Education Program for Kidney Disease

(iPREP-RRT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Non-English speaking, ICU admission, others

Compensation: Varies

Number of Visits: 6

185 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the Education Program for Kidney Disease safe for humans?

The available research does not provide specific safety data for the Education Program for Kidney Disease or its related programs like iPREP-RRT. However, the studies highlight the importance of patient safety in chronic kidney disease management, emphasizing the need for careful monitoring and communication to prevent adverse safety events. ^{1 2 3 4 5}

How is the iPREP-RRT treatment different from other treatments for kidney disease?

The iPREP-RRT treatment is unique because it focuses on an intensive education and referral program, helping patients understand and choose the most suitable renal replacement therapy (RRT) for their condition, which can lead to better preparation and improved outcomes compared to standard treatments that may not emphasize patient education and involvement. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Intensive Patient Referral and Education Program, iPREP-RRT?

Research shows that early patient referral to kidney specialists and education programs can lead to better preparation for kidney treatment and improved survival rates. Additionally, virtual education sessions have been effective in increasing patient access to necessary information, which can help them make informed decisions about their treatment options. ^{3 6 9 11 12}

Are You a Good Fit for This Trial?

This trial is for hospitalized African Americans with advanced chronic kidney disease (CKD). Participants should not have started renal replacement therapy. The program aims to educate and support them in managing their health, focusing on blood pressure control and CKD self-management.

Inclusion Criteria

Self-identify as Black or African American

Admitted to the University of Chicago inpatient general medicine service

My kidney function is significantly reduced (Stage 3B or worse).

Exclusion Criteria

I am unable to give consent because of my mental condition.

Non-English speaking

I am currently in the Intensive Care Unit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Hospital-based Intervention

Participants receive education and self-management support during hospitalization

1 day

1 in-person session

Community-based Intervention

Participants receive ongoing education and support through in-person sessions, phone calls, and text messages

12 weeks

1 in-person session, phone sessions at weeks 4 and 8, weekly text messages

Follow-up

Participants are monitored for knowledge, self-efficacy, and health intent after the intervention

4 weeks

Assessments at weeks 4, 8, 12, and 16

What Are the Treatments Tested in This Trial?

Interventions

• Intensive Patient Referral and Education Program

Trial Overview The iPREP RRT study tests a 12-week program combining hospital- and community-based education, navigation, and self-management support against enhanced usual care. It includes commitment exercises, educational sessions, text messages for health management reinforcement, and blood pressure monitoring.

How Is the Trial Designed?

Group I: Intensive Intervention (iPREP RRT) Experimental Treatment 5 Interventions

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.

Group II: Enhanced Usual Care Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

There is a significant gap between the current management of advanced chronic kidney disease and the ideal care needed to reduce cardiovascular risks and improve patient outcomes, highlighting the need for better infrastructures and training.

Implementing multidisciplinary advanced kidney disease clinics can enhance patient survival and quality of life, while addressing issues like late nephrologist referrals and inadequate patient education on renal replacement therapy options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Reality and desire' in the care of advanced chronic kidney disease. Marrón, B., Craver, L., Remón, C., et al.[2020]

A cooperation program involving nephrologists and dialysis specialists significantly improved patient education and management for chronic kidney disease (CKD), with 92.1% of patients having their prescriptions adjusted and 96.8% receiving nutrition education.

Participation in an educational program for peritoneal dialysis (PD) led to an increase in PD selectivity from 8.8% to 15.0% over two years, highlighting the importance of specialist intervention in enhancing treatment options and patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a cooperative program for peritoneal dialysis. Okada, K., Abe, M., Soma, M.[2019]

Many patients with end-stage renal disease are not properly prepared for starting renal replacement therapy (RRT), which can impact their treatment outcomes.

Early referral to nephrologists and community kidney disease screening can significantly enhance patient preparation for RRT and is linked to improved survival rates after treatment initiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better prevention than cure: optimal patient preparation for renal replacement therapy. Huang, X., Carrero, JJ.[2018]

A quality improvement project successfully increased attendance at kidney replacement therapy (KRT) education sessions for patients with advanced chronic kidney disease (CKD stage 4 and 5) by offering virtual education options, especially beneficial during and after the COVID-19 pandemic.

The virtual sessions provided greater accessibility for patients, reducing travel costs and accommodating those with work or other commitments, ultimately improving patient engagement in their treatment education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Improvement Initiative to Increase Modality Education in a Nephrology Clinic During the COVID-19 Pandemic. Prakash, S., Rabbitt, C., Danylyuk, I., et al.[2023]

A 24-month study involving 62 patients with diabetic nephropathy showed that a disease management education program significantly helped maintain renal function, with only 0 patients in the intervention group requiring renal replacement therapy (RRT) compared to 2 in the control group.

