Clinical trial NCT04032613: Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation
Official title: Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: Hemodialysis
Vascular access
Arteriovenous
Dialysis
End Stage Renal Disease
Patient-reported outcomes
Feasibility
Care process
Patient education
Health system navigation
Chronic kidney disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Geisinger Clinic
name: Duke University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-07-25
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study uses a pre-intervention / post-intervention design to assess outcomes. The study measures the pre-intervention to post-intervention changes in participant: 1) vascular access knowledge, and 2) confidence in navigating dialysis vascular access care process steps.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


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

Primary outcomes:
measure: Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation
timeFrame: Pre- and post-intervention, a total of up to 7 months
measure: Mean Scores of a Questionnaire Evaluating Patient Confidence in Self-managing Kidney Disease Pre- to Post-program Implementation
timeFrame: Pre- and post-intervention, a total of up to 7 months
measure: Mean Scores of a Questionnaire Evaluating Patient Vascular Access Knowledge Pre- to Post-program Implementation
timeFrame: Pre- and post-intervention, a total of up to 7 months
measure: Mean Scores of a Questionnaire Evaluating Provider Confidence Supporting Patients Through the Vascular Access Care Process Pre- to Post-program Implementation
timeFrame: Pre- and post-intervention, a total of up to 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Danville Nephrology Clinic
state: Pennsylvania
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jennifer Flythe, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Geisinger Clinic
name: Jamie Green, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Ebony Boulware, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flythe JE, Narendra JH, Yule C, Manivannan S, Murphy S, Lee SD, Strigo TS, Peskoe S, Pendergast JF, Boulware LE, Green JA. Targeting Patient and Health System Barriers To Improve Rates of Hemodialysis Initiation with an Arteriovenous Access. Kidney360. 2021 Feb 26;2(4):708-720. doi: 10.34067/KID.0007812020. eCollection 2021 Apr 29.