Clinical trial NCT04064086: Trial to Evaluate and Assess the Effect of Comprehensive Pre-ESKD Education on Home Dialysis Use in Veterans
Official title: A Patient-centered, System-based Approach to Improve Informed Dialysis Choice and Outcomes in Veterans With CKD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease
End Stage Renal Disease
Hemodialysis
Peritoneal Dialysis
Keywords: Chronic kidney disease
Pre-dialysis education
Kidney Disease Education
Patient Education
Decision Making
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-08-21
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* Veterans registered to receive healthcare from the NF/SG VHS
* 18 years or older
* Advanced CKD (stage 4 or 5) and not on dialysis

Exclusion Criteria:

* 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

Primary outcomes:
measure: Home Dialysis Use
timeFrame: 0-48 months
Secondary outcomes:
measure: Home Dialysis selection
timeFrame: 0-4 weeks
measure: Kidney Disease Knowledge
timeFrame: 0-4 weeks
measure: confidence in dialysis decision making
timeFrame: 0-4 weeks
measure: post-ESRD Kidney Disease Quality of life-36
timeFrame: 3-48 months
measure: Satisfaction on Dialysis
timeFrame: 3-48 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System, Gainesville, FL
name: Ashutosh M. Shukla, MD MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shukla 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.