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

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 | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article 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 Ashutosh M. Shukla, Jennifer Hale-Gallardo, Tatiana Orozco, Ivette Freytes, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-412522/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 30 Mar, 2022 Read the published version in BMC Nephrology → Version 1 posted 10 You are reading this latest preprint version 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 Urology & Nephrology Chronic Kidney Failure. Renal Insufficiency Patient-Centered Care Shared Decision Making Health Education Quality of Life Home Dialysis Figures Figure 1 Figure 2 Figure 3 Background Progressive chronic kidney disease (CKD) and resultant end stage kidney disease (ESKD) are huge public health burdens with high morbidity and mortality, poor health-related quality of life (HRQoL) and disproportionately high healthcare expenditure. Over 97% of incident ESKD patients are managed by dialysis therapy.[1] Despite equivalent survivals and trends for better patient-reported and health services outcomes, use of various forms of home dialysis therapies remains low (~10%) among the US ESKD population,[2, 1] and ~90% of incident and prevalent ESKD patients are managed by in-center hemodialysis. It is estimated that doubling the current home dialysis rates would save over a billion Medicare dollars each year.[3] Major ESKD stakeholders including providers, professional renal societies, patient advocacy groups, and payors such as Center for Medicare and Medicaid Services (CMS) and the Veterans Health Administration’s (VHA) National Kidney Program recommend increasing home dialysis utilization for the management of ESKD.[4, 5] Professional organizations recommend informed decision-making for all advanced CKD patients for their dialysis modality selection.[6, 7] This requires individual patients/caregivers to comprehend the complex medical, social, and financial aspects of their dialysis options and select the modality best suited to their life. Unfortunately, awareness of CKD and its management options is low among advanced CKD and ESKD patients.[1] Several cohort and a few randomized studies, largely from outside the US have shown that comprehensive pre-ESKD kidney disease education (CPE) improves CKD awareness and increases informed home dialysis selection and use, with the reported home dialysis rates ranging from 35-85% among the CPE recipients.[8] Studies have further shown that provision of CPE improves patient awareness and is associated with beneficial impacts on several pre-, and post-ESKD outcomes.[9, 10] In recent times, we and others have shown that provision of a formal protocol-based CPE, incorporated within the clinical care or as a stand-alone service leads to greater home dialysis selection (50-74%) and use (30-62%) even among the US advanced CKD patients.[11, 12] Nevertheless, provision of kidney disease education occurs uncommonly in the routine care of advanced CKD in the US.[13] More than half of these patients are recognized late in the course of CKD, and receive none to limited pre-ESKD renal care.[1] Even among those receiving longer renal care, lack of validated protocols, concerns regarding the selection bias in the available data, and lack of systemic models establishing feasibility limit a wider, more universal provision of CPE. The Trial to Evaluate and Assess the effects of CPE on Home dialysis in Veterans (TEACH-VET, NCT04064086) is aimed to identify the burden of advanced CKD among Veterans through an EHR–based strategy, and assess the impact of universal CPE on the parameters of informed dialysis decision, home dialysis selection and use, and several related clinical, patient-centered, and health services outcomes. Methods Trial Overview: The overall design of TEACH-VET is depicted in Figure 1. First, the study uses an electronic health records (EHR)–based strategy to identify veterans with advanced CKD (source cohort) and assess their status/need of ongoing specialty nephrology care and CPE. Then, in a mixed method randomized controlled trial (RCT), the study plans to enroll 544 Veterans from the source cohort, and randomize them in 1:1 allocation to the CPE/intervention arm vs. usual clinical care supplemented by kidney disease education material, enhanced usual care (EUC) arm. The study aims to compare the effects of intervention/control on parameters of informed dialysis decision and dialysis modality selection, dialysis modality use, and several clinical, patient-centered and health services outcomes post-ESKD. The also has a qualitative component, which uses semi-structured interviews to explore Veterans’ perceived satisfaction with CPE, their preferences for face-to-face or tele-CPE, and their perceived barriers and facilitators in the selection and use of preferred dialysis modality. The quantitative and qualitative data are collected and will be analyzed separately, and the results will be integrated for a more comprehensive understanding. Conceptual Framework: The structure of TEACH-VET is based on the modified Bandura’s model of social cognitive theory.[14] Social cognitive theory identifies a set of core determinants including knowledge of health risks and health benefits from different health practices, self-efficacy, outcome expectations, and perceived facilitators and social and structural impediments to the changes they seek. These core determinants create the preconditions for, and play a central role in, human motivation, action, and health decisions. DeWalt et al.[15] successfully modified this model in a randomized evaluation of educational intervention in heart failure patients arguing that patient action, i.e., informed decision-making in TEACH-VET leads to positive changes in patient health-related outcomes. Hypothesis and Rationale: We hypothesize that a system-based application of universal CPE and patient-centered initiation of renal replacement therapy will increase home dialysis utilization and improve multiple clinical, patient-centered and health service outcomes (Figure 2). Specifically, CPE will increase Veterans’ self-efficacy, i.e., knowledge of CKD and its management so that they become more confident in making an informed choice for their disease management and dialysis treatment. The contention is also that Veterans’ behavior post-CPE will lead to increased use of home dialysis compared to the usual care group (primary outcome). According to social cognitive theory,[15] individual person-level determinants (e.g., knowledge and confidence) may increase the likelihood of an individual’s executing a behavior (e.g., informed decision-making and self-management). Additionally, environmental factors can also influence behavior; as such, environmental factors the Veterans perceive as barriers and facilitators will be examined (qualitative phase). Finally, CPE-induced behavioral changes may show positive impact on post-ESKD outcomes. Study Population: TEACH-VET was launched in August 2020 across the North Florida/South Georgia (NF/SG) Veterans Health System (VHS), one of the busiest VHS in the US comprising 2 VA medical centers and 10 outpatient clinics. Based on the recommendations by the professional renal organizations and CMS, TEACH-VET aims to target all adult (> 18 years old) Veterans with advanced stage 4 and 5 CKD not on dialysis for enrollment. The study excludes Veterans who are non-English-speaking, homeless or living in assisted living facilities, and with dementia or less than 6-months life-expectancy. Enrollment strategy: To ensure the enrollment targets all prevalent advanced CKD patients, in addition to directly approaching the Veterans attending the renal clinic, TEACH-VET recruits participants through our recently published, EHR–based ‘Opt-Out Source Cohort Strategy.[16] In brief, a ‘source cohort’ of all actively registered Veterans at NF/SG VHS with ICD-10 codes for stage 4(N18.4) and 5 CKD(N18.5) or two latest outpatient estimated glomerular filtration rate (eGFR) of less than 30ml/min at least 90-days apart is generated. The cohort is then sorted in a random order, and the potential participants are approached in consecutive order for their status/need for specialty nephrology care and CPE. All eligible and interested participants are then enrolled into the second phase RCT. Baseline data collection and Randomization : Once enrolled, all participants provide baseline data comprising of patient-reported socio-demographics, education, household composition, and annual family income. Participants are assessed for health literacy by Rapid Estimate of Adult Literacy in Medicine-short form, medical comorbidity by the Charleston Comorbidity Index, and HRQoL by Kidney disease quality of life (KDQoL-36), excluding dialysis items.[17-19] CKD awareness is assessed by the prior validated instrument by Wright et al.[20] Considering this and other similar validated CKD knowledge instruments lack the domains of ESKD knowledge—essential for informed dialysis decision—the team has developed and pilot tested a 29-item ESKD knowledge questionnaire.[21] This questionnaire will be further refined during the TEACH-VET, and the team will report on its findings. A full list and timeline of all collected variables are listed in Figure 1 and Table 1. All enrolled participants are randomized by a computer-generated block randomization schedule devised by the study statistician, in 1:1 ratio into CPE or EUC arm. Considering the primary outcome of dialysis modality use and the strong known influence of socioeconomic factors,[22] the randomization is stratified by the stage of CKD (4 or 5) and annual family income (250% above or below federal poverty level adjusted for total number of household members).[23] Intervention/CPE arm: Participants and their preferred care partner(s) in the intervention arm receive a standardized, evidence-based, two-phase CPE by trained renal educators in an Intent-to-Teach manner. The protocol covers the domains of education recommended by the professional renal organizations and CMS (Table 2),[24, 25, 4, 5] with an interactive, instructor-led audio-visual education, followed by individual patient-oriented counseling session that includes lifestyle simulation discussions. Prior studies have shown the advantages of such two-phase approach on comprehension, fears, and home dialysis selection.[26, 21] Over last decade, we have tested, refined and validated this protocol at two geographically distinct universities and affiliated VAs within the US to ensure literacy level and cultural relevance for the target patient population.[11, 12] For this study, we further pilot-tested the intervention with a local Veteran Engagement Committee made up of a diverse group of 12 Veterans and Veteran caregiver volunteers from Florida. This committee provided specific feedback to further hone the language used and explanations given for describing kidney disease and its management to fellow Veterans. Recently, we demonstrated our protocol can be delivered either face-to-face or through telemedicine with equivalent outcomes in terms of confidence in dialysis decision-making and home dialysis selection.