Phase II Multi-Site Randomized Controlled Trial Testing Integrated Kidney Palliative Care Compared With Usual Chronic Kidney Disease Care (Kidney RISE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 280
- Locations
- 2
- Primary Endpoint
- Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores
Study Overview
Brief Summary
The purpose of study is to investigate whether adding palliative care to usual chronic kidney disease (CKD) care improves symptoms and quality of life for people with CKD. The primary objectives are to 1) determine efficacy of Kidney Palliative Care (KPC) integrated with CKD care on symptom burden compared with usual CKD care, 2) identify clinical and demographic factors associated with differential responses to KPC, and 3) characterize participant and provider experiences with kidney care and factors influencing implementation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Receive care at nephrology clinics or dialysis centers associated with each site.
- •Have CKD stage IV, V (eGFR < 30 mL/min/1.73m2), or be receiving chronic dialysis
- •Speak Spanish or English, and report at IPOS-Renal score of ≥ 3 on a screening survey.
- •Willing to be randomized to either study arm and to comply with the study procedures for the assigned group.
Exclusion Criteria
- •Unable to provide informed consent
- •Has received palliative care (inpatient or outpatient) in the last six months.
- •Enrolled in hospice
- •Has any urgent palliative care needs (i.e. severe pain, emotional distress) identified upon screening. Research staff will be trained to recognize these needs.
- •Non-English and Non-Spanish speakers to correspond with the populations most impacted by CKD in the US.
- •Pregnant individuals.
Outcomes
Primary Outcomes
Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores
Time Frame: Baseline, Week 12
The IPOS-Renal Patient Version includes 10 questions (scored 0-90), with sub-scores for physical symptoms (15 questions, range 0-60), psychological symptoms (four questions, range 0-16), and practical impact of CKD (four questions, range 0-14). Higher scores indicate a higher burden of symptoms and greater distress for the patient.
Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores
Time Frame: Baseline, Week 24
The IPOS-Renal Patient Version includes 10 questions (scored 0-90), with sub-scores for physical symptoms (15 questions, range 0-60), psychological symptoms (four questions, range 0-16), and practical impact of CKD (four questions, range 0-14). Higher scores indicate a higher burden of symptoms and greater distress for the patient.
Secondary Outcomes
- Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey(Baseline, Week 12)
- Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey(Baseline, Week 24)
- Number of participants with advance care planning(Week 12)
- Number of participants with advance care planning(Week 24)
- Change in Patient Activation Measure-13 (PAM-13) scores(Baseline, Week 12)
- Change in Patient Activation Measure-13 (PAM-13) scores(Baseline, Week 24)
- Change in General Anxiety Disorder-7 (GAD-7) scores(Baseline, Week 12)
- Change in General Anxiety Disorder-7 (GAD-7) scores(Baseline, Week 24)