NCT05997875

Transforming Hemodialysis-Related Vascular Access Education

Transforming Hemodialysis-Related Vascular Access Education (THRiVE)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The focus of this study is on vascular access for hemodialysis. This is a randomized clinical trial testing 3 educational approaches to help patients with advanced chronic kidney disease prepare for placement of hemodialysis vascular access. Study participants will each be assigned to one of the 3 approaches: 1) "Education", in which participants will be given a video and brochure that provide information about the types of vascular access and what can be expected before and after the vascular access is placed, 2) "Education-Plus", in which participants will be given the video and brochure and will also have sessions by telehealth with a motivational interviewing coach to provide additional support around vascular access placement, and 3) "Usual Care", in which participants will have the usual education provided by their kidney doctor and clinic staff just as if they were not in the study. Participants in all 3 groups will be asked to complete questionnaires by telephone and may be invited to be interviewed about their experience with the study intervention at the end of the study. Study participation will last for about 12 months, with most of the study activities taking place during the first 3 months.

Conditions

• Chronic Kidney Disease
• Hemodialysis Vascular Access

Interventions

Type	Name	Description
BEHAVIORAL	Educational Materials	Participants are provided with the "Getting Ready: Your Vascular Access Journey" video and brochure about hemodialysis vascular access. The video is available for viewing via smartphone or computer. Both the brochure and video were created with input from patients with chronic kidney disease.
BEHAVIORAL	Motivational Interviewing	Participants receive coaching with telehealth-based motivational interviewing designed to prepare participants to move forward with vascular access creation. Motivational interviewing will consist of a minimum of 3 and maximum of 8 telehealth sessions with a coach. The coach will use patient-centered communication skills to work though the stages of pre-contemplative, contemplative, preparation, action, and maintenance of an arteriovenous vascular access.
BEHAVIORAL	Usual Care	Participants receive the non-standardized vascular access counseling and referral to the chronic kidney disease education class that comprises the standard care provided by their nephrology clinic.
OTHER	Patient Lists for Clinicians: System-Level Intervention	Nephrologists and clinic staff receive monthly, provider-specific, lists of patients potentially appropriate for AV access planning based on eGFR thresholds and kidney failure risk. These criteria identify patients at risk for progression to dialysis and are congruent with evidence-based guidelines for optimal timing of AV access evaluation referral.

Timeline

• Start date: 2023-12-05
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2023-08-18
• Last updated: 2026-03-25

Locations

3 sites across 1 country: United States