[21] To ensure the intervention is standardized and uniform throughout the study, the renal educators are trained by licensed renal providers in the content, and by experienced patient educators in the delivery of the CPE prior to their involvement in the study. Additionally, with the participants’ permission, all CPE sessions are recorded for the first 3 months of the study or after initiation of the new educator, and 10% of randomly selected CPE are recorded throughout the study period. The recorded data is reviewed for credibility, competence, and thoroughness of the educator interactions during CPE. Finally, the study tracks the amount of time educators spend with each participant for individual counseling, reviews the fidelity of important pre-defined topics and their delivery, and keeps detailed notes of any deviations from the CPE protocol. Feedback and additional training is provided as needed to ensure uniformity and standardization. Patients having any question or concerns after education are provided the opportunity to discuss with a licensed dialysis nurse or provider proficient in all renal replacement therapies. To ensure informed dialysis selection, participants are assessed for their confidence in dialysis decision-making and selection of dialysis modality at the end of the CPE session. Intent-to-Teach is assessed by confidence for dialysis decision making (defined by confidence rating of “quite confident” or “very confident”); those with suboptimal scores (“not at all confident” or “a little confident”) or “uncertain of the dialysis modality choice,” are advised to undergo repeat CPE sessions at an average of weekly intervals for a total of up to three counseling sessions (Figure 3). Our pilot studies show a vast majority of CPE recipients reach an informed decision by 3 sessions; when optional, 84% prefer to attend only one session, and when mandated for clinical care or research 96-99% of the patients reach informed dialysis selection by 3 sessions.[11, 21] Considering our preliminary data and to ensure the model is ready-for-dissemination, TEACH-VET allows CPE participants to pragmatically choose the method for CPE, either face-to-face, or through tele-medicine to the affiliated outpatient clinic or within their homes. We will analyze the differences in outcomes between these delivery methods in our secondary analyses. Control/EUC arm: Participants in the EUC arm are provided printed hand-outs directing them to online self-learning CKD resources, freely available through several professional renal organizations, including the VA.[24, 25, 4, 5] While the investigators acknowledge the scientific need for an unaltered control arm, enhancing ‘usual care’ through provision of the self-learning resources was considered the appropriate ethical compromise. To mirror the expected duration between the pre-, and post-CPE data collection in CPE arm, EUC arm participants provide data for post-EUC knowledge, confidence in dialysis decision-making, and dialysis modality selection 10-days after the provision of the self-learning resources. Qualitative study: The qualitative study employs a maximum variation sampling strategy to ensure a diversity of demographic and clinical characteristics.[27] Fifteen Veterans from each of the face-to-face-CPE, tele-CPE and EUC groups respectively are interviewed by telephone for 45-60 minutes using a semi-structured interview guide based on the Theoretical Domains Framework (TDF).[28, 29] Furthermore, an additional 15 Veterans who did not ultimately use their preferred dialysis modality are interviewed 90-days post-ESKD to explore experiences and barriers. The TDF supplies the working analytical framework for identifying factors that influence Veterans’ informed dialysis decision-making and experience with different dialysis modalities, including any perceived factors influencing dialysis decision-making, perceived barriers to home dialysis selection and use, and [for CPE arm] satisfaction with education session and counseling. The verbatim transcriptions for the audio-recorded interviews will be analyzed by two independent coders, organizing the data by domains of the framework, e.g. Knowledge: participants’ knowledge regarding dialysis; Beliefs about capabilities: participants level of confidence; Intentions: CKD management preferences; Social influences: influence of family members, friends, or caregivers; Beliefs about consequences: expectations about CKD management and evaluation of results; Optimism motivation to recommend dialysis to other patients; and Emotions: feelings about CKD treatment options. Post-CPE/EUC follow up: Nephrology, and if not available, the primary providers for the participants are informed of the participants’ preferences for dialysis modality. This communique further instructs the providers regarding the need and importance of the pre-ESKD nephrology care, and the processes and desired timings for the peritoneal dialysis catheter insertion/vascular access creation. The providers are also informed about the contact information and approval processes for the VA ESKD services. Participants are then followed by EHR reviews at quarterly and by telephonic interviews at semi-annual intervals to assess their need/status of dialysis therapies and any changes in their preferred dialysis modality. Participants in CPE arm are allowed to re-access the audio-visual group education session independently throughout the study period. All outcome measures and their collections timings are available in Table 1. Statistical Considerations: We used G*Power version 3.1.9.2 for sample size calculations, which are based on the primary outcome of (home) dialysis use. Using one-tailed test with alpha of 0.05 and 80% power, to detect doubling of home dialysis use in CPE relative to EUC arm —estimating home dialysis actual use to be 10% for EUC (based on the prevalent data) and 20% for CPE—yielded a total sample size of N=108 (54 per arm). Allowing the potential of attrition and missing data that cannot be accommodated by the proposed missing data handling techniques (up to 20% data loss), we will need 136 (68 per arm) to reach ESKD and use dialysis to allow detection of this clinically meaningful effect size. Considering we expect about 25% of the study participants to reach ESKD through the study period, we plan to enroll 544 Veterans with advanced CKD for the study. Analytic plan: We will use multiple regression analysis to examine the effect of the CPE intervention on Veterans’ knowledge of CKD and confidence in dialysis decision making post- intervention or EUC. We will include the baseline knowledge and confidence scores as covariates in the model, to account for pre- intervention/EUC values. We will use orthogonal Helmert contrast codes to test for the effect of both CPE as a whole (collapsed across telehealth and face-to-face delivery methods) vs EUC, and for the effect of tele-CPE vs face-to-face CPE. (Although we do not predict an effect of treatment delivery method, we have planned to include the comparisons derived by the Helmert contrast coding to test and account for any variance that may be introduced by different treatment delivery methods, should such variance/effect emerge.) We will use multiple logistic regression to examine the effect of CPE on Veterans’ initial selection of home dialysis; specification of this logistic regression model for home dialysis initial selection mirrors the regression models for confidence and knowledge, with the exception that the outcome is binary. Additionally, we will use logistic regression with Helmert contrast coding to compare home dialysis actual use between CPE and EUC groups, as well as between tele-CPE and face-to-face-CPE groups (within the overall CPE group). This multiple logistic regression for actual use of home dialysis constitutes the analysis for the primary outcome of this study. For continuous secondary outcomes post-ESKD (e.g. HRQoL), we will use multiple regression analysis with Helmert contrast coding for CPE and EUC comparisons (as used in above regression models), an effect of dialysis modality actually used (home dialysis vs in-center dialysis), and interaction effects between the contrast codes and dialysis modality ([CPE-vs-EUC*Modality] and [tele-CPE vs face-to-face CPE*Modality]. Where applicable, we will include the outcome’s baseline scores and/or other relevant covariates. For dichotomous secondary outcomes post-ESKD (e.g., inpatient initiation of dialysis), we will use multiple logistic regression analysis, with the specification of this model mirroring that for continuous secondary outcomes post-ESKD, with the exception that the outcome is binary. Finally, for the secondary outcome of time to ESKD, we will calculate a Kaplan-Meier estimate. For qualitative sub-study, TDF will supply the working analytical framework.[28] Two researchers will independently code first few transcripts using the framework, reading transcripts line-by-line to capture as many behaviors, values, emotions, and impressions as possible, and comparing results to ensure everything relevant was coded according to the constructs of the framework. An iterative process will be used to refine themes from the framework based on patterns in the data, generating a thematic map.[30] This will provide in-depth understanding of the barriers Veterans’ experience in acquiring the knowledge needed to manage CKD, and facilitators involved in their selection and use of a post-ESKD management strategy. Discussion The burden of progressive CKD transitioning to ESKD is large for patients and healthcare system, and there are several critical systemic deficits in the care of these patients in the current infrastructure. Among these, lack of opportunities for informed dialysis selection and gross underuse of home dialysis have been important, long-targeted yet underachieved concerns. Available studies show that providing CPE can substantially improve these concerns at institutional levels, however, we lack randomized studies, validated protocols, and implementation models to address these concerns at a systemic level. TEACH-VET attempts to examine and address several of these concerns. Nearly half of incident ESKD patients have none to limited (less than 6-months) pre-ESKD nephrology care. 1 These patients have low probabilities for acquiring specialty care or CPE necessary to reach informed dialysis selection, and thus, home dialysis use. Studies have shown EHR-based screening is accurate to a sensitivity and specificity of 99% for the identification of stage 3 or higher CKD. However, these models are not routinely used to identify and improve clinical care in advanced CKD.[31] TEACH-VET will aim to model to identify all Veterans with advanced CKD within the VA database through an EHR-based source cohort, and evaluate their status/need for specialty nephrology care and CPE. If validated, this will provide a blueprint for developing such models in similar mid-large healthcare infrastructures across the country. Several cohort and a few randomized studies from outside the US have shown CPE increases informed home dialysis use. Over last decade, a few cohort studies from within the US have validated these findings.[8] Unfortunately, interpretation these results is limited by the concerns for selection bias. A randomized evaluation of the strategy to provide CPE universally to all advanced CKD patients has not been tested till date in the US general or Veteran populations. The results of TEACH-VET will provide evidence to universalize CPE across the sociodemographic and comorbidity spectrum, and identify limitations related to this strategy. Furthermore, assessment of the parameters of informed decision making, i.e., improvement in CKD/ESKD knowledge and confidence in dialysis decision-making will further assist in differentiating between a patient-centered vs. system-driven increase in home dialysis use. Lack of validated protocols hamper wide-spread adoption of CPE in routine clinical practice. Several private and public organizations, including VA, have recently launched technology-based solutions pooling resources and expertise to a central organization with capacity to reach patient-base beyond individual practices.[4, 32] The effects of such programs have been limited and ill-quantified to date. We have developed and tested our easy-to-implement CPE protocol in different clinical models, i.e., incorporated within the clinical care, as a stand-alone model, and through telemedicine-based delivery. TEACH-VET integrates this further at a systemic level with both face-to-face and telemedicine-based delivery, and assesses their effects on parameters of informed decision-making, home dialysis selection and use, and post-ESKD outcomes. The qualitative component further assesses the patient-preferences for such services and their barriers. These results will provide the necessary evidence to use telemedicine technology for wider dissemination of these services. The cost-effectiveness of CPE and home dialysis have been demonstrated in health economics models. Despite these, need for significant resources, including trained specialists capable of providing CPE have limited routine provision of CPE in clinical practice at systemic levels.[13] Prospective randomized assessments of the inpatient and outpatient service utilizations will provide guide to the health services outcomes in the care of advanced CKD for a universal system-based approach. While studies have assessed the effects of CPE on home dialysis selection and use in general population, the data on Veterans are limited. Veteran ESKD population is known to be significantly older and with greater functional limitations. Furthermore, most Veterans (about 90%) receive their CKD care from within the VHA but, only a minority (about 10%) receive their ESKD care from the VHA. This disconnect hinders CPE and planned transition to ESKD and resultantly, the home dialysis utilization. Home dialysis rates among veterans ESKD (about 7%) are significantly lower than already low rates prevalent in the US general ESKD population. [33, 1] TEACH-VET will evaluate a system-based approach in an area of unmet need and systemic deficit in the care of Veterans with advanced CKD. Finally, the qualitative assessments of Veterans status/preferences for receiving the specialty nephrology care, CPE, and home dialysis therapy have not been performed to date. Together, the results will provide targeted Veteran-specific data, instrumental for future research, while establishing a ready-to-implement model for dissemination across the VHA system. Several cohort-based studies have shown the benefits of CPE on a variety of pre-, and post-ESKD outcomes, including quality of CKD care, time to ESKD, vascular access outcomes, and pre- and post-ESKD survivals.[34, 9, 10] While not powered to detect differences in these outcomes, TEACH-VET will assess a variety of clinical, health services and patient-centered outcomes once these patients develop ESKD. There are few limitations of TEACH-VET. While the study investigates the status/need of the pre-ESKD nephrology care and empowers informed dialysis selection, it doesn’t mandate protocol-based congruence for new nephrology referrals or provider adherence to patient-selected dialysis modality. Thus, by design, it assesses the effects a stand-alone CPE program superimposed on routine nephrology care. The study will report the effects of intervention/control on these events, and the pre-planned subgroup analyses and qualitative assessments will evaluate the impacts of such uncontrolled variables on the study outcomes. Second, to ensure the need for emergent dialysis due to patients’ comorbidities or administrative limitations of infrastructures providing nephrology care within and outside VHA do not impact evaluation of long-term dialysis modality use, TEACH-VET will assess the home dialysis use at 90-day post-ESKD. The study will report these occurrences, and document any difference between the chosen vs. initial modality, and the qualitative assessments will attempt to dissect the facilitators and barriers to their initiation of chosen modality for eventual systems improvements. Finally, we acknowledge the results of TEACH-VET will only provide evidence for adopting and disseminating these strategies within the unique healthcare infrastructure of VHA. Adoption of the findings in the general US healthcare system will require additional studies establishing its efficacy and feasibility. To summarize, studies from around the world as well as from within the US have shown that comprehensive pre-ESKD education may have substantial benefits in the clinical care of advanced CKD, but the evidence to support this effectiveness has not been obtained from well designed, randomized controlled studied from within the US. Furthermore, we lack validated protocols and feasible systemic models to deliver CPE. TEACH-VET aims addresses these deficits through a system-based approach for universal CPE within VHA, delivered via either an in-person visit or telemedicine and investigates its impact on Veterans’ informed dialysis choice and home dialysis rates. Findings from this study will demonstrate whether such a universal approach can improve Veterans clinical, patient-centered and health services outcomes. If successful, this will provide evidence for policymakers to expand and implement such programs across the healthcare system to improve care for patients with advanced CKD, increase home dialysis use, and improve post-ESKD outcomes, while reducing health service utilization and cost. Abbreviations CKD: Chronic Kidney Disease CPE: Comprehensive pre-end stage kidney disease (ESKD) disease education (CPE) EHR: Electronic health records ESRD: End stage renal disease TEACH-VET: Trial to Evaluate and Assess the effects of CPE on Home dialysis in Veterans RCT: Randomized Controlled Trial VHA: Veterans Health Administration Declarations Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Availability of data and materials: Not applicable. Competing interests: The authors declare that they have no competing interests. Funding: This study is supported by the funding from Department of Veterans Affairs, Health Service Research and Development Awards (I01HX002639) and Office of Rural Health FY21 Awards (16004). Shukla AM additionally reports ongoing grant support from the Department of Veterans Affairs, Clinical Science Research and Development Merit Grant (I01CX001661). Authors' contributions AS, JHG, HJ contributed to the concept and design of the study, and production of manuscript. IF and SJ contributed to the concept and design of the study. ZP contributed to the design of the study and production of manuscript. All authors with substantial contributions to have approved the submitted version. Acknowledgements: None Footnotes: None References Saran R, Robinson B, Abbott KC, Agodoa LYC, Bragg-Gresham J, Balkrishnan R, et al. US Renal Data System 2018 Annual Data Report: Epidemiology of Kidney Disease in the United States. American Journal of Kidney Diseases. 2019;73(3):A7-A8. 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Comprehensive pre-ESRD Patient Education (CPE) and choice of dialysis modality. PLOS ONE. 2019;14(4):e0215091. Shukla AM, Bozorgmehri S, Ruchi R, Mohandas R, Hale-Gallardo JL, Ozrazgat-Baslanti T, et al. Utilization of CMS pre-ESRD Kidney Disease Education services and its associations with the home dialysis therapies. Perit Dial Int. 2020 Dec 1:896860820975586. Bandura A. Health Promotion by Social Cognitive Means. Health Education & Behavior. 2004 2004/04/01;31(2):143-64. DeWalt DA, Broucksou KA, Hawk V, Baker DW, Schillinger D, Ruo B, et al. Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial. BMC Health Services Research. 2009 June 11;9(1):99. Shukla AM, Segal MS, Pepine CJ, Cheung AK, Shuster J, Mohandas R, et al. Management of Cardiovascular disease in Kidney disease study: Rationale and Design. American Journal of Nephrology. 2020;52. D'Hoore W, Sicotte C, Tilquin C. Risk adjustment in outcome assessment: the Charlson comorbidity index. Methods of information in medicine. 1993 Nov;32(5):382-7. Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 1994 Oct;3(5):329-38. Arozullah AM, Yarnold PR, Bennett CL, Soltysik RC, Wolf MS, Ferreira RM, et al. Development and validation of a short-form, rapid estimate of adult literacy in medicine. Med Care. 2007 Nov;45(11):1026-33. Wright JA, Wallston KA, Elasy TA, Ikizler TA, Cavanaugh KL. Development and Results of a Kidney Disease Knowledge Survey Given to Patients With CKD. American journal of kidney diseases : the official journal of the National Kidney Foundation. 2011 12/18;57(3):387-95. Easom AM, Shukla AM, Rotaru D, Ounpraseuth S, Shah SV, Arthur JM, et al. Home run—results of a chronic kidney disease Telemedicine Patient Education Study. Clinical Kidney Journal. 2019. Moraes RP-F, Silvia Carreira R, Adam K, Helder Sebastião S, Arthur P, Ricardo Sprenger F, et al. Racial and social disparities in the access to automated peritoneal dialysis - results of a national PD cohort. Scientific Reports. 2017 2017-07-12;7(1):5214. Mehrotra R, Soohoo M, Rivara MB, Himmelfarb J, Cheung AK, Arah OA, et al. Racial and Ethnic Disparities in Use of and Outcomes with Home Dialysis in the United States. Journal of the American Society of Nephrology. 2015 December 10, 2015. central HD. Home Dialysis Basics. Foundation NK. Dialysis. A to Z Health Guide. Manns BJ, Taub K, VanderStraeten C, Jones H, Mills C, Visser M, et al. The impact of education on chronic kidney disease patients' plans to initiate dialysis with self-care dialysis: A randomized trial. Kidney Int. 2005;68(4):1777-83. Baran M, Jones J. Mixed methods research for improved scientific study. 2016. Cane J, O’Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implementation Science. 2012 April 24;7(1):37. Patton MQ. Qualitative research & evaluation methods : integrating theory and practice. 2015. Guest G, MacQueen KM, Namey EE. Applied thematic analysis. Thousand Oaks, CA: SAGE; 2012. Norton JM, Ali K, Jurkovitz CT, Kiryluk K, Park M, Kawamoto K, et al. Development and Validation of a Pragmatic Electronic Phenotype for CKD. Clinical Journal of the American Society of Nephrology. 2019;14(9):1306-14. Diamantidis CJ, Fink W, Yang S, Zuckerman MR, Ginsberg J, Hu P, et al. Directed use of the internet for health information by patients with chronic kidney disease: prospective cohort study. J Med Internet Res. 2013 Nov 15;15(11):e251. Saran R, Pearson A, Tilea A, Shahinian V, Bragg-Gresham J, Heung M, et al. Burden and Cost of Caring for US Veterans With CKD: Initial Findings From the VA Renal Information System (VA-REINS). American Journal of Kidney Diseases. Lacson Jr E, Wang W, DeVries C, Leste K, Hakim RM, Lazarus M, et al. Effects of a Nationwide Predialysis Educational Program on Modality Choice, Vascular Access, and Patient Outcomes. American Journal of Kidney Diseases.58(2):235-42. Tables Table 1. Key Variables and Quantitative Outcomes by the Time of Data Collection Variable Domains and Outcomes Variable Name & Characteristic Time Point Demographics (Baseline data) Age Race/ethnicity Education Annual Family Income Social Support Pre-Intervention Baseline Comorbidities (Baseline data) Comorbidity Index Pre-Intervention Baseline Health Literacy (Baseline data) Health Literacy Score Pre-Intervention Baseline CKD/ESKD Knowledge CKD/ESKD Knowledge Pre-Intervention Baseline Post-Intervention/Control Confidence in dialysis decision-making Confidence in dialysis selection Pre-Intervention Baseline Post-Intervention/Control Dialysis Modality Selection Dialysis modality selection Pre-Intervention Baseline Post-Intervention/Control Dialysis Modality Use (Primary Outcome) Dialysis modality use 90-day post-ESKD Patient Reported HRQoL Pre-Intervention Baseline 90 days post ESKD Patient Reported Satisfaction with Dialysis 90-day post-ESKD Health Service Utilization Number of inpatient stays Number of outpatient visits Post-Intervention to 90-day post-ESKD Clinical Time to ESKD eGFR at ESKD Inpatient initiation of dialysis Vascular Access Presence Vascular Access Use At ESKD Table 2. TEACH-VET Comprehensive Pre-ESKD kidney disease Education (CPE) Protocol domains and Missions Domains of the CPE Missions/Messages of the CPE for Patients Location and Function of the Human Kidneys Overview of Kidneys in Human Health Excretory