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

NCT04520984 | Completed Early Phase 1 DMC

• 1 other identifier: 18-01259
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

  12 weeks

Other Outcomes (1)

• Change in IPOS-Renal symptom assessment score over time in intervention arm

  Baseline, 6 weeks, 12 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Intervention

Other: Integrated ambulatory palliative and nephrology care

Arm 2

OTHER

Standard Care

Other: Standard nephrology care

Interventions

Integrated ambulatory palliative and nephrology care OTHER

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 1

Standard nephrology care OTHER

Standard nephrology care

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• Scherer JS, Rau ME, Krieger A, Xia Y, Zhong H, Brody A, Charytan DM, Chodosh J. A Pilot Randomized Controlled Trial of Integrated Palliative Care and Nephrology Care. Kidney360. 2022 Aug 12;3(10):1720-1729. doi: 10.34067/KID.0000352022. eCollection 2022 Oct 27.

  PMID: 36514730 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Scherer, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 20, 2020
• Study Start: July 12, 2020
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)