A Pragmatic Approach to Chronic Kidney Disease Patient Education in the Delta
Phase: NA
Conditions: Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Patient Engagement
Sponsor: University of Arkansas

Title:  Pragmatic Approach to Chronic Kidney Disease Education in the Delta V.6 
PI:  Manisha Singh, MD 
 
Version #: 2 
Date: 12.14.2022  
Page 1 
 
Official Title: Pragmatic Approach to Chronic Kidney Disease Education in the Delta 
 
NCT05138419 
 
Date: 12/14/2022 
 

Title:  Pragmatic Approach to Chronic Kidney Disease Education in the Delta V.6 
PI:  Manisha Singh, MD 
 
Version #: 2 
Date: 12.14.2022  
Page 2 
 
 
 
Study Title: 
Pragmatic Approach to Chronic Kidney Disease Education in 
the Delta 
 
Principal Investigator:  
Manisha Singh, MD 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 501 
Little Rock, AR 72205 
Telephone:  501.240.5804  
Email: MSingh@uams.edu 
 
 
Study Coordinator 
Andrea Easom MNSc, APRN, BC-FNP, CNN-NP 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 501 
Little Rock, AR 72205 
Telephone:  501.772.0600  
Email: Easomandreak@uams.edu  
 
 
Study location: 
 Up to 5 Harps Pharmacy sites in the Delta 
 
 (Specific sitesTBD after funding) 
 
 
Background and Rationale 
Over 350,000 adult Arkansans have chronic kidney disease (CKD) and 9 out of 10 
(312,000) are unaware they have 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 (1,2,3,4). CKD 
patient education has historically been provided by nephrology clinicians. Yet most 
patients are not referred to nephrology until they are nearing the need for RRT (5). 
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 (1,6). 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 (1,7,8). 
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 

Title:  Pragmatic Approach to Chronic Kidney Disease Education in the Delta V.6 
PI:  Manisha Singh, MD 
 
Version #: 2 
Date: 12.14.2022  
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dialysis have better outcomes and are less costly compared to in-center hemodialysis 
(1,5). 
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 (5). In this 
project they will use their MTM infrastructure to add CKD to their 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 Your 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 3 education arms that offer various levels of support 
or a control arm. 
Using non-nephrology clinicians to expand access to education earlier in their disease 
progress is essential. This project will inform how various levels of support provided by 
pharmacists and their staff using nephrology developed tools can effect patient choice 
allowing comparisons of support time and outcomes. Empowering patients to be 
proactive partners in their health care, through education and accountability, by 
choosing both their RRT and performance goals to protect their 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 (4,5). Developing 
patient-centered approaches to care such as this project can reduce disparities. 
One-on-one outreach to educate and motivate patients and seek their feedback can 
strengthen commitment and adherence to medical regimens.  Learning what to expect 
can promote self-management behaviors. 
The AR Department of Health (ADH) Southeast (SE) region covers most of the Delta 
and was selected because it has 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 (9). 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.  
Harp pharmacists expressed randomization concerns. They report that many of their 
MTM subjects have multiple family members or friends enrolled in the study. This could 
confound randomization into various arms since these subjects are highly likely to 
compare and contrast the details of their intervention. It was decided that a cluster 
randomization schedule would be utilized with each cluster self-selecting a leader that 
would be enrolled in the study and be responsible for education of the other cluster 

Title:  Pragmatic Approach to Chronic Kidney Disease Education in the Delta V.6 
PI:  Manisha Singh, MD 
 
