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IIR 19-202 – HSR Study

IIR 19-202
A Patient-centered, System-based Approach to Improve Informed Dialysis Choice and Outcomes in Veterans with CKD
Ashutosh M. Shukla, MD MBBS
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, FL
Funding Period: March 2020 - September 2026


Background: CKD is the 4th most common diagnosis among Veterans. Each year 13,000 Veterans transition to ESRD. VHA supports over 52,000 ESRD Veterans on dialysis. The care of CKD costs VHA over $18 billion dollars annually. Transition care of these Veterans is uncoordinated and suboptimal as most receive their pre- ESRD care within VHA but over 90% are outsourced for their dialysis, on fee-basis. Thus, the majority of Veterans progressing to ESRD have limited awareness of CKD and its management options including the dialysis modalities. This leads to gross underuse (7%) of home dialysis (HoD). Professional renal societies and VHA national CKD program advocate informed dialysis choice, and greater use of HoD for all patients transitioning to ESRD. European and Canadian reports show that CPE empowers informed choice of dialysis, increases HoD use, and improves the quality of CKD care. However, availability of CPE within VHA is limited and HoD utilization is low. To address these issues, we have developed and pilot-tested a concise CPE model in two different universities and affiliated VA in Florida and Arkansas. Our preliminary findings show that CPE improves patient informed dialysis choice, and increases HoD selection to 74% and HoD use to 61%. In a separate pilot study, we found that tele-CPE is as efficacious as F2F-CPE. Objectives: The overall goal of this RCT is to investigate the impact of CPE on patient knowledge and confidence, HoD selection and use, and patient-reported, health services and clinical outcomes in a cohort of Veterans who were diagnosed with CKD and receive CKD treatment from the North Florida/South Georgia Veterans Health System (NF/SG VHS). The study aligns with HSR&D major research priorities including “patient-centered care, care management, and health promotion” and “health care systems change.” The 4 Specific Aims are: Aim 1: Compare the impact of CPE on Veterans’ knowledge of CKD, their confidence in dialysis decision making, and their selection of dialysis modality, between the CPE and usual care groups. Aim 2: Compare Veterans’ actual use of HoD (Primary Outcome) between the CPE and usual care groups. Aim 3: Examine Veterans’ perceived satisfaction with CPE, explore their preferences for F2F- or Tele-CPE, and investigate barriers and facilitators in the selection and use of their preferred dialysis modality. (Qualitative) Aim 4: Compare the following post-ESRD secondary outcomes between the CPE and usual care groups. Patient reported outcomes: 1) health-related quality of life and 2) satisfaction with dialysis; clinical outcomes: 3) time to ESRD, 4) estimated glomerular filtration rate at ESRD, 5) need for inpatient initiation of dialysis, and 6) vascular access status at ESRD; and health services utilization outcomes: 7) number of inpatient stays, and 8) number of outpatient visits, from enrollment to 90-day post ESRD period. Methods: In this mixed method RCT, we will enroll 800 Veterans with stage 4 or 5 CKD, ≥18 years of age, English speaking, and not yet on dialysis who receive CKD care from NF/SG VHS. In 1:1 ratio, all the consented Veterans will be randomly allocated into intervention (CPE) or control (enhanced usual care or EUC) group. For Aim 1, multiple regression analysis will be applied to model the risk-adjusted post-intervention CKD knowledge and confidence in Veteran dialysis decision making; For Aim 2, logistic regression will be used to compare the HoD selection and use between the CPE and EUC groups. Aim 3 will be a qualitative study using semi-structured interviews to obtain in-depth data on Veterans’ satisfaction with CPE, preference for CPE delivery, and barriers and facilitators to HoD selection and use as a dialysis. For Aim 4, multiple regression analysis will be applied to model the risk-adjusted effects of CPE, HoD, and the group-modality interaction on outcomes. Expected Results: We anticipate that CPE will enhance Veterans’ CKD knowledge and confidence for informed dialysis selection, and increase HoD use, leading to improved Veterans’ and health services outcomes. Next Step: 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.

External Links for this Project

NIH Reporter

Grant Number: I01HX002639-01A2

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None at this time.

DRA: Kidney Disorders
DRE: TRL - Applied/Translational, Treatment - Observational
Keywords: Models of Care
MeSH Terms: None at this time.

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