A Pragmatic Approach to CKD Patient Education

NCT05138419 | Terminated Results

• 1 other identifier: 262853
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease stage3; Chronic Kidney Disease stage4; Chronic Kidney Disease Stage 5; Patient Engagement

Keywords

Patient Education; Patient Engagement; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (6)

• Number of Subjects Who Can Choose a Dialysis Modality by the End of the Study.

  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.

  up to 4 months

• Number of Subjects That Choose a Form of Home Dialysis (Home Hemodialysis or Peritoneal Dialysis) by the End of the Study.

  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).

  up to 4 months

• Number of Subjects Interested in Kidney Transplant (Pre-test)

  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.

  before implementation of the intervention, average of 1 week

• Number of Subjects Interested in Kidney Transplant (Post-test)

  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.

  after the intervention, up to 4 months

• Number of Subjects With a Possible Donor Identified (Pre-test)

  Descriptive statistics will be used to examine the trend in the subjects' selection of a possible donor based on pre-test evaluation form answers.

  before implementation of the intervention, average of 1 week

• Number of Subjects With a Possible Donor Identified (Post-test)

  Descriptive statistics will be used to examine the trend in the subjects' selection of a possible donor based on post-test evaluation form answers.

  after the intervention, up to 4 months

Secondary Outcomes (5)

• 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

Study Arms (3)

Case Management Model (CMM)

ACTIVE COMPARATOR

CMM includes 3 visits of pharmacist initiated discussion of workbook content (including AP \[action plan\] and CKD web-based sites) and AP reinforcement. Pre-testing is done on Visit 1 (V1) and Post testing and program evaluation on V3. Subjects are asked to read 1 chapter a week, write down questions and take tests at the end of chapters. On V1 pharmacist introduces the Workbook System highlighting chapters 1-4 and assist with AP goal selection. On V2, the pharmacist answers questions, provides chapter 4-8 highlights and reviews AP goal progress and food label exercise. On V3, pharmacist answers questions, expands on workbook content and reviews AP goals progress and program evaluation including modality and transplant questions from pre/posttests, identification and ranking of peer cluster leader teaching style and effectiveness, identification of AP goals selected and ranking of helpfulness is completed. Pharmacists track time spent at each visit to compare cost and outcomes.

Other: CKD "What You Need To Know" Workbook System; Other: CKD Action Plan; Other: CKD Web-based Resource List; Other: Food Label reading exercise

Self Study (SS)

ACTIVE COMPARATOR

SS includes 2 visits. Subjects receive the workbook, paper copies of AP and food label exercise. Pre-testing will be done on V1 and Post testing on V2, eight weeks later. Subjects will be asked to read 1 chapter a week for the next 8 weeks. The pharmacist will provide a brief introduction of the workbook (5-10 minutes) and the AP. Only subject initiated questions will be answered. On V2, the pharmacist will answer subject initiated questions and ask about progress in the AP goal attainment and the program evaluation will be completed, as described in arm 1.Pharmacists track time spent at each visit to compare cost and outcomes.

Other: CKD "What You Need To Know" Workbook System; Other: CKD Action Plan; Other: CKD Web-based Resource List; Other: Food Label reading exercise

Control (Ctrl)

SHAM COMPARATOR

Ctrl includes 2 visits. Subjects receive a list of web-based CKD sites, a food label exercise and a copy of the AP with no additional intervention, other than answering subject initiated questions, on V1. Pre-testing will be done on V1 and Post testing on V2 and program evaluation will be done eight weeks later. On V2, the pharmacist will ask about AP goals and answer subject initiated questions. Pharmacists track time spent at each visit to compare cost and outcomes.

Other: CKD Action Plan; Other: CKD Web-based Resource List; Other: Food Label reading exercise

Interventions

CKD Action Plan OTHER

Goals based on international guidelines that can protect kidney function (1 knowledge and 10 action goals) Patient education material used separately for control arm.

Case Management Model (CMM); Control (Ctrl); Self Study (SS)

CKD Web-based Resource List OTHER

CKD Patient education material used separately for control arm

Case Management Model (CMM); Control (Ctrl); Self Study (SS)

Food Label reading exercise OTHER

CKD Patient education material used separately in all arms.

