Clinical trial NCT05997875: Transforming Hemodialysis-Related Vascular Access Education
Official title: Transforming Hemodialysis-Related Vascular Access Education (THRiVE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease
Hemodialysis Vascular Access
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Johns Hopkins University
First posted: 2023-08-18
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Surgery for Creation of Hemodialysis Arteriovenous Access (Effectiveness outcome)
timeFrame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
Secondary outcomes:
measure: Scheduled Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)
timeFrame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
measure: Completed Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)
timeFrame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
measure: Imaging for Planning Arteriovenous Vascular Access Creation (Effectiveness outcome)
timeFrame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
measure: Usable Arteriovenous Vascular Access (Effectiveness outcome)
timeFrame: Up to 4 years after randomization (full duration of the trial)
measure: Vascular Access Knowledge (Effectiveness outcome)
timeFrame: 12 weeks after randomization
measure: Decision Self-Efficacy (Effectiveness outcome)
timeFrame: 12 weeks after randomization
measure: Preparedness for Decision-Making (Effectiveness outcome)
timeFrame: 12 weeks after randomization
measure: Characteristics of Eligible Patients - quantitative reach assessment (Implementation outcome)
timeFrame: Pre-Enrollment
measure: Characteristics of Enrolled Participants - quantitative reach assessment (Implementation outcome)
timeFrame: Baseline
measure: Characteristics of Participants who Complete the Trial - quantitative reach assessment (Implementation outcome)
timeFrame: 12 months
measure: Characteristics of Participants who Withdraw from the Trial - quantitative reach assessment (Implementation outcome)
timeFrame: From eligibility until 12 months
measure: Declined Enrollment - quantitative reach assessment (Implementation outcome)
timeFrame: Pre-enrollment
measure: Reasons for Participation - qualitative reach assessment (Implementation outcome)
timeFrame: 12-16 weeks after randomization
measure: Reasons Nephrologists Opt-Out on Behalf of Patients - qualitative reach assessment (Implementation outcome)
timeFrame: Up to 4 years after trial initiation (full duration of the trial)
measure: Acceptability Intervention Measure - quantitative acceptability assessment (Implementation outcome)
timeFrame: 12 -16 weeks after randomization
measure: Acceptability of Intervention Content, Delivery, and Accessibility - qualitative acceptability assessment (Implementation outcome)
timeFrame: 12 to 16 weeks after randomization
measure: Chronic Kidney Disease Class Attendance - quantitative fidelity assessment (Implementation outcome)
timeFrame: Within 12 months
measure: Receipt of Educational Materials - quantitative fidelity assessment (Implementation outcome)
timeFrame: Within 12 weeks after randomization
measure: Viewing of Video - quantitative fidelity assessment (Implementation outcome)
timeFrame: Within 12 weeks after randomization
measure: Completed Motivational Interviewing Sessions - quantitative fidelity assessment (Implementation outcome)
timeFrame: Within 12 months after randomization
measure: Brochure Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)
timeFrame: Within 12 weeks after randomization
measure: Video Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)
timeFrame: Within 12 weeks after randomization
measure: Participant Contact Attempts for Motivational Interviewing - quantitative barriers/facilitators assessment (Implementation outcome)
timeFrame: 12 month period after randomization
measure: Missed Motivational Interviewing Sessions - quantitative barriers/facilitators assessment (Implementation outcome)
timeFrame: 12 month period after randomization
measure: System-Level Barriers to Arteriovenous Access Creation From Clinical Staff Perspective - qualitative implementation/barriers assessment (Implementation outcome)
timeFrame: Up to 4 years after trial initiation (full duration of the trial)
measure: System-Level Barriers to Arteriovenous Access Creation From Participant Perspective - qualitative implementation/barriers assessment (Implementation outcome)
timeFrame: Within 12 months
Other outcomes:
measure: Creation of Arteriovenous Vascular Access Without Subsequent Need for Hemodialysis
timeFrame: Up to 4 years after randomization (full duration of the trial)
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Laura M. Dember, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Jennifer E. Flythe, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Deidra Crews, MD, ScM
role: PRINCIPAL_INVESTIGATOR
References: