Integrated Palliative Care With Nephrology Care

NYU Langone Health

Status: Completed

Conditions: CKD

Treatments: Other: Ambulatory Supportive Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04998110

21-00507

K23DK125840-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

84 participants in 2 patient groups

Supportive Care Intervention

Experimental group

Description:

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.

Treatment:

Other: Ambulatory Supportive Care

Usual Care Control

No Intervention group

Description:

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