CKD Report Card Pilot Trial

Pilot and Trial of the Chronic Kidney Disease Report Card

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.

Study Overview

• Status: Completed
• Conditions: CKD
• Intervention / Treatment: Behavioral: CKD Report Card

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CKD Knowledge	Kidney Disease Knowledge Survey (KiKs)	Change in CKD Knowledge from Baseline (pre-visit) to CKD Knowledge immediately post clinic visit (within 15-100 minutes post-clinic visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient-physician interaction	Perceived efficacy in patient-physician interactions (PEPPI)	immediately post-nephrology clinic visit (on day of enrollment, within 15-100 minutes post-clinic visit)
communication assessment	communication assessment tool (CAT)	immediately post-nephrology clinic visit (on day of enrollment, within 15-100 minutes post-clinic visit)

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): September 15, 2018
• Study Completion (Actual): September 15, 2018

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 18-0283

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