Decision Aid for Chronic Kidney Disease and Coronary Artery Disease

(MyHeart&CKD Trial)

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

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

What data supports the effectiveness of the treatment My Heart and CKD Online Shared Decision Aid for chronic kidney disease and coronary artery disease?

Research shows that using decision aids, like the My Heart and CKD Online Shared Decision Aid, can help patients with chronic kidney disease make better-informed decisions about their treatment by improving their understanding of their condition and treatment options. ^{1 2 3 4 5}

Is the Decision Aid for Chronic Kidney Disease and Coronary Artery Disease safe for humans?

The research highlights safety concerns specific to chronic kidney disease (CKD), such as medication errors and adverse safety events, which are common in CKD care. However, there is no specific safety data available for the Decision Aid itself. ^{1 4 6 7 8}

How is this treatment for chronic kidney disease and coronary artery disease different from other treatments?

This treatment is unique because it focuses on using a decision aid to help patients with chronic kidney disease (CKD) and coronary artery disease (CAD) make informed choices about their care, potentially reducing the need for invasive procedures like coronary angiography, which carries risks. It emphasizes non-invasive evaluation and personalized decision-making, which is not typically the focus of standard treatments. ^{9 10 11 12 13}

What is the purpose of this trial?

Many people with kidney disease also have heart disease. The procedures used to diagnose and treat heart disease (e.g., angiograms, angioplasty, or surgery) can improve symptoms and cardiovascular outcomes, but pose greater risks of kidney complications for people with chronic kidney disease. It's therefore important that patients with kidney disease and their health care providers understand the benefits versus risks of these procedures and use that information to make informed decisions regarding their health care. Prior research done with patients with kidney disease and their health care providers has led to the develop of a decision aid designed to help doctors provide personalized information on the benefits versus risks of having a heart procedure, as well as help patients communicate their own values and preferences to their doctor. This information is crucial for shared decision making, as previous research has shown that preferences and values vary for individual patients with kidney diseases, and should be incorporated into the decision-making process for heart disease management. The decision aid, called "My Heart Care and CKD", supports shared decision-making between patients with kidney disease and heart their care providers. This trial will implement and evaluate this decision aid within cardiovascular care in a pilot trial in Canada.

Research Team

Matthew T James, MD

Principal Investigator

University of Calgary

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Patient and physician perspectives on shared decision-making for coronary procedures in people with chronic kidney disease: a patient-oriented qualitative study. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Optimizing the use of patients' individual outcome information - Development and usability tests of a Chronic Kidney Disease dashboard. [2022]

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

Value of patient decision aids for shared decision-making in kidney failure. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Protocol of a randomized controlled trial of an erythropoietin stimulating agent decision aid for anemia treatment in kidney disease. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Clinical decision support improves physician guideline adherence for laboratory monitoring of chronic kidney disease: a matched cohort study. [2018]

6. United States 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. [2022]

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

Finding a common language for patient safety in CKD. [2019]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Awareness and Knowledge Among Internal Medicine House-Staff for Dose Adjustment of Cardiovascular Drugs in Chronic Kidney Disease. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Non-invasive evaluation of coronary heart disease in patients with chronic kidney disease using photoplethysmography. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Optimal strategy of coronary revascularization in chronic kidney disease patients: a meta-analysis. [2013]

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

Chronic kidney disease as a coronary artery disease risk equivalent. [2022]

12. Singapore pubmed.ncbi.nlm.nih.gov

Acute coronary syndrome and renal impairment: a systematic review. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Revascularization vs. Conservative Medical Treatment in Patients With Chronic Kidney Disease and Coronary Artery Disease: A Meta-Analysis. [2022]