Trial Outcomes & Findings for Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation (NCT NCT04032613)

Last Updated: 2021-01-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

46 participants

Primary outcome timeframe

Pre- and post-intervention, a total of up to 7 months

Results posted on

2021-01-28

Participant Flow

Participant milestones

Participant milestones
Measure	Vascular Access QI Program Patient Participants 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.	Vascular Access QI Program Provider/Personnel Participants 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.
Overall Study STARTED	21	25
Overall Study COMPLETED	16	23
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Vascular Access QI Program Patient Participants 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.	Vascular Access QI Program Provider/Personnel Participants 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.
Overall Study Did not complete post-program assessment	5	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vascular Access QI Program Patient Participants n=21 Participants 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.	Vascular Access QI Program Provider/Personnel Participants n=25 Participants 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 n=46 Participants Total of all reporting groups
Age, Continuous	63.6 years STANDARD_DEVIATION 15.2 • n=5 Participants	39.6 years STANDARD_DEVIATION 6.9 • n=7 Participants	50.5 years STANDARD_DEVIATION 16.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre- and post-intervention, a total of up to 7 months

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

Outcome measures

Outcome measures
Measure	Vascular Access QI Program Patient Participants n=16 Participants 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.
Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation Pre-program score mean	8.0 score on a scale Standard Deviation 1.3
Mean Scores of a Questionnaire Evaluating Patient Confidence in Navigating Vascular Access Care Pre- to Post-program Implementation Post-program score mean	8.7 score on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: Pre- and post-intervention, a total of up to 7 months

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

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.

Outcome measures

Outcome measures
Measure	Vascular Access QI Program Patient Participants n=16 Participants 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.
Mean Scores of a Questionnaire Evaluating Patient Confidence in Self-managing Kidney Disease Pre- to Post-program Implementation Pre-program score mean	28.1 score on a scale Standard Deviation 4.1
Mean Scores of a Questionnaire Evaluating Patient Confidence in Self-managing Kidney Disease Pre- to Post-program Implementation Post-program score mean	30.8 score on a scale Standard Deviation 5.3

PRIMARY outcome

Timeframe: Pre- and post-intervention, a total of up to 7 months

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

Patient vascular access care knowledge. Measured using 8 team-developed knowledge questions (score range: 0-10). Higher scores reflect higher knowledge of vascular access.

Outcome measures

Outcome measures
Measure	Vascular Access QI Program Patient Participants n=16 Participants 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.
Mean Scores of a Questionnaire Evaluating Patient Vascular Access Knowledge Pre- to Post-program Implementation Pre-program score mean	4.9 score on a scale Standard Deviation 2.8
Mean Scores of a Questionnaire Evaluating Patient Vascular Access Knowledge Pre- to Post-program Implementation Post-program score mean	6.9 score on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: Pre- and post-intervention, a total of up to 7 months

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

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.

Outcome measures

Outcome measures
Measure	Vascular Access QI Program Patient Participants n=23 Participants 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.
Mean Scores of a Questionnaire Evaluating Provider Confidence Supporting Patients Through the Vascular Access Care Process Pre- to Post-program Implementation Pre-program score mean	7.5 score on a scale Standard Deviation 0.9
Mean Scores of a Questionnaire Evaluating Provider Confidence Supporting Patients Through the Vascular Access Care Process Pre- to Post-program Implementation Post-program score mean	7.8 score on a scale Standard Deviation 0.8

Adverse Events

Vascular Access QI Program Patient Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vascular Access QI Program Provider/Personnel Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer E. Flythe, MD, MPH

University of North Carolina at Chapel Hill

Phone: 919-445-2656

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place