CKM JumpStart Tool for Chronic Kidney Disease

Recruiting at 1 trial location

Overseen By Olivia Gaughran, MA

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Dialysis

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

Compensation: Varies

Number of Visits: 3

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool designed to help older patients with advanced kidney disease discuss treatment options with their doctors. The goal is to evaluate the tool's ease of use and effectiveness in facilitating discussions about conservative kidney management. Suitable candidates for this trial are English-speaking patients aged 75 and older with advanced kidney disease, who are willing to discuss their treatment choices and receive care from UW Medicine or VA Puget Sound. As an unphased trial, participants can help develop valuable resources for patient-doctor communication.

Do I need to stop my current medications for this trial?

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

What prior data suggests that this tool is safe for use in patients with chronic kidney disease?

Research shows that the CKM JumpStart Tool helps older patients with advanced kidney disease discuss managing their condition without dialysis. Specific safety data isn't available for this tool because it isn't a drug or medical device; rather, it guides conversations.

As it isn't a physical treatment, typical safety concerns like side effects or adverse reactions don't apply. The tool aims to make discussions about kidney care easier and more effective, ensuring safety in terms of physical health risks. The study examines the tool's effectiveness and its reception by patients and doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CKM JumpStart Tool because it offers a new approach to managing chronic kidney disease (CKD). Unlike traditional treatments that primarily focus on medication to slow disease progression or manage symptoms, this tool is designed to enhance patient engagement and self-management. By providing personalized guidance and actionable steps, the CKM JumpStart Tool aims to empower patients to take a more active role in their health, potentially improving outcomes and quality of life. This innovative method could fill a critical gap, offering a complementary strategy alongside existing treatments like ACE inhibitors or dialysis.

What evidence suggests that the CKM Jumpstart Tool is effective for promoting discussion about conservative kidney management?

Research shows that the CKM JumpStart Tool helps older patients with advanced chronic kidney disease (CKD) discuss conservative kidney management (CKM). CKM is a recognized option for managing advanced CKD for those who do not want dialysis. In this trial, some participants will receive the CKM JumpStart Tool intervention, while others will be in a control group without it. Limited data exists on the tool's effectiveness because testing is still in early stages, but it aims to improve communication. The goal is to facilitate discussions between patients and healthcare providers about CKM as a treatment option. Early signs suggest this could help patients make informed decisions about their care. ^{1 2 3 4 6}

Who Is on the Research Team?

Susan P Wong, MD, MS

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 75 or older with advanced chronic kidney disease (CKD), defined by specific low eGFR levels. Participants must receive care from UW Medicine or VA Puget Sound and be open to discussing treatment options. Those already on maintenance dialysis, or unable to consent are excluded.

Inclusion Criteria

English-speaking

Receive care from a provider at UW Medicine or VA Puget Sound

I am 75 years old or older.

Exclusion Criteria

I am on maintenance dialysis.

I am unable to understand or sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the CKM Jumpstart Tool intervention or usual care

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for discussion of CKM with healthcare providers and user experience of the CKM JumpStart Tool

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CKM Jumpstart Tool

Trial Overview

The study is testing the CKM JumpStart Tool's effectiveness in facilitating conversations between elderly patients with advanced CKD and their healthcare providers about conservative kidney management.

How Is the Trial Designed?

Group I: CKM Jumpstart Tool Experimental Treatment 1 Intervention

Receives intervention

Group II: Control Active Control 1 Intervention

Does not receive intervention

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

Patients with chronic kidney disease (CKD) are particularly vulnerable to adverse drug events during hospitalization, which can lead to significant harm.

The study emphasizes the need for new strategies to minimize medical errors and improve safety for CKD patients in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication errors in chronic kidney disease: one piece in the patient safety puzzle. Fink, JC., Chertow, GM.[2022]

A decision aid focused on conservative kidney management (CKM) significantly improved discussions about CKM between patients with advanced chronic kidney disease (CKD) and their healthcare providers, with 26.4% of patients discussing CKM compared to only 3.0% in the usual care group.

The study, which included 92 patients aged 75 and older, demonstrated that the decision aid was both feasible and acceptable, suggesting it could enhance patient education and decision-making regarding CKD treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Patient Decision Aid About Conservative Kidney Management in Advanced Kidney Disease: A Randomized Pilot Trial. Wong, SPY., Oestreich, T., Prince, DK., et al.[2023]

A quality improvement project in the UK aims to enhance early referral to specialist renal services for patients with End-Stage Kidney Disease (ESKD) by using an innovative database that tracks kidney function over time, potentially reducing late presentations to renal replacement therapy (RRT).

The project will evaluate its effectiveness by measuring the proportion of patients referred to specialist services within 90 days of starting RRT, alongside qualitative assessments of the intervention's adoption by healthcare providers, indicating a comprehensive approach to improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A programme to spread eGFR graph surveillance for the early identification, support and treatment of people with progressive chronic kidney disease (ASSIST-CKD): protocol for the stepped wedge implementation and evaluation of an intervention to reduce late presentation for renal replacement therapy. Gallagher, H., Methven, S., Casula, A., et al.[2022]

The study aims to compare the effectiveness of a facilitated TRANSLATE model versus computer decision support (CDS) alone in improving care for chronic kidney disease (CKD) in primary care settings, involving a cluster randomized controlled trial with practices that have at least 2,000 patients.

This research will assess adherence to treatment guidelines, CKD progression, and all-cause mortality, while also evaluating the cost-effectiveness of the facilitated model, potentially leading to better management of CKD in primary care and improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving evidence-based primary care for chronic kidney disease: study protocol for a cluster randomized control trial for translating evidence into practice (TRANSLATE CKD). Fox, CH., Vest, BM., Kahn, LS., et al.[2023]

Only 7% of patients with chronic kidney disease (CKD) were planning for conservative kidney management (CKM), indicating a lack of awareness or discussion about this treatment option among patients.

While most healthcare providers felt comfortable discussing CKM, none of the clinics had dedicated resources or protocols for CKM, highlighting a significant gap in the implementation of this approach in the United States.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative Kidney Management Practice Patterns and Resources in the United States: A Cross-Sectional Analysis of CKDopps (Chronic Kidney Disease Outcomes and Practice Patterns Study) Data. Scherer, JS., Bieber, B., de Pinho, NA., et al.[2023]

Chronic kidney disease (CKD) that does not require dialysis significantly increases the risk of adverse safety events, which can lead to poor patient outcomes, highlighting the need for better safety measures in CKD care.

Medication errors are prevalent in CKD patients and contribute to safety lapses, indicating that a standardized set of disease-specific safety indicators is essential for improving patient safety and outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding a common language for patient safety in CKD. Fink, JC., Joy, MS., St Peter, WL., et al.[2019]

Patients with chronic kidney disease (CKD) face increased risks of adverse safety events due to medication dosing errors and the use of nephrotoxic drugs, which can worsen kidney function.

Improving outcomes for CKD patients may involve better communication among healthcare providers and empowering patients to manage their condition with support from multidisciplinary care teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse safety events in patients with Chronic Kidney Disease (CKD). Offurum, A., Wagner, LA., Gooden, T.[2017]

A national survey of 67 UK renal units revealed that almost all provide Conservative Kidney Management (CKM) for older patients with stage 5 chronic kidney disease, but practices and organization vary significantly across units.

There is a strong call for more research to compare the outcomes of CKM versus dialysis, as many units lack a common definition of CKM, making it difficult to assess its effectiveness and scale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative care for ESRD in the United Kingdom: a national survey. Okamoto, I., Tonkin-Crine, S., Rayner, H., et al.[2022]

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

Effective conservative kidney management (CKM) is essential for nephrology fellows to learn, especially for patients with end-stage kidney disease who opt out of dialysis, but current training programs lack a standardized curriculum and assessment methods.

The article advocates for the inclusion of CKM in the Accreditation Council for Graduate Medical Education (ACGME) milestones, emphasizing the need for nephrology trainees to acquire knowledge, skills, and attitudes necessary for implementing CKM effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching Conservative Kidney Management and Other Palliative Care Skills in Nephrology Fellowships. Leonberg-Yoo, AK., Gilbert, SJ.[2023]

The Advanced CKD Patient Management Toolkit was pilot tested in two community nephrology practices, showing an increase in guideline conformance from an average of 54% to 59% after implementation.

The toolkit's effectiveness varied by site and was influenced by factors such as the involvement of site champions and the perceived value of the tools, highlighting the importance of customization and targeted implementation in improving patient management for advanced chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of the advanced chronic kidney disease patient management tools: case studies. Patwardhan, MB., Matchar, DB., Samsa, GP., et al.[2008]

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]

A systematic review of five studies involving 494 physicians and 42,852 patients with chronic kidney disease (CKD) found that both computer-assisted and education-based chronic disease management (CDM) interventions did not significantly improve the use of ACE inhibitors or angiotensin receptor blockers compared to usual care.

The results suggest that current CDM strategies for primary care providers managing CKD have minimal impact on improving patient care, indicating a need for alternative or more comprehensive approaches to enhance management of CKD in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic disease management interventions for people with chronic kidney disease in primary care: a systematic review and meta-analysis. Galbraith, L., Jacobs, C., Hemmelgarn, BR., et al.[2019]

The 'My Kidneys & Me' program is a 10-week digital self-management intervention designed to improve patient activation in individuals with chronic kidney disease (CKD) stages 3-4, with a total of 432 participants planned for the study.

The study will assess the feasibility of the intervention and its impact on patient activation levels using the Patient Activation Measure (PAM-13), with outcomes evaluated at baseline, 10 weeks, and 20 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Self-Management Intervention through Lifestyle Education for Kidney health' (the SMILE-K study): protocol for a single-blind longitudinal randomised controlled trial with nested pilot study. Lightfoot, CJ., Wilkinson, TJ., Yates, T., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT05753020?draw=2&rank=1

NCT05753020 | A Pilot Study of The CKM JumpStart Tool

This is a randomized pilot study to test the feasibility and acceptability of a tool to promote discussion about conservative kidney management (CKM) among ...

2.

withpower.com

withpower.com/trial/phase-kidney-diseases-2-2023-4b5b2

CKM JumpStart Tool for Chronic Kidney Disease

Trial Overview The study is testing the CKM JumpStart Tool's effectiveness in facilitating conversations between elderly patients with advanced CKD and their ...

3.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/20/NCT05753020/Prot_000.pdf

A Pilot Study of The CKM JumpStart Tool

Objective(s) and Hypotheses: Conservative kidney management (CKM) is an important therapeutic alternative for patients who do not wish to pursue dialysis ...

4.

ckmcare.com

ckmcare.com/

Conservative Kidney Management

CKM is a treatment option for managing advanced chronic kidney disease. This pathway is a resource for patients and healthcare professionals.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12261656/

Policy strategies to enhance uptake of conservative kidney ...

Conservative kidney management (CKM) is an established treatment option for patients with advanced chronic kidney disease(CKD) who are not ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10624579/

Conservative Kidney Management Practice Patterns and ...

This study is a cross-sectional analysis of data from US nephrology clinics enrolled in the chronic kidney disease Outcomes and Practice Patterns Study ( ...