Integrated Palliative Care With Nephrology Care

NCT04998110 | Completed

• 2 other identifiers: 21-00507K23DK125840-02
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pilot randomized controlled trial testing the effectiveness of integrated ambulatory supportive care visits with standard nephrology outpatient visits for six months in patients with advanced CKD. The study team hypothesizes that patients in the integrated care arm will trend towards improved symptom burden, improved quality of life scores and more engagement in advance care planning. Primary objectives: To test the impact of integrated ambulatory supportive care in nephrology care on symptom burden. Secondary: To test the impact of integrated ambulatory supportive care on quality of life and engagement in advance care planning and to demonstrate study feasibility.

Conditions

CKD

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate

  This will be reported as the percentage of participants who provide informed consent.

  Month 12

• Number of Participants who Maintain Participation in the Study (Retention)

  Reported as percentage of participants who signed informed consent, who completed the study.

  Month 12

• Average number of clinical visits attended per participant (Retention)

  Month 12

• Ability to Collect Planned Data

  This will be reported as the percent of completed data surveys

  Month 12

Secondary Outcomes (3)

• Change in Kidney Disease Quality of Life (KDQOL-36) Score

  Baseline, Month 6

• Engagement in Advance Care Planning

  Baseline, Month 6

• Change in Integrated Palliative Outcome Score-Renal (IPOS-Renal) Score

  Baseline, Month 6

Study Arms (2)

Supportive Care Intervention

EXPERIMENTAL

The supportive care intervention arm will receive their usual ambulatory longitudinal nephrology care integrated with ambulatory supportive care through monthly supportive care visits over six months.

Other: Ambulatory Supportive Care

Usual Care Control

NO INTERVENTION

The usual care control arm will be seen at the discretion of their nephrologist, or receive their usual dialysis if on dialysis.

Interventions

Ambulatory Supportive Care OTHER

Ambulatory supportive care visits monthly for six months - a monthly visit with an ambulatory palliative care provider educated in kidney disease

Supportive Care Intervention

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18
• Documented diagnosis of Chronic Kidney Disease stage IV or V
• Speaks Spanish or English fluently
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.

You may not qualify if:

• Exposure to supportive/palliative care in the last six months either inpatient or outpatient.
• Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation, for example not being able to cognitively understand the questions or to provide informed consent.
• Pregnant women.
• Not fluent in either English or Spanish
• Any urgent supportive/palliative care needs identified on screening interview.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

NYC Health + Hospitals / Bellevue

New York, New York, 10016, United States

Location

Related Publications (1)

• Scherer JS, Wu W, Lyu C, Goldfeld KS, Brody AA, Chodosh J, Charytan D. A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trial. Contemp Clin Trials Commun. 2025 Feb 3;44:101439. doi: 10.1016/j.conctc.2025.101439. eCollection 2025 Apr.

  PMID: 40008278 DERIVED

Study Officials

• Jennifer Scherer, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 10, 2021
• Study Start: January 5, 2022
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Jennifer.scherer@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)