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

Chronic Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04520984
• Other study ID #: 18-01259
• Status: Completed
• Phase: Early Phase 1
• Start date: July 12, 2020
• Est. completion date: April 26, 2021

Study information

• Verified date: October 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

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.
• Standard nephrology care
Standard nephrology care

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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	retention patients at the end of the study		12 weeks
Secondary	percent of returned clinical surveys (IPOS-R and KDQOL-SF 36		12 weeks
Secondary	patient satisfaction as rated on the Press Ganey Survey	Measure satisfaction on a five point scale where "5" is the Top Score.	12 weeks