Functions of the Kidneys Non-excretory Functions of the Kidneys Importance in cardiovascular health Importance in bone health Importance in Anemia CKD and stages? Differentiate CKD from Acute kidney injury Understand Kidney Failure (ESKD) Common Symptoms of Kidney Failure Common Signs of Kidney Failure Options for the management of Kidney Failure? Kidney Transplantation Conservative Care Dialysis therapies Home-based Peritoneal Dialysis Home-based Hemodialysis Center-based Hemodialysis Lifestyle on Dialysis Frequently Asked Questions CPE should be available to all patients with stage 4 and 5 CKD, irrespective of their socio-demographic and comorbidity status, or perceived eligibility for home dialysis therapies For eligible patients, kidney transplantation is the best modality of renal replacement therapy It is important to know the cause of transplant ineligibility, and the possible corrective measures All dialysis modalities have equivalent medical outcomes Unless deemed medically/socially unsuitable by the provider, the choice of dialysis modality is a patient and caregiver’s decision and should be targeted as a shared decision-making process Avoid fear as an overbearing motivator for dialysis modality selection by ensuring the patients that the routine care should provide adequate support for any of the modalities chosen for most patients Decision for dialysis should be attempted early in the course of advanced CKD, if possible, by the end of the CPE session. If not feasible, the patient must plan to attend additional CPE sessions. All patient selections should be evaluated for confidence in dialysis decision making, with the options for patients with low confidence to attend follow up sessions CPE: comprehensive pre-ESRD education, CKD: chronic kidney disease, ESKD: end stage kidney disease Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 30 Mar, 2022 Read the published version in BMC Nephrology → Version 1 posted Editorial decision: Major revision 25 Oct, 2021 Reviews received at journal 02 Aug, 2021 Reviewers agreed at journal 14 Jul, 2021 Reviews received at journal 30 Apr, 2021 Reviewers agreed at journal 20 Apr, 2021 Reviewers invited by journal 20 Apr, 2021 Editor assigned by journal 20 Apr, 2021 Editor invited by journal 20 Apr, 2021 Submission checks completed at journal 19 Apr, 2021 First submitted to journal 11 Apr, 2021 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-412522","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":22126874,"identity":"4ba29f19-e080-4d0b-9261-528eb00f24fb","order_by":0,"name":"Ashutosh M. Shukla","email":"data:image/png;base64,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","orcid":"","institution":"North Florida/South Georgia Veterans Health System","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Ashutosh","middleName":"M.","lastName":"Shukla","suffix":""},{"id":22126875,"identity":"6832717d-b663-4f03-a11c-0ae3587975b7","order_by":1,"name":"Jennifer Hale-Gallardo","email":"","orcid":"","institution":"North Florida/South Georgia Veterans Health 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15:44:05","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-412522/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-412522/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12882-022-02740-8","type":"published","date":"2022-03-30T07:49:44+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":8252016,"identity":"ad8c8272-f1e1-462c-86a7-1059c5869d12","added_by":"auto","created_at":"2021-04-20 23:00:41","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":87683,"visible":true,"origin":"","legend":"Overview of the Study Design and Study Activities for the TEACH-VET\n\nEHR: electronic health records, HRQoL: health related quality of life, CPE: comprehensive pre-ESKD education, EUC: Enhanced usual care, CKD: chronic kidney disease, eGFR: estimated glomerular filtration rate \n","description":"","filename":"Figure1TEACHVET.jpg","url":"https://assets-eu.researchsquare.com/files/rs-412522/v1/41b28a801f7cebe8be0573fc.jpg"},{"id":8252233,"identity":"ac97e800-fc7a-4472-b081-5a7e93e3b508","added_by":"auto","created_at":"2021-04-20 23:03:42","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":71441,"visible":true,"origin":"","legend":" Conceptual Framework for TEACH-VET with Reference to the Study Outcomes ","description":"","filename":"Figure2TEACHVET.jpg","url":"https://assets-eu.researchsquare.com/files/rs-412522/v1/c6e3307b09f7a43d342f90c5.jpg"},{"id":8252232,"identity":"db3db3c6-bb46-417d-b755-5408bf01e5de","added_by":"auto","created_at":"2021-04-20 23:03:42","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":78227,"visible":true,"origin":"","legend":"Intent-to-teach application of the Comprehensive Pre-ESKD kidney disease Education and Data Collection ","description":"","filename":"Figure3TEACHVET.jpg","url":"https://assets-eu.researchsquare.com/files/rs-412522/v1/15156baaf3999b4446a6c1ac.jpg"},{"id":19763120,"identity":"9befbf6f-1a31-4851-b85e-3610fed8455b","added_by":"auto","created_at":"2022-03-30 07:49:47","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":581142,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-412522/v1/2450cacc-8b49-40ba-8aa9-b8387ebbba8e.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"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","fulltext":[{"header":"Background","content":"\u003cp\u003eProgressive chronic kidney disease (CKD) and resultant end stage kidney disease (ESKD) are huge public health burdens with high morbidity and mortality, poor health-related quality of life (HRQoL) and disproportionately high healthcare expenditure. Over 97% of incident ESKD patients are managed by dialysis therapy.[1] Despite equivalent survivals and trends for better patient-reported and health services outcomes, use of various forms of home dialysis therapies remains low (~10%) among the US ESKD population,[2, 1] and ~90% of incident and prevalent ESKD patients are managed by in-center hemodialysis. It is estimated that doubling the current home dialysis rates would save over a billion Medicare dollars each year.[3] Major ESKD stakeholders including providers, professional renal societies, patient advocacy groups, and payors such as Center for Medicare and Medicaid Services (CMS) and the Veterans Health Administration\u0026rsquo;s (VHA) National Kidney Program recommend increasing home dialysis utilization for the management of ESKD.[4, 5]\u003c/p\u003e\n\u003cp\u003eProfessional organizations recommend informed decision-making for all advanced CKD patients for their dialysis modality selection.[6, 7] This requires individual patients/caregivers to comprehend the complex medical, social, and financial aspects of their dialysis options and select the modality best suited to their life. Unfortunately, awareness of CKD and its management options is low among advanced CKD and ESKD patients.[1] Several cohort and a few randomized studies, largely from outside the US have shown that comprehensive pre-ESKD kidney disease education (CPE) improves CKD awareness and increases informed home dialysis selection and use, with the reported home dialysis rates ranging from 35-85% among the CPE recipients.[8] Studies have further shown that provision of CPE improves patient awareness and is associated with beneficial impacts on several pre-, and post-ESKD outcomes.[9, 10] In recent times, we and others have shown that provision of a formal protocol-based CPE, incorporated within the clinical care or as a stand-alone service leads to greater home dialysis selection (50-74%) and use (30-62%) even among the US advanced CKD patients.[11, 12]\u003c/p\u003e\n\u003cp\u003eNevertheless, provision of kidney disease education occurs uncommonly in the routine care of advanced CKD in the US.[13] More than half of these patients are recognized late in the course of CKD, and receive none to limited pre-ESKD renal care.[1] Even among those receiving longer renal care, lack of validated protocols, concerns regarding the selection bias in the available data, and lack of systemic models establishing feasibility limit a wider, more universal provision of CPE. The Trial to Evaluate and Assess the effects of CPE on Home dialysis in Veterans (TEACH-VET, NCT04064086) is aimed to identify the burden of advanced CKD among Veterans through an EHR\u0026ndash;based strategy, and assess the impact of universal CPE on the parameters of informed dialysis decision, home dialysis selection and use, and several related clinical, patient-centered, and health services outcomes.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eTrial Overview: \u003c/strong\u003eThe overall design of TEACH-VET is depicted in Figure 1. First, the study uses an electronic health records (EHR)\u0026ndash;based strategy to identify veterans with advanced CKD (source cohort) and assess their status/need of ongoing specialty nephrology care and CPE. Then, in a mixed method randomized controlled trial (RCT), the study plans to enroll 544 Veterans from the source cohort, and randomize them in 1:1 allocation to the CPE/intervention arm vs. usual clinical care supplemented by kidney disease education material, enhanced usual care (EUC) arm. The study aims to compare the effects of intervention/control on parameters of informed dialysis decision and dialysis modality selection, dialysis modality use, and several clinical, patient-centered and health services outcomes post-ESKD. The also has a qualitative component, which uses semi-structured interviews to explore Veterans\u0026rsquo; perceived satisfaction with CPE, their preferences for face-to-face or tele-CPE, and their perceived barriers and facilitators in the selection and use of preferred dialysis modality. The quantitative and qualitative data are collected and will be analyzed separately, and the results will be integrated for a more comprehensive understanding.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConceptual Framework: \u003c/strong\u003eThe structure of TEACH-VET is based on the modified Bandura\u0026rsquo;s model of social cognitive theory.[14] Social cognitive theory identifies a set of core determinants including knowledge of health risks and health benefits from different health practices, self-efficacy, outcome expectations, and perceived facilitators and social and structural impediments to the changes they seek. These core determinants create the preconditions for, and play a central role in, human motivation, action, and health decisions. DeWalt et al.[15] successfully modified this model in a randomized evaluation of educational intervention in heart failure patients arguing that patient action, i.e., informed decision-making in TEACH-VET leads to positive changes in patient health-related outcomes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHypothesis and Rationale: \u003c/strong\u003eWe hypothesize that a system-based application of universal CPE and patient-centered initiation of renal replacement therapy will increase home dialysis utilization and improve multiple clinical, patient-centered and health service outcomes (Figure 2). Specifically, CPE will increase Veterans\u0026rsquo; self-efficacy, i.e., knowledge of CKD and its management so that they become more confident in making an informed choice for their disease management and dialysis treatment. The contention is also that Veterans\u0026rsquo; behavior post-CPE will lead to increased use of home dialysis compared to the usual care group (primary outcome). According to social cognitive theory,[15] individual person-level determinants (e.g., knowledge and confidence) may increase the likelihood of an individual\u0026rsquo;s executing a behavior (e.g., informed decision-making and self-management). Additionally, environmental factors can also influence behavior; as such, environmental factors the Veterans perceive as barriers and facilitators will be examined (qualitative phase). Finally, CPE-induced behavioral changes may show positive impact on post-ESKD outcomes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Population: \u003c/strong\u003eTEACH-VET was launched in August 2020 across the North Florida/South Georgia (NF/SG) Veterans Health System (VHS), one of the busiest VHS in the US comprising 2 VA medical centers and 10 outpatient clinics. Based on the recommendations by the professional renal organizations and CMS, TEACH-VET aims to target all adult (\u0026gt; 18 years old) Veterans with advanced stage 4 and 5 CKD not on dialysis for enrollment. The study excludes Veterans who are non-English-speaking, homeless or living in assisted living facilities, and with dementia or less than 6-months life-expectancy.