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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Other: Integrated ambulatory palliative and nephrology care; Other: Standard nephrology care

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Intervention	Other: Integrated ambulatory palliative and nephrology care; 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.
Other: Arm 2; Standard Care	Other: Standard nephrology care; Standard nephrology care

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2020
• Primary Completion (Actual): April 26, 2021
• Study Completion (Actual): April 26, 2021

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 18-01259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No