Feasibility of Enhanced Dialysis Education (EDU) Intervention for Chronic Kidney Disease (CKD) Patients (CKD-EDU)

Feasibility of Enhanced Dialysis Education (EDU) Intervention for Chronic Kidney Disease (CKD) Patients ≥ 75 Years of Age and Their Caregivers (CKD-EDU Study) - A Pilot Study

The investigators are studying the feasibility, acceptability, and outcomes of an intervention called Enhanced Dialysis Education (EDU) Intervention. CKD-EDU is a palliative care-based dialysis decision-making intervention that involves educating patients and caregivers about dialysis and engaging them in shared decision-making. Half of the enrolled patients will receive CKD-EDU and the other half will receive Usual Care.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Other: usual care; Behavioral: CKD-EDU

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥75 years old
2. Presence of advanced CKD stage 4 or 5 (i.e. e GFR ≤ 25 ml/min)
3. Patient's nephrologist is enrolled in the study and has seen that nephrologist at least once
4. Speaks English
5. Have not attended a dialysis education class or met with the dialysis education coordinator.
6. Have not made a dialysis decision

Exclusion Criteria:

1. Patient has already been seen by a palliative care clinician or is enrolled in hospice
2. Is already on dialysis
3. Hospitalized at the time of recruitment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: usual care	Other: usual care; Nephrologist based usual care
Experimental: CKD-EDU arm	Behavioral: CKD-EDU; Palliative Care based coaching intervention for support with dialysis-related decision making.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants receiving the intervention	We'll assess feasibility by determining the reach of the intervention	24 months
Acceptability of the intervention	We'll assess the acceptability of the CKD-PC intervention by qualitative interviews by reporting the percentage of patients with a favorable response to the intervention.	24 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2018
• Primary Completion (Actual): February 9, 2021
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 0071204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No