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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG082891 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
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The investigators are conducting a study to see which program better helps older patients with kidney disease choose their treatment. Investigators are also investigating if either program can reduce the number of hospital or emergency room visits in the first 6 months of the study, as well as potentially improve end-of-life care for older adults.
Half of the participants will receive Program A, while the other half will receive Program B. Investigators will compare the two groups to see which participants feel better prepared about their kidney therapy decisions, experience improved end-of-life care, and have fewer emergency room visits and hospital admissions.
Participants in Program A will receive information from the National Kidney Foundation and meet with a kidney therapy educator. Participants in Program B will get information about kidney disease treatment and meet with a decision-support specialist who's an expert in decision-making.
Older adults ≥75 years represent the fastest-growing population to initiate dialysis in the US; despite the life-altering effects of dialysis on quality of life, dialysis is often presented as a default without considering patient preferences, prognosis, and alternative options such as conservative kidney management. This study will test the first palliative care intervention for older patients with advanced chronic kidney disease to improve the kidney therapy decision-making process. This research not only has the potential to help thousands of older patients with advanced chronic kidney disease who often have unanswered questions, unmet information needs, and restricted opportunities to share personal treatment preferences with their nephrologists but also has the possibility of creating new models of collaborative care by integrating palliative care into routine nephrology care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Program A | Active Comparator | Kidney therapy education and support with kidney therapy educator. |
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| Program B | Active Comparator | Behavioral: CKD-EDU Palliative care-based decision-support intervention for support with kidney therapy decision-making. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Program A | Behavioral | Subjects in the Control group will receive 1) National Kidney Foundation information, and 2) support from a kidney therapy educator. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 12 weeks | Determine whether the intervention improves kidney therapy decision-making at 12 weeks by using the Decisional Conflict Scale. Score ranges from 0-100. Lower scores indicate better outcomes. | Baseline, 4-6 weeks, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in patients' well-being at 6 months using the Burden of Kidney Disease Subscale | Determine whether the intervention improves patient well-being at 6 months using the Burden of Kidney Disease Subscale, a 4-question scale with response options ranging from 'definitely true (0)' to 'definitely false (3)'. Higher scores indicate better outcomes. | Base line 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brooke Study Coordinator | Contact | 585-275-7033 | KidneyEducation@urmc.rochester.edu | |
| Allison Study Coordinator | Contact | 585-210-2515 | KidneyEducation@urmc.rochester.edu |
| Name | Affiliation | Role |
|---|---|---|
| Fahad Saeed, MBBS, MSCI | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UR Medicine Nephrology - Strong West | Recruiting | Brockport | New York | 14420 | United States |
Only de-identified qualitative data will be available to other researchers.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D016344 | Medicare Part A |
| ID | Term |
|---|---|
| D006278 | Medicare |
| D008483 | Medical Assistance |
| D011632 | Public Assistance |
| D005380 | Financing, Government |
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Research coordinators responsible for administering assessments will remain blinded to the patient's randomization status.
| Program B | Behavioral | Subjects in the intervention group will receive 1) a video and paper decision aid, and 2) coaching from a decision support specialist. The visits will be aimed at supporting patients with kidney therapy decision-making. |
|
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| Changes in number of hospital admissions, intensive care admissions, and emergency room visits | Review electronic health records to determine whether the intervention reduces the number of hospital admissions, intensive care admissions, and emergency room visits between study entry and 6 months. | Baseline, 6 months |
| Differences in end-of-life care between intervention and control arm | Review patients' medical charts to determine whether the intervention improves end-of-life care treatment during the last 30 days of life, as measured by the rates of aggressive procedures such as cardiopulmonary resuscitation (CPR), dialysis, intubation, gastrostomy (G-tube), etc. | Baseline to 6 months |
| Nephrology Clinic - Thompson Professional Building | Recruiting | Canandaigua | New York | 14424 | United States |
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| Nephrology Clinic - St. James Medical Office Building | Recruiting | Hornell | New York | 14843 | United States |
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| Highland Hospital | Recruiting | Rochester | New York | 14620 | United States |
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| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642 | United States |
|
| 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 |
| D005381 |
| Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D007878 | Legislation as Topic |
| D012926 | Social Control, Formal |