Education Programs for Chronic Kidney Disease

(ExPAND Trial)

Enrolling by invitation at 28 trial locations

Overseen By Matthew Ryan, MSPH, MBA

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: George Washington University

Disqualifiers: Acute kidney injury, Transplant list, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how to best assist older patients with chronic kidney disease in making informed treatment decisions. It compares two approaches: one educates patients about all treatment options, including alternatives to dialysis, while the other adds extra support such as symptom management and care planning. The goal is to determine which method better aids patients in choosing the right treatment and reduces decision-related stress. Patients with chronic kidney disease experiencing significant kidney function decline who have not yet started dialysis might be suitable for this trial. As an unphased trial, this study provides patients the opportunity to contribute to research that could enhance decision-making and reduce stress for others facing similar health challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these educational approaches are safe for patients with chronic kidney disease?

Research shows that education programs for chronic kidney disease (CKD) primarily help patients understand their choices. These programs aim to enhance decision-making and condition management, which is crucial for those with CKD. Specific safety information for these education programs is not available, likely because they focus on teaching and decision support rather than medical treatments.

The Educate and Engage Plus Kidney Supportive Care Program, which provides extra support for those choosing different treatment plans (such as palliative care), also lacks detailed safety information. This program's main goal is to offer additional help through care organization, symptom management, and emotional support.

Since both approaches in the trial emphasize education and support instead of medical treatments, they are likely very safe. They aim to provide patients with knowledge and support, making them low-risk in terms of physical safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these education programs for chronic kidney disease because they offer a fresh approach to patient care. Unlike traditional treatments that primarily focus on medication and dialysis, these programs emphasize patient education and engagement, empowering patients to make informed decisions about their health. The Educate and Engage Plus Kidney Supportive Care Program goes a step further by integrating supportive care, aiming to improve overall patient wellbeing and possibly slow disease progression. This holistic approach can potentially enhance quality of life, which is why it stands out from conventional methods.

What evidence suggests that this trial's approaches could be effective for chronic kidney disease?

Research has shown that when patients with chronic kidney disease (CKD) learn about their treatment options, they can make better decisions. Studies have found that shared decision-making (SDM) programs, where patients actively choose their treatments, can reduce uncertainty and increase satisfaction. In this trial, participants will be assigned to one of two approaches. The Educate and Engage approach provides clear information and uses proven tools to help patients make decisions, encouraging them to consider different treatment plans.

The Educate and Engage Plus Kidney Supportive Care Program, on the other hand, offers additional support for those who choose alternative treatment plans. This includes organizing care and managing symptoms, which can improve quality of life. Early results suggest that patients who receive this extra support feel they receive better care. Overall, these strategies aim to empower patients in their treatment journey, potentially leading to better outcomes and satisfaction. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for older patients with kidney failure who are exploring treatment options. Participants should be willing to engage in educational programs about kidney disease, use decision aids, and participate in shared decision-making processes.

Inclusion Criteria

I am a caregiver of a patient who chose an alternative treatment plan.

Currently practicing or employed at participating clinic

I have chronic kidney disease and am treated at a participating clinic.

Exclusion Criteria

Exclusion Criteria for surveys and interviews:

My low eGFR is due to a sudden kidney injury, as confirmed by my doctors.

I am eligible for a kidney transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educate and Engage

Nephrology practices implement a bundle to encourage participation in a kidney disease education program, use of decision aids, and engagement in shared decision-making.

10 months

Monthly visits for education and decision-making support

Educate and Engage Plus Kidney Supportive Care Program

Nephrology practices add a primary palliative care program to support patients choosing alternative treatment plans with care coordination, symptom management, and psychosocial support.

10 months

Monthly visits for supportive care and follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment, including chart reviews and surveys.

4 months

Follow-up surveys at Month 4 and Month 9 after enrollment

What Are the Treatments Tested in This Trial?

Interventions

• Educate and Engage
• Educate and Engage Plus Kidney Supportive Care Program

Trial Overview The study compares two approaches: 'Educate and Engage' which involves education and shared decision-making support, versus 'Educate and Engage Plus Kidney Supportive Care Program' that adds palliative care support for those choosing alternative treatments.

How Is the Trial Designed?

Group I: Educate and Engage Plus Kidney Supportive Care Program Experimental Treatment 1 Intervention

Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 2.

Group II: Educate and Engage Experimental Treatment 1 Intervention

Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 1.

Educate and Engage is already approved in United States for the following indications:

Approved in United States as Educate and Engage for:

• Patient Education for Kidney Failure Treatment Options

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

West Virginia University Research Corporation

Collaborator

Trials

2

Recruited

3,500+

University of Bristol

Collaborator

Trials

114

Recruited

25,030,000+

Published Research Related to This Trial

Patients with chronic renal disease should receive comprehensive counseling and educational support to enhance their quality of life.

Healthcare systems need to develop educational programs that utilize existing staff resources, as no additional funding has been allocated for patient education in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient education]. Tourette-Turgis, C., Isnard-Bagnis, C.[2013]

Shared decision-making (SDM) significantly increases satisfaction among individuals with kidney failure when choosing a dialysis modality, highlighting the importance of patient involvement in treatment decisions.

