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

The University of Chicago

Status: Enrolling

Conditions: Chronic Kidney Disease; Hypertension

Treatments: Behavioral: Text-based reinforcement for general health self-management; Behavioral: Written Patient Education; Behavioral: Blood pressure monitoring; Behavioral: Community-based education session, reinforcement for self-management; Behavioral: Commitment to Change; Behavioral: In-Person Patient Education; Behavioral: Text-based reinforcement for CKD self-management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06397456

IRB20-1663

R01DK124597 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

Intensive Intervention (iPREP RRT)

Experimental group

Description:

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.

Treatment:

Behavioral: Text-based reinforcement for CKD self-management

Behavioral: Commitment to Change

Behavioral: In-Person Patient Education

Behavioral: Community-based education session, reinforcement for self-management

Behavioral: Blood pressure monitoring

Enhanced Usual Care

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Text-based reinforcement for general health self-management

Behavioral: Written Patient Education