Shared Decision Making in Dialysis

Browse trials for

• Kidney Failure, Chronic 2,085
• Renal Insufficiency, Chronic 3,144

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 102 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Study arms

• Experimental
  intervention

  Behavioral: DIAL-SDM

• Other
  control

  Usual care

  Other: usual care

Interventions

• BehavioralDIAL-SDM

  Communication intervention for nephrologists and coaching intervention for patients.

• Otherusual care

  regular nephrology care

Primary outcomes

1. 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.

   Time frame: Approximately 12-14 weeks

2. 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.

   Time frame: Approximately 12-14 weeks

3. 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.

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

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Aug 28, 2025
• Informed consent form · Nov 9, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes