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

Primary Purpose

Chronic Kidney Disease, Chronic Kidney Disease Requiring Chronic Dialysis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vascular Access Navigation and Education Quality Improvement Program
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Disease focused on measuring Hemodialysis, Vascular access, Arteriovenous, Dialysis, End Stage Renal Disease, Patient-reported outcomes, Feasibility, Care process, Patient education, Health system navigation, Chronic kidney disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geisinger Danville Nephrology Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vascular access quality improvement program participants

Arm Description

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

Outcomes

Primary Outcome Measures

Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation
Patient confidence in ability to navigate the vascular access creation process. Measured using 3 team-developed confidence questions (score range: 1-10). Higher scores reflect higher confidence in navigating vascular access care.
Mean Scores of a Questionnaire Evaluating Patient Confidence in Self-managing Kidney Disease Pre- to Post-program Implementation
Patient confidence in ability to self-manage kidney disease. Measured using a modified version of the 8-item Perceived Kidney Disease Self-Management Scale (score range: 8-40). Higher scores reflect higher confidence in self-management of patient's kidney disease.
Mean Scores of a Questionnaire Evaluating Patient Vascular Access Knowledge Pre- to Post-program Implementation
Patient vascular access care knowledge. Measured using 8 team-developed knowledge questions (score range: 0-10). Higher scores reflect higher knowledge of vascular access.
Mean Scores of a Questionnaire Evaluating Provider Confidence Supporting Patients Through the Vascular Access Care Process Pre- to Post-program Implementation
Provider confidence in ability to help patients navigate the vascular access creation process. Measured using 11 team-developed confidence questions (score range: 1-10). Higher scores reflect higher confidence supporting patients through the vascular access care process.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2019
Last Updated
January 11, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Geisinger Clinic, Duke University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04032613
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
June 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Geisinger Clinic, Duke University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vascular access quality improvement program participants
Arm Type
Experimental
Arm Description
All participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program.
Intervention Type
Other
Intervention Name(s)
Vascular Access Navigation and Education Quality Improvement Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation
Description
Patient confidence in ability to navigate the vascular access creation process. Measured using 3 team-developed confidence questions (score range: 1-10). Higher scores reflect higher confidence in navigating vascular access care.
Time Frame
Pre- and post-intervention, a total of up to 7 months
Title
Mean Scores of a Questionnaire Evaluating Patient Confidence in Self-managing Kidney Disease Pre- to Post-program Implementation
Description
Patient confidence in ability to self-manage kidney disease. Measured using a modified version of the 8-item Perceived Kidney Disease Self-Management Scale (score range: 8-40). Higher scores reflect higher confidence in self-management of patient's kidney disease.
Time Frame
Pre- and post-intervention, a total of up to 7 months
Title
Mean Scores of a Questionnaire Evaluating Patient Vascular Access Knowledge Pre- to Post-program Implementation
Description
Patient vascular access care knowledge. Measured using 8 team-developed knowledge questions (score range: 0-10). Higher scores reflect higher knowledge of vascular access.
Time Frame
Pre- and post-intervention, a total of up to 7 months
Title
Mean Scores of a Questionnaire Evaluating Provider Confidence Supporting Patients Through the Vascular Access Care Process Pre- to Post-program Implementation
Description
Provider confidence in ability to help patients navigate the vascular access creation process. Measured using 11 team-developed confidence questions (score range: 1-10). Higher scores reflect higher confidence supporting patients through the vascular access care process.
Time Frame
Pre- and post-intervention, a total of up to 7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Flythe, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jamie Green, MD, MS
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ebony Boulware, MD, MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Danville Nephrology Clinic
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data generated in this study are protected under data use agreements among Geisinger, Duke University, and the University of North Carolina at Chapel Hill. We cannot directly share the source data without written approval from these institutions. If scientists are interested in accessing de-identified study data, we will work with all institutions to obtain the necessary data use agreement modifications.
IPD Sharing Time Frame
Starting 6 months after publication, pending data use agreement modifications.
IPD Sharing Access Criteria
Principal Investigators will review all requests for data, per data use agreement modifications.
Citations:
PubMed Identifier
35373037
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.
Results Reference
derived

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

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