The intervention group also experienced improved hemoglobin A1c (HbA1c) levels, while the control group saw a worsening of their HbA1c, indicating that the education program not only helped with kidney health but also with blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a disease management program focused on acquisition of self-management skills in pre-dialysis patients with diabetic nephropathy: 24 months follow-up. Kazawa, K., Takeshita, Y., Yorioka, N., et al.[2022]

Chronic kidney disease (CKD) patients face a high risk of adverse safety events due to factors like impaired kidney function and polypharmacy, which can lead to serious outcomes such as hospitalization and accelerated kidney function loss.

Telemedicine, particularly through interactive voice-response systems, offers a promising way for CKD patients to communicate safety-related issues to healthcare providers, although many patients face challenges in accessing these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. Weiner, S., Fink, JC.[2022]

The implementation of a renal pharmacist consultant service (RPCS) at hospital admission successfully identified renal drug-related problems (rDRP) in 26.9% of urological patients, leading to significant improvements in appropriate prescribing practices by physicians.

Written recommendations for prescription changes were more accepted when provided in paper form (62.5% acceptance) compared to digital format (42.9% acceptance), highlighting the importance of effective communication methods in enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a renal pharmacist consultant service - Information sharing in paper versus digital form. Seiberth, S., Bauer, D., Schönermarck, U., et al.[2021]

Chronic kidney disease (CKD) is often underrecognized in healthcare, making it a high-risk condition for safety events that can worsen kidney function and lead to end-stage renal disease.

Improving recognition of CKD and implementing disease-specific safety indicators could help reduce adverse safety events and slow the progression of kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. Fink, JC., Brown, J., Hsu, VD., et al.[2023]

In a 6-month study involving 67 chronic kidney disease (CKD) patients, a clinical pharmacist's evaluation identified 142 drug-related problems (DRPs) in 93% of participants, highlighting issues like untreated indications and incorrect dosages.

The intervention not only detected these problems but also facilitated immediate therapeutic adjustments and improved patient education, revealing that many patients were unaware of their treatment benefits and engaged in self-medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of drug-related problems in ambulatory chronic kidney disease patients: a 6-month prospective study. Belaiche, S., Romanet, T., Allenet, B., et al.[2019]

A structured Pre-Dialysis Education Programme (PDEP) significantly influenced patients' choices of renal replacement therapy (RRT) modalities, with 102 out of 177 patients opting for self-care options after participating in the program.

Among the 242 patients studied, those with chronic glomerulonephritis or chronic interstitial nephritis were more likely to choose self-care therapies, suggesting that the underlying cause of end-stage renal disease (ESRD) may impact treatment preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of a pre-dialysis education programme (PDEP) on the mode of renal replacement therapy. Goovaerts, T., Jadoul, M., Goffin, E.[2022]

The expert group developed comprehensive recommendations for renal replacement therapy (RRT) in critically ill patients, addressing key areas such as when to start therapy, technical aspects, and safety protocols, based on the GRADE system.

These guidelines aim to standardize RRT practices in adult and pediatric intensive care settings, helping clinicians make informed decisions to improve patient outcomes in acute renal failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal replacement therapy in adult and pediatric intensive care : Recommendations by an expert panel from the French Intensive Care Society (SRLF) with the French Society of Anesthesia Intensive Care (SFAR) French Group for Pediatric Intensive Care Emergencies (GFRUP) the French Dialysis Society (SFD). Vinsonneau, C., Allain-Launay, E., Blayau, C., et al.[2023]

In a study of 913 adults with acute kidney injury (AKI) undergoing renal replacement therapy (RRT), it was found that the criteria for starting RRT in intensive care units (ICUs) differed from those outside ICUs, particularly in the prevalence of septic AKI and the methods of dialysis used.

Despite these differences in criteria and treatment approaches, the overall patient mortality rates were similar between ICU and non-ICU settings, indicating that the setting of care did not significantly affect outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Renal Replacement Therapy in Intensive Care Units versus Outside Intensive Care Units: Are They Different? Ponce, D., Zamoner, W., Addad, V., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

'Reality and desire' in the care of advanced chronic kidney disease. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Implementation of a cooperative program for peritoneal dialysis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Better prevention than cure: optimal patient preparation for renal replacement therapy. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Quality Improvement Initiative to Increase Modality Education in a Nephrology Clinic During the COVID-19 Pandemic. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

Efficacy of a disease management program focused on acquisition of self-management skills in pre-dialysis patients with diabetic nephropathy: 24 months follow-up. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Implementation of a renal pharmacist consultant service - Information sharing in paper versus digital form. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

Identification of drug-related problems in ambulatory chronic kidney disease patients: a 6-month prospective study. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Influence of a pre-dialysis education programme (PDEP) on the mode of renal replacement therapy. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Renal replacement therapy in adult and pediatric intensive care : Recommendations by an expert panel from the French Intensive Care Society (SRLF) with the French Society of Anesthesia Intensive Care (SFAR) French Group for Pediatric Intensive Care Emergencies (GFRUP) the French Dialysis Society (SFD). [2023]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Acute Renal Replacement Therapy in Intensive Care Units versus Outside Intensive Care Units: Are They Different? [2022]