Version #: 2 
Date: 12.14.2022  
Page 4 
members. All cluster members will undergo the same testing. 
Specific Aims  
The primary aim is to assess the effectiveness of pharmacists and their staff to educate 
CKD and high risk patients evaluating effectiveness through patient choice of RRT in 
each arm (e.g. home dialysis choice rate). Secondary aims include 1) Identify actions 
patients are willing to take to protect their kidney function using the CKD Action Plan 
that contains 10 performance goals based on international CKD guidelines that can 
slow CKD progression 2). Describe outcomes and methods used by peer leaders to 
educate cluster members using the same goals. 4) Compare costs (based on 
pharmacist and pharmacy associate time) with outcomes in each arm. 
Study Design and Procedures  
This study is a randomized control pilot study using non-nephrology clinicians to 
educate patients who are at high risk for CKD how to protect their kidneys and be ready 
for RRT if and when needed by utilizing nephrology developed educational tools. 
Harp’s pharmacists will screen patients in their MTM program and enroll them in familial 
or peer clusters consisting of 1 or more subjects and randomize them into 1 of the 4 
study arms using a site specific randomization schedule. Each arm will receive pre and 
post testing and health literacy evaluation. Two education arms will use the 139 page 
CKD: What You Need to Know workbook including the CKD Action Plan as self-study 
tools and follow-up during regular MTM appointment. The 3 arms include 2 education 
arms and a control arm with various levels of intervention: Arm 1) case management 
model including pharmacist initiated discussion of workbook content and action plan 
reinforcement, Arm 2) brief introduction of the workbook and action plan reinforcement, 
Arm and Arm 3) the control group will receive a list of web-based CKD sites and a copy 
of the action plan with no additional intervention. Patient initiated CKD discussions will 
be tracked by both the pharmacist and staff by topic and time spent. Time spent by the 
pharmacist and staff will be calculated along with outcomes and compared in each 
group. Data collected upon enrollment will include year of birth, race, gender, county of 
residence, history of CKD, diabetes, hypertension and/or heart failure, patient reported 
blood pressure, AIC, eGFR and hemoglobin, smoking history, renal transplant history 
and if is under the care of or has been seen by a nephrologist in the past.   
The CKD: What You Need to Know Workbook is 139 pages and includes: 
o An Introduction 
o 8 Chapters plus resources:  
1. Kidneys and Chronic Kidney Disease (CKD) 
2. Protecting Your kidneys and Slowing CKD Progression 
3. Your Choices for Dialysis and Transplantation  
4. Lab Results: What they mean & What you can control 
5. Chronic Kidney Disease & Eating Habits 

Title:  Pragmatic Approach to Chronic Kidney Disease Education in the Delta V.6 
PI:  Manisha Singh, MD 
 
Version #: 2 
Date: 12.14.2022  
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6. Chronic Kidney Disease & Meds 
7. Learning to Cope with Kidney Disease 
8. Paying for Your CKD Treatment 
9. CKD Action Plan 
10. Web-based Resources 
11. Kidney Talk: What do these words mean? 
12. Resources 
Each section ends with “Frequently Asked Questions”, “Test Your Knowledge” and has 
space  for notes. Patient testimonies are found at the back of 6 chapters. 
The workbook went through health literacy editing with a goal of a 5th grade reading 
level. The chapters ranged from 3rd to 7th grade levels. It was felt that it was important 
for subjects to learn or at least be exposed to words that were kidney related and 
frequently used by their health care providers. So the first time each of these words 
were used in the workbook they were red and the definition was in the kidney talk 
section on that page. Then the first time the word appeared in subsequent chapters the 
word was in red but no definition was on that page. 
Subjects will be randomized into 1 of 2 education arms that offer various levels of 
support or a control arm using a site specific computer generated randomization 
schedule. Presumed monthly visits. 
Study 
Arm 
Handouts Visit 1* 
 Visit 2 
Visit 3 
 End of 
Study      
June 2022  
Testing 
 
Pre-test 
 
Post-Test 
Evaluation 
1:  Case 
Study 
Model 
Workbook 
Action Plan 
(V1) 
 
Label 
reading 
Exercise 
(V2) 
Pharmacist 
initiated 
review of 
workbook 
and assist 
with Action 
Plan goal 
selection 
Action Plan 
Reinforcement. 
Discuss 
Chapters 1-4. 
Provide “Label 
Reading 
Exercise” 
Action Plan 
Reinforcement. 
Discuss 
Chapters 5-8 
and resources. 
Review results 
of Label 
exercise 
Open 
conversations 
from each 
party for all 
arms after 
evaluation 
2: Minimal 
Instruction  
Workbook 
Action Plan 
Briefly 
explain 
handouts 
with focus 
on Action 
Plan.(5-10 
minutes) 
Action Plan 
Reinforcement. 
Answer 
patient’s 
questions. 
Action Plan 
Reinforcement. 
Answer 
patient’s 
questions. 
As Above 
3: Control 
Resource 
List 
Action Plan 
Answer 
patient’s 
questions. 
Answer 
patient’s 
questions. 
Answer 
patient’s 
questions. 
As Above 
*On first visit, education arms subjects will be asked to read 1 chapter of the workbook 
weekly. All subjects will receive a CKD Action Plan and be asked to set individual goals. 
Secondary outcome data collected at each visit include both self-reported and/or 

Title:  Pragmatic Approach to Chronic Kidney Disease Education in the Delta V.6 
PI:  Manisha Singh, MD 
 
Version #: 2 
Date: 12.14.2022  
Page 6 
pharmacist or physician confirmed blood pressure and AIC, eGFR, hemoglobin. Patient 
and/or pharmacist initiated CKD conversation and topics including CKD action plan goal 
progress. The action plan has 1 knowledge goal related to CKD cause, eGFR and trend 
and 10 performance goals based on international guidelines and best practices 
including AIC goal of 7 or less, blood pressure goal of less than 140/90, exercise goal of 
30 minutes 5 times a week, medications that may need to be avoided (ex: ibuprofen) or 
may need to be taken (ex: Statin) if you have CKD and DM or over 50 years old), 
smoking cessation, kidney friendly diet (may need to modify salt, phosphorus and/or 
protein intake and be edema free [ may require monitoring and adjust salt and water 
intake], home monitoring of  blood pressure, blood sugar and weight, weight 
management and anemia (goal hemoglobin above 10g/dL) 
Study Population 
High Risk Subjects will be identified from the Harps MTM program or others having 
multiple known medical problems (CKD, HTN, DM or heart disease). Know Your Kidney 
Number Posters which will be available statewide by the time the study starts will be 
posted in the pharmacy. Even though they are not study specific, they provide pertinent 
CKD information that could motivate subjects to want to learn more about how to protect 
their kidneys. Study Patient information Sheets will be available for interested parties.  
A total of 100 clusters of 1 or more people from familial or peers groups will be enrolled. 
The actual number of subjects will depend on the volume of clusters with more than 1 
person. This would include approximately 1/3 of the Harps MTM subjects that have both 
DM and HTN.    
Inclusion Criteria 
• 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 
Exclusion Criteria 
• 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 
 
Risks and Benefits 
A risk to study participants is the potential for loss of confidentiality of study 
data.   
Measures to protect the confidentiality of study data will be implemented as 
described in the Data Handling and Recordkeeping section below.  

Title:  Pragmatic Approach to Chronic Kidney Disease Education in the Delta V.6 
PI:  Manisha Singh, MD 
 
Version #: 2 
Date: 12.14.2022  
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Potential benefits include the education received can motivate changes that 
can protect their kidney function, slow CKD progression and empower them 
to become more active in their health care.  
Ongoing monitoring of international guidelines will be done to ensure 
education goals remain current.  
Data Handling and Recordkeeping 
All data received from Harps will be de-identified prior to being sent to 
UAMS. UAMS study tools will be de-identified. At randomization, the subject 
will receive a study number including: Harps site #, enrollment #, study arm 
#, subject initials, and # of people in cluster. In clusters with more than 1 
person, the leader will be 1, the 2nd person will be 2, the 3rd 3. The cluster 
members initials will not be used, they will link to the leader. 
Example the first cluster in the study consists of 2 people at site 3 lead by 
John Doe and randomized to study arm 2. The study number would be 
3.1.2.JD.1 for the leader and 3.1.2.JD.2 for the 2nd person.   
Data sent to UAMS Research Team. Data can be submitted in REDCap or 
on Paper. 
After 
Visit 1 
Intake Sheet including that includes demographics and medical 
history, Pre-Test, List of Meds 
 
After 
Final 
Visit  
Data Collection Sheet 1, Post-test, Program Evaluation & List of 
Meds 
 
 
 
 
EOS: death, start of dialysis or transplantation. 
Data will be stored in the UAMS Research office with access limited to study 
personnel only. UAMS-maintained computers and servers will be used to 
maintain databased information.  
The Principal Investigator will carefully monitor study procedures to protect 
the safety of research subjects, the quality of the data and the integrity of the 
study.   
At the conclusion of the study, the data will be maintained and later 
destroyed in accordance with UAMS policy which is for seven years after 
final reporting or publication of a project, or longer if required by a sponsor or 
regulation. Any data from subjects who opt out will not be kept for future use.  
 
