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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
280
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.
Emory University
Atlanta, Georgia, United States
NYU Langone Health
New York, New York, United States
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
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
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
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.
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Time frame: Baseline, Week 24
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
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
Change in Patient Activation Measure-13 (PAM-13) scores
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.
Time frame: Baseline, Week 12
Change in Patient Activation Measure-13 (PAM-13) scores
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.
Time frame: Baseline, Week 24
Change in General Anxiety Disorder-7 (GAD-7) scores
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.
Time frame: Baseline, Week 12
Change in General Anxiety Disorder-7 (GAD-7) scores
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.
Time frame: Baseline, Week 24