NCT04032613|CompletedResults
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Sponsor study identifier
Secondary identifiers
NIH
interventional
46
1 country
1
Study Start
July 30, 2019
Actual (reported)Primary Completion
April 30, 2020
Actual (reported)Study Completion
June 22, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 22, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 26, 2019
Actual (reported)July 25, 2019
Actual (reported)July 30, 2019
Actual (reported)April 30, 2020
Actual (reported)June 22, 2020
Actual (reported)December 17, 2020
Actual (reported)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.
Pre- and post-intervention, a total of up to 7 months
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.
Pre- and post-intervention, a total of up to 7 months
All participants enrolled in the study who are involved in the 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Geisinger Danville Nephrology Clinic
Danville, Pennsylvania, 17822, United States
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.
Jennifer Flythe, MD, MPH
University of North Carolina, Chapel Hill
Jamie Green, MD, MS
Geisinger Clinic
Ebony Boulware, MD, MPH
Duke University
46 participants (actual enrollment reported by the registry).
First Submitted
June 26, 2019
First Posted
July 25, 2019
Study Start
Renal Effects of Melatonin Trial in Chronic 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.
Pre- and post-intervention, a total of up to 7 months
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.
Pre- and post-intervention, a total of up to 7 months
Contact the study team to confirm eligibility.
July 30, 2019
Primary Completion
April 30, 2020
Actual (reported)Study Completion
June 22, 2020
Actual (reported)Last Updated
January 28, 2021
Results First Posted
December 17, 2020
Record last verified: 2020-08
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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