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

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT04032613
• Collaborator: Geisinger Clinic (Other), Duke University (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 46
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease; Chronic Kidney Disease Requiring Chronic Dialysis	Other: Vascular Access Navigation and Education Quality Improvement Program	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.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)
• Primary Purpose: Health Services Research
• Official Title: Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation: a Pilot Study
• Actual Study Start Date: Jul 30, 2019
• Actual Primary Completion Date: Apr 30, 2020
• Actual Study Completion Date: Jun 22, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vascular access quality improvement program participants All participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program.	Other: Vascular Access Navigation and Education Quality Improvement Program; 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.

Outcome Measures

Primary Outcome Measures

1. Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation [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.

2. Mean Scores of a Questionnaire Evaluating Patient Confidence in Self-managing Kidney Disease Pre- to Post-program Implementation [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.

3. Mean Scores of a Questionnaire Evaluating Patient Vascular Access Knowledge Pre- to Post-program Implementation [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.

4. Mean Scores of a Questionnaire Evaluating Provider Confidence Supporting Patients Through the Vascular Access Care Process Pre- to Post-program Implementation [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

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

Exclusion Criteria

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geisinger Danville Nephrology Clinic	Danville	Pennsylvania	United States	17822

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• Geisinger Clinic
• Duke University
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Jennifer Flythe, MD, MPH, University of North Carolina, Chapel Hill
• Principal Investigator: Jamie Green, MD, MS, Geisinger Clinic
• Principal Investigator: Ebony Boulware, MD, MPH, Duke University

Study Documents (Full-Text)

• Study Protocol - Jul 19, 2019
• Statistical Analysis Plan - Jul 19, 2019

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT04032613
• Other Study ID Numbers: 18-1912; 1R21DK116115
• First Posted: Jul 25, 2019
• Last Update Posted: Jan 28, 2021
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of North Carolina, Chapel Hill: Hemodialysis; Vascular access; Arteriovenous; Dialysis; End Stage Renal Disease; Patient-reported outcomes; Feasibility; Care process; Patient education; Health system navigation; Chronic kidney disease
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

Participant Flow

Arm/Group Title	Vascular Access QI Program Patient Participants	Vascular Access QI Program Provider/Personnel Participants
Arm/Group Description	All patient participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement (QI) Program. Vascular Access Navigation and Education Quality Improvement Program: 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.	All provider/personnel participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program. Vascular Access Navigation and Education Quality Improvement Program: 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.
Period Title: Overall Study
STARTED	21	25
COMPLETED	16	23
NOT COMPLETED	5	2

Baseline Characteristics

Arm/Group Title	Vascular Access QI Program Patient Participants	Vascular Access QI Program Provider/Personnel Participants	Total
Arm/Group Description	All patient participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program. Vascular Access Navigation and Education Quality Improvement Program: 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.	All provider/personnel participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program. Vascular Access Navigation and Education Quality Improvement Program: 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.	Total of all reporting groups
Overall Participants	21	25	46
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.6 (15.2)	39.6 (6.9)	50.5 (16.6)
Sex: Female, Male (Count of Participants)
Female	5 23.8%	12 48%	17 37%
Male	16 76.2%	13 52%	29 63%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 4%	1 2.2%
Not Hispanic or Latino	21 100%	24 96%	45 97.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	2 8%	2 4.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	21 100%	22 88%	43 93.5%
More than one race	0 0%	1 4%	1 2.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	21 100%	25 100%	46 100%

Outcome Measures

1. Primary Outcome

Title	Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation
Description	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.
Time Frame	Pre- and post-intervention, a total of up to 7 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Vascular Access QI Program Patient Participants
Arm/Group Description	All patient participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program. Vascular Access Navigation and Education Quality Improvement Program: 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.
Measure Participants	16
Pre-program score mean	8.0 (1.3)
Post-program score mean	8.7 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vascular Access QI Program Patient Participants
	Comments
	Type of Statistical Test	Other
	Comments	Paired sample t-test
Statistical Test of Hypothesis	p-Value	0.20
	Comments	Statistically significant p-value is <0.05
	Method	Paired sample t-test
	Comments

2. Primary Outcome

Title	Mean Scores of a Questionnaire Evaluating Patient Confidence in Self-managing Kidney Disease Pre- to Post-program Implementation
Description	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.
Time Frame	Pre- and post-intervention, a total of up to 7 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Vascular Access QI Program Patient Participants
Arm/Group Description	All patient participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program. Vascular Access Navigation and Education Quality Improvement Program: 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.
Measure Participants	16
Pre-program score mean	28.1 (4.1)
Post-program score mean	30.8 (5.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vascular Access QI Program Patient Participants
	Comments
	Type of Statistical Test	Other
	Comments	Paired sample t-test
Statistical Test of Hypothesis	p-Value	0.05
	Comments	Statistically significant p-value is <0.05
	Method	Paired sample t-test
	Comments

3. Primary Outcome

Title	Mean Scores of a Questionnaire Evaluating Patient Vascular Access Knowledge Pre- to Post-program Implementation
Description	Patient vascular access care knowledge. Measured using 8 team-developed knowledge questions (score range: 0-10). Higher scores reflect higher knowledge of vascular access.
Time Frame	Pre- and post-intervention, a total of up to 7 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Vascular Access QI Program Patient Participants
Arm/Group Description	All patient participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program. Vascular Access Navigation and Education Quality Improvement Program: 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.
Measure Participants	16
Pre-program score mean	4.9 (2.8)
Post-program score mean	6.9 (1.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vascular Access QI Program Patient Participants
	Comments
	Type of Statistical Test	Other
	Comments	Paired sample t-test
Statistical Test of Hypothesis	p-Value	0.004
	Comments	Statistically significant p-value is <0.05
	Method	Paired sample t-test
	Comments

4. Primary Outcome

Title	Mean Scores of a Questionnaire Evaluating Provider Confidence Supporting Patients Through the Vascular Access Care Process Pre- to Post-program Implementation
Description	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.
Time Frame	Pre- and post-intervention, a total of up to 7 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Vascular Access QI Program Provider/Personnel Participants
Arm/Group Description	All provider/personnel participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program. Vascular Access Navigation and Education Quality Improvement Program: 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.
Measure Participants	23
Pre-program score mean	7.5 (0.9)
Post-program score mean	7.8 (0.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vascular Access QI Program Patient Participants
	Comments
	Type of Statistical Test	Other
	Comments	Paired sample t-test
Statistical Test of Hypothesis	p-Value	0.14
	Comments	Statistically significant p-value is <0.05
	Method	Paired sample t-test
	Comments

Adverse Events

Time Frame	From the time informed consent is obtained to study participation end, an approximate total of 7 months.
Arm/Group Title	Vascular Access QI Program Patient Participants		Vascular Access QI Program Provider/Personnel Participants
Arm/Group Description	All patient participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program. Vascular Access Navigation and Education Quality Improvement Program: 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.		All provider/personnel participants enrolled in the study who are involved in the Vascular Access Navigation and Education Quality Improvement Program. Vascular Access Navigation and Education Quality Improvement Program: 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.
All Cause Mortality
	Vascular Access QI Program Patient Participants		Vascular Access QI Program Provider/Personnel Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/25 (0%)
Serious Adverse Events
	Vascular Access QI Program Patient Participants		Vascular Access QI Program Provider/Personnel Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Vascular Access QI Program Patient Participants		Vascular Access QI Program Provider/Personnel Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.