Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy (iPREP-RRT)

Intensive Patient Referral and Education Program prior to Renal Replacement Therapy (iPREP-RRT) is a 12-week intervention that identifies hospitalized African Americans with advanced chronic kidney disease (CKD) and provides them with hospital- and community-based education, navigation and self-management support. Participants will be randomized to the iPREP-RRT intervention versus enhanced usual care.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Chronic Kidney Disease
• Intervention / Treatment: Behavioral: In-Person Patient Education; Behavioral: Commitment to Change; Behavioral: Blood pressure monitoring; Behavioral: Text-based reinforcement for CKD self-management; Behavioral: Community-based education session, reinforcement for self-management; Behavioral: Written Patient Education; Behavioral: Text-based reinforcement for general health self-management

Detailed Description

The Intensive Patient Referral and Education Program prior to Renal Replacement Therapy (iPREP-RRT) will determine the efficacy of the hospital-based patient intervention (HPI) in improving patient knowledge, self-efficacy, and intent for chronic kidney disease (CKD) self-management and renal replacement therapy (RRT) planning; and 2) determine the efficacy of the community-based patient intervention (CPI) during a 12 week outpatient follow-up program that combines outpatient follow-up with multiple modes of communication (in-person session, phone calls and personalized text messaging) and navigation in increasing participants' initiation and maintenance of CKD self-management and RRT planning, compared to enhanced usual care (attention controls).

The goal is to improve knowledge and outcomes for African American patients with advanced CKD through the iPREP-RRT. To accomplish this goal, investigators will 1) determine the efficacy of the hospital-based patient intervention (HPI) in improving participant knowledge, self-efficacy, and intent for CKD self-management and RRT planning; and 2) determine the efficacy of the community-based patient intervention (CPI) during a 12 week outpatient program that combines outpatient follow-up with multiple modes of communication (in-person session, phone calls and personalized text messaging) and navigation in increasing initiation and maintenance of CKD self-management and RRT planning, compared to enhanced usual care. To that end, investigators will conduct a one-site randomized controlled trial, where participants will be randomized in a 1:1 ratio into either the intervention (iPREP-RRT) or control groups (enhanced usual care). The randomization will be stratified by baseline blood pressure (controlled or uncontrolled). Participants will receive 2 in-person education sessions (during hospitalization and week 12), phone sessions at weeks 4 and 8, and weekly personalized text message contact. The duration of the intervention will be 12 weeks, and participants and controls will be assessed pre-intervention, immediately post-hospital based intervention, at 4 ,8 and 12 weeks during community-based intervention and 4 weeks post-intervention (16 weeks).

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medical Center
      • Contact: Akilah King, MSW; Email: Akilah.King@bsd.uchicago.edu
      • Contact: Milda Saunders, MD; Phone Number: 773-702-5941; Email: msaunders@uchicago.edu
      • Principal Investigator: Milda R. Saunders, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients over the age of 18 and under 70
• Admitted to the University of Chicago inpatient general medicine service
• Likely hospital stay greater than 48 hours
• Diagnosis of advanced CKD (Stage 3B or above, as determine by problem list, ICD- 10 codes or eGFR<45 during admission and from previous medical encounters)
• Self-identify as Black or African American

Exclusion Criteria:

• Non-English speaking
• Unable to communicate due to current medical status
• Unable to consent due to mental status
• Expected hospital stay less than 24 hour
• Current admission in ICU

