Pilot Randomized-controlled Trial of Integrated Palliative and Nephrology Care Versus Usual Nephrology Care.

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Randomized-Controlled Study Of The Impact Of Integrated Palliative And Nephrology Care Versus Usual Nephrology Care On Symptom Burden, Quality Of Life And Advance Care Planning In Patients With Chronic Kidney Disease Stage V Not On Dialysis

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Other: Integrated ambulatory palliative and nephrology care
* Other: Standard nephrology care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Age ≥18 Fluent English speaker eGFR≤15 mL/min/1.73m2 (diagnosis of CKD stage V) Able to give consent Must be followed by a faculty group practice nephrologist Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Diagnosis of dementia Non-English speaker Have been seen by a palliative care provider prior to study entry Pregnant women On dialysis or have received a kidney transplant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Intervention | Other: Integrated ambulatory palliative and nephrology care<br>* 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.<br>|
| Other: Arm 2<br>Standard Care | Other: Standard nephrology care<br>* Standard nephrology care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 satisfaction on a five point scale where 5 is the Top Score. | 12 weeks |