Shared Decision Making in Dialysis

NCT04392440 | Completed Results

• 2 other identifiers: STUDY00004907K23DK121939
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Renal Disease; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Assessed across all coaching sessions (First Visit, Second Visit, and Follow-Up Call) over approximately 12-14 weeks post-baseline

Study Arms (2)

intervention

EXPERIMENTAL

Behavioral: DIAL-SDM

control

OTHER

Usual care

Other: usual care

Interventions

DIAL-SDM BEHAVIORAL

Communication intervention for nephrologists and coaching intervention for patients.

intervention

usual care OTHER

regular nephrology care

control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.")
• years of age or older.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a small, pilot, cluster-randomized trial with a limited sample size (N=60 patients).

Results Point of Contact

• Title: Fahad Saeed, MD, Principal Investigator
• Organization: Strong Nephrology

Fahad_Saeed@urmc.rochester.edu

585-275-4517

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 18, 2020
• Study Start: February 28, 2022
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: March 20, 2026
• Results First Posted: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)