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive Intervention (iPREP RRT); The intervention is administered by a patient educator (PE), a culturally concordant health educator. S/he will review the CKD and RRT education materials on a tablet device with the participant, answer any questions they have, and using motivational interviewing techniques get a commitment for future action. The participant and the patient educator will work together to decide on potential CKD self-management and RRT options and/or next steps. The PE will teach the participant how to use the home blood pressure monitor and will leave it with the participant. The patient educator will check in with the participant through text messages and follow-up phone calls.	Behavioral: In-Person Patient Education; In-person patient education about CKD, CKD risk factor management and renal replacement therapy options.; Behavioral: Commitment to Change; Motivational interviewing to assist participants in committing to change in CKD management or RRT selection.; Behavioral: Blood pressure monitoring; Participants will learn how to check their blood pressure and will receive a blood pressure cuff for home.; Behavioral: Text-based reinforcement for CKD self-management; Patient educator will use text messages based on social cognitive theory to remind participants about and reinforce goals set around CKD self-management, blood pressure control and RRT selection; Behavioral: Community-based education session, reinforcement for self-management; Patient educator will use provide a "booster" session based on social cognitive theory to remind participants about and reinforce goals set around CKD self-management, blood pressure control and RRT selection
Placebo Comparator: Enhanced Usual Care; The enhanced usual care is administered by a patient educator (PE), a culturally concordant health educator. The PE will drop off written general health education materials. The patient educator will check in with the participant through text messages.	Behavioral: Written Patient Education; Written patient education booklet about general health care management including taking medications, having a primary care doctor, weight management and exercise.; Behavioral: Text-based reinforcement for general health self-management; Patient educator will use text messages to send general health management messages

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney Disease Knowledge Questionnaire (KIKS)	The Kidney Disease Knowledge Questionnaire (KIKS) is a validated instrument that assesses CKD knowledge. Scores range from 0 (no knowledge)-28 (full knowledge). Change =Post intervention-Baseline scores, and Follow-up (Week 4, Week 12, Week 16)-Baseline	Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16
ESRD Knowledge	The Kidney Failure Treatment Knowledge is an investigator developed tool that assesses knowledge of 6 ESKD treatment options using a Likert scale (0=no knowledge and 4=a great deal of knowledge). Possible scores range from 0-24. Change =Post intervention-Baseline scores, and Follow-up (Week 4, Week 12, Week 16)-Baseline	Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16
Blood Pressure Knowledge	Blood Pressure Knowledge Scale (BPKS, revised) is an 11-item scale; a summed score is computed. Scores range from 7 to 77 and higher scores indicate greater knowledge. Change =Post intervention-Baseline scores, and Follow-up (Week 4, Week 12, Week 16)-Baseline	Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16
CKD Self-Management	The CKD Self-Management Knowledge Toolkit (CKD-SMKT) is a validated 10 item survey to assess participants CKD self-management behaviors. The survey consists of 2 true /false questions for each of the 10 self-care domains and can be scored from 0 (no self-care) to 20 (full self-care). Change is Follow-up Score (Week 8, Week 12, Week 16)-Baseline	Baseline, Week 8, Week 12, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CKD Self-Efficacy	CKD Self-Efficacy Scale (CKD-SE), 25-item CKD-SE instrument can be used for the early identification of patients with low self-efficacy. The scale is from 0 to 10 points, and a larger number indicates a higher level of confidence regarding the management activity. The total score on the scale ranges between 25 and 250. The total score can be classified into three categories: low self-efficacy (score less than 30), moderate (scores between 30 to 70), and high self-efficacy (score more than 70). Change is Follow-up Score (Week 8, Week 12, Week 16)-Baseline	Baseline, 1 day Post Brief Intervention, Week 4, Week 8, Week 12, Week 16
CKD Health Intent	The Health Intent Survey is an investigator-developed tool to measure participants stated intent to make healthy lifestyle changes. There are 12 questions each scored on a 5 point scale from 1=extremely unlikely to 5=extremely likely (60 total possible points with higher scores better). Change=Follow-up (1 day post-intervention, Wk4, wk 8, wk 12, wk16) - baseline.	Baseline, 1 day Post-Brief Intervention, Week 4

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 12, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Motivational Interviewing; African American; Hospitalized Patients
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Hypertension; Renal Insufficiency, Chronic; Equipment and Supplies; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Diagnostic Equipment; Sphygmomanometers; Self-Management; Blood Pressure Monitors
• Other Study ID Numbers: IRB20-1663; R01DK124597 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will share de-identified, aggregate data with other researchers. Additional sharing not permitted by current IRB permission.

Drug and device information, study documents

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