Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Chicago
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- ESRD Knowledge
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
The care provider will not be involved in the enrollment or assessment process. The outcomes assessor will analyze the outcomes without knowledge of allocation.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
ESRD Knowledge
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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 Outcomes
- CKD Self-Efficacy(Baseline, 1 day Post Brief Intervention, Week 4, Week 8, Week 12, Week 16)
- CKD Health Intent(Baseline, 1 day Post-Brief Intervention, Week 4)