Integrated Palliative Care With Nephrology Care

NCT ID: NCT04998110

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2025-04-17

Brief Summary

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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

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Conditions

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CKD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The statistician will be blinded.

Study Groups

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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.

Group Type EXPERIMENTAL

Ambulatory Supportive Care

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ambulatory Supportive Care

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Scherer, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYC Health + Hospitals / Bellevue

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40008278 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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K23DK125840-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-00507

Identifier Type: -

Identifier Source: org_study_id

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