Multisite Research 
Harps district director and research coordinator will be responsible for the 
education and oversite of each of their sites and not be responsible to UAMS 
IRB oversight. UAMS will supply the educational tools for both pharmacist, 
their staff and study subjects. This will include the CKD: What You Need to 

Title:  Pragmatic Approach to Chronic Kidney Disease Education in the Delta V.6 
PI:  Manisha Singh, MD 
 
Version #: 2 
Date: 12.14.2022  
Page 8 
Know workbook, slide sets, CKD action plan, Label reading exercise, Web-
based resource list, data collection sheets, pre and post tests and program 
evaluation. UAMS staff will participate in the initial education of Harps staff 
and future education, as requested. UAMS will make the 10 points of CKD 
Care for Primary Care Providers (PCPs) available to both Harps staff and 
local PCPs, as requested. 
Harps oversight staff and UAMS research staff will have monthly web-based 
or face to face meetings, with additional communication as needed. 
Reporting requirements are the same for each site and outlined in the data 
section above. A central site may be selected by Harps when the sites are 
selected and serve as a model or mentoring site. 
Data Analysis 
Study arms will be compared by RRT choice using logistic regression that 
includes covariates found to differ between the groups. Results will be 
reported in terms of odds ratios and their 95% confidence intervals. Each 
group will be compared on the ability to choose a modality by the end of their 
2nd or 3rd MTM visit, depending on their study arm and at the end of the 
study (June 2022) by comparing pre and post testing and program evaluation 
answers. To ensure balance in patient characteristics across clusters chi-
square or Fisher’s exact test, as appropriate, will be used to evaluate 
categorical measures, whereas two-sample t-test or Wilcoxon rank test, as 
appropriate, will be used for continuous measures. 
The primary study aim is the ability of the participants to choose a dialysis 
modality by the end of their second or third visit, depending on their study 
arm. Descriptive statistics will be used to examine the trend in the patients’ 
ability to choose a dialysis modality, level of interest in kidney transplant, the 
selection of a possible donor and having enough information to decide 
across the two assessment periods.  
Home dialysis (HOD) is underutilized in management of End Stage Renal 
Disease (ESRD) and there is a near universal agreement amongst 
nephrologists and professional societies for improving its rates with a target 
of around 30-40% of the prevalent ESRD population. Patients, when 
provided with comprehensive early CKD education, have repeatedly 
indicated their preferences at similar rates (around 30-40%) for HOD. 
Despite these findings, the rates of HOD are on the decline. The ADH SE 
region’s HOD rate for incident ESRD patients is less than 3%, AR rate is 
11%, the national rate in 10% and the pilot study using the CKD: What you 
Need to Know rate was 44% for the 68 subjects needing to start RRT by the 
end of the study and an addition 3 % were able to get pre-emptive 
transplants.  
It is likely that the lack of patient awareness and education play a critical role 
in the low incident HOD rates. The factors that contribute to this lack of 
patient awareness and education include the fact that comprehensive 

Title:  Pragmatic Approach to Chronic Kidney Disease Education in the Delta V.6 
PI:  Manisha Singh, MD 
 
Version #: 2 
Date: 12.14.2022  
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education programs require time- and resource consuming processes, needs 
multidisciplinary expertise, and are only partially compensated by the current 
reimbursement standards in the nation. Hence, only limited medical 
universities and few nephrology practices provide these programs.  With over 
300,000 Arkansans unaware they have CKD and close to 50,000 more 
having CKD but little access to proper education, expanding the pool of 
clinicians and sites that can deliver comprehensive nephrology developed 
patient education to a larger patient population over a wider geographical 
area in a cost effective manner has the potential to improve patient outcomes 
and save health care dollars. It is estimated that HOD saves as much as 
$19,000 per patient per year compared to in-center hemodialysis (). 
Demonstrating that non-nephrology clinicians can effectively educate and 
support these patients will provide models that other clinicians can use. 
Increased access to local CKD patient education can improve outcomes for 
minorities, especially in rural areas, who 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. 
Secondary outcomes will be compared in all clusters. Because randomization 
seldom results in samples that are balanced on all baseline characteristics, 
information on control variables relevant to choice of dialysis mode will be 
collected, including age, gender, baseline intent to start home based dialysis, 
whether currently being followed by a nephrologist, patient engagement 
measured by the percent of visits where CKD patient initiated discussion took 
place and self-reported and provider confirmed outcomes listed in study plan. 
Pharmacists and staff time will be compared between arms and linked to costs 
to support each intervention arm. Tests appropriate for the measure will be 
used when comparing baseline characteristics between the research arms. 
The sample size was based on what was appropriate for what could be 
reasonably be accomplished in the time frame with the available funding. 
Power based on the primary aim was a secondary consideration. A 
population of 100 clusters could result in a much larger population of 
subjects depending on the size of the clusters. Utilizing clusters to essentially 
train peer educators and describe their training methods, as well as, the 
outcomes of each of their cluster members can inform future research 
involving CKD peer educator led CKD patient education programs. 
Ethical Considerations 
This study will be conducted in accordance with all applicable government 
regulations and University of Arkansas for Medical Sciences research 
policies and procedures.  This protocol and any amendments will be 
submitted and approved by the UAMS Institutional Review Board (IRB) to 
conduct the study.  

