Shared Decision Making in Dialysis (DIAL-SDM)

March 19, 2026 updated by: Fahad Saeed, University of Rochester

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 ≤ 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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 ≤ 20 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.

Exclusion Criteria:

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
  • Cognitive impairment
  • Does not speak English

For Caregivers:

  • If Support is offered primarily in a professional role (e.g., clergy).
  • Cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: intervention
Behavioral: DIAL-SDM
Communication intervention for nephrologists and coaching intervention for patients.
Other: control
Usual care
Other: usual care
regular nephrology care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Feasibility of Intervention Measure
Time Frame: Approximately 12-14 weeks
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.
Approximately 12-14 weeks
Mean Acceptability of Intervention Measure
Time Frame: Approximately 12-14 weeks
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.
Approximately 12-14 weeks
Mean Total Fidelity of Intervention Measure
Time Frame: Assessed across all coaching sessions (First Visit, Second Visit, and Follow-Up Call) over approximately 12-14 weeks post-baseline
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.
Assessed across all coaching sessions (First Visit, Second Visit, and Follow-Up Call) over approximately 12-14 weeks post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00004907
  • K23DK121939 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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