Chronic Kidney Diseases
Conditions
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.
Interventions
BEHAVIORALProgram A
Subjects in the Control group will receive 1) National Kidney Foundation information, and 2) support from a kidney therapy educator.
BEHAVIORALProgram B
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.
Sponsors
University of Rochester
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Research coordinators responsible for administering assessments will remain blinded to the patient's randomization status.
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 12 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in patients' well-being at 6 months using the Burden of Kidney Disease Subscale | 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. |
| Changes in number of hospital admissions, intensive care admissions, and emergency room visits | 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. |
| Differences in end-of-life care between intervention and control arm | 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. |
Countries
United States
Contacts
CONTACTBrooke Study Coordinator
CONTACTAllison Study Coordinator
PRINCIPAL_INVESTIGATORFahad Saeed, MBBS, MSCI
University of Rochester
Outcome results
None listed