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Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy

NCT06397456 · University of Chicago
In plain English

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About this study
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).
Eligibility criteria
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 design
Enrollment target: 180 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-09-04
Estimated completion: 2026-06-30
Last updated: 2025-11-14
Interventions
Behavioral: In-Person Patient EducationBehavioral: Commitment to ChangeBehavioral: Blood pressure monitoringBehavioral: Written Patient EducationBehavioral: Text-based reinforcement for CKD self-managementBehavioral: Community-based education session, reinforcement for self-managementBehavioral: Text-based reinforcement for general health self-management
Primary outcomes
  • Kidney Disease Knowledge Questionnaire (KIKS) (Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16)
  • ESRD Knowledge (Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16)
  • Blood Pressure Knowledge (Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16)
Sponsor
University of Chicago · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
All locations (1)
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States