Transforming Hemodialysis-Related Vascular Access Education

Chronic Kidney Disease Clinical Trial

— THRiVE  

Official title:

Transforming Hemodialysis-Related Vascular Access Education (THRiVE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05997875
• Other study ID #: 853978
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: Leah Bernardo
• Phone: +1 215-746-4755
• Email: lleah[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 or scheduled 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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Johns Hopkins University, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Creation of Arteriovenous Vascular Access Without Subsequent Need for Hemodialysis	The creation of an arteriovenous vascular access without a subsequent need for hemodialysis is a potential unintended consequence of interventions.	Up to 4 years after randomization (full duration of the trial)
Primary	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	Scheduled Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)	The proportion of participants with a scheduled appointment with a surgeon for evaluation for vascular access creation.	Within 12 months after randomization or before hemodialysis initiation, whichever comes first
Secondary	Completed Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)	The proportion of participants with a completed appointment with a surgeon for evaluation for vascular access creation.	Within 12 months after randomization or before hemodialysis initiation, whichever comes first
Secondary	Imaging for Planning Arteriovenous Vascular Access Creation (Effectiveness outcome)	The proportion of participants with completed vascular imaging via ultrasound or angiography for planning arteriovenous vascular access creation surgery.	Within 12 months after randomization or before hemodialysis initiation, whichever comes first
Secondary	Usable Arteriovenous Vascular Access (Effectiveness outcome)	For participants who start hemodialysis, the proportion with a usable arteriovenous access at dialysis initiation.	Up to 4 years after randomization (full duration of the trial)
Secondary	Vascular Access Knowledge (Effectiveness outcome)	The change from baseline in vascular access knowledge as measured by the Patient Perceived Vascular Access Knowledge scale. The total score ranges from 0 to 10, with higher scores indicating a higher level of vascular access knowledge.	12 weeks after randomization
Secondary	Decision Self-Efficacy (Effectiveness outcome)	The change from baseline in decision self-efficacy as measured by the Decision Self-Efficacy Scale. The total score ranges from 0 to 11, with higher scores indicating a higher level of self-efficacy when making decisions about hemodialysis vascular access.	12 weeks after randomization
Secondary	Preparedness for Decision-Making (Effectiveness outcome)	A participant's level of preparedness for decision-making as measured by the Preparation for Decision-Making Scale. The total score ranges from 0-100, with higher scores indicating a higher perceived level of preparation for decision-making.	12 weeks after randomization
Secondary	Characteristics of Eligible Patients - quantitative reach assessment (Implementation outcome)	An assessment of the demographic and socioeconomic characteristics of patients who are eligible for the trial.	Pre-Enrollment
Secondary	Characteristics of Enrolled Participants - quantitative reach assessment (Implementation outcome)	An assessment of the demographic and socioeconomic characteristics of patients who enroll in the trial.	Baseline
Secondary	Characteristics of Participants who Complete the Trial - quantitative reach assessment (Implementation outcome)	An assessment of the demographic and socioeconomic characteristics of participants who complete the trial.	12 months
Secondary	Characteristics of Participants who Withdraw from the Trial - quantitative reach assessment (Implementation outcome)	An assessment of the demographic and socioeconomic characteristics of participants who withdraw from the trial.	From eligibility until 12 months
Secondary	Declined Enrollment - quantitative reach assessment (Implementation outcome)	The reasons for declining enrollment as documented in screening logs and provided in aggregate for an enrolling center.	Pre-enrollment
Secondary	Reasons for Participation - qualitative reach assessment (Implementation outcome)	The reasons for participation and non-participation as identified through qualitative interviews	12-16 weeks after randomization
Secondary	Reasons Nephrologists Opt-Out on Behalf of Patients - qualitative reach assessment (Implementation outcome)	The reasons that nephrologists opt out of having an eligible patient approached by the research team for possible enrollment as identified through qualitative interviews.	Up to 4 years after trial initiation (full duration of the trial)
Secondary	Acceptability Intervention Measure - quantitative acceptability assessment (Implementation outcome)	The acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM). The total score ranges from 1-5, with higher scores indicating a higher level of acceptability of the intervention.	12 -16 weeks after randomization
Secondary	Acceptability of Intervention Content, Delivery, and Accessibility - qualitative acceptability assessment (Implementation outcome)	The acceptability of the content, delivery, and accessibility of educational materials and motivational interviewing coaching as identified through qualitative interviews.	12 to 16 weeks after randomization
Secondary	Chronic Kidney Disease Class Attendance - quantitative fidelity assessment (Implementation outcome)	The proportion of participants who attend a Chronic Kidney Disease education class provided by their nephrology clinic	Within 12 months
Secondary	Receipt of Educational Materials - quantitative fidelity assessment (Implementation outcome)	The proportion of participants with confirmed receipt of the "Getting Ready" brochure (only be assessed for the Education and Education-Plus groups)	Within 12 weeks after randomization
Secondary	Viewing of Video - quantitative fidelity assessment (Implementation outcome)	The proportion of participants with confirmed viewing of the "Getting Ready" video, which will only be assessed for the Education and Education-Plus groups.	Within 12 weeks after randomization
Secondary	Completed Motivational Interviewing Sessions - quantitative fidelity assessment (Implementation outcome)	The proportion of participants who completed the scheduled motivational interviewing sessions (only be assessed for the Education-Plus group)	Within 12 months after randomization
Secondary	Brochure Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)	The selected mode for delivery of the "Getting Ready" brochure by center, clinic, and participant sociodemographic characteristics.	Within 12 weeks after randomization
Secondary	Video Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)	The selected mode for viewing of the "Getting Ready" video by center, clinic, and participant sociodemographic characteristics.	Within 12 weeks after randomization
Secondary	Participant Contact Attempts for Motivational Interviewing - quantitative barriers/facilitators assessment (Implementation outcome)	The number and type (email, phone, text messaging) of attempted and confirmed participant contacts by the motivational interviewing coach.	12 month period after randomization
Secondary	Missed Motivational Interviewing Sessions - quantitative barriers/facilitators assessment (Implementation outcome)	The number of missed motivational interviewing sessions.	12 month period after randomization
Secondary	System-Level Barriers to Arteriovenous Access Creation From Clinical Staff Perspective - qualitative implementation/barriers assessment (Implementation outcome)	System-level barriers to arteriovenous vascular access creation and relevant system contextual factors as identified through qualitative interviews.	Up to 4 years after trial initiation (full duration of the trial)
Secondary	System-Level Barriers to Arteriovenous Access Creation From Participant Perspective - qualitative implementation/barriers assessment (Implementation outcome)	System-level barriers to arteriovenous vascular access creation and relevant system contextual factors as identified through qualitative interviews.	Within 12 months