Comprehensive Pre-ESKD Education for Chronic Kidney Disease

(TEACH-VET Trial)

Overseen By Ashutosh M Shukla, MD MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Non-English, Homeless, Dementia, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

544 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is intended to correct an important systemic deficit in the care of chronic kidney disease (CKD), VHA's fourth most common healthcare condition with high mortality and healthcare burden. Currently, many Veterans with CKD have poor awareness of their condition. This leads to suboptimal care. The investigators anticipate that the proposed comprehensive pre-end stage renal disease (ESRD) education (CPE) will enhance Veterans' CKD knowledge and their confidence in making an informed selection of an appropriate dialysis modality, and lead to an increase in the use of home dialysis (HoD) - an evidence-based, yet underutilized dialysis modality. Further, this study will allow us to examine whether such Veteran-informed dialysis choice can improve Veteran and health services outcomes. If successful, this study may deliver a ready to roll-out strategy to meet the CKD care needs of the Veterans and reduce VHA healthcare costs.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Comprehensive Pre-ESKD Education for Chronic Kidney Disease is an effective treatment?

The available research shows that Comprehensive Pre-ESKD Education helps patients with chronic kidney disease make more informed choices about their treatment options, particularly in choosing home dialysis. Studies indicate that this education can lead to a higher rate of home dialysis, which is often preferred by patients. Additionally, it has been shown to decrease the need for dialysis and reduce mortality rates. However, the effectiveness of this education program can vary, and more consistent data is needed to fully confirm its benefits. ^{1 2 3 4 5}

What safety data exists for Comprehensive Pre-ESKD Education for CKD?

The available research does not directly address safety data for Comprehensive Pre-ESKD Education. However, it highlights the importance of patient education in improving outcomes and informed choices in dialysis. The studies emphasize the need for structured education programs but do not provide specific safety data related to adverse events or risks associated with the education itself. ^{2 5 6 7 8}

Is Comprehensive Pre-ESRD Patient Education (CPE) a promising treatment for chronic kidney disease?

Yes, Comprehensive Pre-ESRD Patient Education (CPE) is a promising treatment for chronic kidney disease. It helps patients choose home dialysis more often, reduces medical costs, slows down kidney disease progression, and can extend survival time before needing dialysis. ^{1 2 9 10 11}

Research Team

Ashutosh M. Shukla, MD MBBS

Principal Investigator

North Florida/South Georgia Veterans Health System, Gainesville, FL

Eligibility Criteria

This trial is for Veterans aged 18 or older with advanced chronic kidney disease (stage 4 or 5) who are not on dialysis and receive healthcare from the NF/SG VHS. It excludes non-English speakers, those with dementia, homeless veterans, those in assisted living or nursing homes, and individuals expected to live less than six months.

Inclusion Criteria

Veterans who are registered to receive healthcare from the NF/SG VHS.

My kidney disease is advanced but I'm not on dialysis.

I am 18 years old or older.

Exclusion Criteria

Veterans who are expected to live less than 6 months.

I am a veteran diagnosed with dementia.

Non-English speakers

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Comprehensive Pre-ESRD Education (CPE)

Participants receive comprehensive pre-end stage renal disease education to improve CKD knowledge and confidence in dialysis decision making

0-4 weeks

Up to 3 sessions (in-person or telemedicine)

Enhanced Usual Care

Participants receive usual care enhanced by self-learning CKD information

0-4 weeks

Follow-up

Participants are monitored for home dialysis use and post-ESRD outcomes

3-48 months

Treatment Details

Interventions

• Comprehensive Pre-ESRD Patient Education (CPE)

Trial Overview The study tests whether comprehensive pre-end stage renal disease education can improve knowledge of CKD among Veterans and lead to more choosing home dialysis—a better but underused treatment. The impact on patient confidence and health service outcomes will also be evaluated.

Participant Groups

Group I: Comprehensive Pre-ESRD Patient Education (CPE) Active Control 1 Intervention

These patients will receive CPE for a total of up to 3 session in an intent-to-teach format, either via Face-to-face or telemedicine delivery.

