Transforming Hemodialysis-Related Vascular Access Education (THRiVE)

University of Pennsylvania

Status: Enrolling

Conditions: Hemodialysis Vascular Access; Chronic Kidney Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05997875

853978

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 3 patient groups

Education

Experimental group

Treatment:

Behavioral: Educational Materials

Other: Patient Lists for Clinicians: System-Level Intervention

Behavioral: Usual Care

Education-Plus

Experimental group

Treatment:

Behavioral: Educational Materials

Other: Patient Lists for Clinicians: System-Level Intervention

Behavioral: Motivational Interviewing

Behavioral: Usual Care

Usual Care

Other group

Treatment:

Other: Patient Lists for Clinicians: System-Level Intervention

Behavioral: Usual Care