Outcomes of a Palliative Care Intervention to Improve Kidney Therapy Decision-Making for Older People With Advanced Chronic Kidney Disease (CKD) (CKD-EDU)

The investigators are conducting a study to see if an educational program called Chronic Kidney Disease-Education (CKD-EDU) can help make better kidney therapy decisions and improve the well-being of older adults. Investigators are also investigating if this program can reduce the number of hospital or emergency room visits in the first 6 months of the study, as well as potentially improve end-of-life care for older adults.

Half of the participants will receive the CKD-EDU intervention, while the other half will continue with their usual nephrology care. Investigators will compare the two groups to see if participants who received the intervention feel better prepared about their kidney therapy decisions, experience improved end-of-life care, and have fewer emergency room visits, hospital admissions,

Participants in the intervention group will get information about kidney disease treatment and meet with a palliative care specialist who's an expert in decision-making.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Behavioral: CKD-EDU; Behavioral: Usual Care

Detailed Description

Older adults ≥75 years represent the fastest-growing population to initiate dialysis in the US; despite the life-altering effects of dialysis on quality of life, dialysis is often presented as a default without considering patient preferences, prognosis, and alternative options such as conservative kidney management. This study will test the first palliative care intervention for older patients with advanced chronic kidney disease to improve the kidney therapy decision-making process. This research not only has the potential to help thousands of older patients with advanced chronic kidney disease who often have unanswered questions, unmet information needs, and restricted opportunities to share personal treatment preferences with their nephrologists but also has the possibility of creating new models of collaborative care by integrating palliative care into routine nephrology care.

• Study Type: Interventional
• Enrollment (Estimated): 326
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brooke Daigneault; Phone Number: 585-275-7033; Email: brooke_daigneault@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
      • Contact: Brooke Daigneault; Phone Number: 585-275-7033; Email: brooke_daigneault@urmc.rochester.edu
      • Principal Investigator: Fahad Saeed, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 75 years old
• Estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73 m2 as measured by non-race-based eGFR assays
• Speaks English
• Has not yet made a dialysis decision

Exclusion Criteria:

• Has already decided on dialysis or active medical care without dialysis.
• Has already been seen by a Palliative Care (PC) clinician or is enrolled in hospice
• Currently on dialysis
• Unable to provide informed consent or complete orally administered surveys due to health, sensory, or cognitive impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CKD-EDU Intervention arm; Behavioral: CKD-EDU Palliative care-based decision support intervention for support with kidney therapy decision-making	Behavioral: CKD-EDU; Subjects in the intervention group will receive 1) a video and paper decision aid , and 2) coaching from a palliative care clinician. The visits will be aimed to support patients with kidney therapy decision making.
Active Comparator: Usual Care Control arm; Routine nephrology clinical care.	Behavioral: Usual Care; Subjects in the Control Group will receive the usual care from their nephrologist and a dialysis educator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 4-6 weeks	Determine whether the intervention improves kidney therapy decision-making at 4-6 weeks by using the Decisional Conflict Scale. Score ranges from 0-100. Lower scores indicate better outcomes.	Baseline, 4-6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in patients' well-being at 6 months using the Burden of Kidney Disease Subscale	Determine whether the intervention improves patient well-being at 6 months using the Burden of Kidney Disease Subscale, a 4-question scale with response options ranging from 'definitely true (0)' to 'definitely false (3)'. Higher scores indicate better outcomes.	Base line 6 months
Changes in number of hospital admissions, intensive care admissions, and emergency room visits	Review electronic health records to determine whether the intervention reduces the number of hospital admissions, intensive care admissions, and emergency room visits between study entry and 6 months.	Baseline, 6 months
Differences in end-of-life care between intervention and control arm	Review patients' medical charts to determine whether the intervention improves end-of-life care treatment during the last 30 days of life, as measured by the rates of aggressive procedures such as cardiopulmonary resuscitation (CPR), dialysis, intubation, gastrostomy (G-tube), etc.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Fahad Saeed, MBBS, MSCI, University of Rochester

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: STUDY00009330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only de-identified qualitative data will be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No