Group II: Enhanced Usual Care Active Control 1 Intervention

This group will receive usual care. This care will be enhanced by providing them with the freely available education material for the Kidney Disease Education

Comprehensive Pre-ESRD Patient Education (CPE) is already approved in United States for the following indications:

Approved in United States as Comprehensive Pre-ESRD Patient Education for:

• Chronic Kidney Disease Education
• Pre-Dialysis Education
• Home Dialysis Education

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Multidisciplinary pre-dialysis education (MPE) significantly reduced the need for unplanned urgent dialysis (8.7% vs 24.2%) and shortened hospital stays for chronic kidney disease patients, indicating improved management before starting dialysis.

While MPE did not show a significant survival advantage, it was associated with a lower incidence of cardiovascular events (adjusted hazard ratio of 0.24) and a trend towards reduced infection rates, suggesting potential benefits in overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of multidisciplinary pre-dialysis education in advanced chronic kidney disease: Propensity score matched cohort analysis. Cho, EJ., Park, HC., Yoon, HB., et al.[2022]

In a study of 108 patients over 22 months, 70% of those who received comprehensive predialysis education (CPE) chose home dialysis options, indicating that education significantly influences patient choices.

The implementation of the CPE program led to a remarkable 216% increase in the home dialysis census, nearly doubling the prevalence of home dialysis among all dialysis patients to 38%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Comprehensive Predialysis Education Program on the Home Dialysis Therapies: A Retrospective Cohort Study. Shukla, AM., Easom, A., Singh, M., et al.[2020]

In a study of 573 chronic kidney disease (CKD) patients, those who received multidisciplinary predialysis education (MPE) had a significantly lower incidence of dialysis (13.9%) compared to those who did not receive MPE (43%), indicating that MPE can effectively delay the need for dialysis.

The overall mortality rate was also much lower in the MPE group (1.7%) compared to the non-MPE group (10.1%), suggesting that MPE not only helps in delaying dialysis but also improves survival rates among late-stage CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary predialysis education decreases the incidence of dialysis and reduces mortality--a controlled cohort study based on the NKF/DOQI guidelines. Wu, IW., Wang, SY., Hsu, KH., et al.[2022]

A 3-year pilot study involving chronic kidney disease (CKD) patients showed that comprehensive predialysis education (CPE) delivered through telemedicine (TM) was as effective as face-to-face (FTF) education in helping patients make informed choices about renal replacement therapy (RRT).

After education, nearly 90% of participants from both TM (87%) and FTF (95%) were able to choose a treatment modality, with home dialysis options more than doubling in both groups, indicating that education significantly empowers patients in their treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home run-results of a chronic kidney disease Telemedicine Patient Education Study. Easom, AM., Shukla, AM., Rotaru, D., et al.[2022]

A structured, stand-alone Comprehensive Pre-ESRD Patient Education (CPE) program significantly increases patient awareness and preference for Home Dialysis (HoD) among advanced CKD patients in the US, suggesting that many would choose HoD if informed properly.

Implementing this CPE protocol not only accelerates the adoption of HoD but also helps reduce disparities in its utilization, indicating that such educational initiatives could improve dialysis choices and outcomes across healthcare institutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do the US advanced kidney disease patients want? Comprehensive pre-ESRD Patient Education (CPE) and choice of dialysis modality. Shukla, AM., Hinkamp, C., Segal, E., et al.[2020]

A review of 69 patient education materials (PEMs) on chronic kidney disease (CKD) found that 79% were rated as 'adequate' in terms of readability and content, with an overall mean rating of 58.3%.

PEMs that included patient-centered content and opportunities for interaction received higher ratings, and materials suitable for a literacy level of 6th grade or lower were associated with better understanding among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of printed patient-educational materials for chronic kidney disease. Tuot, DS., Davis, E., Velasquez, A., et al.[2022]

Patients with chronic kidney disease (CKD) are particularly vulnerable to adverse drug events during hospitalization, which can lead to significant harm.

