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| Name | Class |
|---|---|
| University of Alberta | OTHER |
| Alberta Health services | OTHER |
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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.
Heart disease is a common comorbidity in individuals with chronic kidney disease (CKD). However, patients with CKD are 20-50% less likely to receive heart tests and treatments for acute coronary syndromes and there is also substantial variability in management for patient with CKD and stable coronary disease. The variability and disparities in care for people with CKD are attributed to three common obstacles: concern over potential kidney function deterioration from procedures, limited understanding of the benefits and risks of invasive versus medical treatment approaches for individual patients with CKD, and inadequate strategies to align treatment decisions with patient values and preferences. Addressing these barriers necessitates a shift towards patient-centered care and informed decision-making in cardiovascular and kidney care. Offering personalized risk information and decision support to patients with CKD and their care providers could help surmount these obstacles. These patient-oriented approaches to heart disease care require weighing treatment decisions' risks and benefits through informed discussions between patients and providers.
Shared decision-making (SDM), a collaborative approach between patients and healthcare providers, integrates clinical knowledge with patient values, preferences, and risk tolerance to personalize care decisions. SDM, when integrated into care practices, enhances patient satisfaction and experiences. However, despite its benefits, only a minority of Canadian patients report experiencing SDM, highlighting the need for its broader implementation.
Patient decision aids (PDAs) are tools for facilitating collaborative medical decisions, particularly when multiple treatment options exist. PDAs equip patients with information on treatment choices, associated risks, and benefits, and help them clarify their values in the decision-making process. A Cochrane Systematic Review highlighted that when utilized, PDAs enhance patient knowledge, ensure informed decision-making, and foster active patient involvement in the decision process. Guideline frameworks like the International Patient Decision Aid Standards (IPDAS) and Ottawa Framework ensure the rigor and standardization of PDA development.
Trial Objectives:
This study will implement and evaluate a decision aid for use by patients with CKD and heart disease and their healthcare providers when making treatment decisions for coronary artery disease, including with acute coronary syndrome and stable coronary artery disease.
Specific objectives are:
Primary objective: Conduct an implementation pilot study in Canada, deploying the decision aid accompanied by implementation training and resources for culturally sensitive shared decision-making within clinical care.
Secondary objective: To document and evaluate the feasibility, acceptability, and satisfaction with use of the decision aid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision aid intervention | Experimental | Patients in this group will receive care from their physician incorporating the use of the decision aid. |
|
| Usual Care | No Intervention | Patients in this group will receive usual care from their physician without the use of the decision aid. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision aid | Other | Decision aid for use by physicians and patients with CKD when deciding upon an invasive vs a conservative approach to management of coronary artery disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decisional Conflict Scale (O'Connor -8 question) | Patient's perceptions of modifiable factors contributing to uncertainty with their decision such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. | Following patient-physician encounter (within 2 weeks) |
| Patient Nine-item Shared Decision-Making Questionnaire (SDM-Q-9) | Assessment of patient's perceived level of involvement in decision-making related to their own treatment. | Following patient-physician encounter (within 2 weeks) |
| Knowledge of Treatment Risks | Patient's knowledge of the risks of kidney failure versus a heart attack in the future associated with the treatment choices of invasive versus optimal medical management presented in the decision aid | Following patient-physician encounter (within 2 weeks) |
| Accuracy of Risk Perception | Whether a patient's perception of risk of the risk of kidney failure corresponds to the estimated risk of this outcome for a similar person receiving invasive management as presented in the decision aid | Following patient-physician encounter (within 2 weeks) |
| Value-Choice Congruence | Whether a patient's choice of invasive versus optimal medical management is consistent with their most important stated values | Following patient-physician encounter (within 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Preferred Choice | The patient's inclination towards a preferred choice of treatment with invasive versus conservative management | Following patient physician encounter (within 2 weeks) and 3 months later |
| Actual Choice |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pantea Javaheri, MRSc | Contact | 1 (403) 220 2465 | pantea.javaheri@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Matthew T James, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Recruiting | Calgary | Alberta | T2N 2T9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33552527 | Background | Wilson T, Javaheri P, Finlay J, Hazlewood G, Wilton SB, Sajobi T, Levin A, Pearson W, Connolly C, James MT. Treatment Preferences for Cardiac Procedures of Patients With Chronic Kidney Disease in Acute Coronary Syndrome: Design and Pilot Testing of a Discrete Choice Experiment. Can J Kidney Health Dis. 2021 Jan 27;8:2054358120985375. doi: 10.1177/2054358120985375. eCollection 2021. | |
| 33303572 |
| Label | URL |
|---|---|
| Shared Decision-Making for Heart and Kidney Disease | View source |
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Maintenance of data privacy and security .
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Cluster randomized stepped wedge design
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Whether invasive or optimal medical therapy was actually chosen by the patient and physician.
| Following patient-physician encounter (within 2 weeks) |
| Adherence to Chosen Option | Whether the treatment received (invasive or medical therapy) remained the same as the initially chosen option | Three months following the patient-physician encounter |
| Decisional Regret Scale (O-Connor - 5 question) | Evaluation of feelings of dissatisfaction or disappointment following the decision, reflecting on whether the individual would make the same decision given the chance again | Three months following the patient-physician encounter |
| Acceptability Scale (O'Connor - 10 question) | Patient's rating of the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making. | Following patient-physician encounter (within 2 weeks) |
| Physician Nine-item Shared Decision-Making Questionnaire (SDM-Q-9) | Assessment of physician's perceived level of patient involvement in decision-making related to their own treatment. | Following patient-physician encounter (within 2 weeks) |
| University of Alberta Hospital | Recruiting | Edmonton | Alberta | T6G 0M9 | Canada |
|
| Background |
| Finlay J, Wilson T, Javaheri PA, Pearson W, Connolly C, Elliott MJ, Graham MM, Norris CM, Wilton SB, James MT. Patient and physician perspectives on shared decision-making for coronary procedures in people with chronic kidney disease: a patient-oriented qualitative study. CMAJ Open. 2020 Dec 10;8(4):E860-E868. doi: 10.9778/cmajo.20200039. Print 2020 Oct-Dec. |
| 36892063 | Background | Wilson TA, Hazlewood GS, Sajobi TT, Wilton SB, Pearson WE, Connolly C, Javaheri PA, Finlay JL, Levin A, Graham MM, Tonelli M, James MT. Preferences of Patients With Chronic Kidney Disease for Invasive Versus Conservative Treatment of Acute Coronary Syndrome: A Discrete Choice Experiment. J Am Heart Assoc. 2023 Mar 21;12(6):e028492. doi: 10.1161/JAHA.122.028492. Epub 2023 Mar 9. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |