Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy

Not Applicable

Recruiting

• Conditions: Chronic Kidney Disease; Hypertension
• Interventions: Behavioral: In-Person Patient Education; Behavioral: Written Patient Education; Behavioral: Text-based reinforcement for general health self-management; 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

• Registration Number: NCT06397456
• Lead Sponsor: University of Chicago

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-03
• Status Verified: 2024-08
• Study Start: 2024-09-04
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 185

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Intervention (iPREP RRT)	Blood pressure monitoring	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.
Intensive Intervention (iPREP RRT)	Text-based reinforcement for CKD self-management	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.
Enhanced Usual Care	Text-based reinforcement for general health self-management	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.
Intensive Intervention (iPREP RRT)	In-Person Patient Education	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.
Intensive Intervention (iPREP RRT)	Commitment to Change	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.
Intensive Intervention (iPREP RRT)	Community-based education session, reinforcement for self-management	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.
Enhanced Usual Care	Written Patient Education	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.

Primary Outcome Measures

Name	Time	Method
ESRD Knowledge	Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16	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
Blood Pressure Knowledge	Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16	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
Kidney Disease Knowledge Questionnaire (KIKS)	Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16	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
CKD Self-Management	Baseline, Week 8, Week 12, Week 16	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

Secondary Outcome Measures

Name	Time	Method
CKD Self-Efficacy	Baseline, 1 day Post Brief Intervention, Week 4, Week 8, Week 12, Week 16	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
CKD Health Intent	Baseline, 1 day Post-Brief Intervention, Week 4	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.

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States