End Stage Renal DiseaseDIAL-SDMNCT04392440
Shared Decision Making in Dialysis
A study testing DIAL-SDM in people with End Stage Renal Disease and Chronic Kidney Diseases, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- End Stage Renal Disease, Chronic Kidney Diseases
- What is being tested?
- DIAL-SDM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2022to 14 May 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- Cognitive impairment
- Does not speak English
- For Caregivers:
- If Support is offered primarily in a professional role (e.g., clergy).
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Testing of a Communication Intervention to Promote Shared Dialysis Decision Making in Older Patients With Chronic Kidney Disease (DIAL-SDM Trial)
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.
- Conditions
- End Stage Renal Disease, Chronic Kidney Diseases
- Being tested
- DIAL-SDM, usual care
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIAL-SDMBehavioural
Communication intervention for nephrologists and coaching intervention for patients.
usual careOther
regular nephrology care
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Not described Receives: Behavioral: DIAL-SDM |
| control | Other | Usual care Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Feasibility of Intervention Measure
Feasibility was assessed using a structured questionnaire that asked participants whether the coaching, question prompt list, booklet, and videos seemed possible, doable, easy to use, and able to be carried out in practice. Each item was rated on a scale from 1 ("completely disagree") to 5 ("completely agree"). Item scores were summed for each participant to create a total feasibility score, ranging from a minimum of 4 to a maximum of 20, with higher scores indicating greater feasibility. Assessments occurred at 12 and 14 weeks post-baseline; all data collected within this window were averaged to yield a single value per participant, and group means were reported.
Measured: Approximately 12-14 weeks
Mean Acceptability of Intervention Measure
Acceptability was assessed using the Acceptability of Intervention Measure. Patients and caregivers rated comfort with coaching, helpfulness for dialysis decision making, and likelihood to recommend it, as well as the question prompt list, booklet, and videos. Items were scored 0 to 4 and summed to total scores ranging from 6 to 15, with higher scores indicating greater acceptability and a more favorable outcome. Nephrologists rated approval, appeal, and acceptance of the coaching intervention on a 1 to 5 scale, summed to total scores ranging from 4 to 20, with higher scores indicating greater acceptability and a more favorable outcome. Assessments were collected 12 to 14 weeks post baseline and averaged per participant.
Measured: Approximately 12-14 weeks
Mean Total Fidelity of Intervention Measure
Fidelity of coaching sessions was assessed using standardized Patient Coach Fidelity Check Forms for each session type: First Visit (maximum score = 51), Second Visit (maximum score = 42), and Follow-Up Phone Call (maximum score = 33). Each item was rated from 0 ("not at all") to 3 ("completely"). For each participant, scores from the First Visit, Second Visit, and Follow-up Call were converted to percentages (0-100%), then averaged to create a single fidelity score per participant, reflecting coaching quality across all sessions. Higher scores indicate greater fidelity. Assessments occurred between 12 and 14 weeks post-baseline; all data collected within this window were averaged to yield a single value per participant, and group means were reported.
Measured: Assessed across all coaching sessions (First Visit, Second Visit, and Follow-Up Call) over approximately 12-14 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start28 Feb 2022
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Fahad Saeed, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392440
- Sponsor's protocol ID
- STUDY00004907
- Other IDs
- K23DK121939
- Acronym
- DIAL-SDM
- Status last verified
- Aug 2026
- First submitted
- 1 May 2020
- Last updated
- 22 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes