Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT05997875

Conditions

Chronic Kidney Disease

Hemodialysis Vascular Access

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Educational Materials

Motivational Interviewing

Usual Care

Patient Lists for Clinicians: System-Level Intervention

Study Details

Brief 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

Study ID

NCT05997875

Start date

Dec 5, 2023

Status verified date

Mar, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 years or older
2. Nephrology visit for chronic kidney disease during the last 18 months
3. Most recent eGFR less than or equal to 20 ml/min/1.73 m2 or 2-year Kidney Failure Risk Equation score greater than 40%
4. Documentation in the medical record or confirmation from the treating nephrologist of a patient-nephrologist discussion about hemodialysis

Exclusion Criteria:

1. Planning for peritoneal dialysis, preemptive transplant, or conservative management of kidney failure
2. Previous placement of an AV access
3. Prior appointment with surgeon for AV access evaluation or creation
4. Cognitive dysfunction or severe visual impairment that prevents use of the education materials
5. Does not speak either English or Spanish

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Education

experimental: Education-Plus

other: Usual Care

Interventions

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.

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.

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.

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.

Primary outcome measure

  • Surgery for Creation of Hemodialysis Arteriovenous Access (Effectiveness outcome) [ Time Frame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first ]

Central Contacts and Locations

Central contacts

Leah Bernardo

+1 215-746-4755lleah@pennmedicine.upenn.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Deidra Crews, MD, ScM

410-502-0518Dcrews1@jhmi.edu

Principal Investigator:

Deidra Crews, MD, ScM

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Principal Investigator:

Jennifer E. Flythe, MD, MPH

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19106

Contacts

Laura Dember, MD

2155735264ldember@pennmedicine.upenn.edu

Leah Bernardo, BA

2157464755lleah@pennmedicine.upenn.edu

Principal Investigator:

Laura M. Dember, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-03-25.