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Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Chronic Kidney Disease
Chronic Kidney Disease Requiring Chronic Dialysis

Treatments

Other: Vascular Access Navigation and Education Quality Improvement Program

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04032613
1R21DK116115 (U.S. NIH Grant/Contract)
18-1912

Details and patient eligibility

About

More than 80% of individuals in the U.S. start maintenance hemodialysis (HD) with a central venous catheter, despite substantial evidence that starting HD with an arteriovenous (AV) access improves quality of life, lowers mortality, and decreases healthcare costs. Health system- and patient-level barriers contribute to low rates of AV access creation prior to HD initiation. Evidence-based, pre-dialysis interventions to improve these low rates and associated clinical outcomes are lacking.

A Vascular Access Navigation and Education Quality Improvement Program will be implemented in the Geisinger Danville, PA chronic kidney disease clinic. Individuals who choose to participate in a research sub-study of the program will complete questionnaires to assess their vascular access care knowledge and confidence before and after participation in the quality improvement program.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients:

  • Receive care at the Geisinger Danville Nephrology Clinic
  • Age ≥ 18 years
  • eGFR ≤ 25 mL/min/1.73 m and 2-year kidney failure risk score >10% based on kidney failure risk equation, or nephrologist recommendation for vascular access
  • Participation in the Vascular Access Navigation and Education Quality Improvement Program

Providers: Professional involved in dialysis vascular access care (e.g., nephrologist, surgeon, kidney disease clinic nurse, etc.) at Geisinger in Danville, PA

Exclusion Criteria

Patients:

  • Too far into the vascular access creation process to benefit from the intervention (e.g. completed vascular access surgery appointment or has a surgery appointment scheduled within the next 4 weeks),
  • Inability to consent, or
  • Inability to complete interviews in English

Providers: None

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

46 participants in 1 patient group

Vascular access quality improvement program participants
Experimental group
Description:
All participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program.
Treatment:
Other: Vascular Access Navigation and Education Quality Improvement Program

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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