Chronic Kidney DiseaseNCT04032613

Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation

A study testing Vascular Access Navigation and Education Quality Improvement Program in people with Chronic Kidney Disease and Chronic Kidney Disease Requiring Chronic Dialysis, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease, Chronic Kidney Disease Requiring Chronic Dialysis
What is being tested?: Vascular Access Navigation and Education Quality Improvement Program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteUnited States
Study dates: 30 Jul 2019to 22 Jun 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients:
Receive care at the Geisinger Danville Nephrology Clinic
Age ≥ 18 years
eGFR ≤ 25 mL/min/1.73 m and 2-year kidney failure risk score >10% based on kidney failure risk equation, or nephrologist recommendation for vascular access
Participation in the Vascular Access Navigation and Education Quality Improvement Program
Providers: Professional involved in dialysis vascular access care (e.g., nephrologist, surgeon, kidney disease clinic nurse, etc.) at Geisinger in Danville, PA

Who cannot join

Patients:
Too far into the vascular access creation process to benefit from the intervention (e.g. completed vascular access surgery appointment or has a surgery appointment scheduled within the next 4 weeks),
Inability to consent, or
Inability to complete interviews in English
Providers: None

Trial locations and contacts

1 site in 1 country.

United States1 site

Geisinger Danville Nephrology Clinic
Danville, Pennsylvania, 17822

Other trials in United States

About this study

Official title: Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation: a Pilot Study

More than 80% of individuals in the U.S. start maintenance hemodialysis (HD) with a central venous catheter, despite substantial evidence that starting HD with an arteriovenous (AV) access improves quality of life, lowers mortality, and decreases healthcare costs. Health system- and patient-level barriers contribute to low rates of AV access creation prior to HD initiation. Evidence-based, pre-dialysis interventions to improve these low rates and associated clinical outcomes are lacking.

A Vascular Access Navigation and Education Quality Improvement Program will be implemented in the Geisinger Danville, PA chronic kidney disease clinic. Individuals who choose to participate in a research sub-study of the program will complete questionnaires to assess their vascular access care knowledge and confidence before and after participation in the quality improvement program.

Conditions: Chronic Kidney Disease, Chronic Kidney Disease Requiring Chronic Dialysis
Being tested: Vascular Access Navigation and Education Quality Improvement Program
Keywords: Hemodialysis, Vascular access, Arteriovenous, Dialysis, End Stage Renal Disease, Patient-reported outcomes, Feasibility, Care process, Patient education, Health system navigation, Chronic kidney disease
Medical subject headings: Renal Insufficiency, Chronic, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vascular Access Navigation and Education Quality Improvement ProgramOther
A Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic. Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program.

Study groups in NCT04032613
Study group	Role	What they receive
Vascular access quality improvement program participants	Experimental	All participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program. Receives: Other: Vascular Access Navigation and Education Quality Improvement Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation
Patient confidence in ability to navigate the vascular access creation process. Measured using 3 team-developed confidence questions (score range: 1-10). Higher scores reflect higher confidence in navigating vascular access care.
Measured: Pre- and post-intervention, a total of up to 7 months
Mean Scores of a Questionnaire Evaluating Patient Confidence in Self-managing Kidney Disease Pre- to Post-program Implementation
Patient confidence in ability to self-manage kidney disease. Measured using a modified version of the 8-item Perceived Kidney Disease Self-Management Scale (score range: 8-40). Higher scores reflect higher confidence in self-management of patient's kidney disease.
Measured: Pre- and post-intervention, a total of up to 7 months
Mean Scores of a Questionnaire Evaluating Patient Vascular Access Knowledge Pre- to Post-program Implementation
Patient vascular access care knowledge. Measured using 8 team-developed knowledge questions (score range: 0-10). Higher scores reflect higher knowledge of vascular access.
Measured: Pre- and post-intervention, a total of up to 7 months
Mean Scores of a Questionnaire Evaluating Provider Confidence Supporting Patients Through the Vascular Access Care Process Pre- to Post-program Implementation
Provider confidence in ability to help patients navigate the vascular access creation process. Measured using 11 team-developed confidence questions (score range: 1-10). Higher scores reflect higher confidence supporting patients through the vascular access care process.
Measured: Pre- and post-intervention, a total of up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 201922 Jun 2020

