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

NCT ID: NCT04032613

Last Updated: 2021-01-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-30

Study Completion Date

2020-06-22

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease Chronic Kidney Disease Requiring Chronic Dialysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Vascular access quality improvement program participants

All participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program.

Group Type EXPERIMENTAL

Vascular Access Navigation and Education Quality Improvement Program

Intervention Type OTHER

A Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic. Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program.

Interventions

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Vascular Access Navigation and Education Quality Improvement Program

A Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic. Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Geisinger Clinic

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Flythe, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Jamie Green, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Ebony Boulware, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Geisinger Danville Nephrology Clinic

Danville, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35373037 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1R21DK116115

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-1912

Identifier Type: -

Identifier Source: org_study_id

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