Title:  Pragmatic Approach to Chronic Kidney Disease Education in the Delta V.6 
PI:  Manisha Singh, MD 
 
Version #: 2 
Date: 12.14.2022  
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This study meets the criteria for exempt review and does not require formal 
consent of the subjects. However, a Patient Information Sheet explaining the 
study will be provided to interested parties. After discussion with Harp’s 
pharmacist, verbal consent will be obtained and completion of the pre-test 
will be evidence of consent. UAMS will receive no HIPAA data on subjects. 
All data will be de-identified as outlined above and a HIPPA waiver has been 
requested. 
Dissemination of Data 
Results of this study may be used for presentations, posters, or publications. 
The publications will not contain any identifiable information that could be 
linked to a participant.   
The study will be listed on clinicaltrials.gov in accordance with the Clinical 
Journal of the American Society of Nephrology requirements. The final, 
anonymized dataset will be made publicly available by request to the PI.  
 
 
References 
1. Andrea M Easom, Ashutosh M Shukla, Dumitru Rotaru, Songthip Ounpraseuth, 
Sudhir V Shah, John M Arthur, Manisha Singh, Home run—results of a chronic kidney 
disease Telemedicine Patient Education Study, Clinical Kidney Journal, , sfz096, 
https://doi.org/10.1093/ckj/sfz096  
2. Shukla AM, Easom A, Singh M et al. Shah. Effects of a comprehensive predialysis 
education program on the home dialysis therapies: a retrospective cohort study. Perit 
Dial Int 2017; 37:542–547  
3. Neil N, Guest S, Wong L et al. The financial implications for Medicare of greater use 
of peritoneal dialysis. Clin Ther 2009; 31: 880–888  
4. Waterman AD, Browne T, Waterman BM et al. Attitudes and behaviors of African 
Americans regarding early detection of kidney disease. Am J Kidney Dis 2008; 51: 554–
562  
5. United States Renal Data System. 2018 USRDS annual data report: Epidemiology of 
kidney disease in the United States. National Institutes of Health, National Institute of 
Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2018.  
6. Szczech LA, Stewart RC, Su H-L,DeLoskey RJ, Astor BC, et al. (2014) Primary Care 
Detection of Chronic Kidney Disease in Adults with type-2 Diabetes: The ADD-CKD 
Study (Awareness, Detection and Drug Therapy in Type 2 Diabetes and Chronic Kidney 
Disease). PLoS ONE 9(11): e110535. doi:10.1371/journal.pone. 0110535  
7. Weis L, Metzger M, Haymann J-P, Thervet E, Flamant M, et al. (2013) Renal 
Function Can Improve at Any Stage of Chronic Kidney Disease. PLoS ONE 8(12): 
e81835. doi:10.1371/journal.pone.0081835  

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8. Hobby, G, Easom, A, Singh, M. Meeting Treatment Challenges of Chronic Kidney 
Disease. The Journal of Arkansas Medical Society 2018 (9). 
https://afmc.org/download/849/2018/86686  
9. ESRD Network 13. Customized 2728 Data Report by ADH Regions, (2018). Available 
on request from AR CKD Advisory Committee. 
 
 
 

Title:  Pragmatic Approach to Chronic Kidney Disease Education in the Delta V.6 
PI:  Manisha Singh, MD 
 
Version #: 2 
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