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEnrollment strategy: \u003c/strong\u003eTo ensure the enrollment targets all prevalent advanced CKD patients, in addition to directly approaching the Veterans attending the renal clinic, TEACH-VET recruits participants through our recently published, EHR\u0026ndash;based \u0026lsquo;Opt-Out Source Cohort Strategy.[16] In brief, a \u0026lsquo;source cohort\u0026rsquo; of all actively registered Veterans at NF/SG VHS with ICD-10 codes for stage 4(N18.4) and 5 CKD(N18.5) or two latest outpatient estimated glomerular filtration rate (eGFR) of less than 30ml/min at least 90-days apart is generated. The cohort is then sorted in a random order, and the potential participants are approached in consecutive order for their status/need for specialty nephrology care and CPE. All eligible and interested participants are then enrolled into the second phase RCT.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBaseline data collection and Randomization\u003c/strong\u003e: Once enrolled, all participants provide baseline data comprising of patient-reported socio-demographics, education, household composition, and annual family income. Participants are assessed for health literacy by Rapid Estimate of Adult Literacy in Medicine-short form, medical comorbidity by the Charleston Comorbidity Index, and HRQoL by Kidney disease quality of life (KDQoL-36), excluding dialysis items.[17-19] CKD awareness is assessed by the prior validated instrument by Wright et al.[20] Considering this and other similar validated CKD knowledge instruments lack the domains of ESKD knowledge\u0026mdash;essential for informed dialysis decision\u0026mdash;the team has developed and pilot tested a 29-item ESKD knowledge questionnaire.[21] This questionnaire will be further refined during the TEACH-VET, and the team will report on its findings. A full list and timeline of all collected variables are listed in Figure 1 and Table 1.\u003c/p\u003e\n\u003cp\u003eAll enrolled participants are randomized by a computer-generated block randomization schedule devised by the study statistician, in 1:1 ratio into CPE or EUC arm. Considering the primary outcome of dialysis modality use and the strong known influence of socioeconomic factors,[22] the randomization is stratified by the stage of CKD (4 or 5) and annual family income (250% above or below federal poverty level adjusted for total number of household members).[23]\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention/CPE arm: \u003c/strong\u003eParticipants and their preferred care partner(s) in the intervention arm receive a standardized, evidence-based, two-phase CPE by trained renal educators in an Intent-to-Teach manner. The protocol covers the domains of education recommended by the professional renal organizations and CMS (Table 2),[24, 25, 4, 5] with an interactive, instructor-led audio-visual education, followed by individual patient-oriented counseling session that includes lifestyle simulation discussions. Prior studies have shown the advantages of such two-phase approach on comprehension, fears, and home dialysis selection.[26, 21] Over last decade, we have tested, refined and validated this protocol at two geographically distinct universities and affiliated VAs within the US to ensure literacy level and cultural relevance for the target patient population.[11, 12] For this study, we further pilot-tested the intervention with a local Veteran Engagement Committee made up of a diverse group of 12 Veterans and Veteran caregiver volunteers from Florida. This committee provided specific feedback to further hone the language used and explanations given for describing kidney disease and its management to fellow Veterans. Recently, we demonstrated our protocol can be delivered either face-to-face or through telemedicine with equivalent outcomes in terms of confidence in dialysis decision-making and home dialysis selection.[21]\u003c/p\u003e\n\u003cp\u003eTo ensure the intervention is standardized and uniform throughout the study, the renal educators are trained by licensed renal providers in the content, and by experienced patient educators in the delivery of the CPE prior to their involvement in the study. Additionally, with the participants\u0026rsquo; permission, all CPE sessions are recorded for the first 3 months of the study or after initiation of the new educator, and 10% of randomly selected CPE are recorded throughout the study period. The recorded data is reviewed for credibility, competence, and thoroughness of the educator interactions during CPE. Finally, the study tracks the amount of time educators spend with each participant for individual counseling, reviews the fidelity of important pre-defined topics and their delivery, and keeps detailed notes of any deviations from the CPE protocol. Feedback and additional training is provided as needed to ensure uniformity and standardization. Patients having any question or concerns after education are provided the opportunity to discuss with a licensed dialysis nurse or provider proficient in all renal replacement therapies.\u003c/p\u003e\n\u003cp\u003eTo ensure informed dialysis selection, participants are assessed for their confidence in dialysis decision-making and selection of dialysis modality at the end of the CPE session. Intent-to-Teach is assessed by confidence for dialysis decision making (defined by confidence rating of \u0026ldquo;quite confident\u0026rdquo; or \u0026ldquo;very confident\u0026rdquo;); those with suboptimal scores (\u0026ldquo;not at all confident\u0026rdquo; or \u0026ldquo;a little confident\u0026rdquo;) or \u0026ldquo;uncertain of the dialysis modality choice,\u0026rdquo; are advised to undergo repeat CPE sessions at an average of weekly intervals for a total of up to three counseling sessions (Figure 3). Our pilot studies show a vast majority of CPE recipients reach an informed decision by 3 sessions; when optional, 84% prefer to attend only one session, and when mandated for clinical care or research 96-99% of the patients reach informed dialysis selection by 3 sessions.[11, 21] Considering our preliminary data and to ensure \u0026nbsp;the model is ready-for-dissemination, TEACH-VET allows CPE participants to pragmatically choose the method for CPE, either face-to-face, or through tele-medicine to the affiliated outpatient clinic or within their homes. We will analyze the differences in outcomes between these delivery methods in our secondary analyses.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eControl/EUC arm: \u003c/strong\u003eParticipants in the EUC arm are provided printed hand-outs directing them to online self-learning CKD resources, freely available through several professional renal organizations, including the VA.[24, 25, 4, 5] While the investigators acknowledge the scientific need for an unaltered control arm, enhancing \u0026lsquo;usual care\u0026rsquo; through provision of the self-learning resources was considered the appropriate ethical compromise. To mirror the expected duration between the pre-, and post-CPE data collection in CPE arm, EUC arm participants provide data for post-EUC knowledge, confidence in dialysis decision-making, and dialysis modality selection 10-days after the provision of the self-learning resources.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQualitative study:\u0026nbsp; \u003c/strong\u003eThe qualitative study employs a maximum variation sampling strategy to ensure a diversity of demographic and clinical characteristics.[27] Fifteen Veterans from each of the face-to-face-CPE, tele-CPE and EUC groups respectively are interviewed by telephone for 45-60 minutes using a semi-structured interview guide based on the Theoretical Domains Framework (TDF).[28, 29] Furthermore, an additional 15 Veterans who did not ultimately use their preferred dialysis modality are interviewed 90-days post-ESKD to explore experiences and barriers. The TDF supplies the working analytical framework for identifying factors that influence Veterans\u0026rsquo; informed dialysis decision-making and experience with different dialysis modalities, including any perceived factors influencing dialysis decision-making, perceived barriers to home dialysis selection and use, and [for CPE arm] satisfaction with education session and counseling. The verbatim transcriptions for the audio-recorded interviews will be analyzed by two independent coders, organizing the data by domains of the framework, e.g. Knowledge: participants\u0026rsquo; knowledge regarding dialysis; Beliefs about capabilities: participants level of confidence; Intentions: CKD management preferences; Social influences: influence of family members, friends, or caregivers; Beliefs about consequences: expectations about CKD management and evaluation of results; Optimism motivation to recommend dialysis to other patients; and Emotions: feelings about CKD treatment options.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePost-CPE/EUC follow up: \u003c/strong\u003eNephrology, and if not available, the primary providers for the participants are informed of the participants\u0026rsquo; preferences for dialysis modality. This communique further instructs the providers regarding the need and importance of the pre-ESKD nephrology care, and the processes and desired timings for the peritoneal dialysis catheter insertion/vascular access creation. The providers are also informed about the contact information and approval processes for the VA ESKD services. Participants are then followed by EHR reviews at quarterly and by telephonic interviews at semi-annual intervals to assess their need/status of dialysis therapies and any changes in their preferred dialysis modality. Participants in CPE arm are allowed to re-access the audio-visual group education session independently throughout the study period. All outcome measures and their collections timings are available in Table 1.