Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy

Overview

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).

Interventions

• 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 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 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
• Behavioral Text-based reinforcement for general health self-management
  Patient educator will use text messages to send general health management messages

Primary outcome measures

• Kidney Disease Knowledge Questionnaire (KIKS) [Time frame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16]
• ESRD Knowledge [Time frame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16]
• Blood Pressure Knowledge [Time frame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16]
• CKD Self-Management [Time frame: Baseline, Week 8, Week 12, Week 16]

Secondary outcome measures (2)

• CKD Self-Efficacy [Time frame: Baseline, 1 day Post Brief Intervention, Week 4, Week 8, Week 12, Week 16]
• CKD Health Intent [Time frame: Baseline, 1 day Post-Brief Intervention, Week 4]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

United States · 1 center

• University of Chicago Medical Center — Chicago

Identifiers

NCT: NCT06397456 · IRB20-1663 · R01DK124597

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