Trial to Evaluate and Assess the Effect of Comprehensive Pre-ESKD Education on Home Dialysis Use in Veterans
TEACH-VET
A Patient-centered, System-based Approach to Improve Informed Dialysis Choice and Outcomes in Veterans With CKD
2 other identifiers
interventional
656
1 country
1
Brief Summary
This study is intended to correct an important systemic deficit in the care of chronic kidney disease (CKD), VHA's fourth most common healthcare condition with high mortality and healthcare burden. Currently, many Veterans with CKD have poor awareness of their condition. This leads to suboptimal care. The investigators anticipate that the proposed comprehensive pre-end stage renal disease (ESRD) education (CPE) will enhance Veterans' CKD knowledge and their confidence in making an informed selection of an appropriate dialysis modality, and lead to an increase in the use of home dialysis (HoD) - an evidence-based, yet underutilized dialysis modality. Further, this study will allow us to examine whether such Veteran-informed dialysis choice can improve Veteran and health services outcomes. If successful, this study may deliver a ready to roll-out strategy to meet the CKD care needs of the Veterans and reduce VHA healthcare costs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2019
CompletedFirst Posted
Study publicly available on registry
August 21, 2019
CompletedStudy Start
First participant enrolled
March 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
ExpectedDecember 31, 2025
December 1, 2025
5.5 years
August 19, 2019
December 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Home Dialysis Use
Patient receiving either CPE or Enhanced usual care (EUC) will be followed for the diagnosis of ESRD and initiation of dialysis. The investigators will follow the use of peritoneal dialysis or home hemodialysis at day 90 into the dialysis as the home dialysis (HoD) use primary outcome.
0-48 months
Secondary Outcomes (5)
Home Dialysis selection
0-4 weeks
Kidney Disease Knowledge
0-4 weeks
confidence in dialysis decision making
0-4 weeks
post-ESRD Kidney Disease Quality of life-36
3-48 months
Satisfaction on Dialysis
3-48 months
Study Arms (2)
Comprehensive Pre-ESRD Patient Education (CPE)
ACTIVE COMPARATORThese patients will receive CPE for a total of up to 3 session in an intent-to-teach format, either via Face-to-face or telemedicine delivery.
Enhanced Usual Care
ACTIVE COMPARATORThis group will receive usual care. This care will be enhanced by providing them with the freely available education material for the Kidney Disease Education
Interventions
Structured education session/s
freely available resources
Eligibility Criteria
You may qualify if:
- Veterans registered to receive healthcare from the NF/SG VHS
- years or older
- Advanced CKD (stage 4 or 5) and not on dialysis
You may not qualify if:
- Non-English speakers
- Veterans who are homeless or living in assisted living facilities or nursing homes
- Veterans with diagnosed dementia
- Veterans with the life-expectancy less than 6 months
- Any additional special concerns of a Veteran's provider
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135, United States
Related Publications (11)
Shukla AM, Cavanaugh KL, Jia H, Hale-Gallardo J, Wadhwa A, Fischer MJ, Reule S, Palevsky PM, Fried LF, Crowley ST. Needs and Considerations for Standardization of Kidney Disease Education in Patients with Advanced CKD. Clin J Am Soc Nephrol. 2023 Sep 1;18(9):1234-1243. doi: 10.2215/CJN.0000000000000170. Epub 2023 May 8.
PMID: 37150877RESULTCampbell-Montalvo R, Ftouni D, Shell P, Subhash S, Pearce K, Shukla AM. Understanding how patient education affects the process of treatment decision-making: Cultural model change in kidney disease therapy. Patient Educ Couns. 2025 Oct;139:109254. doi: 10.1016/j.pec.2025.109254. Epub 2025 Jul 5.
PMID: 40663840RESULTPearce KE, Guo Y, Subhash S, Ftouni D, Visconti B, Wadhwa A, Agarwal A, Jia H, Shukla AM. Decision Readiness and Determinants of KRT among Veterans with Advanced CKD. Clin J Am Soc Nephrol. 2025 Apr 11;20(7):931-939. doi: 10.2215/CJN.0000000713.
PMID: 40215111RESULTShukla AM, Visconti B, Pearce K, Orozco T, Hale-Gallardo J, Subhash S, Freytes IM, Jia H, Romero S, Guo Y. Development and Validation of KRT Knowledge Instrument. Clin J Am Soc Nephrol. 2024 Jul 1;19(7):877-886. doi: 10.2215/CJN.0000000000000472. Epub 2024 May 15.
PMID: 38748976RESULTChamarthi G, Orozco T, Hale-Gallardo J, Subhash S, Shell P, Pearce K, Jia H, Shukla AM. Informed Dialysis Modality Selection Among Veterans With Advanced CKD: A Community-Level Needs Assessment. Kidney Med. 2024 Apr 26;6(6):100832. doi: 10.1016/j.xkme.2024.100832. eCollection 2024 Jun.
PMID: 38873241RESULTChamarthi G, Orozco T, Shell P, Fu D, Hale-Gallardo J, Jia H, Shukla AM. Electronic Phenotype for Advanced Chronic Kidney Disease in a Veteran Health Care System Clinical Database: Systems-Based Strategy for Model Development and Evaluation. Interact J Med Res. 2023 Jul 24;12:e43384. doi: 10.2196/43384.
PMID: 37486757RESULTCampbell-Montalvo R, Jia H, Shukla AM. Supporting Shared Decision-Making and Home Dialysis in End-Stage Kidney Disease. Int J Nephrol Renovasc Dis. 2022 Sep 8;15:229-237. doi: 10.2147/IJNRD.S375347. eCollection 2022.
PMID: 36105650RESULTOrozco T, Segal E, Hinkamp C, Olaoye O, Shell P, Shukla AM. Development and validation of an end stage kidney disease awareness survey: Item difficulty and discrimination indices. PLoS One. 2022 Sep 9;17(9):e0269488. doi: 10.1371/journal.pone.0269488. eCollection 2022.
PMID: 36083893RESULTShukla AM, Hale-Gallardo J, Orozco T, Freytes I, Purvis Z, Romero S, Jia H. 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. BMC Nephrol. 2022 Mar 30;23(1):121. doi: 10.1186/s12882-022-02740-8.
PMID: 35354430RESULTShukla AM, Cavanaugh KL, Wadhwa A, Crowley ST, Fried L. Basic Requirements for Improving Home Dialysis Utilization: Universal Access to Specialty Nephrology Care and Comprehensive Pre-ESKD Education. J Am Soc Nephrol. 2023 Jan 1;34(1):21-25. doi: 10.1681/ASN.2022060685. Epub 2022 Oct 25. No abstract available.
PMID: 36283810RESULTCheng XBJ, Chan CT. Systems Innovations to Increase Home Dialysis Utilization. Clin J Am Soc Nephrol. 2024 Jan 1;19(1):108-114. doi: 10.2215/CJN.0000000000000298. Epub 2023 Aug 31.
PMID: 37651291DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashutosh M. Shukla, MD MBBS
North Florida/South Georgia Veterans Health System, Gainesville, FL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The study compares a comprehensive education with the standard of care. Thus it is not possible to mask investigator, participant or care provider. However, our statistician will assess the outcomes aggregates in a blinded manner.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2019
First Posted
August 21, 2019
Study Start
March 25, 2020
Primary Completion
September 30, 2025
Study Completion (Estimated)
September 30, 2027
Last Updated
December 31, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share