Case Management Model (CMM); Control (Ctrl); Self Study (SS)

CKD "What You Need To Know" Workbook System OTHER

139 page Workbook including CKD Action Plan, Web-Based Resources, Interactive CKD Patient education material

Case Management Model (CMM); Self Study (SS)

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (6)

• Easom AM, Shukla AM, Rotaru D, Ounpraseuth S, Shah SV, Arthur JM, Singh M. Home run-results of a chronic kidney disease Telemedicine Patient Education Study. Clin Kidney J. 2019 Aug 22;13(5):867-872. doi: 10.1093/ckj/sfz096. eCollection 2020 Oct.

  PMID: 33123362 BACKGROUND

• Shukla AM, Easom A, Singh M, Pandey R, Rotaru D, Wen X, Shah SV. Effects of a Comprehensive Predialysis Education Program on the Home Dialysis Therapies: A Retrospective Cohort Study. Perit Dial Int. 2017 Sep-Oct;37(5):542-547. doi: 10.3747/pdi.2016.00270. Epub 2017 May 25.

  PMID: 28546368 BACKGROUND

• Neil N, Guest S, Wong L, Inglese G, Bhattacharyya SK, Gehr T, Walker DR, Golper T. The financial implications for Medicare of greater use of peritoneal dialysis. Clin Ther. 2009 Apr;31(4):880-8. doi: 10.1016/j.clinthera.2009.04.004.

  PMID: 19446160 BACKGROUND

• Waterman AD, Browne T, Waterman BM, Gladstone EH, Hostetter T. Attitudes and behaviors of African Americans regarding early detection of kidney disease. Am J Kidney Dis. 2008 Apr;51(4):554-62. doi: 10.1053/j.ajkd.2007.12.020. Epub 2008 Mar 6.

  PMID: 18371531 BACKGROUND

• Szczech LA, Stewart RC, Su HL, DeLoskey RJ, Astor BC, Fox CH, McCullough PA, Vassalotti JA. 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. 2014 Nov 26;9(11):e110535. doi: 10.1371/journal.pone.0110535. eCollection 2014.

  PMID: 25427285 BACKGROUND

• Weis L, Metzger M, Haymann JP, Thervet E, Flamant M, Vrtovsnik F, Gauci C, Houillier P, Froissart M, Letavernier E, Stengel B, Boffa JJ; NephroTest Study Group. Renal function can improve at any stage of chronic kidney disease. PLoS One. 2013 Dec 13;8(12):e81835. doi: 10.1371/journal.pone.0081835. eCollection 2013.

  PMID: 24349134 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Patient Participation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Early termination due to the pharmacies staffing problems. Major barriers were pharmacist time and low literacy levels of many of their patients. Funding was too low but if data showed positive outcomes for patients getting early CKD education in local pharmacies, Medicare could expand CKD education coverage to include pharmacists (currently limited to. Nephrology clinicians).

Results Point of Contact

• Title: Andrea Easom, APRN
• Organization: University of Arkansas for Medical Sciences

easomandreak@uams.edu

5018379556

Study Officials

• Manisha Singh, MD

  UAMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized control pilot study using non-nephrology clinicians to educate patients at high risk for CKD how to protect the kidneys and be ready for RRT if needed utilizing nephrology developed educational tools. Pharmacists screen subjects in the MTM program or with the same medical conditions, enroll them in familial or peer clusters of 1 or more subjects and randomized into 1 of the 3 study arms using a site specific randomization schedule. In clusters of more than 1 subject, the group chooses a leader who receives the assigned intervention and shares it other cluster members. All subjects will receive pre and post testing, health literacy evaluation and completes a program evaluation. The 3 arms include 2 education arms and a control arm with various levels of intervention. The two education arms use the CKD: What You Need to Know Workbook including the CKD AP as self-study tools. The control arm receives the CKD AP and a list of CKD Web-based Resources.

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: December 1, 2021
• Study Start: February 13, 2023
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: January 7, 2026
• Results First Posted: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)