Clinical trial NCT06410144: Chronic Kidney Disease-Education (CKD-EDU)
Official title: Improving Kidney Therapy Decision-Making for Older People With Advanced Chronic Kidney Disease (CKD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2024-05-13
Enrollment: 326
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators are conducting a study to see which program better helps older patients with kidney disease choose their treatment. Investigators are also investigating if either 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 Program A, while the other half will receive Program B. Investigators will compare the two groups to see which participants feel better prepared about their kidney therapy decisions, experience improved end-of-life care, and have fewer emergency room visits and hospital admissions.

Participants in Program A will receive information from the National Kidney Foundation and meet with a kidney therapy educator. Participants in Program B will get information about kidney disease treatment and meet with a decision-support specialist who's an expert in decision-making.

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 75 years old
* Has advanced kidney disease with kidney function less than 30%
* 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 for kidney-related issues or is enrolled in hospice
* Currently on dialysis
* Unable to provide informed consent or complete verbally administered surveys due to health, sensory, or cognitive impairment.

Primary outcomes:
measure: Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 12 weeks
timeFrame: Baseline, 4-6 weeks, and 12 weeks
Secondary outcomes:
measure: Changes in patients' well-being at 6 months using the Burden of Kidney Disease Subscale
timeFrame: Base line 6 months
measure: Changes in number of hospital admissions, intensive care admissions, and emergency room visits
timeFrame: Baseline, 6 months
measure: Differences in end-of-life care between intervention and control arm
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Brockport
country: United States
facility: UR Medicine Nephrology - Strong West
state: New York
city: Canandaigua
country: United States
facility: Nephrology Clinic - Thompson Professional Building
state: New York
city: Hornell
country: United States
facility: Nephrology Clinic - St. James Medical Office Building
state: New York
city: Rochester
country: United States
facility: Highland Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Fahad Saeed, MBBS, MSCI
role: PRINCIPAL_INVESTIGATOR
References: