Comprehensive Pre-ESKD Education for Chronic Kidney Disease
(TEACH-VET Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Non-English, Homeless, Dementia, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345What 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.
25678Is 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.
1291011Eligibility 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
+2 more
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Group I: Comprehensive Pre-ESRD Patient Education (CPE)Active Control1 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 CareActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
North Florida/South Georgia Veterans Health System, Gainesville, FLGainesville, FL
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Effect of multidisciplinary pre-dialysis education in advanced chronic kidney disease: Propensity score matched cohort analysis. [2022]The mortality and morbidity of end-stage renal failure patients remains high despite recent advances in pre-dialysis care. Previous studies suggesting a positive effect of pre-dialysis education were limited by unmatched comparisons between the recipients and non-recipients of education. The present study aimed to clarify the roles of the multidisciplinary pre-dialysis education (MPE) in chronic kidney disease patients.
Effects of a Comprehensive Predialysis Education Program on the Home Dialysis Therapies: A Retrospective Cohort Study. [2020]Improvement in the rates of home dialysis has been a desirable but difficult-to-achieve target for United States nephrology. Provision of comprehensive predialysis education (CPE) in institutes with established home dialysis programs has been shown to facilitate a higher home dialysis choice amongst chronic kidney disease (CKD) patients. Unfortunately, limited data have shown the efficacy of such programs in the United States or in institutes with small home dialysis (HoD) programs.
Multidisciplinary predialysis education decreases the incidence of dialysis and reduces mortality--a controlled cohort study based on the NKF/DOQI guidelines. [2022]Observational studies have demonstrated that multidisciplinary predialysis education (MPE) improves the post-dialysis outcomes of chronic kidney disease (CKD) patients. However, the beneficial effect of MPE remains unclear in prospective controlled studies.
Home run-results of a chronic kidney disease Telemedicine Patient Education Study. [2022]Chronic kidney disease (CKD) incidence is increasing and associated mortality and morbidity are high. Educating patients is effective in delaying progression and establishing optimal renal replacement therapy (RRT). Tele-education/telemedicine (TM) can be an effective tool to provide such education, but there are no available data quantifying its effectiveness. We attempted to establish such evidence correlating the effect of education in patient choices and with the start of actual RRT. We present results from a 3-year pilot study evaluating the effectiveness of comprehensive predialysis education (CPE) through TM for CKD patients compared with a standard care group [face to face (FTF)]. The patient's ability to choose RRT was the primary endpoint.
What do the US advanced kidney disease patients want? Comprehensive pre-ESRD Patient Education (CPE) and choice of dialysis modality. [2020]Improvement in Home Dialysis (HoD) utilizations as a mean to improve the patient reported and health services outcomes, has been a long-held goal of the providers and healthcare system in United States. However, measures to improve HoD rates have yielded limited success so far. Lack of patient awareness of chronic kidney disease (CKD) and its management options, is one of the important barriers against patient adoption of HoD. Despite ample evidence that Comprehensive pre-ESERD Patient Education (CPE) improves patient awareness and informed HoD choice, use of CPE among US advanced CKD patients is low. Need for significant resources, lack of validated data showing unequivocal and reproducible benefits, and the lack of validated CPE protocols proven to have consistent efficacy in improving not only patient awareness but also HoD rates in US population, are major limitations deterring adoption of CPE in routine clinical practice. We recently demonstrated that if a structured, protocol based CPE is integrated within the routine nephrology care for patients with advanced CKD, it substantially improves informed HoD choice and utilizations. However, this requires establishing CPE resources within each nephrology practice. Efficacy of a stand-alone CPE model, independent of clinical care, has not been examined till date. In this report we report the efficacy of our structured CPE protocol, delivered outside the realm of routine nephrology care-as a stand-alone patient education program, in a geographically distant region, and show that: when provided opportunity for informed dialysis choice, a majority of advanced CKD patients in US would prefer HoD. We also show that initiating CPE leads to accelerated growth in HoD utilizations and reduces disparities in HoD utilizations, goals for system improvements. Finally, the reproducibility of our structured CPE protocol with consistent efficacy data suggest that initiating such programs at institutional levels has the potential to improve informed dialysis selection and HoD rates across any similar large healthcare institute within US.
Assessment of printed patient-educational materials for chronic kidney disease. [2022]Awareness of chronic kidney disease (CKD) is suboptimal among patients with CKD, perhaps due to poor readability of patient education materials (PEMs). We reviewed the suitability and readability of common PEMs that focused on 5 content areas: basics of CKD, risk factors for CKD development, risk factors for CKD progression, complications of CKD and self-management strategies to improve kidney health.
Medication errors in chronic kidney disease: one piece in the patient safety puzzle. [2022]Patients with chronic kidney disease (CKD) are at increased risk of harm as a consequence of errors in medical care. Hug and colleagues highlight the significance of adverse drug events in hospitalized patients with CKD. Their findings demonstrate the role adverse drug events play in the safety of patients with CKD and underscore the importance of novel strategies intended to reduce such medical errors.
Adverse Safety Event Characteristics and Predictive Factors in Hospital Encounters for Patients with Chronic Kidney Disease. [2020]Adverse safety events (ASE) during hospitalization may contribute to renal decline or poor outcomes. Understanding factors contributing to ASE in chronic kidney disease (CKD) is limited. The objective is to compare differences and determine predictors of renal pertinent ASE in discharges for CKD.
Multidisciplinary predialysis education reduced the inpatient and total medical costs of the first 6 months of dialysis in incident hemodialysis patients. [2022]The multidisciplinary pre-dialysis education (MPE) retards renal progression, reduce incidence of dialysis and mortality of CKD patients. However, the financial benefit of this intervention on patients starting hemodialysis has not yet been evaluated in prospective and randomized trial.
Predialysis psychoeducational intervention extends survival in CKD: a 20-year follow-up. [2022]Predialysis psychoeducational interventions increase patient knowledge about chronic kidney disease (CKD) and its treatment and extend time to dialysis therapy without compromising physical well-being in the short run. The present research examines long-term survival after predialysis psychoeducational intervention. In addition, we examined whether survival differed because of early (ie, > or = 3 months) versus late referral to nephrology.
Provision of Kidney Disease Education Service Is Associated with Improved Vascular Access Outcomes among US Incident Hemodialysis Patients. [2023]Pre-ESKD Kidney Disease Education (KDE) has been shown to improve multiple CKD outcomes, but its effect on vascular access outcomes is not well studied. In 2010, Medicare launched KDE reimbursements policy for patients with advanced CKD.