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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Chronic Kidney Disease Requiring Chronic Dialysis

• Registration Number: NCT04032613
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-25
• Study Start: 2019-07-30
• Primary Completion: 2020-04-30
• Study Completion: 2020-06-22
• Status Verified: 2020-08
• Results First Submitted: 2020-11-20
• Results First Submitted QC: 2020-11-20
• Results First Posted: 2020-12-17
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation	Pre- and post-intervention, a total of up to 7 months	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	Pre- and post-intervention, a total of up to 7 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: 8-40). 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	Pre- and post-intervention, a total of up to 7 months	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	Pre- and post-intervention, a total of up to 7 months	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.

Trial Locations

Locations (1)

Geisinger Danville Nephrology Clinic; 🇺🇸 Danville, Pennsylvania, United States