RecruitingNot ApplicableNCT05997875

Transforming Hemodialysis-Related Vascular Access Education

Transforming Hemodialysis-Related Vascular Access Education (THRiVE)

Sponsor

University of Pennsylvania

Enrollment

360 participants

Start Date

Dec 5, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease Hemodialysis Vascular Access

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests new educational tools to help people with advanced kidney disease understand their options for dialysis access — specifically, the type of connection surgically created in the arm (called an arteriovenous or AV access) used for hemodialysis. **You may be eligible if...** - You are 18 years or older - You have visited a kidney specialist (nephrologist) for chronic kidney disease in the past 18 months - Your kidney function is very low (eGFR of 20 or below) or your risk of needing dialysis within 2 years is high - Your nephrologist has already spoken with you about hemodialysis as a treatment option - You speak English or Spanish **You may NOT be eligible if...** - You are planning to use peritoneal dialysis, receive a kidney transplant before needing dialysis, or choose comfort care instead - You have already had an AV access created or had a consultation with a surgeon about it - You have significant cognitive difficulties or severe vision problems that prevent you from using educational materials Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEducational 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.

BEHAVIORALMotivational 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.

BEHAVIORALUsual 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.

OTHERPatient 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.