About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Kidney RISE
Behavioral
Core components include assessment of symptoms (IPOS-Renal), illness understanding, goals of care, advance care planning, spiritual needs, and screening for health-related social needs (HRSNs) using the validated Centers for Medicare and Medicaid Services (CMS) Accountable Health Communities (AHC) Survey. Plans will address symptom management with evidence-based algorithms, linkage to social or spiritual supports, and shared decision-making appropriate to CKD stage.

Treatment groups

280 Participants

are divided into 2 treatment groups

Group A: Integrated Kidney Palliative CareExperimental treatment 1 intervention

Group B: Usual Chronic Kidney Disease (CKD) CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores

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.

Time frame

Baseline, Week 12

2

Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores

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.

Time frame

Baseline, Week 24

Secondary outcomes

1

Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey

The KDQOL-36 is a 36-item short-form survey designed to measure the health-related quality of life for individuals with kidney disease and those on dialysis. Items 1-12 (SF-12): Measures generic physical and mental health functioning. Items 13-16 (Burden of Kidney Disease): Assesses how much kidney disease interferes with daily life. Items 17-28 (Symptoms and Problems): Evaluates common physical issues and symptoms related to kidney failure. Items 29-36 (Effects of Kidney Disease): Focuses on daily impacts like fluid restrictions, work around the house, and personal life. Transformed to a 0-100 scale, where higher scores represent a better quality of life.

Time frame

Baseline, Week 12

2

Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey

The KDQOL-36 is a 36-item short-form survey designed to measure the health-related quality of life for individuals with kidney disease and those on dialysis. Items 1-12 (SF-12): Measures generic physical and mental health functioning. Items 13-16 (Burden of Kidney Disease): Assesses how much kidney disease interferes with daily life. Items 17-28 (Symptoms and Problems): Evaluates common physical issues and symptoms related to kidney failure. Items 29-36 (Effects of Kidney Disease): Focuses on daily impacts like fluid restrictions, work around the house, and personal life. Transformed to a 0-100 scale, where higher scores represent a better quality of life.

Time frame

Baseline, Week 24

3

Number of participants with advance care planning

Outcome measure will be assessed by chart review. Advance care planning includes proxy, Medical Orders for Life-Sustaining Treatment (MOLST)/Physician/Provider Orders for Life-Sustaining Treatment (POLST), and advance care planning conversations.

Time frame

Week 12

4

Number of participants with advance care planning

Outcome measure will be assessed by chart review. Advance care planning includes proxy, Medical Orders for Life-Sustaining Treatment (MOLST)/Physician/Provider Orders for Life-Sustaining Treatment (POLST), and advance care planning conversations.

Time frame

Week 24

Kidney RISE: Randomized Integrated Supportive CarE Trial

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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