Integrated Palliative Care With Nephrology Care

Pilot Randomized Controlled Trial of Integrated Palliative Care With Nephrology Care

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.

Study Overview

• Status: Recruiting
• Conditions: CKD
• Intervention / Treatment: Other: Ambulatory Supportive Care

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Scherer, MD; Phone Number: 347-899-0772; Email: Jennifer.Scherer@nyulangone.org
• Study Contact Backup: Name: Haley Gross; Phone Number: 646-501-0750; Email: Haley.Gross@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYC Health + Hospitals / Bellevue
      • Contact: Jennifer Scherer, MD; Email: Jennifer.Scherer@nyulangone.org
      • Contact: Angela McCarthy; Email: Angela.McCarthy@nyulangone.org
      • Principal Investigator: Jennifer Scherer, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Exposure to supportive/palliative care in the last six months either inpatient or outpatient.
2. 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.
3. Pregnant women.
4. Not fluent in either English or Spanish
5. Any urgent supportive/palliative care needs identified on screening interview.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Care Intervention; 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; Ambulatory supportive care visits monthly for six months - a monthly visit with an ambulatory palliative care provider educated in kidney disease
No Intervention: Usual Care Control; The usual care control arm will be seen at the discretion of their nephrologist, or receive their usual dialysis if on dialysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Integrated Palliative Outcome Score-Renal (IPOS-Renal) Score	The scoring will include 11 questions on the degree of impact kidney-specific symptoms have had on patients over the past week, plus additional items on concerns beyond symptoms, such as information needs, practical issues, and family anxiety. This includes one question that has 15 sub-questions asking about specific physical symptoms. All scores are on a scale of 0-90, with lower scores representing less problems.	Baseline, Month 6
Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 3
Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 6
Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 9
Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 12
Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 15
Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 18
Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 21
Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 24
Number of Participants who Maintain Participation in the Study (Retention)		Month 3
Number of Participants who Maintain Participation in the Study (Retention)		Month 6
Number of Participants who Maintain Participation in the Study (Retention)		Month 9
Number of Participants who Maintain Participation in the Study (Retention)		Month 12
Number of Participants who Maintain Participation in the Study (Retention)		Month 15
Number of Participants who Maintain Participation in the Study (Retention)		Month 18
Number of Participants who Maintain Participation in the Study (Retention)		Month 21
Number of Participants who Maintain Participation in the Study (Retention)		Month 24
Number of participant dropouts (Retention)		Month 3
Number of participant dropouts (Retention)		Month 6
Number of participant dropouts (Retention)		Month 9
Number of participant dropouts (Retention)		Month 12
Number of participant dropouts (Retention)		Month 15
Number of participant dropouts (Retention)		Month 18
Number of participant dropouts (Retention)		Month 21
Number of participant dropouts (Retention)		Month 24
Average number of clinical visits attended per participant (Retention)		Month 3
Average number of clinical visits attended per participant (Retention)		Month 6
Average number of clinical visits attended per participant (Retention)		Month 9
Average number of clinical visits attended per participant (Retention)		Month 12
Average number of clinical visits attended per participant (Retention)		Month 15
Average number of clinical visits attended per participant (Retention)		Month 18
Average number of clinical visits attended per participant (Retention)		Month 21
Average number of clinical visits attended per participant (Retention)		Month 24
Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 3
Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 6
Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 9
Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 12
Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 15
Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 18
Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 21
Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Kidney Disease Quality of Life (KDQOL-36) Score	The KDQOL is a 36-item quality of life survey that includes five domains: Physical Component Summary (PCS), a Mental Component Summary (MCS), Burden of Kidney Disease Score, Symptoms and Problems of Kidney Disease Score, and Effect of Kidney Disease Score. All scores are on a scale of 0-100, with higher scores representing better quality of life.	Baseline, Month 6
Engagement in Advance Care Planning	Advance care planning will be measured by total number of advance care planning conversations held + number of documents such as surrogate decision makers, health care proxies, or treatment limiting directives.	Baseline, Month 6

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jennifer Scherer, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Estimated): October 15, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 21-00507; K23DK125840-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
• IPD Sharing 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.
• IPD Sharing 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.
• 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