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical Considerations: \u003c/strong\u003eWe used G*Power version 3.1.9.2 for sample size calculations, which are based on the primary outcome of (home) dialysis use. Using one-tailed test with alpha of 0.05 and 80% power, to detect doubling of home dialysis use in CPE relative to EUC arm \u0026mdash;estimating home dialysis actual use to be 10% for EUC (based on the prevalent data) and 20% for CPE\u0026mdash;yielded a total sample size of N=108 (54 per arm). Allowing the potential of attrition and missing data that cannot be accommodated by the proposed missing data handling techniques (up to 20% data loss), we will need 136 (68 per arm) to reach ESKD and use dialysis to allow detection of this clinically meaningful effect size. Considering we expect about 25% of the study participants to reach ESKD through the study period, we plan to enroll 544 Veterans with advanced CKD for the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAnalytic plan: \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe will use multiple regression analysis to examine the effect of the CPE intervention on Veterans\u0026rsquo; knowledge of CKD and confidence in dialysis decision making post- intervention or EUC. We will include the baseline knowledge and confidence scores as covariates in the model, to account for pre- intervention/EUC values. We will use orthogonal Helmert contrast codes to test for the effect of both CPE as a whole (collapsed across telehealth and face-to-face delivery methods) vs EUC, and for the effect of tele-CPE vs face-to-face CPE. (Although we do not predict an effect of treatment delivery method, we have planned to include the comparisons derived by the Helmert contrast coding to test and account for any variance that may be introduced by different treatment delivery methods, should such variance/effect emerge.) We will use multiple logistic regression to examine the effect of CPE on Veterans\u0026rsquo; initial selection of home dialysis; specification of this logistic regression model for home dialysis initial selection mirrors the regression models for confidence and knowledge, with the exception that the outcome is binary. Additionally, we will use logistic regression with Helmert contrast coding to compare home dialysis actual use between CPE and EUC groups, as well as between tele-CPE and face-to-face-CPE groups (within the overall CPE group). This multiple logistic regression for actual use of home dialysis constitutes the analysis for the primary outcome of this study.\u003c/p\u003e\n\u003cp\u003eFor continuous secondary outcomes post-ESKD (e.g. HRQoL), we will use multiple regression analysis with Helmert contrast coding for CPE and EUC comparisons (as used in above regression models), an effect of dialysis modality actually used (home dialysis vs in-center dialysis), and interaction effects between the contrast codes and dialysis modality ([CPE-vs-EUC*Modality] and [tele-CPE vs face-to-face CPE*Modality]. Where applicable, we will include the outcome\u0026rsquo;s baseline scores and/or other relevant covariates. For dichotomous secondary outcomes post-ESKD (e.g., inpatient initiation of dialysis), we will use multiple logistic regression analysis, with the specification of this model mirroring that for continuous secondary outcomes post-ESKD, with the exception that the outcome is binary. Finally, for the secondary outcome of time to ESKD, we will calculate a Kaplan-Meier estimate. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFor qualitative sub-study, TDF will supply the working analytical framework.[28] Two researchers will independently code first few transcripts using the framework, reading transcripts line-by-line to capture as many behaviors, values, emotions, and impressions as possible, and comparing results to ensure everything relevant was coded according to the constructs of the framework. An iterative process will be used to refine themes from the framework based on patterns in the data, generating a thematic map.[30] This will provide in-depth understanding of the barriers Veterans\u0026rsquo; experience in acquiring the knowledge needed to manage CKD, and facilitators involved in their selection and use of a post-ESKD management strategy.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe burden of progressive CKD transitioning to ESKD is large for patients and healthcare system, and there are several critical systemic deficits in the care of these patients in the current infrastructure. Among these, lack of opportunities for informed dialysis selection and gross underuse of home dialysis have been important, long-targeted yet underachieved concerns. Available studies show that providing CPE can substantially improve these concerns at institutional levels, however, we lack randomized studies, validated protocols, and implementation models to address these concerns at a systemic level. TEACH-VET attempts to examine and address several of these concerns.\u003c/p\u003e\n\u003cp\u003eNearly half of incident ESKD patients have none to limited (less than 6-months) pre-ESKD nephrology care.\u003csup\u003e1\u003c/sup\u003e These patients have low probabilities for acquiring specialty care or CPE necessary to reach informed dialysis selection, and thus, home dialysis use. Studies have shown EHR-based screening is accurate to a sensitivity and specificity of 99% for the identification of stage 3 or higher CKD. However, these models are not routinely used to identify and improve clinical care in advanced CKD.[31] TEACH-VET will aim to model to identify all Veterans with advanced CKD within the VA database through an EHR-based source cohort, and evaluate their status/need for specialty nephrology care and CPE. If validated, this will provide a blueprint for developing such models in similar mid-large healthcare infrastructures across the country. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSeveral cohort and a few randomized studies from outside the US have shown CPE increases informed home dialysis use. Over last decade, a few cohort studies from within the US have validated these findings.[8] Unfortunately, interpretation these results is limited by the concerns for selection bias. A randomized evaluation of the strategy to provide CPE universally to all advanced CKD patients has not been tested till date in the US general or Veteran populations. The results of TEACH-VET will provide evidence to universalize CPE across the sociodemographic and comorbidity spectrum, and identify limitations related to this strategy. Furthermore, assessment of the parameters of informed decision making, i.e., improvement in CKD/ESKD knowledge and confidence in dialysis decision-making will further assist in differentiating between a patient-centered vs. system-driven increase in home dialysis use.\u003c/p\u003e\n\u003cp\u003eLack of validated protocols hamper wide-spread adoption of CPE in routine clinical practice. Several private and public organizations, including VA, have recently launched technology-based solutions pooling resources and expertise to a central organization with capacity to reach patient-base beyond individual practices.[4, 32] The effects of such programs have been limited and ill-quantified to date. We have developed and tested our easy-to-implement CPE protocol in different clinical models, i.e., incorporated within the clinical care, as a stand-alone model, and through telemedicine-based delivery. TEACH-VET integrates this further at a systemic level with both face-to-face and telemedicine-based delivery, and assesses their effects on parameters of informed decision-making, home dialysis selection and use, and post-ESKD outcomes. \u0026nbsp;The qualitative component further assesses the patient-preferences for such services and their barriers. These results will provide the necessary evidence to use telemedicine technology for wider dissemination of these services.\u003c/p\u003e\n\u003cp\u003eThe cost-effectiveness of CPE and home dialysis have been demonstrated in health economics models. Despite these, need for significant resources, including trained specialists capable of providing CPE have limited routine provision of CPE in clinical practice at systemic levels.[13] Prospective randomized assessments of the inpatient and outpatient service utilizations will provide guide to the health services outcomes in the care of advanced CKD for a universal system-based approach.\u003c/p\u003e\n\u003cp\u003eWhile studies have assessed the effects of CPE on home dialysis selection and use in general population, the data on Veterans are limited. Veteran ESKD population is known to be significantly older and with greater functional limitations. Furthermore, most Veterans (about 90%) receive their CKD care from within the VHA but, only a minority (about 10%) receive their ESKD care from the VHA. This disconnect hinders CPE and planned transition to ESKD and resultantly, the home dialysis utilization. Home dialysis rates among veterans ESKD (about 7%) are significantly lower than already low rates prevalent in the US general ESKD population. [33, 1] TEACH-VET will evaluate a system-based approach in an area of unmet need and systemic deficit in the care of Veterans with advanced CKD. Finally, the qualitative assessments of Veterans status/preferences for receiving the specialty nephrology care, CPE, and home dialysis therapy have not been performed to date. Together, the results will provide targeted Veteran-specific data, instrumental for future research, while establishing a ready-to-implement model for dissemination across the VHA system.\u003c/p\u003e\n\u003cp\u003eSeveral cohort-based studies have shown the benefits of CPE on a variety of pre-, and post-ESKD outcomes, including quality of CKD care, time to ESKD, vascular access outcomes, and pre- and post-ESKD survivals.[34, 9, 10] While not powered to detect differences in these outcomes, TEACH-VET will assess a variety of clinical, health services and patient-centered outcomes once these patients develop ESKD.\u003c/p\u003e\n\u003cp\u003eThere are few limitations of TEACH-VET. While the study investigates the status/need of the pre-ESKD nephrology care and empowers informed dialysis selection, it doesn\u0026rsquo;t mandate protocol-based congruence for new nephrology referrals or provider adherence to patient-selected dialysis modality. Thus, by design, it assesses the effects a stand-alone CPE program superimposed on routine nephrology care. The study will report the effects of intervention/control on these events, and the pre-planned subgroup analyses and qualitative assessments will evaluate the impacts of such uncontrolled variables on the study outcomes. Second, to ensure the need for emergent dialysis due to patients\u0026rsquo; comorbidities or administrative limitations of infrastructures providing nephrology care within and outside VHA do not impact evaluation of long-term dialysis modality use, TEACH-VET will assess the home dialysis use at 90-day post-ESKD. The study will report these occurrences, and document any difference between the chosen vs. initial modality, and the qualitative assessments will attempt to dissect the facilitators and barriers to their initiation of chosen modality for eventual systems improvements. Finally, we acknowledge the results of TEACH-VET will only provide evidence for adopting and disseminating these strategies within the unique healthcare infrastructure of VHA. Adoption of the findings in the general US healthcare system will require additional studies establishing its efficacy and feasibility.\u003c/p\u003e\n\u003cp\u003eTo summarize, studies from around the world as well as from within the US have shown that comprehensive pre-ESKD education may have substantial benefits in the clinical care of advanced CKD, but the evidence to support this effectiveness has not been obtained from well designed, randomized controlled studied from within the US. Furthermore, we lack validated protocols and feasible systemic models to deliver CPE. TEACH-VET aims addresses these deficits through a system-based approach for universal CPE within VHA, delivered via either an in-person visit or telemedicine and investigates its impact on Veterans\u0026rsquo; informed dialysis choice and home dialysis rates. Findings from this study will demonstrate whether such a universal approach can improve Veterans clinical, patient-centered and health services outcomes. If successful, this will provide evidence for policymakers to expand and implement such programs across the healthcare system to improve care for patients with advanced CKD, increase home dialysis use, and improve post-ESKD outcomes, while reducing health service utilization and cost.