Education Programs for Chronic Kidney Disease

(ExPAND Trial)

Recruiting at 27 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

3000 Participants Needed

Trial Summary

What is the purpose of this trial?

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 failure, specifically, to ensure patients are actively involved in a shared decision making (SDM) process covering a full range of treatment choices and have meaningful access to that full range of choices. These include standard in-center or home dialysis as well as alternative treatment plans (ATPs): active medical care without dialysis, time-limited trial of dialysis, palliative dialysis, and deciding not to decide. Approach 1 - Educate and Engage: Nephrology practices encourage their patients to a) participate in a kidney disease education program providing a balanced presentation of all options including ATPs, b) use evidence-based patient decision aids that include ATPs, and c) engage in SDM with staff trained in communication skills and best practices. Approach 2 - Educate and Engage Plus Kidney Supportive Care Program: Nephrology practices add a primary palliative care program to support patients who choose ATPs and their families. The program provides care coordination, symptom management, advance care planning, and psychosocial support to supplement usual care from their nephrologist. To compare the two approaches, the investigators will conduct a repeated, cross-sectional stepped wedge cluster randomized trial involving 20-25 chronic kidney disease clinics at 8 practice organizations around the United States. Aim 1: Compare the effectiveness of Approaches 1 and 2 in a) increasing proportion of patients choosing ATP and b) reducing patient-reported decisional conflict about treatment. Aim 2: Compare the patient and family experience of ATP care between Approaches 1 and 2 in terms of quality of life, services used, and end of life (EOL) experience. Aim 2a will focus on experience while patients are receiving an ATP. Aim 2b will describe the EOL experience. Aim 3: Evaluate implementation of each approach through a mixed-methods design based on the expanded RE-AIM framework. For Aims 1 and 2, researchers will collect information by chart review and surveys with patients and caregivers. For Aim 3, information will be reported by site managers as part of monthly progress reports. Clinic administrators, clinical providers, and staff will complete surveys before and after implementation of each approach.

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 data supports the effectiveness of the treatment Educate and Engage, Shared Decision Making (SDM) Approach, Kidney Disease Education Program, Educate and Engage Plus Kidney Supportive Care Program for chronic kidney disease?

Research shows that shared decision making (SDM) helps patients with chronic kidney disease make informed choices by combining medical evidence with personal values, leading to better treatment decisions. Education programs are crucial for understanding treatment options and supporting SDM, which can improve patient engagement and satisfaction. ^{1 2 3 4 5}

Is the Education Program for Chronic Kidney Disease safe for humans?

The research articles reviewed do not provide specific safety data for the education programs related to chronic kidney disease, but they focus on shared decision-making and patient education, which are generally considered safe as they involve providing information and support rather than medical interventions. ^{1 2 3 6 7}

How is the Educate and Engage Plus Kidney Supportive Care Program treatment different from other treatments for chronic kidney disease?

This treatment is unique because it focuses on shared decision-making (SDM), which involves patients actively participating in their treatment choices by balancing clinical evidence with their personal values and beliefs. It emphasizes education and collaboration between patients and healthcare professionals, which is not typically a focus in standard treatments for chronic kidney disease. ^{1 2 3 6 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient Education for Kidney Failure Treatment: A Mixed-Methods Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Healthcare professional education in shared decision making in the context of chronic kidney disease: a scoping review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Shared Decision Making in Health Care Visits for CKD: Patients' Decisional Role Preferences and Experiences. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Whose choice is it? Shared decision making in nephrology care. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Shared decision-making in advanced kidney disease: a scoping review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Shared Decision-Making for a Dialysis Modality. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Needs and Considerations for Standardization of Kidney Disease Education in Patients with Advanced CKD. [2023]

8. France pubmed.ncbi.nlm.nih.gov

[Patient education]. [2013]