Transforming Hemodialysis-Related Vascular Access Education

Official title

Transforming Hemodialysis-Related Vascular Access Education (THRiVE)

Overview

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.

Interventions

• 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.

Primary outcome measures

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

Secondary outcome measures (12)

• Scheduled Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome) [Time frame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first]
• Completed Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome) [Time frame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first]
• Imaging for Planning Arteriovenous Vascular Access Creation (Effectiveness outcome) [Time frame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first]
• Usable Arteriovenous Vascular Access (Effectiveness outcome) [Time frame: Up to 4 years after randomization (full duration of the trial)]
• Vascular Access Knowledge (Effectiveness outcome) [Time frame: 12 weeks after randomization]
• Decision Self-Efficacy (Effectiveness outcome) [Time frame: 12 weeks after randomization]
• Preparedness for Decision-Making (Effectiveness outcome) [Time frame: 12 weeks after randomization]
• Characteristics of Eligible Patients - quantitative reach assessment (Implementation outcome) [Time frame: Pre-Enrollment]
• Characteristics of Enrolled Participants - quantitative reach assessment (Implementation outcome) [Time frame: Baseline]
• Characteristics of Participants who Complete the Trial - quantitative reach assessment (Implementation outcome) [Time frame: 12 months]
• Characteristics of Participants who Withdraw from the Trial - quantitative reach assessment (Implementation outcome) [Time frame: From eligibility until 12 months]
• Declined Enrollment - quantitative reach assessment (Implementation outcome) [Time frame: Pre-enrollment]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

United States · 3 centers

• Johns Hopkins University — Baltimore
• University of North Carolina at Chapel Hill — Chapel Hill
• University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT05997875 · 853978

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