Transforming Hemodialysis-Related Vascular Access Education

NCT05997875 | Recruiting DMC

• 1 other identifier: 853978
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Surgery for Creation of Hemodialysis Arteriovenous Access (Effectiveness outcome)

  The proportion of participants who have arteriovenous access creation surgery.

  Within 12 months after randomization or before hemodialysis initiation, whichever comes first

Secondary Outcomes (26)

• Scheduled Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)

  Within 12 months after randomization or before hemodialysis initiation, whichever comes first

• Completed Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)

  Within 12 months after randomization or before hemodialysis initiation, whichever comes first

• Imaging for Planning Arteriovenous Vascular Access Creation (Effectiveness outcome)

  Within 12 months after randomization or before hemodialysis initiation, whichever comes first

• Usable Arteriovenous Vascular Access (Effectiveness outcome)

  Up to 4 years after randomization (full duration of the trial)

• Vascular Access Knowledge (Effectiveness outcome)

  12 weeks after randomization

Other Outcomes (1)

• Creation of Arteriovenous Vascular Access Without Subsequent Need for Hemodialysis

  Up to 4 years after randomization (full duration of the trial)

Study Arms (3)

Education

EXPERIMENTAL

Behavioral: Educational Materials; Behavioral: Usual Care; Other: Patient Lists for Clinicians: System-Level Intervention

Education-Plus

EXPERIMENTAL

Behavioral: Educational Materials; Behavioral: Motivational Interviewing; Behavioral: Usual Care; Other: Patient Lists for Clinicians: System-Level Intervention

Usual Care

OTHER

Behavioral: Usual Care; Other: Patient Lists for Clinicians: System-Level Intervention

Interventions

Educational Materials BEHAVIORAL

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.

Education; Education-Plus

Motivational Interviewing BEHAVIORAL

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.

Education-Plus

Usual Care BEHAVIORAL

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.

Education; Education-Plus; Usual Care

Patient Lists for Clinicians: System-Level Intervention OTHER

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.

Education; Education-Plus; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Nephrology visit for chronic kidney disease during the last 18 months
• 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%
• Documentation in the medical record or confirmation from the treating nephrologist of a patient-nephrologist discussion about hemodialysis

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of North Carolina, Chapel Hill: collaborator
• Johns Hopkins University: collaborator

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19106, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Laura M. Dember, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Jennifer E. Flythe, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Deidra Crews, MD, ScM

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Bernardo

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 18, 2023
• Study Start: December 5, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

US (3)