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CompletedNCT04119570Updated May 6, 2023

CKD Report Card Pilot Trial

An interventional study of CKD Report Card in CKD, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by University of Chicago · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled May 2018, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The investigators will study physician-patient communication at the UCMC nephrology fellow clinic and to test an intervention, the CKD Report Card, to improve that communication and patient knowledge of CKD.

Read the detailed description

The goals of the study are to 1) characterize the effectiveness and patient-centeredness of patient-physician interaction during a nephrology clinic visit both with and without use of the CKD Report Card, and 2) to determine which physician and patient characteristics are associated with effective and patient centered communication. There will be block enrollment. For Nephrology physicians who agreed to participate will complete a baseline questionnaire. Research assistants will approach patients of participating providers in clinic waiting rooms, with the goal of enrolling patients for each provider For half of the study, investigators will enroll patients in the study and observe patient-physician communication and use a survey measure CKD knowledge pre-visit and post-visit. For the second half of the study, investigators will give participants the CKD Report Card, an investigator-developed handout, to use during the clinic visit. Investigators will observe patient-physician communication and use a survey to measure CKD knowledge pre-visit and post-visit. For both groups, eligible participants will give informed consent and will complete a baseline questionnaire; research assistants will place a digital audio-recording device in the examination room to record the patient-provider encounter. Following the medical encounter, research assistants will administered an interview with patients, assessing demographic, social, and behavioral characteristics, as well as their experience of care and ratings of provider communication.

02

Conditions studied

  • CKD
03

In context

Lead sponsor

University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 71 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • English-speaking adult patients (age 18 or older)
  • Identified in the medical record as non-Hispanic Black or non- Hispanic White
  • seen in University of Chicago nephrology clinic with a participating nephrologist

Exclusion criteria

Exclusion Criteria:

  • not able to communicate in English
  • lacking ability to consent to study
  • does not identify as non-Hispanic Black or non-Hispanic
  • without chronic kidney disease
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • No intervention
    No intervention

    Participants will have their clinic visit as per usual care.

  • Active comparator
    CKD Report Card

    Participants will receive the CKD Report Card prior to the clinic visit.

    Behavioral: CKD Report Card

Interventions

  • BehavioralCKD Report Card

    The CKD Report Card is a handout based on a NKDEP Educational Sheet that includes basic information about kidney disease and spaces where patient can record information about their own kidney disease

06

What researchers measure

Primary outcomes

  1. CKD Knowledge

    Kidney Disease Knowledge Survey (KiKs)

    Time frame: Change in CKD Knowledge from Baseline (pre-visit) to CKD Knowledge immediately post clinic visit (within 15-100 minutes post-clinic visit)

Secondary outcomes

  1. patient-physician interaction

    Perceived efficacy in patient-physician interactions (PEPPI)

    Time frame: immediately post-nephrology clinic visit (on day of enrollment, within 15-100 minutes post-clinic visit)

  2. communication assessment

    communication assessment tool (CAT)

    Time frame: immediately post-nephrology clinic visit (on day of enrollment, within 15-100 minutes post-clinic visit)

07

Study locations

1 site
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04119570
Responsible party
Sponsor
First posted
Oct 8, 2019
Start date
May 15, 2018
Primary completion
Sep 15, 2018
Completion
Sep 15, 2018
Last update
May 6, 2023

Study contacts

Milda R. Saunders, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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