The study emphasizes the need for new strategies to minimize medical errors and improve safety for CKD patients in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication errors in chronic kidney disease: one piece in the patient safety puzzle. Fink, JC., Chertow, GM.[2022]

10.3% of patients with chronic kidney disease (CKD) experienced adverse safety events (ASE) during hospitalization, with the most common being nausea-vomiting-diarrhea (50.7%), lower extremity edema (21.3%), and confusion (18%).

Factors such as older age, female gender, rural hospital settings, and specific comorbidities (like anemia and neurological disorders) significantly increased the odds of experiencing ASE, highlighting areas for potential intervention to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Safety Event Characteristics and Predictive Factors in Hospital Encounters for Patients with Chronic Kidney Disease. Davis-Ajami, ML., Fink, JC., Baernholdt, M., et al.[2020]

In a study of 425 patients starting hemodialysis, those who participated in multidisciplinary pre-dialysis education (MPE) experienced significantly lower medical costs in the first 6 months after starting treatment, averaging $9,147.60 compared to $11,190.60 for those who did not participate.

MPE patients also had fewer hospitalizations and shorter hospital stays, primarily due to reduced cardiovascular issues and fewer vascular access surgeries, indicating that pre-dialysis education can lead to better health outcomes and lower healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary predialysis education reduced the inpatient and total medical costs of the first 6 months of dialysis in incident hemodialysis patients. Yu, YJ., Wu, IW., Huang, CY., et al.[2022]

Patients with chronic kidney disease (CKD) who received predialysis psychoeducational interventions had a median survival that was 2.25 years longer compared to those who received usual care, based on a study of 335 patients followed for an average of 8.5 years.

The psychoeducational intervention also led to a median survival increase of 8.0 months after starting dialysis therapy, indicating its long-term benefits in managing CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predialysis psychoeducational intervention extends survival in CKD: a 20-year follow-up. Devins, GM., Mendelssohn, DC., Barré, PE., et al.[2022]

Patients who received Pre-ESKD Kidney Disease Education (KDE) services showed more than double the rates of successful arteriovenous fistula (AVF) and composite AVF/arteriovenous graft (AVG) utilization compared to those who did not receive KDE, indicating a significant improvement in vascular access outcomes.

The KDE cohort also had a 40% lower rate of central venous catheter (CVC) use, suggesting that education prior to dialysis initiation can lead to better vascular access management and potentially reduce complications associated with catheter use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provision of Kidney Disease Education Service Is Associated with Improved Vascular Access Outcomes among US Incident Hemodialysis Patients. Ruchi, R., Bozorgmehri, S., Chamarthi, G., et al.[2023]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Effect of multidisciplinary pre-dialysis education in advanced chronic kidney disease: Propensity score matched cohort analysis. [2022]

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

Effects of a Comprehensive Predialysis Education Program on the Home Dialysis Therapies: A Retrospective Cohort Study. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Multidisciplinary predialysis education decreases the incidence of dialysis and reduces mortality--a controlled cohort study based on the NKF/DOQI guidelines. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Home run-results of a chronic kidney disease Telemedicine Patient Education Study. [2022]

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

What do the US advanced kidney disease patients want? Comprehensive pre-ESRD Patient Education (CPE) and choice of dialysis modality. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Assessment of printed patient-educational materials for chronic kidney disease. [2022]

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

Medication errors in chronic kidney disease: one piece in the patient safety puzzle. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Safety Event Characteristics and Predictive Factors in Hospital Encounters for Patients with Chronic Kidney Disease. [2020]

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

Multidisciplinary predialysis education reduced the inpatient and total medical costs of the first 6 months of dialysis in incident hemodialysis patients. [2022]

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

Predialysis psychoeducational intervention extends survival in CKD: a 20-year follow-up. [2022]

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

Provision of Kidney Disease Education Service Is Associated with Improved Vascular Access Outcomes among US Incident Hemodialysis Patients. [2023]