Decision Aid for Chronic Kidney Disease and Coronary Artery Disease

(MyHeart&CKD Trial)

Not yet recruiting at 1 trial location

Overseen By Pantea Javaheri, MRSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: End stage kidney failure, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tool called "My Heart and CKD Online Shared Decision Aid" to help individuals understand the pros and cons of heart procedures when they also have kidney disease. It aims to facilitate discussions between patients and their doctors about what matters most before deciding on heart treatments. This is crucial because heart procedures can benefit heart disease but may also cause kidney problems. Individuals with both chronic kidney disease and coronary artery disease—who are not on dialysis or facing imminent end-stage kidney failure—might be suitable for this trial. The study will evaluate whether using this decision aid in Canada improves how patients and doctors make these important health decisions together. As an unphased trial, it offers a unique opportunity for patients to contribute to research that could enhance decision-making tools for others with similar health challenges.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this decision aid is safe for patients with chronic kidney disease and coronary artery disease?

Research has shown that the "My Heart Care and CKD" decision aid helps people with kidney disease and heart conditions make informed care choices. This tool improves communication between patients and doctors by providing personalized information about the risks and benefits of heart procedures.

As the decision aid is neither a medication nor a medical procedure, it poses no physical safety risks. It functions as an online tool to support shared decision-making. Previous research ensured it meets the needs of both patients and healthcare providers, confirming its ease of use and effectiveness in aiding healthcare decisions.

Overall, there are no known safety concerns with using the decision aid. It empowers patients with information and support, without directly affecting their health condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "My Heart and CKD Online Shared Decision Aid" because it offers a new approach to managing chronic kidney disease and coronary artery disease. Unlike typical treatments that focus solely on medical interventions, this decision aid empowers patients by involving them in the decision-making process with their physicians. It provides personalized information and helps patients understand their options, potentially leading to more informed decisions and better health outcomes. This patient-centered approach is what sets it apart from the usual care, which often lacks this level of patient engagement and shared decision-making.

What evidence suggests that the "My Heart and CKD" decision aid is effective for shared decision-making in patients with chronic kidney disease and coronary artery disease?

Research has shown that the "My Heart and CKD" decision aid, which participants in this trial may receive, helps individuals with chronic kidney disease (CKD) make informed decisions about heart treatments. Designed with the needs of both patients and doctors in mind, this tool provides personalized information on the pros and cons of heart procedures, facilitating the sharing of patient preferences. Studies have found significant variation in patient preferences, highlighting the importance of a tool to guide these discussions. By improving communication between patients and doctors, this decision aid aims to enhance shared decision-making in managing heart disease for those with kidney problems. ^{3 5 6 7 8}

Who Is on the Research Team?

Matthew T James, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic kidney disease and coronary artery disease. They must be able to communicate in English or French, either directly or through a support person, and have the cognitive ability to make decisions or have someone who can decide for them.

Inclusion Criteria

I have a type of heart disease that affects my coronary arteries.

I can communicate in English or French, or I have someone who can translate for me.

I have chronic kidney disease.

Exclusion Criteria

Patient is not expected to survive to hospital discharge

I have had a severe type of heart attack.

I am on dialysis or my kidney function is very low.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation and Evaluation

Implementation of the decision aid for use by patients with CKD and heart disease and their healthcare providers during clinical care encounters.

3 months

Multiple encounters as needed

Follow-up

Participants are monitored for adherence to chosen treatment options and decisional outcomes.

3 months

Follow-up assessments at 2 weeks and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• My Heart and CKD Online Shared Decision Aid

Trial Overview The 'My Heart and CKD' online decision aid is being tested. It's designed to help patients with kidney and heart diseases understand the benefits versus risks of heart procedures, aiding in shared decision-making with their healthcare providers.

How Is the Trial Designed?

Group I: Decision aid intervention Experimental Treatment 1 Intervention

Patients in this group will receive care from their physician incorporating the use of the decision aid.

Group II: Usual Care Active Control 1 Intervention

Patients in this group will receive usual care from their physician without the use of the decision aid.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Published Research Related to This Trial

Only 56% of healthcare professionals used patient decision aids like 'Three Good Questions' and the Dutch Kidney Guide during kidney failure treatment education, indicating limited implementation of these tools.

Patients reported higher satisfaction with their education in hospitals that utilized these decision aids, but their experience of shared decision-making did not improve after healthcare professionals received training on these aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of patient decision aids for shared decision-making in kidney failure. van Eck van der Sluijs, A., Vonk, S., Bonenkamp, AA., et al.[2023]

A survey of 1,029 chronic kidney disease (CKD) patients revealed that many are willing to accept risks associated with preventative medications, especially as they approach late-stage disease, highlighting the importance of risk-benefit discussions in treatment decisions.

Clinician recommendations and support in managing side effects significantly influence patients' willingness to start and continue new medications, indicating the need for effective communication between patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating Early-Stage CKD With New Medication Therapies: Results of a CKD Patient Survey Informing the 2020 NKF-FDA Scientific Workshop on Clinical Trial Considerations for Developing Treatments for Early Stages of Common, Chronic Kidney Diseases. Damron, KC., Friedman, R., Inker, LA., et al.[2022]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12457206/

Human-Centred Design & Development of a Shared Decision ... Human-centred design processes effectively guided creation of a decision aid for patients with CKD and physicians making shared CAD treatment decisions.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41001261/

Human-Centred Design & Development of a Shared ... Human-centred design processes effectively guided creation of a decision aid for patients with CKD and physicians making shared CAD ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2590059525000202

Integrating Clinical Reasoning Into a Patient Decision Aid ... This resource uses both the clinical reasoning of health professionals making decisions about kidney disease management to structure the decision problem and ...

4. jacc.org jacc.org/doi/10.1016/j.jacc.2019.08.1017

Chronic Kidney Disease and Coronary Artery ... CKD and end-stage kidney disease not only increase the risk of CAD, but they also modify its clinical presentation and cardinal symptoms.

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.028492

Preferences of Patients With Chronic Kidney Disease for ... This discrete choice experiment measured the preferences of patients with CKD for future cardiovascular events versus acute kidney injury and kidney failure

6. withpower.com withpower.com/trial/decision-aid-for-chronic-kidney-disease-and-coronary-artery-disease-16c7d

Decision Aid for Chronic Kidney Disease and Coronary Artery ... The decision aid, called "My Heart Care and CKD", supports shared decision-making between patients with kidney disease and heart their care providers. This ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06920927/feasibility-and-pilot-testing-of-my-heart-and-ckd-online-shared-decision-aid?activelyRecruiting=false&page=789&id=780&slug=chest-pain

Feasibility and Pilot Testing of "My Heart and CKD" Online ... The decision aid, called "My Heart Care and CKD", supports shared decision-making between patients with kidney disease and heart their care ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.050686

Cardiovascular Disease in Chronic Kidney Disease Patients with CKD exhibit a pronounced risk for cardiovascular events: 50% of all patients with CKD stage 4 to 5 have CVD, and cardiovascular ...