Educational Strategies for Advanced Kidney Disease
(THRiVE Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pennsylvania
Disqualifiers: Peritoneal dialysis, Preemptive transplant, Cognitive dysfunction, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
36789How 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.
1391011Eligibility 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 am 18 years old or older.
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.
+1 more
Exclusion Criteria
I do not speak English or Spanish.
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.
+2 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment2 Interventions
Group II: Education-PlusExperimental Treatment4 Interventions
Group III: EducationExperimental Treatment3 Interventions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of North Carolina at Chapel HillChapel Hill, NC
University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor
Johns Hopkins UniversityCollaborator
University of North Carolina, Chapel HillCollaborator
References
Make Your Wishes About You (MY WAY): Using Motivational Interviewing to Foster Advance Care Planning for Patients with Chronic Kidney Disease. [2019]Advance care planning for persons with chronic kidney disease is under-utilized despite evidence it can improve care at the end of life. Motivational interviewing and Stages of Change Theory can help healthcare professionals elicit behavior change. This article outlines an approach to advance care planning using motivational interviewing with a healthcare coach to assist patients in expressing their unique values and wishes regarding care at the end of life. This Make Your Wishes About You (MY WAY) approach to advance care planning for patients with chronic kidney disease includes patient education material and a coach training curriculum freely available from the Coalition for Supportive Care of Kidney Patients.
Is there data to support the concept that educated, empowered patients have better outcomes? [2019]Achieving positive patient outcomes through the delivery of high quality services encompasses a broad range of indicators, including quality of life, employment, satisfaction with care, utilization of services, cost-benefit, as well as the clinical indices frequently targeted. Empowering and educational initiatives have been shown to positively impact the quality of life of renal patients in both the psychosocial and functional domains. This has extreme relevance in the context of overall care, as empirical evidence has indicated that health-related quality of life measures are associated with improved hospitalization and survival. Home care and self-care training have been associated with better quality of life measures in hemodialysis. Educational efforts have also been associated with better outcomes such as decreased utilization of medical services, the maintenance of employment, consumer satisfaction with care, and a positive cost-benefit. There are data to support that the educated, empowered patient has better outcomes. This evidence will be explored.
Intervening on health literacy by knowledge translation processes in kidney transplantation: A feasibility study. [2022]Patients awaiting kidney transplantation need to be prepared ahead of the upcoming transplantation by developing targeted pre- and post-transplant knowledge. On this background, we designed a new health literacy intervention, including a film and a counselling session, based on motivational interviewing for dialysis patients provided by dialysis nurses.
[The Effects of an Empowerment Education Program for Kidney Transplantation Patients]. [2019]This study was conducted to develop an Empowerment Education Program (EEP) for kidney transplant patients and to test the program's effects on uncertainty, self-care ability, and compliance.
Patient empowerment and motivational interviewing: engaging patients to self-manage their own care. [2022]Patient empowerment is centered on the belief that patients should be in control of their own care and that behavioral changes and adherence to therapies cannot be achieved unless patients internalize the need for self-change. Data have consistently shown improved outcomes among patients on dialysis who are engaged, empowered and self-managing. Motivational interviewing provides a technique that can be applied by nephrology nurses to partner with patients and engage them in the management of their own care.
Needs and Considerations for Standardization of Kidney Disease Education in Patients with Advanced CKD. [2023]Kidney health advocacy organizations and leaders in the nephrology community have repeatedly emphasized the need to increase home dialysis utilization in the United States. Limited awareness and understanding of options for the management of kidney failure among patients living with advanced CKD is a significant barrier to increasing the selection and use of home dialysis. Studies have shown that providing targeted comprehensive patient education before the onset of kidney failure can improve patients' awareness of kidney disease and substantially increase the informed utilization of home dialysis. Unfortunately, in the absence of validated evidence-based education protocols, outcomes associated with home dialysis use vary widely among published studies, potentially affecting the routine implementation and reporting of these services among patients with advanced CKD. This review provides pragmatic guidance on establishing effective patient-centered education programs to empower patients to make informed decisions about their KRT and, in turn, increase home dialysis use.
A Randomized Controlled Trial of a Mobile Clinical Decision Aid to Improve Access to Kidney Transplantation: iChoose Kidney. [2022]Kidney transplantation is the preferred treatment for patients with end-stage renal disease, as it substantially increases a patient's survival and is cost saving compared to a lifetime of dialysis. However, transplantation is not universally chosen by patients with renal failure, and limited knowledge about the survival benefit of transplantation vs. dialysis may play a role. We created a mobile application clinical decision aid called iChoose Kidney to improve access to individualized prognosis information comparing dialysis and transplantation outcomes. We describe the iChoose Kidney study, a randomized controlled trial designed to test the clinical efficacy of a mobile health decision aid among end-stage renal disease patients referred for kidney transplantation at three large, diverse transplant centers across the U.S. Approximately 450 patients will be randomized to receive either: (1) standard of care or "usual" transplantation education, or (2) standard of care plus iChoose Kidney. The primary outcome is change in knowledge about the survival benefit of kidney transplantation vs. dialysis from baseline to immediate follow-up; secondary outcomes include change in treatment preferences, improved decisional conflict, and increased access to kidney transplantation. Analyses are also planned to examine effectiveness across subgroups of race, socioeconomic status, health literacy and health numeracy. Engaging patients in health care choices can increase patient empowerment and improve knowledge and understanding of treatment choices. If the effectiveness of iChoose Kidney has a greater impact on patients with low health literacy, lower socioeconomic status, and minority race, this decision aid could help reduce disparities in access to kidney transplantation.
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]To report a study protocol that refines then examines feasibility, preliminary efficacy and satisfaction of ADHERE, an intervention using motivational interviewing and brief cognitive behaviorial therapy as a mechanism for goal-oriented systematic patient education to promote symptom management and adherence among cancer patients prescribed oral anti-cancer agents.
Applying best practices to designing patient education for patients with end-stage renal disease pursuing kidney transplant. [2023]Despite the known benefits of kidney transplant, less than 30% of the 615 000 patients living with end-stage renal disease (ESRD) in the United States have received a transplant. More than 100 000 people are presently on the transplant waiting list. Although the shortage of kidneys for transplant remains a critical factor in explaining lower transplant rates, another important and modifiable factor is patients' lack of comprehensive education about transplant. The purpose of this article is to provide an overview of known best practices from the broader literature that can be used as an evidence base to design improved education for ESRD patients pursuing a kidney transplant. Best practices in chronic disease education generally reveal that education that is individually tailored, understandable for patients with low health literacy, and culturally competent is most beneficial. Effective education helps patients navigate the complex health care process successfully. Recommendations for how to incorporate these best practices into transplant education design are described. Providing more ESRD patients with transplant education that encompasses these best practices may improve their ability to make informed health care decisions and increase the numbers of patients interested in pursuing transplant.
Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial. [2021]Predialysis education for patients with advanced chronic kidney disease (CKD) typically focuses narrowly on haemodialysis and peritoneal dialysis as future treatment options. However, patients who are older or seriously ill may not want to pursue dialysis and/or may not benefit from this treatment. Conservative kidney management, a reasonable alternative treatment, and advance care planning (ACP) are often left out of patient education and shared decision-making. In this study, we will pilot an educational intervention (Conservative Kidney Management Options and Advance Care Planning Education-COPE) to improve knowledge of conservative kidney management and ACP among patients with advanced CKD who are older and/or have poor functional status.
Educating Patients about CKD: The Path to Self-Management and Patient-Centered Care. [2022]Patient education is associated with better patient outcomes and supported by international guidelines and organizations, but a range of barriers prevent widespread implementation of comprehensive education for people with progressive kidney disease, especially in the United States. Among United States patients, obstacles to education include the complex nature of kidney disease information, low baseline awareness, limited health literacy and numeracy, limited availability of CKD information, and lack of readiness to learn. For providers, lack of time and clinical confidence combine with competing education priorities and confusion about diagnosing CKD to limit educational efforts. At the system level, lack of provider incentives, limited availability of practical decision support tools, and lack of established interdisciplinary care models inhibit patient education. Despite these barriers, innovative education approaches for people with CKD exist, including self-management support, shared decision making, use of digital media, and engaging families and communities. Education efficiency may be increased by focusing on people with progressive disease, establishing interdisciplinary care management including community health workers, and providing education in group settings. New educational approaches are being developed through research and quality improvement efforts, but challenges to evaluating public awareness and patient education programs inhibit identification of successful strategies for broader implementation. However, growing interest in improving patient-centered outcomes may provide new approaches to effective education of people with CKD.