Clinical Trials Directory

Trials / Completed

CompletedNCT04392440

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)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
102 (actual)
Sponsor
University of Rochester · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALDIAL-SDMCommunication intervention for nephrologists and coaching intervention for patients.
OTHERusual careregular nephrology care

Timeline

Start date
2022-02-28
Primary completion
2024-05-14
Completion
2024-05-14
First posted
2020-05-18
Last updated
2026-03-20
Results posted
2026-03-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04392440. Inclusion in this directory is not an endorsement.