A Randomized Controlled Trial to Evaluate and Assess the Effect of Comprehensive Pre-End Stage Kidney Disease Education on Home Dialysis Use in Veterans, Rationale and Design

Abstract

Background Informed dialysis selection and greater home dialysis use are the two long-desired, underachieved targets of advanced chronic kidney disease care in the US healthcare system. Observational institutional studies have shown that comprehensive pre-end stage kidney disease (ESKD) disease education (CPE) can improve both these outcomes. However, lack of validated protocols, well-controlled studies, and systemic models have limited wide-spread adoption of CPE in the US. We hypothesized that a universal CPE and patient-centered initiation of renal replacement therapy can improve multiple clinical, patient-centered and health service outcomes in advanced chronic kidney disease (CKD) and ESKD.Methods Trial to Evaluate and Assess the effects of CPE on Home dialysis in Veterans (TEACH-VET) is a mixed method randomized controlled trial aimed to evaluate the effects of a system-based approach for providing CPE to all Veterans with advanced CKD across a regional healthcare System. The study will randomize 544 Veterans with non-dialysis stage 4 and 5 CKD in a 1:1 allocation stratified by their annual family income and the stage of CKD to an intervention (CPE) arm or control arm. Intervention arm will receive a two-phase CPE in an intent-to-teach manner. Control arm will receive usual clinical care supplemented by resources for the freely-available kidney disease information. Participants will be followed after intervention/control for the duration of the study or until 90-days post-ESKD, whichever occurs earlier.Results The primary outcome will assess the proportion of Veterans using home dialysis at 90-days post-ESKD, and secondary outcomes will include post-intervention/control CKD knowledge, confidence in dialysis decision and home dialysis selection. Qualitative arm of the study will use semi-structured interviews to in-depth assess Veterans’ satisfaction with the intervention, preference for delivery, and barriers and facilitators to home dialysis selection and use. Several post-ESKD clinical, patient-centered and health services outcomes will be assessed 90-days post-ESKD as additional secondary outcomes.Conclusion The results will provide evidence regarding the need and efficacy of a system-based, patient-centered approach towards universal CPE for all patients with advanced CKD. If successful, this may provide a blueprint for developing such programs across the similar healthcare infrastructures throughout the country.Trial registration: NCT04064086

Basic Requirements for Improving Home Dialysis Utilization: Universal Access to Specialty Nephrology Care and Comprehensive Pre-ESKD Education

“…22 TEACH-VET is a randomized controlled study aimed to integrate an easy-to-implement, stand-alone KDE delivered to the patient and their caregivers in an intent-to-teach manner into the routine care of veterans with advanced CKD and assess its effects on informed dialysis decision making, home dialysis selection and use, and several clinical, patient-centered, and health-service outcomes. 17 These studies will provide critical evidence regarding the needs and efficacy of a system-based approach to universal pre-ESKD KDE for all patients with advanced CKD.…”

“…An ongoing study, TEACH-VET, aims to develop and test an EHR-based model to identify advanced CKD within the Veterans Administration database and evaluate their need/status of nephrology care by proactively initiating communications with the patients and their primary providers. 17 If validated, these strategies can be applied across any mid-large EHR system, although thoughtful safeguards will be needed to ensure that the final decision regarding nephrology care is achieved through the trusted relationships between these patients and their primary providers. Additionally, we need statutory clarifications in the Stark Law to allow and incentivize individual healthcare organizations to develop and implement proactive mass-referral systems in the conventional non-HMO systems.…”