Clinical trial NCT05138419: A Pragmatic Approach to CKD Patient Education
Official title: A Pragmatic Approach to Chronic Kidney Disease Patient Education in the Delta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease stage3
Chronic Kidney Disease stage4
Chronic Kidney Disease Stage 5
Patient Engagement
Keywords: Patient Education
Patient Engagement
Chronic Kidney Disease
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: 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.

Harp pharmacists expressed randomization concerns. Harp's Pharmacy reported that many of the 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 the patient's intervention. The research team 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 the education of the other cluster members. All cluster members will undergo the same testing.

Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects who can choose a dialysis modality by the end of the study.
timeFrame: up to 4 months
measure: Number of subjects that choose a form of home dialysis (Home Hemodialysis or peritoneal dialysis) by the end of the study.
timeFrame: up to 4 months
measure: Number of subjects interested in kidney transplant (pre-test)
timeFrame: before implementation of the intervention, average of 1 week
measure: Number of subjects interested in kidney transplant (post-test)
timeFrame: after the intervention, up to 4 months
measure: Number of subjects with a possible donor identified (pre-test)
timeFrame: before implementation of the intervention, average of 1 week
measure: Number of subjects with a possible donor identified (post-test)
timeFrame: after the intervention, up to 4 months
Secondary outcomes:
measure: Intra cluster analysis to evaluate effectiveness of each teaching style used by peer educators
timeFrame: Up to 4 months
measure: Patient Engagement (percent of applicable Action Plan (AP) goals selected)
timeFrame: up to 4 months
measure: Patient engagement (percent of visits where a patient-initiated CKD discussion takes place)
timeFrame: up to 4 months
measure: Patient engagement (percent of goals met)
timeFrame: up to 4 months
measure: Amount of time spent by pharmacist and staff per subject
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: UAMS
name: Manisha Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.