Pilot Randomized-controlled Trial of Integrated Palliative and Nephrology Care Versus Usual Nephrology Care.

NCT ID: NCT04520984

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-12
• Study Completion Date: 2021-04-26

Brief Summary

The objective of this application is to conduct a pilot study testing the impact of integrated nephrology and palliative care versus standard nephrology care on patient-reported outcomes. This study is a preliminary study designed to determine feasibility of a palliative care study inclusive of kidney disease patients and to look for trends in impact over a 12-week follow-up period. Measurements will be taken at time one (time of enrollment) and time two (12 weeks). Our central hypothesis is that integration of palliative care with standard nephrology care in the ambulatory care of patients with a glomerular filtration rate (eGFR) ≤15ml/min/1.73m2 will trend towards improved symptom control, quality of life, and increased documentation of advance care planning when compared to usual nephrology care. We expect 10-15 patients per arm.

Conditions

Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Intervention

Group Type: EXPERIMENTAL

Integrated ambulatory palliative and nephrology care

Intervention Type: OTHER

Monthly ambulatory care visits with the kidney palliative care team in the intervention group for three months.

The intervention in this study is addition of a palliative care team to the care team of the subject. This intervention will not change or impact their regular nephrology care. The subjects in the intervention arm will be seen by the palliative care team three times over the 12-week study period (once per month).The intervention will be delivered by a physician trained in both palliative care and nephrology, the PI of the study.

Arm 2

Standard Care

Group Type: OTHER

Standard nephrology care

Intervention Type: OTHER

Standard nephrology care

Interventions

Integrated ambulatory palliative and nephrology care

Monthly ambulatory care visits with the kidney palliative care team in the intervention group for three months.

The intervention in this study is addition of a palliative care team to the care team of the subject. This intervention will not change or impact their regular nephrology care. The subjects in the intervention arm will be seen by the palliative care team three times over the 12-week study period (once per month).The intervention will be delivered by a physician trained in both palliative care and nephrology, the PI of the study.

Intervention Type: OTHER

Standard nephrology care

Standard nephrology care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Age ≥18

2. Fluent English speaker

3. eGFR≤15 mL/min/1.73m2 (diagnosis of CKD stage V)

4. Able to give consent

5. Must be followed by a faculty group practice nephrologist

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Diagnosis of dementia

2. Non-English speaker

3. Have been seen by a palliative care provider prior to study entry

4. Pregnant women

5. On dialysis or have received a kidney transplant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Scherer, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

References

Scherer JS, Rau ME, Krieger A, Xia Y, Zhong H, Brody A, Charytan DM, Chodosh J. A Pilot Randomized Controlled Trial of Integrated Palliative Care and Nephrology Care. Kidney360. 2022 Aug 12;3(10):1720-1729. doi: 10.34067/KID.0000352022. eCollection 2022 Oct 27.

Reference Type: DERIVED

PMID: 36514730 (View on PubMed)

Other Identifiers

18-01259

Identifier Type: -

Identifier Source: org_study_id