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

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NYU Langone Health

Status and phase

Completed
Early Phase 1

Conditions

Chronic Kidney Diseases

Treatments

Other: Integrated ambulatory palliative and nephrology care
Other: Standard nephrology care

Study type

Interventional

Funder types

Other

Identifiers

NCT04520984
18-01259

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

  • Age ≥18
  • Fluent English speaker
  • eGFR≤15 mL/min/1.73m2 (diagnosis of CKD stage V)
  • Able to give consent
  • 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:

  • Diagnosis of dementia
  • Non-English speaker
  • Have been seen by a palliative care provider prior to study entry
  • Pregnant women
  • On dialysis or have received a kidney transplant

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 2 patient groups

Arm 1
Experimental group
Description:
Intervention
Treatment:
Other: Integrated ambulatory palliative and nephrology care
Arm 2
Other group
Description:
Standard Care
Treatment:
Other: Standard nephrology care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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