Manisha Singh, M.D.

UAMS Chronic Kidney Disease (CKD) Patient Education Study 

Subject Information Sheet 

Why: Chronic Kidney Disease (CKD) is more common in people with Diabetes or High Blood Pressure. People with early stages of CKD may not feel sick. In the final stage of CKD people need dialysis or a kidney transplant to stay alive. Currently, in the USA, there are more than 700,000 people on dialysis and approximately 97,000 people on the waiting list for a kidney transplant. For people with CKD, education is very important to help them learn how to protect their kidneys and slow the progression of kidney disease and to make the best treatment decision if they need to start dialysis or get a transplant. This study will provide education about CKD and different options of dialysis and kidney transplant.

Who: Anyone that has less than 45% kidney function (eGFR 45 or less) who is 18 years old or over, speaks and reads English, is not already on dialysis and has no major problems with reasoning or dependency can qualify to participate in this study if they have not already attended a CKD education class or classes that lasted over 2 hours. 

What: This study will allow patients to choose how they would like to obtain their CKD education. Either by attending classes in person (Group1), attending from home using their computer or tablet if they have google chrome or Firefox as their browser (Group2) or to use the workbook as a self-study tool (Group 3). All classes are taught by specialists (MD, advance practice nurse (APN), dietitian, pharmacist and/or social worker). They include a comprehensive education program designed to show you what to do to slow the progression of CKD, what your options are if your kidneys fail and how to prepare for dialysis or kidney transplantation, if needed. Then how to see the effect the education may have on your outcomes. Though there will be people present at multiple sites, we can all see and speak to each other. The classes will be small and you will have time to ask questions of all the specialists. 

There are three groups:

At the time of enrollment, participants in all groups will be asked to complete study paperwork, a CKD knowledge questionnaire and a quality of life survey. Group 3, participants choosing the self-study option, will receive the comprehensive workbook “CKD What You Need to Know”.

Group 1 and 2:  Will receive their workbook on their first visit. The workbook content will be taught over 3 classes. Group 1 will attend classes in person at UAMS. Group 2 will attend via teleconference from home. They will need to have google chrome or Firefox as their web browser. Each class will each be 2 ½ hours long. After each class a knowledge questionnaire will be given and on the final class the quality of life survey and a program evaluation will also be given.  Each class will be taught by the kidney specialists that are experts in the topics being discussed in that class. Slides and videos will be used to enhance workbook content. Group 3: The comprehensive CKD Workbook will be provided for self-study at the time of enrollment. Within 30-60 days, during a return visit, all Class 3 testing will be completed and there will be an opportunity to ask questions.

Telephone follow-up will be done twice, at six months and one year, to check on how you are feeling and if you have changed your decision or started on a treatment option.

How are the groups assigned?  Each participant can choose which group they want to join.

When: At the time of enrollment you can choose when and how you complete the classes. Class 1 is usually offered the first Thursday of every month, class 2 on the second Thursday and class 3 on the third Thursday. The fourth Thursday is open for make-up classes.

You can choose monthly visits or you can choose to complete them in little as little as three weeks.

Compensation:   Groups 1 and 2 participants will receive a $20 money card at the end of each of the three classes for compensation for travel and testing for a maximum of $60. Group 3 participants will receive $40 at their return visit after they have completed testing.  

Contact: If you have any questions regarding the project or participation, please feel free to call Dr. Manisha Singh or Andrea Easom, APRN, FNP-BC, CNN-NP at the UAMS Nephrology Office at 501-686-5295 or 501-603-1531. If you have questions regarding your participation as a research subject, please call the University of Arkansas for Medical Sciences’ Institutional Review Board at 501-686-5667.

This study is currently closed for recruitment.  No future participation is needed for this study.

Download the Pilot Study article (PDF)

Patient Information Sheet

Did you know that?

• 350,000 Adult Arkansans for Chronic Kidney Disease (CKD) yet 9 out of 10 of them don’t know it! That leaves 312,000 unaware they have CKD.
• Diabetes and hypertension are the two leading causes of kidney disease.
• Kidney function can improve with life style changes and proper care.

Harps and UAMS have a CKD patient education study where you can learn what CKD is, what you need to know to protect your kidneys and what to expect if dialysis or a kidney transplant is ever needed. There are three arms of the study. Education methods are different in each arm. Each person or group of people (if more than one person is in the household or has close friends that want to study together) will be randomly assigned into an arm. If your group has more than one person, the group will select someone in the group to be a leader and that person will be responsible to teach the others in the group.

Everyone in the groups completes the same tests: a 12 question pre-test, an 11 question post-test and a program evaluation to see what was learned, how you liked the program and get your feedback. Everyone can individually get their CKD questions answered at their routine pharmacy visits. Everyone will get educational materials that will be explained to you including a CKD Action Plan that outlines actions you can take to protect your kidneys. 

CKD education has normally been provided by kidney experts but in a UAMS pilot study, patients said they would have liked to have the educated earlier so they could have made changes earlier that would protect their kidneys and hopefully prevent them from needing dialysis. With the large number of Arkansans that are unaware they have CKD, there is a need for a larger pool providers that can provide CKD education. This study is testing the effectiveness of pharmacist and their staff using tools developed by kidney experts to educate high risk patients on CKD in several self-study models with varying levels of pharmacist involvement. It will also inform on the methods used and effectiveness of peer educators.

After reading this information, if you may be interested in this study, please talk to your pharmacist to see if you qualify for the study and to get any questions you may have answered. Please note that this study is available at participating pharmacies only.  Check with your local pharmacy for details.  Along with completing the tests described above, basic information will be collected from pharmacy records.  Your decision to participate or not will not affect your present or future care at UAMS or your Pharmacy.

Only the investigator and people who make sure we do the research the right way, like the UAMS IRB and the federal Office for Human Research Protections would be able to see the study information. Authorization to use this health information will not expire. If you do not wish to participate in this study any longer or have any questions or concerns about this study, you can contact Andrea Easom at 501-772-0600. If you have questions about your rights as a research participant or want to talk to someone not connected to the study team, you may contact Institutional Review Board at 501-686-5667 for more information.

Manisha Singh, M.D.

There are approximately 350,000 adult Arkansans with chronic kidney disease (CKD), however, only 10% are aware that they have it. Primary-care providers (PCPs) are powerful partners for positive changes to protect kidney function and slow CKD progression since they encounter patients long before the nephrologists. However, CKD detection by PCPs is low, as is their awareness of the steps required to adequately manage CKD. In this study, we will assess the ability of checklists to create short and long-term knowledge gains in PCPs. We will also explore barriers that prevent optimized CKD care, including nephrology referrals. A 10-step checklist of CKD guidelines with companion tools will be used to support PCP awareness and provide an outline for care.
You are invited to participate in a research study. Approximately 300 primary care providers in Arkansas are needed to complete this study. This is one facet of the overall goal to improve CKD awareness in Arkansas. The results of this study will inform the development of further studies addressing an interactive CKD checklist to improve outpatient CKD care.

We have created four tools for stimulating CKD awareness and management strategies. These tools will be downloaded after the pre-test to all participating providers for their access.

Tools include:

1. Provider CKD checklist: 10 steps for managing early CKD
2. Rationale for the 10 steps: Rationale commentary addressing recommended goals of CKD management.
3. Potential ICD codes that can be used when managing CKD patients and estimated reimbursement.
4. Patient handout explaining why these tests may be ordered by their provider in clinic.

For educational training, you will be provided a one hour-long lecture didactic along with a review of the literature. The lecture is recorded on a video learn-on-demand (LOD) module. You will be awarded CME credits upon completion as described in the activity Information page within LOD. It is expected to take less than 30 minutes to read the provided literature review.

If you join the study, we will give you a checklist with rationale data for each recommendation as a practice improvement strategy. Each participant will complete a pre- and post-test on the day they read the checklists followed by another post-test after 6 months to assess the durability of knowledge gained and improvement if any in the management of the CKD patients within your practice. (No direct patient contact will be initiated by our team) We will send a six month follow-up email which will contain a link that will direct each participant into our database to fill out a survey. 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.
Your decision on whether or not to participate will have no bearing on your employment status.

Participation is completely voluntary. You are free not to participate or to withdraw at any time, for whatever reason. No matter what decision you make, there will be no penalty or loss of benefit to which you are entitled.

Completion of the survey will be taken as consent to use the data collected for the research described.

If you have any questions or concerns about the research study, you can contact Dr. Manisha Singh at 501-240-5804. If you can’t reach Dr. Singh or would like to speak to someone not directly related to the study, you can contact the Institutional Review Board at 501-686-5667 with questions about your rights as a participant or to discuss any problems or concerns about the research.

Thank you for your time and dedication by helping UAMS achieve a goal to improve patient care.

You can access this Learn On Demand Module to participate using the link below:

https://learnondemand.org/lms/activity?@curriculum.id=1&@activity.id=7459557&@activity.bundleActivityId=-1