First posted25 Jul 2019
Study start30 Jul 2019
Primary completion30 Apr 2020
Study completion22 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Model description: This study uses a pre-intervention / post-intervention design to assess outcomes. The study measures the pre-intervention to post-intervention changes in participant: 1) vascular access knowledge, and 2) confidence in navigating dialysis vascular access care process steps.
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04032613
Sponsor's protocol ID: 18-1912
Other IDs: 1R21DK116115
Status last verified: Aug 2020
First submitted: 26 Jun 2019
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data generated in this study are protected under data use agreements among Geisinger, Duke University, and the University of North Carolina at Chapel Hill. We cannot directly share the source data without written approval from these institutions. If scientists are interested in accessing de-identified study data, we will work with all institutions to obtain the necessary data use agreement modifications.

Publications

Flythe JE, Narendra JH, Yule C, Manivannan S, Murphy S, Lee SD, Strigo TS, Peskoe S, Pendergast JF, Boulware LE, Green JA. Targeting Patient and Health System Barriers To Improve Rates of Hemodialysis Initiation with an Arteriovenous Access. Kidney360. 2021 Feb 26;2(4):708-720. doi: 10.34067/KID.0007812020. eCollection 2021 Apr 29.
PubMed 35373037

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation: a Pilot Study
ClinicalTrials.gov ID: NCT04032613
Acronym / sponsor ID: 18-1912
Conditions: Chronic Kidney Disease, Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: Hemodialysis, Vascular access, Arteriovenous, Dialysis, End Stage Renal Disease, Patient-reported outcomes, Feasibility, Care process
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: Geisinger Clinic, Duke University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 30 Jul 2019 (actual)
Primary completion: 30 Apr 2020 (actual)
Study completion: 22 Jun 2020 (actual)
First posted: 25 Jul 2019 (actual)
Results: Posted 17 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This study uses a pre-intervention / post-intervention design to assess outcomes. The study measures the pre-intervention to post-intervention changes in participant: 1) vascular access knowledge, and 2) confidence in navigating dialysis vascular access care process steps.

Arm	Type	Receives
Vascular access quality improvement program participants	Experimental	Other: Vascular Access Navigation and Education Quality Improvement ProgramAll participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Receive care at the Geisinger Danville Nephrology Clinic
Age ≥ 18 years
eGFR ≤ 25 mL/min/1.73 m and 2-year kidney failure risk score >10% based on kidney failure risk equation, or nephrologist recommendation for vascular access
Participation in the Vascular Access Navigation and Education Quality Improvement Program
Providers: Professional involved in dialysis vascular access care (e.g., nephrologist, surgeon, kidney disease clinic nurse, etc.) at Geisinger in Danville, PA

Key exclusion criteria (5 listed)

Too far into the vascular access creation process to benefit from the intervention (e.g. completed vascular access surgery appointment or has a surgery appointment scheduled within the next 4 weeks),
Inability to consent, or
Inability to complete interviews in English
Providers: None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vascular Access Navigation and Education Quality Improvement ProgramA Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic. Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program.	Other	Vascular access quality improvement program participants

Primary outcome

Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation
Time frame: Pre- and post-intervention, a total of up to 7 months
Patient confidence in ability to navigate the vascular access creation process. Measured using 3 team-developed confidence questions (score range: 1-10). Higher scores reflect higher confidence in navigating vascular access care.
Mean Scores of a Questionnaire Evaluating Patient Confidence in Self-managing Kidney Disease Pre- to Post-program Implementation
Time frame: Pre- and post-intervention, a total of up to 7 months
Patient confidence in ability to self-manage kidney disease. Measured using a modified version of the 8-item Perceived Kidney Disease Self-Management Scale (score range: 8-40). Higher scores reflect higher confidence in self-management of patient's kidney disease.
Mean Scores of a Questionnaire Evaluating Patient Vascular Access Knowledge Pre- to Post-program Implementation
Time frame: Pre- and post-intervention, a total of up to 7 months
Patient vascular access care knowledge. Measured using 8 team-developed knowledge questions (score range: 0-10). Higher scores reflect higher knowledge of vascular access.
Mean Scores of a Questionnaire Evaluating Provider Confidence Supporting Patients Through the Vascular Access Care Process Pre- to Post-program Implementation
Time frame: Pre- and post-intervention, a total of up to 7 months
Provider confidence in ability to help patients navigate the vascular access creation process. Measured using 11 team-developed confidence questions (score range: 1-10). Higher scores reflect higher confidence supporting patients through the vascular access care process.

Results and safety

Results posted to the registry on 17 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vascular Access QI Program Patient Participants	21	16
Vascular Access QI Program Provider/Personnel Participants	25	23

Primary outcome: Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation

Time frame: Pre- and post-intervention, a total of up to 7 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Vascular Access QI Program Patient Participants n = 16
Pre-program score mean	8.0 (1.3)
Post-program score mean	8.7 (1.3)

Vascular Access QI Program Patient Participants: p = 0.20, Paired sample t-test

Population analysed: All Vascular Access QI program patient participants enrolled in the study who completed both the pre- and post-program evaluation questionnaires.

Primary outcome: Mean Scores of a Questionnaire Evaluating Patient Confidence in Self-managing Kidney Disease Pre- to Post-program Implementation

Time frame: Pre- and post-intervention, a total of up to 7 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Vascular Access QI Program Patient Participants n = 16
Pre-program score mean	28.1 (4.1)
Post-program score mean	30.8 (5.3)

Vascular Access QI Program Patient Participants: p = 0.05, Paired sample t-test

Population analysed: All Vascular Access QI program patient participants enrolled in the study who completed both the pre- and post-program evaluation questionnaires.

Primary outcome: Mean Scores of a Questionnaire Evaluating Patient Vascular Access Knowledge Pre- to Post-program Implementation

Time frame: Pre- and post-intervention, a total of up to 7 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Vascular Access QI Program Patient Participants n = 16
Pre-program score mean	4.9 (2.8)
Post-program score mean	6.9 (1.9)

Vascular Access QI Program Patient Participants: p = 0.004, Paired sample t-test

Population analysed: All Vascular Access QI program patient participants enrolled in the study who completed both the pre- and post-program evaluation questionnaires.

Primary outcome: Mean Scores of a Questionnaire Evaluating Provider Confidence Supporting Patients Through the Vascular Access Care Process Pre- to Post-program Implementation

Time frame: Pre- and post-intervention, a total of up to 7 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Vascular Access QI Program Provider/Personnel Participants n = 23
Pre-program score mean	7.5 (0.9)
Post-program score mean	7.8 (0.8)

Vascular Access QI Program Provider/Personnel Participants: p = 0.14, Paired sample t-test

Population analysed: All Vascular Access QI program provider \& personnel participants enrolled in the study who completed both the pre- and post-program evaluation questionnaires.

Adverse events

Time frame: From the time informed consent is obtained to study participation end, an approximate total of 7 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vascular Access QI Program Patient Participants	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Vascular Access QI Program Provider/Personnel Participants	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35373037Flythe JE, Narendra JH, Yule C, Manivannan S, Murphy S, Lee SD, Strigo TS, Peskoe S, Pendergast JF, Boulware LE, Green JA. Targeting Patient and Health System Barriers To Improve Rates of Hemodialysis Initiation with an Arteriovenous Access. Kidney360. 2021 Feb 26;2(4):708-720. doi: 10.34067/KID.0007812020. eCollection 2021 Apr 29.
Individual participant dataSharing planned: Yes. The data generated in this study are protected under data use agreements among Geisinger, Duke University, and the University of North Carolina at Chapel Hill. We cannot directly share the source data without written approval from these institutions. If scientists are interested in accessing de-identified study data, we will work with all institutions to obtain the necessary data use agreement modifications.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Flythe, MD, MPH principal investigator

University of North Carolina, Chapel Hill

Jamie Green, MD, MS principal investigator

Geisinger Clinic

Ebony Boulware, MD, MPH principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation (time frame: Pre- and post-intervention, a total of up to 7 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04032613, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.