Decision Support Tool for Chronic Kidney Disease

Not currently recruiting at 1 trial location

Overseen By Chandana Gowdara, MAS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VA Palo Alto Health Care System

Disqualifiers: Cognitive impairment

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based tool designed to assist people with advanced chronic kidney disease in making dialysis decisions. Researchers aim to determine if this tool reduces confusion, aligns treatment choices with personal values, and is user-friendly. The trial includes two groups: one using the tool and a control group that does not. It suits English-speaking individuals aged 65 and older with a kidney function measurement (estimated GFR) under 25 who are not eligible for a kidney transplant. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance decision-making tools for kidney disease patients.

Will I have to stop taking my current medications?

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

What prior data suggests that this web-based dialysis decision support tool is safe for individuals with advanced chronic kidney disease?

Research has shown that online tools for making dialysis decisions are safe for use. Studies have found that these tools enhance patients' understanding of their options without causing harm. Since these tools offer information and support without involving drugs or medical procedures, they present no side effects like those from medications. No issues have been reported with these digital aids, which aim to reduce stress and help people make better health decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the web-based dialysis decision support tool for chronic kidney disease because it offers a personalized approach to treatment decisions. Unlike traditional methods, which often involve direct consultations, this tool empowers patients by providing easy access to tailored information and options regarding their dialysis treatment. This digital approach aims to enhance patient autonomy and understanding, potentially leading to more informed decisions and better alignment with personal health goals. By streamlining access to information and supporting decision-making, the tool could improve patient satisfaction and outcomes in managing chronic kidney disease.

What evidence suggests that this web-based dialysis decision support tool is effective for chronic kidney disease?

Research has shown that online tools can help people with chronic kidney disease make better treatment decisions. In this trial, participants in the intervention arm will use a web-based dialysis decision support tool. Studies have found that such tools reduce uncertainty, helping patients feel more confident and clear about their choices. They also ensure that the chosen treatment aligns with the patient's values, increasing the likelihood of selecting a plan that fits personal needs and goals. Patients generally favor these tools, making them a promising option for those facing complex decisions about dialysis. ^{1 3 6 7 8}

Who Is on the Research Team?

Manjula Tamura, MD, MPH

Principal Investigator

U.S. Department of Veterans Affairs - Palo Alto Health Care System

Are You a Good Fit for This Trial?

This trial is for individuals with advanced chronic kidney disease who are facing decisions about dialysis. The study seeks participants willing to use a web-based tool designed to support these decisions. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am 65 years old or older.

English speaking

Not a candidate for kidney transplant based on nephrologist assessment.

Exclusion Criteria

Patients with cognitive impairment will be excluded; however, their family member or caregiver is eligible to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline surveys assessing demographics, knowledge of kidney failure treatments, and decisional conflict during a nephrology clinic visit

1 visit

1 visit (in-person)

Intervention

Participants access the web-based dialysis decision support tool with follow-up support provided by the study coordinator

1-4 weeks

Follow-up

Participants complete follow-up surveys to re-evaluate knowledge, decisional conflict, values-treatment concordance, and the quality of shared decision-making. Telephone interviews are conducted to explore participants' understanding of treatment options and gather feedback on the decision support tool

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Web-based dialysis decision support tool

Trial Overview The study is testing a web-based dialysis decision support tool, aiming to see if it helps reduce decisional conflict and improves alignment between patients' values and their chosen treatments. It also evaluates the tool's ease of use and satisfaction among users.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Web-based dialysis decision support tool

Group II: Control Active Control 1 Intervention

Historical controls

Who Is Running the Clinical Trial?

VA Palo Alto Health Care System

Lead Sponsor

Trials

97

Recruited

58,500+

Published Research Related to This Trial

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]

A consensus workshop with 24 participants, including 11 patients and 6 caregivers, identified key content preferences for an e-health tool to support chronic kidney disease self-management, emphasizing the need for reliable information on kidney health, diet, medication, and mental health.

Preferred features for the e-health tool included visuals, health tracking capabilities, and easy access to healthcare providers, highlighting the importance of user-friendly design in enhancing patient engagement and self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferences for a self-management e-health tool for patients with chronic kidney disease: results of a patient-oriented consensus workshop. Donald, M., Beanlands, H., Straus, S., et al.[2020]

Patients with end-stage renal disease can choose and change their treatment options, making the way information is presented crucial for their decision-making process.

Using structured 'patient decision aids' that follow simple principles can help patients make informed choices about dialysis options, leading to better treatment compliance and improved health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to select among dialysis options. Mooney, A.[2019]

The 'Kidney Failure Decision Aid' was developed to support shared decision-making in kidney failure treatment by providing real-world outcome information, including survival probabilities and treatment event rates, through a paper hand-out, an interactive website, and a personal summary sheet.

Initial testing showed that while some patients found survival probabilities confronting, both patients and clinicians believed the PtDA would enhance informed decision-making and align treatment choices with patient values and preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online patient decision aid for kidney failure treatment modality decisions. Engels, N., van der Nat, PB., Ankersmid, JW., et al.[2022]

A new decision aid, consisting of a 50-minute video and an informational handbook, was developed to help patients with end-stage renal disease (ESRD) and their families understand treatment options for renal replacement therapy (RRT).

Preliminary evaluations showed that the materials were well-received and comprehensible, with the handbook written at a 4th to 6th grade reading level, making it accessible for patients with varying health literacy and cognitive abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a decision aid to inform patients' and families' renal replacement therapy selection decisions. Ameling, JM., Auguste, P., Ephraim, PL., et al.[2021]

The implementation of digital health tools in four chronic kidney disease clinics successfully identified 1,032 patients, with 24% classified as high-risk for kidney failure, demonstrating the efficacy of these tools in patient management.

The digital tools improved shared decision-making, as evidenced by 91% of patients completing a values clarification tool and 87% having their treatment preferences documented in the electronic health record, indicating high acceptability and usability among patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Digital Health System Tools to Support Decision Making and Treatment Preparation in CKD: The PREPARE NOW Study. Green, JA., Ephraim, PL., Hill-Briggs, F., et al.[2022]

The development of an intelligent decision support system for managing chronic kidney failure aims to enhance treatment by utilizing existing knowledge and adapting based on real-time data from its use.

This system incorporates various decision support techniques to address the complexities and challenges faced by healthcare practitioners in managing end-stage renal disease patients, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing decision support for dialysis treatment of chronic kidney failure. Raghavan, SR., Ladik, V., Meyer, KB.[2019]

A nonrandomized controlled trial involving 361 hemodialysis patients found that a computer-based clinical decision support system did not significantly improve blood pressure control compared to standard care over 12 months.

Despite providing audits and management suggestions to physicians, the intervention did not lead to a higher proportion of patients achieving target blood pressure levels, indicating that this approach may not be effective in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support to improve blood pressure control in hemodialysis patients: a nonrandomized controlled trial. Thompson, S., Hemmelgarn, B., Wiebe, N., et al.[2015]

A clinical decision support (CDS) tool significantly improved the appropriate adjustment of medication prescriptions for patients with kidney impairment, with adjustments made 17% of the time in the intervention group compared to only 5.7% in the control group.

The CDS tool was particularly effective with prospective alerts, leading to appropriate adjustments in 55.6% of cases, highlighting its potential to enhance patient safety in medication prescribing for those with renal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of real-time alerting on appropriate prescribing in kidney disease: a cluster randomized controlled trial. Awdishu, L., Coates, CR., Lyddane, A., et al.[2018]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03522740

NCT03522740 | Decision Aid for Renal Therapy The objective of this trial is to compare the effectiveness of two widely used strategies, in-person education alone versus in-person education plus an ...

2. withpower.com withpower.com/trial/decision-support-tool-for-chronic-kidney-disease-9f8fd

Decision Support Tool for Chronic Kidney Disease The aim of this study is to evaluate the impact of a web-based dialysis decision support tool on decisional conflict, and values-treatment concordance and ...

3. pcori.org pcori.org/research-results/2024/implementing-decision-aid-renal-therapy-dart-achieve-widespread-goal-concordant-timely-treatment-decisions-older-adults-kidney-failure

Implementing the Decision Aid for Renal Therapy (DART) ... Healthcare and Health Outcomes: Percent of participants with a planned dialysis start; Number of dialysis crashes; Percent of participants ...

4. kidneymedicinejournal.org kidneymedicinejournal.org/article/S2590-0595(25)00020-2/fulltext

Integrating Clinical Reasoning Into a Patient Decision Aid ... This article describes 2 studies underpinning the development of the Yorkshire Dialysis and Conservative Care Decision Aid.

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076251332832

Interactive decision aid on therapy decision making for ... Patients with advanced chronic kidney disease (CKD) face challenging decisions about kidney replacement therapy (KRT) options.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11125858/

Digital Health Support: Current Status and Future ... This narrative essay offers an update on currently available digital health technologies used in the management of HD patients and envisions future ...

7. ebm.bmj.com ebm.bmj.com/content/29/Suppl_1/A19.1

042 Decision support interventions for dialysis choice The purpose of this case study was to explore the use of a decision support intervention provided by a nurse recently trained in decision coaching.

8. reporter.nih.gov reporter.nih.gov/project-details/10911955

Developing Tools for Dialysis Decision Support in Older ... This project will address the information needs of patients and clinicians by generating new tools to support informed decision- making and goal-concordant care ...