Integrated Palliative Care With Nephrology Care

Not Applicable

Completed

• Conditions: CKD

• Registration Number: NCT04998110
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-10
• Study Start: 2022-01-05
• Primary Completion: 2025-04-17
• Study Completion: 2025-04-17
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment Rate	Month 12	This will be reported as the percentage of participants who provide informed consent.
Number of Participants who Maintain Participation in the Study (Retention)	Month 12	Reported as percentage of participants who signed informed consent, who completed the study.
Average number of clinical visits attended per participant (Retention)	Month 12
Ability to Collect Planned Data	Month 12	This will be reported as the percent of completed data surveys

Secondary Outcome Measures

Name	Time	Method
Change in Kidney Disease Quality of Life (KDQOL-36) Score	Baseline, Month 6	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.
Engagement in Advance Care Planning	Baseline, Month 6	Advance care planning will be measured by total number of advance care planning conversations held.
Change in Integrated Palliative Outcome Score-Renal (IPOS-Renal) Score	Baseline, Month 6	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.

Trial Locations

Locations (1)

NYC Health + Hospitals / Bellevue; 🇺🇸 New York, New York, United States