Clinical trial NCT04520984: Pilot Randomized-controlled Trial of Integrated Palliative and Nephrology Care Versus Usual Nephrology Care.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Kidney Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Age ≥18
2. Fluent English speaker
3. eGFR≤15 mL/min/1.73m2 (diagnosis of CKD stage V)
4. Able to give consent
5. 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:

1. Diagnosis of dementia
2. Non-English speaker
3. Have been seen by a palliative care provider prior to study entry
4. Pregnant women
5. On dialysis or have received a kidney transplant

Primary outcomes:
measure: Change in IPOS-Renal symptom assessment score
timeFrame: Baseline, week 12
measure: Change in KDQOL-SF 36 Quality of Life Scores
timeFrame: Baseline, week 12
measure: Difference between the number of documented advanced care planning between arms
timeFrame: Week 12
Secondary outcomes:
measure: retention patients at the end of the study
timeFrame: 12 weeks
measure: percent of returned clinical surveys (IPOS-R and KDQOL-SF 36
timeFrame: 12 weeks
measure: patient satisfaction as rated on the Press Ganey Survey
timeFrame: 12 weeks
Other outcomes:
measure: Change in IPOS-Renal symptom assessment score over time in intervention arm
timeFrame: Baseline, 6 weeks, 12 weeks
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jennifer Scherer, MD
role: PRINCIPAL_INVESTIGATOR
References: