Chronic Kidney Disease, Chronic Kidney Disease Requiring Chronic Dialysis
Conditions
Keywords
Hemodialysis, Vascular access, Arteriovenous, Dialysis, End Stage Renal Disease, Patient-reported outcomes, Feasibility, Care process, Patient education, Health system navigation, Chronic kidney disease
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.
Interventions
OTHERVascular 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.
Sponsors
Geisinger Clinic
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 21 |
| 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. | 25 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not complete post-program assessment | 5 | 2 |
Baseline characteristics
| Characteristic | Vascular Access QI Program Patient Participants | Total | Vascular Access QI Program Provider/Personnel Participants |
|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 15.2 | 50.5 years STANDARD_DEVIATION 16.6 | 39.6 years STANDARD_DEVIATION 6.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 45 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 43 Participants | 22 Participants |
| Region of Enrollment United States | 21 Participants | 46 Participants | 25 Participants |
| Sex: Female, Male Female | 5 Participants | 17 Participants | 12 Participants |
| Sex: Female, Male Male | 16 Participants | 29 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 25 |
| other Total, other adverse events | 0 / 21 | 0 / 25 |
| serious Total, serious adverse events | 0 / 21 | 0 / 25 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vascular Access QI Program Patient Participants | 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 |
| Vascular Access QI Program Patient Participants | 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 |
p-value: 0.2Paired sample t-test
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vascular Access QI Program Patient Participants | 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 |
| Vascular Access QI Program Patient Participants | 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 |
p-value: 0.05Paired sample t-test
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vascular Access QI Program Patient Participants | 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 |
| Vascular Access QI Program Patient Participants | 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 |
p-value: 0.004Paired sample t-test
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vascular Access QI Program Patient Participants | 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 |
| Vascular Access QI Program Patient Participants | 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 |
p-value: 0.14Paired sample t-test