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NCT04392440 · ClinicalTrials.gov registry record · NA
Shared Decision Making in Dialysis
A NA study, sponsored by University of Rochester.
- Completed
- Registry status
- NA
- Development phase
- 102
- Enrollment target
NCT04392440 is a NA study that has completed, run by University of Rochester. The registered enrollment target is 102 participants.
The verdict
NCT04392440, a NA study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
Study Summary
Older patients ≥65 years with chronic kidney disease (CKD) face challenges in decision making about dialysis. These patients report little effort by physicians to elicit treatment preferences, discuss prognoses, or explain the burdens/benefits of dialysis options including conservative management. Older patients with CKD often prefer maintaining the quality of life over prolonging life, and many regret their decision to start dialysis: nearly one quarter withdraw from dialysis each year. Shared dialysis decision-making requires active engagement between nephrologists and patients to align patient, caregiver, and physician communication around common goals. The proposed study is a pilot randomized cluster trial of a dialysis shared decision-making (DIAL-SDM) intervention for nephrologists (n=20) and their patients ≥65 years old (n=60) with an estimated glomerular filtration rate (eGFR) of ≤ 20 ml/min/ /1.73 m2. Nephrologists in the Intervention Group will receive 3 communication training sessions, delivered by a standardized patient instructor (SPI) who enact clinical scenarios and offer feedback. In parallel, patients (and caregivers, if available) will receive 2 coaching sessions provided by health coaches, who will explore each patient's relevant contextual information (values, preferences, and goals), and help them identify and practice important questions for their nephrologist. Nephrologists in the Control Group will provide their patients with usual care. The study outcomes will be assessed during two nephrology office visits and at 6 months.
Interventions
- OTHER usual care
- BEHAVIORAL DIAL-SDM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2022-02-28 |
| Est. Completion | 2024-05-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04392440
The ClinicalTrials.gov registry entry for NCT04392440 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which usual care is the first listed.
NCT04392440 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04392440 about?
NCT04392440 is a clinical study titled "Shared Decision Making in Dialysis". Older patients ≥65 years with chronic kidney disease (CKD) face challenges in decision making about dialysis. These patients report little effort by physicians to elicit treatment preferences, discuss prognoses, or explain the burdens/benefits of dialysis options including conservative management. O...
What is the current status of trial NCT04392440?
This trial is currently completed. It is a NA study. The enrollment target is 102 participants. The study started on 2022-02-28. Estimated completion is 2024-05-14.
What interventions are being tested in trial NCT04392440?
The interventions under investigation include: usual care (OTHER), DIAL-SDM (BEHAVIORAL).
Who is sponsoring clinical trial NCT04392440?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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