Chronic Kidney Disease (Stages 4 and 5)
Conditions
Keywords
CKD
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.
Interventions
BEHAVIORALKidney RISE
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.
Sponsors
NYU Langone Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomization stratified by receipt of dialysis or not and site location.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Receive care at nephrology clinics or dialysis centers associated with each site. 2. Have CKD stage IV, V (eGFR \< 30 mL/min/1.73m2), or be receiving chronic dialysis 3. Speak Spanish or English, and report at IPOS-Renal score of ≥ 3 on a screening survey. 4. Willing to be randomized to either study arm and to comply with the study procedures for the assigned group.
Exclusion criteria
1. Unable to provide informed consent 2. Has received palliative care (inpatient or outpatient) in the last six months. 3. Enrolled in hospice 4. Has any urgent palliative care needs (i.e. severe pain, emotional distress) identified upon screening. Research staff will be trained to recognize these needs. 5. Non-English and Non-Spanish speakers to correspond with the populations most impacted by CKD in the US. 6. Pregnant individuals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey | Baseline, Week 12 | 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. |
| Number of participants with advance care planning | Week 12 | 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. |
| Change in Patient Activation Measure-13 (PAM-13) scores | Baseline, Week 12 | The PAM-13 is a 13-item survey that evaluates a person's knowledge, skills, and confidence in managing their own health and healthcare. 13 statements answered on a 4-point Likert scale (strongly disagree to strongly agree). Scores range from 0-100. Score ≤ 47.0: Disengagement and disbelief; the person may not feel an active role is important. Score 47.1-55.1: Increasing awareness and knowledge, but still lacks confidence to take action. Score 55.2-67.0: Taking action and gaining readiness to manage health behaviors. Score ≥ 67.1: Sustainment; the person adopts and maintains healthy behaviors even under stress. |
| Change in General Anxiety Disorder-7 (GAD-7) scores | Baseline, Week 12 | GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety. |
Countries
United States
Contacts
CONTACTJennifer Scherer, MD, MS, FASN
CONTACTRachel Monahan
PRINCIPAL_INVESTIGATORJennifer Scherer, MD, MS, FASN
NYU Langone Health
Outcome results
None listed