Clinical trial NCT06397456: Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy
Official title: Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease
Hypertension
Keywords: Hospitalized Patients
African American
Motivational Interviewing
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-05-03
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Kidney Disease Knowledge Questionnaire (KIKS)
timeFrame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16
measure: ESRD Knowledge
timeFrame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16
measure: Blood Pressure Knowledge
timeFrame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16
measure: CKD Self-Management
timeFrame: Baseline, Week 8, Week 12, Week 16
Secondary outcomes:
measure: CKD Self-Efficacy
timeFrame: Baseline, 1 day Post Brief Intervention, Week 4, Week 8, Week 12, Week 16
measure: CKD Health Intent
timeFrame: Baseline, 1 day Post-Brief Intervention, Week 4
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
References: