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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DK116115 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Geisinger Clinic | OTHER |
| Duke University | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular Access Navigation and Education Quality Improvement Program | Other | 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 | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Pre- and post-intervention, a total of up to 7 months |
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Inclusion Criteria
Patients:
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:
Providers: None
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Danville Nephrology Clinic | Danville | Pennsylvania | 17822 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35373037 | Derived | 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. |
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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.
Starting 6 months after publication, pending data use agreement modifications.
Principal Investigators will review all requests for data, per data use agreement modifications.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2019 | Nov 13, 2020 |
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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.
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| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All Vascular Access QI program patient participants enrolled in the study who completed both the pre- and post-program evaluation questionnaires. | Posted | Mean | Standard Deviation | score on a scale | Pre- and post-intervention, a total of up to 7 months |
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| 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. | All Vascular Access QI program patient participants enrolled in the study who completed both the pre- and post-program evaluation questionnaires. | Posted | Mean | Standard Deviation | score on a scale | Pre- and post-intervention, a total of up to 7 months |
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| 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. | All Vascular Access QI program patient participants enrolled in the study who completed both the pre- and post-program evaluation questionnaires. | Posted | Mean | Standard Deviation | score on a scale | Pre- and post-intervention, a total of up to 7 months |
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| 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. | All Vascular Access QI program provider & personnel participants enrolled in the study who completed both the pre- and post-program evaluation questionnaires. | Posted | Mean | Standard Deviation | score on a scale | Pre- and post-intervention, a total of up to 7 months |
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From the time informed consent is obtained to study participation end, an approximate total of 7 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
| EG001 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer E. Flythe, MD, MPH | University of North Carolina at Chapel Hill | 919-445-2656 | jflythe@med.unc.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2019 | Nov 20, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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