N/A
Completed N=46
Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation
Chronic Kidney Disease · Chronic Kidney Disease Requiring Chronic Dialysis
Source: ClinicalTrials.gov NCT04032613 ↗
Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation — 8.0; 8.7 score on a scale — p=0.20
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation |
8.0; 8.7 | 0.20 |
| PRIMARY Mean Scores of a Questionnaire Evaluating Patient Confidence in Self-managing Kidney Disease Pre- to Post-program Implementation |
28.1; 30.8 | 0.05 |
| PRIMARY Mean Scores of a Questionnaire Evaluating Patient Vascular Access Knowledge Pre- to Post-program Implementation |
4.9; 6.9 | 0.004 sig |
| PRIMARY Mean Scores of a Questionnaire Evaluating Provider Confidence Supporting Patients Through the Vascular Access Care Process Pre- to Post-program Implementation |
7.5; 7.8 | 0.14 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04032613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.