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eCKD: Chronic Kidney Disease\u003c/p\u003e\n\u003cp\u003eCPE: Comprehensive pre-end stage kidney disease (ESKD) disease education (CPE)\u003c/p\u003e\n\u003cp\u003eEHR: Electronic health records\u003c/p\u003e\n\u003cp\u003eESRD: End stage renal disease\u003c/p\u003e\n\u003cp\u003eTEACH-VET: Trial to Evaluate and Assess the effects of CPE on Home dialysis in Veterans\u003c/p\u003e\n\u003cp\u003eRCT: Randomized Controlled Trial\u003c/p\u003e\n\u003cp\u003eVHA: Veterans Health Administration\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate: \u0026nbsp;\u003c/strong\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication: \u003c/strong\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials: \u003c/strong\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests: \u003c/strong\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e This study is supported by the funding from Department of Veterans Affairs, Health Service Research and Development Awards (I01HX002639) and Office of Rural Health FY21 Awards (16004). Shukla AM additionally reports ongoing grant support from the Department of Veterans Affairs, Clinical Science Research and Development Merit Grant (I01CX001661).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors' contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAS, JHG, HJ contributed to the concept and design of the study, and production of manuscript.\u003c/p\u003e\n\u003cp\u003eIF and SJ contributed to the concept and design of the study.\u003c/p\u003e\n\u003cp\u003eZP contributed to the design of the study and production of manuscript.\u003c/p\u003e\n\u003cp\u003eAll authors with substantial contributions to have approved the submitted version.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements: \u003c/strong\u003eNone\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFootnotes: \u003c/strong\u003eNone\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eSaran R, Robinson B, Abbott KC, Agodoa LYC, Bragg-Gresham J, Balkrishnan R, et al. US Renal Data System 2018 Annual Data Report: Epidemiology of Kidney Disease in the United States. American Journal of Kidney Diseases. 2019;73(3):A7-A8.\u003c/li\u003e\n\u003cli\u003eMehrotra R, Chiu Y, Kalantar-Zadeh K, Bargman J, Vonesh E. Similar outcomes with hemodialysis and peritoneal dialysis in patients with end-stage renal disease. Archives of Internal Medicine. 2011;171(2):110-18.\u003c/li\u003e\n\u003cli\u003eLiu FX, Treharne C, Culleton B, Crowe L, Arici M. The financial impact of increasing home-based high dose haemodialysis and peritoneal dialysis. BMC Nephrology. 2014 October 02;15(1):161.\u003c/li\u003e\n\u003cli\u003eProgram NKDE. Kidney Failure.\u003c/li\u003e\n\u003cli\u003eYoung HN, Chan MR, Yevzlin AS, Becker BN. The rationale, implementation, and effect of the Medicare CKD education benefit. Am J Kidney Dis. Mar;57(3):381-6.\u003c/li\u003e\n\u003cli\u003eGALLA JH. Clinical Practice Guideline on Shared Decision-Making in the Appropriate Initiation of and Withdrawal from Dialysis. Journal of the American Society of Nephrology. 2000 July 1, 2000;11(7):1340-42.\u003c/li\u003e\n\u003cli\u003eMoss AH. Ethical Principles and Processes Guiding Dialysis Decision-Making. Clinical Journal of the American Society of Nephrology. 2011 September 1, 2011;6(9):2313-17.\u003c/li\u003e\n\u003cli\u003eDevoe DJ, Wong B, James MT, Ravani P, Oliver MJ, Barnieh L, et al. Patient Education and Peritoneal Dialysis Modality Selection: A Systematic Review and Meta-analysis. American Journal of Kidney Diseases. 2016;68(3):422-33.\u003c/li\u003e\n\u003cli\u003eDevins GM, Mendelssohn DC, Barr\u0026eacute; PE, Taub K, Binik YM. Predialysis psychoeducational intervention extends survival in CKD: a 20-year follow-up. Am J Kidney Dis. 2005 Dec;46(6):1088-98.\u003c/li\u003e\n\u003cli\u003eCollister D, Pyne L, Cunningham J, Donald M, Molnar A, Beaulieu M, et al. 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Clinical Journal of the American Society of Nephrology. 2019;14(9):1306-14.\u003c/li\u003e\n\u003cli\u003eDiamantidis CJ, Fink W, Yang S, Zuckerman MR, Ginsberg J, Hu P, et al. Directed use of the internet for health information by patients with chronic kidney disease: prospective cohort study. J Med Internet Res. 2013 Nov 15;15(11):e251.\u003c/li\u003e\n\u003cli\u003eSaran R, Pearson A, Tilea A, Shahinian V, Bragg-Gresham J, Heung M, et al. Burden and Cost of Caring for US Veterans With CKD: Initial Findings From the VA Renal Information System (VA-REINS). American Journal of Kidney Diseases.\u003c/li\u003e\n\u003cli\u003eLacson Jr E, Wang W, DeVries C, Leste K, Hakim RM, Lazarus M, et al. Effects of a Nationwide Predialysis Educational Program on Modality Choice, Vascular Access, and Patient Outcomes. American Journal of Kidney Diseases.58(2):235-42.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cstrong\u003e\u003cspan style='font-size:16px;line-height:150%;font-family:\"Arial\",sans-serif;color:#1B3051;'\u003eTable 1.\u0026nbsp;\u003c/span\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cspan style='font-size:16px;line-height:150%;font-family:\"Arial\",sans-serif;color:black;'\u003eKey Variables and Quantitative Outcomes by the Time of Data Collection\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003ctable style=\"border: none;border-collapse:collapse;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 166.5pt;border-top: none;border-right: none;border-left: none;border-image: initial;border-bottom: 1pt solid black;padding: 0in 5.75pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eVariable Domains and Outcomes\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 193.5pt;border-top: none;border-right: none;border-left: none;border-image: initial;border-bottom: 1pt solid black;padding: 0in 5.75pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eVariable Name \u0026amp; Characteristic\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 2.5in;border-top: none;border-right: none;border-left: none;border-image: initial;border-bottom: 1pt solid black;padding: 0in 5.75pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eTime Point\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width:166.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eDemographics (Baseline data)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:193.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eAge\u003c/span\u003e\u003c/p\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eRace/ethnicity\u003c/span\u003e\u003c/p\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eEducation\u003c/span\u003e\u003c/p\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eAnnual Family Income\u003c/span\u003e\u003c/p\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eSocial Support\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:2.5in;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003ePre-Intervention Baseline\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width:166.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eComorbidities (Baseline data)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:193.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eComorbidity Index\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:2.5in;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003ePre-Intervention Baseline\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width:166.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eHealth Literacy (Baseline data)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:193.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eHealth Literacy Score\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:2.5in;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003ePre-Intervention Baseline\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width:166.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eCKD/ESKD\u0026nbsp;\u003c/span\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eKnowledge\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:193.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eCKD/ESKD Knowledge\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:2.5in;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cdiv style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\n \u003cul style=\"margin-bottom:0in;list-style-type: disc;margin-left:-0.25in;\"\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003ePre-Intervention Baseline\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003ePost-Intervention/Control\u003c/span\u003e\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width:166.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eConfidence in dialysis decision-making\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:193.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eConfidence in dialysis selection\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:2.5in;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cdiv style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\n \u003cul style=\"margin-bottom:0in;list-style-type: disc;margin-left:-0.25in;\"\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003ePre-Intervention Baseline\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003ePost-Intervention/Control\u003c/span\u003e\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width:166.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eDialysis Modality Selection\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:193.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eDialysis modality selection\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:2.5in;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cdiv style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\n \u003cul style=\"margin-bottom:0in;list-style-type: disc;margin-left:-0.25in;\"\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003ePre-Intervention Baseline\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003ePost-Intervention/Control\u003c/span\u003e\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width:166.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eDialysis Modality Use\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cstrong\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003e(Primary Outcome)\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:193.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eDialysis modality use\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:2.5in;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003e90-day post-ESKD\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width:166.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003ePatient Reported\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:193.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eHRQoL\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:2.5in;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cdiv style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\n \u003cul style=\"margin-bottom:0in;list-style-type: disc;margin-left:-0.25in;\"\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003ePre-Intervention Baseline\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003e90 days post ESKD\u003c/span\u003e\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width:166.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003ePatient Reported\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:193.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eSatisfaction with Dialysis\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:2.5in;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003e90-day post-ESKD\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width:166.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eHealth Service Utilization\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:193.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eNumber of inpatient stays\u003c/span\u003e\u003c/p\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eNumber of outpatient visits\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:2.5in;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003ePost-Intervention to 90-day post-ESKD\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width:166.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eClinical\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:193.5pt;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eTime to ESKD\u003c/span\u003e\u003c/p\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eeGFR at ESKD\u003c/span\u003e\u003c/p\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eInpatient initiation of dialysis\u003c/span\u003e\u003c/p\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eVascular Access Presence\u003c/span\u003e\u003c/p\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eVascular Access Use\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:2.5in;border:none;border-bottom:solid black 1.0pt;padding:0in 5.75pt 0in 5.75pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-family:\"Arial\",sans-serif;color:black;'\u003eAt ESKD\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cstrong\u003e\u003cspan style='font-size:16px;line-height:150%;font-family:\"Arial\",sans-serif;color:#1B3051;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style='font-size:16px;line-height:107%;font-family:\"Arial\",sans-serif;color:#1B3051;'\u003e\u003cbr\u003e\u0026nbsp;\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:16px;line-height:107%;font-family:\"Arial\",sans-serif;color:#1B3051;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cstrong\u003e\u003cspan style='font-size:16px;line-height:150%;font-family:\"Arial\",sans-serif;color:#1B3051;'\u003eTable 2. TEACH-VET Comprehensive Pre-ESKD kidney disease Education (CPE) Protocol domains and Missions\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003ctable style=\"border-collapse:collapse;border:none;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width:283.5pt;border:solid windowtext 1.0pt;background:#AEAAAA;padding:0in 5.4pt 0in 5.4pt;height:33.7pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-size:16px;line-height: 150%;font-family:\"Arial\",sans-serif;color:#1B3051;'\u003eDomains of the CPE\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:256.0pt;border:solid windowtext 1.0pt;border-left: none;background:#AEAAAA;padding:0in 5.4pt 0in 5.4pt;height:33.7pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-size:16px;line-height: 150%;font-family:\"Arial\",sans-serif;color:#1B3051;'\u003eMissions/Messages of the CPE for Patients\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 283.5pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cdiv style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\n \u003cul style=\"margin-bottom:0in;list-style-type: disc;margin-left:-0.25in;\"\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eLocation and Function of the Human Kidneys\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eOverview of Kidneys in Human Health\u0026nbsp;\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\n \u003cdiv style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\n \u003col style=\"margin-bottom:0in;list-style-type: circle;\"\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eExcretory Functions of the Kidneys\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eNon-excretory Functions of the Kidneys\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\n \u003cdiv style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\n \u003cul style=\"margin-bottom:0in;list-style-type: square;\"\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eImportance in cardiovascular health\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eImportance in bone health\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eImportance in Anemia\u003c/span\u003e\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/div\u003e\n \u003c/li\u003e\n \u003c/ol\u003e\n \u003c/div\u003e\n \u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eCKD and stages?\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\n \u003cdiv style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\n \u003col style=\"margin-bottom:0in;list-style-type: circle;\"\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eDifferentiate CKD from Acute kidney injury\u003c/span\u003e\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/div\u003e\n \u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eUnderstand Kidney Failure (ESKD)\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\n \u003cdiv style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\n \u003col style=\"margin-bottom:0in;list-style-type: circle;\"\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eCommon Symptoms of Kidney Failure\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eCommon Signs of Kidney Failure\u0026nbsp;\u003c/span\u003e\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/div\u003e\n \u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eOptions for the management of Kidney Failure?\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\n \u003cdiv style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\n \u003col style=\"margin-bottom:0in;list-style-type: circle;\"\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eKidney Transplantation\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eConservative Care\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eDialysis therapies\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\n \u003cdiv style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\n \u003cul style=\"margin-bottom:0in;list-style-type: square;\"\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eHome-based Peritoneal Dialysis\u0026nbsp;\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eHome-based Hemodialysis\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eCenter-based Hemodialysis\u003c/span\u003e\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/div\u003e\n \u003c/li\u003e\n \u003c/ol\u003e\n \u003c/div\u003e\n \u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eLifestyle on Dialysis\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eFrequently Asked Questions\u003c/span\u003e\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/div\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 256pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cdiv style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\n \u003cul style=\"margin-bottom:0in;list-style-type: disc;margin-left:-0.25in;\"\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eCPE should be available to all patients with stage 4 and 5 CKD, irrespective of their socio-demographic and comorbidity status, or perceived eligibility for home dialysis therapies\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eFor eligible patients, kidney transplantation is the best modality of renal replacement therapy\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eIt is important to know the cause of transplant ineligibility, and the possible corrective measures \u0026nbsp;\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eAll dialysis modalities have equivalent medical outcomes\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eUnless deemed medically/socially unsuitable by the provider, the choice of dialysis modality is a patient and caregiver\u0026rsquo;s decision and should be targeted as a shared decision-making process\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eAvoid fear as an overbearing motivator for dialysis modality selection by ensuring the patients that the routine care should provide adequate support for any of the modalities chosen for most patients\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eDecision for dialysis should be attempted early in the course of advanced CKD, if possible, by the end of the CPE session. If not feasible, the patient must plan to attend additional CPE sessions.\u0026nbsp;\u003c/span\u003e\u003c/li\u003e\n \u003cli style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cspan style='line-height:150%;font-family:\"Arial\",sans-serif;font-family:\"Arial\",sans-serif;font-size:12.0pt;color:black;'\u003eAll patient selections should be evaluated for confidence in dialysis decision making, with the options for patients with low confidence to attend follow up sessions\u003c/span\u003e\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cspan style='font-size:16px;line-height:150%;font-family:\"Arial\",sans-serif;color:#1B3051;'\u003eCPE: comprehensive pre-ESRD education, CKD: chronic kidney disease, ESKD: end stage kidney disease\u003c/span\u003e\u003cstrong\u003e\u003cspan style='font-size:16px;line-height:150%;font-family:\"Arial\",sans-serif;color:#1B3051;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-nephrology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bnep","sideBox":"Learn more about [BMC Nephrology](http://bmcnephrol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bnep/default.aspx","title":"BMC Nephrology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Chronic Kidney Failure. Renal Insufficiency, Patient-Centered Care, Shared Decision Making, Health Education, Quality of Life, Home Dialysis","lastPublishedDoi":"10.21203/rs.3.rs-412522/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-412522/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground \u003c/strong\u003eInformed 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.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eMethods \u003c/strong\u003eTrial 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.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eResults \u003c/strong\u003eThe 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.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConclusion \u003c/strong\u003eThe 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.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eTrial registration: \u003c/strong\u003eNCT04064086\u003c/p\u003e","manuscriptTitle":"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","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2021-04-20 23:00:40","doi":"10.21203/rs.3.rs-412522/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2021-10-26T03:42:23+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2021-08-02T06:30:43+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"7c841b00-a526-452a-87e8-ebc97e349bed","date":"2021-07-14T05:53:59+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2021-04-30T15:02:02+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"65fed574-6564-4413-8926-a98b211ddf25","date":"2021-04-20T19:56:17+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2021-04-20T19:44:26+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2021-04-20T19:41:24+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2021-04-20T04:15:21+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2021-04-19T14:20:40+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Nephrology","date":"2021-04-11T15:35:16+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-nephrology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bnep","sideBox":"Learn more about [BMC Nephrology](http://bmcnephrol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bnep/default.aspx","title":"BMC Nephrology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"37479f20-1213-4c6d-a21f-f9a15ff151a0","owner":[],"postedDate":"April 20th, 2021","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":3781661,"name":"Urology \u0026 Nephrology"}],"tags":[],"updatedAt":"2022-03-30T07:49:44+00:00","versionOfRecord":{"articleIdentity":"rs-412522","link":"https://doi.org/10.1186/s12882-022-02740-8","journal":{"identity":"bmc-nephrology","isVorOnly":false,"title":"BMC Nephrology"},"publishedOn":"2022-03-30 07:49:44","publishedOnDateReadable":"March 30th, 2022"},"versionCreatedAt":"2021-04-20 23:00:40","video":"","vorDoi":"10.1186/s12882-022-02740-8","vorDoiUrl":"https://doi.org/10.1186/s12882-022-02740-8","workflowStages":[]},"version":"v1","identity":"rs-412522","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-412522","identity":"rs-412522","version":["v1"]},"buildId":"WrCJVZZCHTDjtuVLN7oU0","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}