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

Early Phase 1

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Other: Integrated ambulatory palliative and nephrology care; Other: Standard nephrology care

• Registration Number: NCT04520984
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-07-12
• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-18
• Study First Posted: 2020-08-20
• Primary Completion: 2021-04-26
• Study Completion: 2021-04-26
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Integrated ambulatory palliative and nephrology care	Intervention
Arm 2	Standard nephrology care	Standard Care

Primary Outcome Measures

Name	Time	Method
Change in KDQOL-SF 36 Quality of Life Scores	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.
Difference between the number of documented advanced care planning between arms	Week 12	advanced care planning = health care proxy, Medical Order for Life Sustaining Treatment \[MOLST\], or a Do Not Resituate form
Change in IPOS-Renal symptom assessment score	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.

Secondary Outcome Measures

Name	Time	Method
percent of returned clinical surveys (IPOS-R and KDQOL-SF 36	12 weeks
retention patients at the end of the study	12 weeks
patient satisfaction as rated on the Press Ganey Survey	12 weeks	Measure satisfaction on a five point scale where "5" is the Top Score.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States