Chronic Kidney Disease-Education (CKD-EDU)

University of Rochester

Status: Enrolling

Conditions: Chronic Kidney Diseases

Treatments: Behavioral: Program B; Behavioral: Program A

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06410144

R01AG082891 (U.S. NIH Grant/Contract)

STUDY00009330

Details and patient eligibility

About

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.

Full 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.

Enrollment: 326 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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326 participants in 2 patient groups

Program A

Active Comparator group

Description:

Kidney therapy education and support with kidney therapy educator.

Treatment:

Behavioral: Program A

Program B

Active Comparator group

Description:

Behavioral: CKD-EDU Palliative care-based decision-support intervention for support with kidney therapy decision-making.

Treatment:

Behavioral: Program B