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

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ClinicalTrials.gov Identifier: NCT04520984
Recruitment Status : Completed
First Posted : August 20, 2020
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Other: Integrated ambulatory palliative and nephrology care Other: Standard nephrology care Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 12, 2020
Actual Primary Completion Date : April 26, 2021
Actual Study Completion Date : April 26, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
Arm 2
Standard Care
 Other: Standard nephrology care
Standard nephrology care


Outcome Measures
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Primary Outcome Measures :
  1. Change in IPOS-Renal symptom assessment score [ Time Frame: Baseline, week 12 ]
    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.

  2. Change in KDQOL-SF 36 Quality of Life Scores [ Time Frame: Baseline, week 12 ]
    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.

  3. Difference between the number of documented advanced care planning between arms [ Time Frame: Week 12 ]
    advanced care planning = health care proxy, Medical Order for Life Sustaining Treatment [MOLST], or a Do Not Resituate form


Secondary Outcome Measures :
  1. retention patients at the end of the study [ Time Frame: 12 weeks ]
  2. percent of returned clinical surveys (IPOS-R and KDQOL-SF 36 [ Time Frame: 12 weeks ]
  3. patient satisfaction as rated on the Press Ganey Survey [ Time Frame: 12 weeks ]
    Measure satisfaction on a five point scale where "5" is the Top Score.


Other Outcome Measures:
  1. Change in IPOS-Renal symptom assessment score over time in intervention arm [ Time Frame: Baseline, 6 weeks, 12 weeks ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04520984


Locations
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United States, New York
NYU Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Jennifer Scherer, MD NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04520984    
Other Study ID Numbers: 18-01259
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency