Chronic Kidney Disease-Education (CKD-EDU)
ConditionChronic Kidney Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 75 years old
Has advanced kidney disease with kidney function less than 30%
Speaks English
Has not yet made a dialysis decision
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Program A
BehavioralSubjects in the Control group will receive 1) National Kidney Foundation information, and 2) support from a kidney therapy educator.
Program B
BehavioralSubjects 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.
Treatment groups
326 Participants
are divided into 2 treatment groupsGroup A: Program AActive comparator 1 intervention
Group B: Program BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 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.
Time frame
Baseline, 4-6 weeks, and 12 weeksSecondary outcomes
1
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.
Time frame
Base line 6 months2
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.
Time frame
Baseline, 6 months3
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.
Time frame
Baseline to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Rochester
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov