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NCT Number: NCT06410144

Chronic Kidney Disease-Education (CKD-EDU)

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UR Medicine Nephrology - Strong West, Brockport, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Program A

Behavioral

Subjects in the Control group will receive 1) National Kidney Foundation information, and 2) support from a kidney therapy educator.

Program B

Behavioral

Subjects in the intervention group will receive 1) a video and paper decision aid, and 2) coaching from a decision support specialist. The visits will be aimed at supporting patients with kidney therapy decision-making.

Other names: CKD-EDU Intervention

Primary outcomes

  1. Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 12 weeks

    Time frame: Baseline, 4-6 weeks, and 12 weeks

    Determine whether the intervention improves kidney therapy decision-making at 12 weeks by using the Decisional Conflict Scale. Score ranges from 0-100. Lower scores indicate better outcomes.

Secondary outcomes

  1. Changes in patients' well-being at 6 months using the Burden of Kidney Disease Subscale

    Time frame: Base line 6 months

    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.

  2. Changes in number of hospital admissions, intensive care admissions, and emergency room visits

    Time frame: Baseline, 6 months

    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.

  3. Differences in end-of-life care between intervention and control arm

    Time frame: Baseline to 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Study Coordinator

CONTACT

[email protected]

585-210-2515

Brooke Study Coordinator

CONTACT

[email protected]

585-275-7033

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Improving Kidney Therapy Decision-Making for Older People With Advanced Chronic Kidney Disease (CKD)

Acronym: CKD-EDU

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 13, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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