For SDM to be effective, educational materials must be clear, unbiased, and tailored to the individual's needs, ensuring that all patients are empowered to actively participate in their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Decision-Making for a Dialysis Modality. Yu, X., Nakayama, M., Wu, MS., et al.[2022]

Education programs for patients with advanced chronic kidney disease often lack consistency in quality and content, focusing heavily on dialysis while neglecting conservative management options and other important topics like prognosis and mental health.

These programs do not effectively support shared decision-making (SDM) due to a lack of tailored information and involvement from nephrologists, highlighting the need for improved communication and integration of educational content into clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Education for Kidney Failure Treatment: A Mixed-Methods Study. Koch-Weser, S., Porteny, T., Rifkin, DE., et al.[2022]

A scoping review of 24 studies on shared decision making (SDM) training for healthcare professionals caring for chronic kidney disease (CKD) patients revealed that while there is some evidence of effectiveness, the quality and design of these studies vary significantly, with only 5 being of high quality.

The review highlighted a lack of standardized curricula and public access to educational materials, indicating that while training exists, its impact on improving SDM processes from the patient's perspective remains largely untested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare professional education in shared decision making in the context of chronic kidney disease: a scoping review. Meijers, B., Wellekens, K., Montomoli, M., et al.[2023]

A comprehensive review identified 145 interventions aimed at supporting shared decision-making (SDM) for treatment decisions in advanced kidney disease, including prognostic tools, educational programs, patient decision aids, and multicomponent initiatives.

Despite the variety of interventions, there is no clear evidence on which is the most effective for SDM, and many studies are based on observational research with inconsistent outcome measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared decision-making in advanced kidney disease: a scoping review. Engels, N., de Graav, GN., van der Nat, P., et al.[2022]

A study involving 122 patients with chronic kidney disease (CKD) revealed that many patients prefer shared decision making (SDM) for treatment choices, but their actual experiences often did not match these preferences, indicating a gap in patient involvement during consultations.

Despite a strong desire for shared decision making, observed levels of SDM during healthcare visits were low, suggesting that healthcare professionals may not be adequately engaging patients in the decision-making process regarding their CKD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Decision Making in Health Care Visits for CKD: Patients' Decisional Role Preferences and Experiences. van der Horst, DEM., Hofstra, N., van Uden-Kraan, CF., et al.[2023]

Shared decision making (SDM) is a patient-centered approach that empowers individuals with end-stage renal disease (ESRD) to actively participate in their healthcare decisions, considering both empirical evidence and personal values.

Implementing SDM in ESRD care can enhance communication between patients and nephrology teams, potentially improving treatment outcomes and patient satisfaction, while also addressing the ethical application of new renal technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whose choice is it? Shared decision making in nephrology care. Murray, MA., Bissonnette, J., Kryworuchko, J., et al.[2013]

Increasing awareness and understanding of home dialysis options among patients with advanced chronic kidney disease (CKD) is crucial for improving its utilization in the U.S.

Targeted patient education before kidney failure can significantly enhance knowledge about kidney disease and promote informed choices regarding home dialysis, but the lack of standardized education protocols leads to inconsistent outcomes in home dialysis implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Needs and Considerations for Standardization of Kidney Disease Education in Patients with Advanced CKD. Shukla, AM., Cavanaugh, KL., Jia, H., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10308615/

Healthcare professional education in shared decision ... We performed a scoping review to study the effectiveness of training or education about shared decision making of healthcare professionals treating patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6236635/

Barriers to Education and Shared Decision Making in the ... There are numerous barriers to effective education and informed decision making in the chronic kidney disease (CKD) population.

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06243068

Expanding and Promoting Alternative Care and ... The goal of this clinical trial is to compare two health system-based approaches for offering kidney failure treatment options to older patients with kidney ...

4. ajkd.org ajkd.org/article/S0272-6386(23)00734-5/fulltext

Shared Decision Making in Health Care Visits for CKD Research on shared decision making (SDM) in chronic kidney disease (CKD) has focused almost exclusively on the modality of kidney replacement treatment.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06243068

Study Details | NCT06243068 | Expanding and Promoting ... Approach 1 - Educate and Engage: Nephrology practices encourage their patients to a) participate in a kidney disease education program providing a balanced ...

6. withpower.com withpower.com/trial/phase-chronic-kidney-disease-ckd-8-2024-53854

Education Programs for Chronic Kidney Disease ... The research articles reviewed do not provide specific safety data for the education programs related to chronic kidney disease, but they focus on shared ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4822666/

Educating Patients about CKD: The Path to Self-Management ... Innovative education approaches for people with CKD exist, including self-management support, shared decision making, use of digital media, and engaging ...

8. mdpi.com mdpi.com/2673-8236/5/3/32

Advanced Chronic Kidney Disease and Patient Education This review provides a comprehensive analysis of all aspects of pre-dialysis education and best practices for advanced CKD patient education.

9. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-023-03229-8

Healthcare professional education in shared decision making ... We aimed to identify the available evidence on SDM training and education of healthcare professionals caring for people with chronic kidney ...