Trial to Evaluate and Assess the Effect of Comprehensive Pre-ESKD Education on Home Dialysis Use in Veterans

Chronic Kidney Disease Clinical Trial

— TEACH-VET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04064086
• Other study ID #: IIR 19-202
• Secondary ID: I01HX002639
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: Ashutosh M Shukla, MD MBBS
• Phone: (352) 376-1611
• Email: ashutosh.shukla[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 544
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• End Stage Renal Disease
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic
• Peritoneal Dialysis
• Renal Insufficiency, Chronic

Intervention

Other:
• Comprehensive Pre-ESRD Patient Education (CPE)
Structured education session/s
• Provision of the freely available resources for Kidney Disease Education
freely available resources

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System, Gainesville, FL	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Home Dialysis selection	post-CPE/EUC dialysis modality selection and examining the rates of home dialysis selection. post-CPE assessments will be made when subject is deemed confident in dialysis selection (see selection outcome). Post-EUC assessments will be made 10 days after the provision of the education material.	0-4 weeks
Secondary	Kidney Disease Knowledge	pre- and post- kidney disease knowledge assessments after CPE/EUC. post-CPE assessments will be made when subject is deemed confident in dialysis selection (see selection outcome). Post-EUC assessments will be made 10 days after the provision of the education material.	0-4 weeks
Secondary	confidence in dialysis decision making	post-CPE/EUC confidence in dialysis decision making. ). Intent-to-Teach will be assessed by confidence for dialysis decision making (defined by confidence rating of "quite confident" or "very confident"); those with suboptimal scores ("not at all confident" or "a little confident") or "uncertain of the dialysis modality choice," will undergo repeat CPE sessions weekly for up to 3 sessions. Based on our pilot studies showing the need for about 1.7 CPE session, the investigators expect that patients enrolled in CPE group will do post-CPE Aim 1 data collection (secondary outcome) at an average of 10 days	0-4 weeks
Secondary	post-ESRD Kidney Disease Quality of life-36	post CPE/EUC. This will only be measured in subjects that start dialysis therapy, 90 days post initiation of dialysis.	3-48 months
Secondary	Satisfaction on Dialysis	post CPE/EUC. This will only be measured in subjects that start dialysis therapy, 90 days post initiation of dialysis.	3-48 months