Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Kidney Disease
  • End Stage Renal Disease
  • Hemodialysis
  • Peritoneal Dialysis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: 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.Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Chronic kidney disease (CKD) is the 4th most common diagnosis among Veterans. Each year, over 13,000 Veterans transition from CKD to end stage renal disease (ESRD), a disease with high mortality and poor health related quality of life (HRQoL). Over 52,000 Veterans with ESRD are currently on dialysis...

Chronic kidney disease (CKD) is the 4th most common diagnosis among Veterans. Each year, over 13,000 Veterans transition from CKD to end stage renal disease (ESRD), a disease with high mortality and poor health related quality of life (HRQoL). Over 52,000 Veterans with ESRD are currently on dialysis and CKD/ESRD care costs VA over $18 billion per year. The majority of Veterans progressing from CKD to ESRD have limited to no awareness of CKD and its treatment options. This hinders Veterans' informed dialysis selection resulting in a gross underuse (7%) of home dialysis (HoD). As there are no significant differences in mortality among different dialysis modalities, VHA National Kidney Program and professional renal societies advocate informed dialysis selection and greater use of HoD to facilitate improvements in Veterans' post-ESRD clinical and health services utilization outcomes. Reports from Europe and Canada show that providing comprehensive pre-ESRD patient education (CPE) improves the quality of CKD care and empowers patients to make informed dialysis modality selection. Data further show that informed modality selection substantially corrects the underuse of HoD as desired by the healthcare systems, including VHA. However, across VHA, many Veterans with CKD are identified too late to benefit from CPE; and even for those identified and under renal care, the availability of CPE is limited. This results in suboptimal pre-ESRD care and preparation, and continued low HoD utilization. Thus, there is an urgent systemic need to provide CPE to all pre-ESRD (stage 4 and 5 CKD) Veterans and study its effectiveness prospectively within the VHA. This study aims to evaluate the impact of the comprehensive pre-ESRD patient education on high-impact outcomes for Veterans and health services, across a local Veterans Healthcare System (VHS). The investigators will compare the impact of CPE (intervention), delivered either in-person or through telemedicine, with the usual care (control) enhanced by the provision of the self-learning CKD information among Veterans with advanced CKD across the North Florida/South Georgia VHS. The investigators' study has four aims, consisting of one primary outcome (HoD use) and multiple secondary outcomes, to help us understand the impact of CPE on patients' informed decision making and on important post-ESRD clinical, patient-reported, and health services outcomes. 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. H1.1: CPE will improve Veterans' knowledge of CKD and its management. H1.2: CPE will improve Veterans' confidence in making an informed selection of a dialysis modality. H1.3: CPE will increase Veterans' selection of HoD. Aim 2: Compare Veterans' actual use of HoD (Primary Outcome) between the CPE and usual care groups. H2.1: Veterans in the CPE group will show increased HoD use. 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. H4: Veterans in the CPE group will show improvement in these secondary outcomes. Findings from this study will help to achieve the long-term goal of better meeting the needs of Veterans with advanced CKD by improving Veterans' knowledge of CKD and its management, and promoting evidence-based Veteran-centered ESRD care.

Tracking Information

NCT #
NCT04064086
Collaborators
Not Provided
Investigators
Principal Investigator: Ashutosh M. Shukla, MD MBBS North Florida/South Georgia Veterans Health System, Gainesville, FL