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

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ClinicalTrials.gov Identifier: NCT04032613
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
Geisinger Clinic
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Chronic Kidney Disease Requiring Chronic Dialysis Other: Vascular Access Navigation and Education Quality Improvement Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation: a Pilot Study
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: 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.




Primary Outcome Measures :
  1. Mean change in scores of a questionnaire evaluating patient confidence in navigating vascular access care pre- to post-program implementation [ Time Frame: Pre- and post-intervention, a total of up to 6 months ]
    Patient confidence in ability to navigate the vascular access creation process. Measured using 3 team-developed confidence questions (score range: 1 (low confidence) - 10 (high confidence)).

  2. Mean change in scores of a questionnaire evaluating patient confidence in self-managing kidney disease pre- to post-program implementation [ Time Frame: Pre- and post-intervention, a total of up to 6 months ]
    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 (low confidence) - 40 (high confidence)).

  3. Mean change in scores of a questionnaire evaluating patient vascular access knowledge pre- to post-program implementation [ Time Frame: Pre- and post-intervention, a total of up to 6 months ]
    Patient vascular access care knowledge. Measured using 8 team-developed knowledge questions (score range: 0 (low knowledge) - 10 (advanced knowledge)).

  4. Mean change in scores of a questionnaire evaluating provider confidence supporting patients through the vascular access care process pre- to post-program implementation [ Time Frame: Pre- and post-intervention, a total of up to 6 months ]
    Provider confidence in ability to help patients navigate the vascular access creation process. Measured using 11 team-developed confidence questions (score range: 1 (low confidence) - 10 (high confidence)).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients:

  • Receive care at the Geisinger Danville Nephrology Clinic
  • Age ≥ 18 years
  • eGFR ≤ 20 mL/min/1.73m, 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032613


Contacts
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Contact: Jennifer Flythe, MD, MPH 919-445-2656 jflythe@med.unc.edu
Contact: Julia Narendra, MPH 919-445-2686 julia_narendra@med.unc.edu

Locations
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United States, Pennsylvania
Geisinger Danville Nephrology Clinic Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Jamie Green, MD, MS    570-214-8688    jgreen1@geisinger.edu   
Contact: Christina Yule, BS    570-214-5233    cmyule@geisinger.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Geisinger Clinic
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Jennifer Flythe, MD, MPH University of North Carolina, Chapel Hill
Principal Investigator: Jamie Green, MD, MS Geisinger Clinic
Principal Investigator: Ebony Boulware, MD, MPH Duke University

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04032613     History of Changes
Other Study ID Numbers: 18-1912
1R21DK116115 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Starting 6 months after publication, pending data use agreement modifications.
Access Criteria: Principal Investigators will review all requests for data, per data use agreement modifications.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
End Stage Renal Disease
Chronic kidney disease
Hemodialysis
Vascular access
Arteriovenous
Dialysis
Patient-reported outcomes
Feasibility
Care process
Patient education
Health system navigation
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency