Evidence map›Paper›PMID 35354430›Full record

ArticleBMC nephrology2022

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, Zachary Purvis, Sergio Romero, Huanguang Jia

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC nephrology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04064086 (A Patient-centered, System-based Approach to Improve Informed Dialysis Choice and Outcomes in Veterans With CKD), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.9field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04064086 naactive not recruitingnot on this map

A Patient-centered, System-based Approach to Improve Informed Dialysis Choice and Outcomes in Veterans With CKD

TypeinterventionalSponsorVA Office of Research and DevelopmentRan2020 to 2027Enrolled656ConditionsChronic Kidney Disease, End Stage Renal Disease, Hemodialysis, Peritoneal DialysisArmsComprehensive Pre-ESRD Patient Education (CPE), Provision of the freely available resources for Kidney Disease Education
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 13 citations in OpenAlex.

  1. Decision Readiness and Determinants of KRT among Veterans with Advanced CKD.Clinical journal of the American Society of Nephrology : CJASN · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Ashutosh M ShuklaNorth Florida / South Georgia Veteran Healthcare System, Gainesville, FL, USA. Ashutosh.Shukla@medicine.ufl.edu.
Jennifer Hale-GallardoNorth Florida / South Georgia Veteran Healthcare System, Gainesville, FL, USA.
Tatiana OrozcoNorth Florida / South Georgia Veteran Healthcare System, Gainesville, FL, USA.
Ivette FreytesNorth Florida / South Georgia Veteran Healthcare System, Gainesville, FL, USA.
Zachary PurvisNorth Florida / South Georgia Veteran Healthcare System, Gainesville, FL, USA.
Sergio RomeroNorth Florida / South Georgia Veteran Healthcare System, Gainesville, FL, USA.
Huanguang JiaNorth Florida / South Georgia Veteran Healthcare System, Gainesville, FL, USA.
North Florida/South Georgia Veterans Health System · US

Funding

Hydroxychloroquine for the Management of CVD in CKDI01CX001661 · VA · VETERANS HEALTH ADMINISTRATION · PI MARK S. SEGAL, Ashutosh M Shukla · 2019 to 2026
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A Patient-centered, System-based Approach to Improve Informed Dialysis Choice and Outcomes in Veterans with CKDI01HX002639 · VA · VETERANS HEALTH ADMINISTRATION · PI JIA, HUANGUANG, SHUKLA, ASHUTOSH M · 2020 to 2025
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CSRD VA I01 CX001661HSRD VA I01 HX002639
6 · The paper itself

Abstract

backgroundInformed dialysis selection and greater home dialysis use are the two long-desired, underachieved targets of advanced chronic kidney disease (CKD) care in the US healthcare system. Observational institutional studies have shown that comprehensive pre-kidney failure, conventionally referred to as end stage kidney 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 kidney replacement therapy can improve multiple clinical, patient-centered and health service outcomes in advanced CKD and kidney failure requiring dialysis therapy.

methodsTrial to Evaluate and Assess the effects of CPE on Home dialysis in Veterans (TEACH-VET) is a multi-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-kidney failure, whichever occurs earlier.

resultsThe primary outcome will assess the proportion of Veterans using home dialysis at 90-days post-kidney failure, 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-kidney failure clinical, patient-centered and health services outcomes will be assessed 90-days post-kidney failure as additional secondary outcomes.

conclusionThe 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 registrationNCT04064086 .

Indexed as

Kidney Failure, ChronicRenal Insufficiency, ChronicVeteransHemodialysis, HomeHumansRandomized Controlled Trials as TopicRenal DialysisChronic kidney diseaseEnd stage kidney diseaseHealth educationKidney failurePatient-centered careQuality of life, home DialysisRenal insufficiencyShared decision making

Identifiers

PMID35354430
PMCPMC8966272
OpenAlexW4225592991

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.