Educational Strategies for Advanced Kidney Disease

(THRiVE Trial)

Recruiting at 1 trial location

Overseen By Clara Walling

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Peritoneal dialysis, Preemptive transplant, Cognitive dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

360 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on educational strategies rather than medication changes.

What data supports the effectiveness of the treatment Educational Strategies for Advanced Kidney Disease?

Research shows that educational and empowerment programs can improve the quality of life for kidney patients by helping them manage their own care better. Motivational interviewing, a part of this treatment, has been effective in encouraging behavior change and improving patient outcomes in kidney disease management. ^{1 2 3 4 5}

Is the educational strategy for advanced kidney disease safe for humans?

The educational strategies, including motivational interviewing and tailored education, have been used safely in various health conditions, such as cancer and kidney disease, to improve patient understanding and management of their health. ^{3 6 7 8 9}

How is the treatment 'Educational Strategies for Advanced Kidney Disease' different from other treatments for kidney disease?

This treatment is unique because it combines educational materials and motivational interviewing to help patients with advanced kidney disease understand their options, including conservative management and advance care planning, which are often overlooked in standard care. It focuses on culturally and linguistically tailored education, making it more accessible and relevant to diverse patient populations. ^{1 3 9 10 11}

What is the purpose of this trial?

The focus of this study is on vascular access for hemodialysis. This is a randomized clinical trial testing 3 educational approaches to help patients with advanced chronic kidney disease prepare for placement of hemodialysis vascular access. Study participants will each be assigned to one of the 3 approaches: 1) "Education", in which participants will be given a video and brochure that provide information about the types of vascular access and what can be expected before and after the vascular access is placed, 2) "Education-Plus", in which participants will be given the video and brochure and will also have sessions by telehealth with a motivational interviewing coach to provide additional support around vascular access placement, and 3) "Usual Care", in which participants will have the usual education provided by their kidney doctor and clinic staff just as if they were not in the study. Participants in all 3 groups will be asked to complete questionnaires by telephone and may be invited to be interviewed about their experience with the study intervention at the end of the study. Study participation will last for about 12 months, with most of the study activities taking place during the first 3 months.

Research Team

Deidra Crews, MD, ScM

Principal Investigator

Johns Hopkins University

Laura M. Dember, MD

Principal Investigator

University of Pennsylvania

Jennifer Flythe, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for adults over 18 with advanced chronic kidney disease who've discussed hemodialysis with their doctor, visited a nephrologist in the last 18 months, and have specific lab results indicating severe kidney function decline. It's not for those already planning different kidney failure treatments or who can't use the educational materials due to cognitive or visual impairments.

Inclusion Criteria

I have discussed starting hemodialysis with my kidney doctor.

I have seen a kidney specialist for my chronic kidney disease in the last 18 months.

My kidney function is severely reduced or my risk of kidney failure is high.

Exclusion Criteria

I am planning treatment for kidney failure that doesn't involve regular dialysis.

I have an appointment with a surgeon for an evaluation or to create a pathway for dialysis.

You have had a previous surgery to create a blood access point.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education Phase

Participants receive educational materials and support based on their assigned group: Education, Education-Plus, or Usual Care.

12 weeks

Telehealth sessions and telephone questionnaires

Follow-up

Participants are monitored for outcomes such as vascular access evaluation and decision self-efficacy.

12 months

Treatment Details

Interventions

• Educational Materials
• Motivational Interviewing
• Usual Care

Trial Overview The study compares three ways of teaching about vascular access for hemodialysis: 'Education' uses a video and brochure; 'Education-Plus' adds motivational interviews via telehealth; 'Usual Care' is what patients normally get from doctors. Participants will be randomly assigned to one method and share feedback through questionnaires and possible interviews.

Participant Groups

Group I: Usual Care Experimental Treatment 2 Interventions

Group II: Education-Plus Experimental Treatment 4 Interventions

Group III: Education Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Findings from Research

Advance care planning is often overlooked for patients with chronic kidney disease, but it can significantly enhance end-of-life care, highlighting the need for better implementation.

The MY WAY approach, which incorporates motivational interviewing and a healthcare coach, provides a structured method for patients to articulate their values and preferences regarding end-of-life care, with resources available for both patients and healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Make Your Wishes About You (MY WAY): Using Motivational Interviewing to Foster Advance Care Planning for Patients with Chronic Kidney Disease. Anderson, E., Aldous, A., Lupu, D.[2019]

Empowering and educational initiatives significantly improve the quality of life for renal patients, impacting both psychosocial and functional aspects, which is crucial for overall patient care.

Patients who receive home care and self-care training in hemodialysis show better quality of life, reduced medical service utilization, and higher satisfaction with care, highlighting the benefits of patient education and empowerment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there data to support the concept that educated, empowered patients have better outcomes? Latham, CE.[2019]

A new health literacy intervention, which included a film and motivational interviewing sessions led by dialysis nurses, was positively received by both patients and nurses, indicating its feasibility and acceptability for preparing patients for kidney transplantation.

The intervention fostered meaningful dialogue that enhanced patients' understanding and confidence, although nurses found the motivational interviewing approach challenging, highlighting the need for additional training and support for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervening on health literacy by knowledge translation processes in kidney transplantation: A feasibility study. Andersen, MH., Urstad, KH., Larsen, MH., et al.[2022]

The Empowerment Education Program (EEP) significantly reduced uncertainty in kidney transplant patients, with improvements observed immediately after the program and four weeks later, indicating lasting effects.

Patients who participated in the EEP also showed significant increases in self-care ability and compliance with treatment, suggesting that the program effectively supports their health management post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Effects of an Empowerment Education Program for Kidney Transplantation Patients]. Kim, SH., You, HS.[2019]

Engaging and empowering patients in their own care leads to better health outcomes for those on dialysis, highlighting the importance of patient involvement in treatment decisions.

Motivational interviewing is an effective technique that nephrology nurses can use to help patients take control of their care and encourage self-management behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient empowerment and motivational interviewing: engaging patients to self-manage their own care. McCarley, P.[2022]

Increasing awareness and understanding of home dialysis options among patients with advanced chronic kidney disease (CKD) is crucial for improving its utilization in the U.S.

Targeted patient education before kidney failure can significantly enhance knowledge about kidney disease and promote informed choices regarding home dialysis, but the lack of standardized education protocols leads to inconsistent outcomes in home dialysis implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Needs and Considerations for Standardization of Kidney Disease Education in Patients with Advanced CKD. Shukla, AM., Cavanaugh, KL., Jia, H., et al.[2023]

The iChoose Kidney mobile application is being tested in a randomized controlled trial involving approximately 450 patients to improve knowledge about the survival benefits of kidney transplantation compared to dialysis.

If successful, the iChoose Kidney app could empower patients, particularly those with low health literacy and from minority backgrounds, potentially reducing disparities in access to kidney transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Mobile Clinical Decision Aid to Improve Access to Kidney Transplantation: iChoose Kidney. Patzer, RE., Basu, M., Mohan, S., et al.[2022]

The ADHERE intervention, which combines motivational interviewing and brief cognitive behavioral therapy, aims to improve symptom management and adherence to oral anti-cancer agents among cancer patients, with a study involving 65 participants across two phases.

This nurse-led program is designed to standardize patient education and support self-management at home, potentially enhancing the effectiveness of cancer treatment by empowering patients to take charge of their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A trial examining an advanced practice nurse intervention to promote medication adherence and symptom management in adult cancer patients prescribed oral anti-cancer agents: study protocol. Spoelstra, SL., Burhenn, PS., DeKoekkoek, T., et al.[2019]

Less than 30% of patients with end-stage renal disease (ESRD) in the U.S. have received a kidney transplant, highlighting a significant gap in treatment despite the known benefits of transplantation.

Improving education for ESRD patients about kidney transplants, particularly through tailored, understandable, and culturally competent approaches, could increase patient interest and informed decision-making regarding transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying best practices to designing patient education for patients with end-stage renal disease pursuing kidney transplant. Skelton, SL., Waterman, AD., Davis, LA., et al.[2023]

The study aims to improve knowledge about conservative kidney management and advance care planning among older patients with advanced chronic kidney disease (CKD) through a pilot educational intervention called COPE, focusing on patients aged 70 and older or with poor functional status.

This randomized controlled trial will assess the effectiveness of the COPE intervention in enhancing patient knowledge and communication preferences regarding kidney management options, with outcomes measured at multiple time points over 12 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial. Stallings, TL., Temel, JS., Klaiman, TA., et al.[2021]

Patient education is crucial for improving outcomes in individuals with progressive kidney disease, but various barriers such as low health literacy, limited information availability, and provider time constraints hinder its implementation in the U.S.

Innovative educational strategies, including self-management support and community engagement, show promise in enhancing patient education, particularly for those with advanced kidney disease, despite challenges in evaluating their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educating Patients about CKD: The Path to Self-Management and Patient-Centered Care. Narva, AS., Norton, JM., Boulware, LE.[2022]

References

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

Make Your Wishes About You (MY WAY): Using Motivational Interviewing to Foster Advance Care Planning for Patients with Chronic Kidney Disease. [2019]

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

Is there data to support the concept that educated, empowered patients have better outcomes? [2019]

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

Intervening on health literacy by knowledge translation processes in kidney transplantation: A feasibility study. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

[The Effects of an Empowerment Education Program for Kidney Transplantation Patients]. [2019]

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

Patient empowerment and motivational interviewing: engaging patients to self-manage their own care. [2022]

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

Needs and Considerations for Standardization of Kidney Disease Education in Patients with Advanced CKD. [2023]

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

A Randomized Controlled Trial of a Mobile Clinical Decision Aid to Improve Access to Kidney Transplantation: iChoose Kidney. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A trial examining an advanced practice nurse intervention to promote medication adherence and symptom management in adult cancer patients prescribed oral anti-cancer agents: study protocol. [2019]

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

Applying best practices to designing patient education for patients with end-stage renal disease pursuing kidney transplant. [2023]

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

Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial. [2021]

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

Educating Patients about CKD: The Path to Self-Management and Patient-Centered Care. [2022]