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The objective of this application is to conduct a pilot study testing the impact of integrated nephrology and palliative care versus standard nephrology care on patient-reported outcomes. This study is a preliminary study designed to determine feasibility of a palliative care study inclusive of kidney disease patients and to look for trends in impact over a 12-week follow-up period. Measurements will be taken at time one (time of enrollment) and time two (12 weeks). Our central hypothesis is that integration of palliative care with standard nephrology care in the ambulatory care of patients with a glomerular filtration rate (eGFR) ≤15ml/min/1.73m2 will trend towards improved symptom control, quality of life, and increased documentation of advance care planning when compared to usual nephrology care. We expect 10-15 patients per arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Intervention |
|
| Arm 2 | Other | Standard Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated ambulatory palliative and nephrology care | Other | Monthly ambulatory care visits with the kidney palliative care team in the intervention group for three months. The intervention in this study is addition of a palliative care team to the care team of the subject. This intervention will not change or impact their regular nephrology care. The subjects in the intervention arm will be seen by the palliative care team three times over the 12-week study period (once per month).The intervention will be delivered by a physician trained in both palliative care and nephrology, the PI of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IPOS-Renal symptom assessment score | IPOS-Renal is a short measure (11 questions), combining the most common symptoms renal patients experience plus additional items from IPOS on concerns beyond symptoms, such as information needs, practical issues, family anxiety. The total score reflects symptom burden and can range from zero to 68, where 0 is least symptom burden and 68 is highest symptom burden. | Baseline, week 12 |
| Change in KDQOL-SF 36 Quality of Life Scores | The KDQOL-36 has five scales, including two generic HRQOL scales from the SF-12 version 1 (12 items total) and three kidney-specific scales (24 items total). The SF-12 PCS and MCS are scored on a T-score metric (mean=50, SD=10, in the United States general population), with higher scores indicating better HRQOL. | Baseline, week 12 |
| Difference between the number of documented advanced care planning between arms | advanced care planning = health care proxy, Medical Order for Life Sustaining Treatment [MOLST], or a Do Not Resituate form | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| retention patients at the end of the study | 12 weeks | |
| percent of returned clinical surveys (IPOS-R and KDQOL-SF 36 | 12 weeks | |
| patient satisfaction as rated on the Press Ganey Survey |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IPOS-Renal symptom assessment score over time in intervention arm | Exploratory end-points include change in symptom burden over time in the intervention arm. These subjects are expected to have three visits with symptom surveys filled out at each visit. We hypothesize that symptom burden will improve over time. | Baseline, 6 weeks, 12 weeks |
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Scherer, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36514730 | Derived | Scherer JS, Rau ME, Krieger A, Xia Y, Zhong H, Brody A, Charytan DM, Chodosh J. A Pilot Randomized Controlled Trial of Integrated Palliative Care and Nephrology Care. Kidney360. 2022 Aug 12;3(10):1720-1729. doi: 10.34067/KID.0000352022. eCollection 2022 Oct 27. |
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The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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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|
| Standard nephrology care | Other | Standard nephrology care |
|
Measure satisfaction on a five point scale where "5" is the Top Score. |
| 12 weeks |
| 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 |