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NCT Number: NCT04520984

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

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated ambulatory palliative and nephrology care

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.

Standard nephrology care

Other

Standard nephrology care

Primary outcomes

  1. Change in IPOS-Renal symptom assessment score

    Time frame: Baseline, week 12

    IPOS-Renal is a short measure (11 questions), combining the most common symptoms renal patients experience plus additional items from IPOS on concerns beyond symptoms, such as information needs, practical issues, family anxiety. The total score reflects symptom burden and can range from zero to 68, where 0 is least symptom burden and 68 is highest symptom burden.

  2. Change in KDQOL-SF 36 Quality of Life Scores

    Time frame: Baseline, week 12

    The KDQOL-36 has five scales, including two generic HRQOL scales from the SF-12 version 1 (12 items total) and three kidney-specific scales (24 items total). The SF-12 PCS and MCS are scored on a T-score metric (mean=50, SD=10, in the United States general population), with higher scores indicating better HRQOL.

  3. Difference between the number of documented advanced care planning between arms

    Time frame: Week 12

    advanced care planning = health care proxy, Medical Order for Life Sustaining Treatment [MOLST], or a Do Not Resituate form

Secondary outcomes

  1. retention patients at the end of the study

    Time frame: 12 weeks

  2. percent of returned clinical surveys (IPOS-R and KDQOL-SF 36

    Time frame: 12 weeks

  3. patient satisfaction as rated on the Press Ganey Survey

    Time frame: 12 weeks

    Measure satisfaction on a five point scale where "5" is the Top Score.

Other outcomes

  1. Change in IPOS-Renal symptom assessment score over time in intervention arm

    Time frame: Baseline, 6 weeks, 12 weeks

    Exploratory end-points include change in symptom burden over time in the intervention arm. These subjects are expected to have three visits with symptom surveys filled out at each visit. We hypothesize that symptom burden will improve over time.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

A Pilot Randomized-Controlled Study Of The Impact Of Integrated Palliative And Nephrology Care Versus Usual Nephrology Care On Symptom Burden, Quality Of Life And Advance Care Planning In Patients With Chronic Kidney Disease Stage V Not On Dialysis

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2020
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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