NCT04392440Completed
Shared Decision Making in Dialysis
Pilot Testing of a Communication Intervention to Promote Shared Dialysis Decision Making in Older Patients With Chronic Kidney Disease (DIAL-SDM Trial)
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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 ≤ 25 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 102 (actual)
- First submitted
- 1 May 2020
- Start date
- 28 Feb 2022
- Primary completion date
- 14 May 2024
- Lead sponsor
- University of Rochester
- Diseases
- Chronic kidney disease
- NCT number
- NCT04392440
What you commit to
- Study type: Interventional
- Participants enrolled: 102
- From 28 Feb 2022 to the primary completion date, 14 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cognitive impairment
- Cognitive impairment
Other
- For Nephrologists:
- \- Expecting to leave in six months.
- For Patients:
- Patient has already been seen by a palliative care clinician or is enrolled in hospice
- Is already on dialysis
- Hospitalized at the time of recruitment
- Does not speak English
- For Caregivers:
- If Support is offered primarily in a professional role (e.g., clergy).
Who the study is looking for
- For nephrologist:
- Member of Strong nephrology group working at Strong Memorial Hospital
- Treat patients with CKD
- For patients:
- Age ≥65 years old
- Presence of advanced CKD stage 4 or 5 (i.e. e GFR ≤ 25 ml/min)
- Patient's nephrologist is enrolled in the study, and has seen that nephrologist at least once
- Speaks English
- Have not attended a dialysis education class or met with the dialysis education coordinator.
- Have not made a dialysis decision
- For Caregivers:
- Self-identified caregiver (per definition:"family member, partner, friend or someone else who is involved with your health care issues, for example, someone who you talk to about personal issues including medical decisions or who comes to doctor appointments with you. This person may also help with routine day-to-day activities, like transportation or paperwork.")
- 21 years of age or older.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.