Transforming Hemodialysis-Related Vascular Access Education

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Pennsylvania
Study ID
NCT05997875
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 5, 2023
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Education
  • Experimental: Education-Plus
  • Other: Usual Care

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

Locations (3)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21218
Deidra Crews, MD, ScM
[email protected]
410-502-0518
Deidra Crews, MD, ScM (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Jennifer E. Flythe, MD, MPH
Jennifer E. Flythe, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19106
Laura Dember, MD
[email protected]
2155735264
Leah Bernardo, BA
[email protected]
2157464755
Laura M. Dember, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
Johns Hopkins University· Baltimore, MDUniversity of North Carolina at Chapel Hill· Chapel Hill, NCUniversity of Pennsylvania· Philadelphia, PA

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