kidney transplant based on post-test evaluation form answers.
Number of Subjects With a Possible Donor Identified (Pre-test)
时间窗: before implementation of the intervention, average of 1 week
Descriptive statistics will be used to examine the trend in the subjects' selection of a possible donor based on pre-test evaluation form answers.
Number of Subjects With a Possible Donor Identified (Post-test)
时间窗: after the intervention, up to 4 months
Descriptive statistics will be used to examine the trend in the subjects' selection of a possible donor based on post-test evaluation form answers.
Number of Subjects Who Can Choose a Dialysis Modality by the End of the Study.
时间窗: up to 4 months
This primary study aim is to increase the subject's ability to select a dialysis modality. Descriptive statistics will be used to examine the trend in the subjects' ability to choose or not choose a dialysis modality. Descriptive statistics will be used to examine the trend of patients answers based on comparisons of responses on pre and post tests and evaluation form with the options of Incenter Hemodialysis (ICH), Home Hemodialysis (HH), Peritoneal Dialysis (PD), No Dialysis, don't have enough information to make a to make a decision.
Number of Subjects That Choose a Form of Home Dialysis (Home Hemodialysis or Peritoneal Dialysis) by the End of the Study.
时间窗: up to 4 months
This aim is to identify the impact interventions have on the subject's choice of modality (home dialysis versus in-center hemodialysis). Descriptive statistics will be used to examine the trend of patients answers based on comparisons of responses on pre and post tests and evaluation form with the options of Incenter Hemodialysis (ICH), Home Hemodialysis (HH), Peritoneal Dialysis (PD).
Number of Subjects Interested in Kidney Transplant (Pre-test)
时间窗: before implementation of the intervention, average of 1 week
Descriptive statistics will be used to examine the trend in the subjects' level of interest in kidney transplant based on pre-test, post-test and evaluation form answers.
Number of Subjects Interested in Kidney Transplant (Post-test)
时间窗: after the intervention, up to 4 months
Descriptive statistics will be used to examine the trend in the subjects' level of interest in kidney transplant based on post-test evaluation form answers.
Number of Subjects With a Possible Donor Identified (Pre-test)
时间窗: before implementation of the intervention, average of 1 week
Descriptive statistics will be used to examine the trend in the subjects' selection of a possible donor based on pre-test evaluation form answers.
Number of Subjects With a Possible Donor Identified (Post-test)
时间窗: after the intervention, up to 4 months
Descriptive statistics will be used to examine the trend in the subjects' selection of a possible donor based on post-test evaluation form answers.
次要结局
- Patient Engagement (Percent of Applicable Action Plan (AP) Goals Selected)(up to 4 months)
- Amount of Time Spent by Pharmacist and Staff Per Subject(up to 4 months)
- Intra Cluster Analysis to Evaluate Effectiveness of Each Teaching Style Used by Peer Educators(Up to 4 months)
- Intra Cluster Analysis to Evaluate Effectiveness of Each Teaching Style Used by Peer Educators(Up to 4 months)
- Patient Engagement (Percent of Applicable Action Plan (AP) Goals Selected)(up to 4 months)
- Patient Engagement (Percent of Visits Where a Patient-initiated CKD Discussion Takes Place)(up to 4 months)
- Patient Engagement (Percent of Goals Met)(up to 4 months)
- Amount of Time Spent by Pharmacist and Staff Per Subject(up to 4 months)