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
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change in KDQOL-SF 36 Quality of Life Scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •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
Outcomes
Primary Outcomes
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.
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
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.
Secondary Outcomes
- 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)