Clinical trial NCT06920927: Feasibility and Pilot Testing of "My Heart and CKD" Online Shared Decision Aid
Official title: Feasibility and Pilot Testing of the "My Heart and CKD" Online Shared Decision Aid
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease
Coronary Artery Disease
Keywords: Decision aid
Shared decision making
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: Alberta Health services
First posted: 2025-04-10
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cluster randomized stepped wedge design
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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:

1. To measure the effectiveness of delivery of personalized information for patients with CKD and heart disease and their health care providers within clinical care. The investigators will measure use and completion of the decision-aid during clinical care encounters for management of heart disease within an implementation pilot trial. Quantitative and qualitative methods will be used to measure how effectively the decision aid conveys personalized information. The investigators will also examine how closely management decisions correlate with risk estimates for patients who received the decision aid. Measures from patients with and without use of the decision aid will be compared using a cluster randomized, pre- versus post-implementation, design, to evaluate effectiveness.
2. To work towards better recognition of patient preferences and their incorporation into decision making, the investigators will measure the knowledge, experience, and satisfaction of patients who receive the decision-aid within the implementation pilot trial. The investigators will compare the expressed preferences of patients to the management approach that patients received and determine whether greater concordance is achieved using the decision aid than observed in the absence of a decision aid.
3. To examine the decision aid's effects on awareness, understanding, and incorporation of shared decision-making practices, the investigators will survey and interview health care providers on knowledge and confidence with shared decision-making before and after use of the decision aid. The investigators will also measure the decisional conflict of patients who received the decision aid and those who did not, which is an outcome measure that has been shown to improve with interventions that support shared decision-making.

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.

Eligibility criteria: Inclusion Criteria:

* Adult (18 years of age or older)
* Chronic kidney disease
* Coronary artery disease (non-ST elevation acute coronary syndrome (ACS) or symptoms or signs of stable coronary heart disease)
* Able to communicate in English or French or through a support person who speaks English or French
* Patient has the cognitive ability or has a surrogate decision maker capable of participating in shared decision making based on the discretion of the attending physician

Exclusion Criteria:

* End stage kidney failure already being treated with dialysis or with an eGFR \< 10mL/min/1.73m2
* ST-elevation myocardial infarction
* Patient is not expected to survive to hospital discharge

Primary outcomes:
measure: Decisional Conflict Scale (O'Connor -8 question)
timeFrame: Following patient-physician encounter (within 2 weeks)
measure: Patient Nine-item Shared Decision-Making Questionnaire (SDM-Q-9)
timeFrame: Following patient-physician encounter (within 2 weeks)
measure: Knowledge of Treatment Risks
timeFrame: Following patient-physician encounter (within 2 weeks)
measure: Accuracy of Risk Perception
timeFrame: Following patient-physician encounter (within 2 weeks)
measure: Value-Choice Congruence
timeFrame: Following patient-physician encounter (within 2 weeks)
Secondary outcomes:
measure: Preferred Choice
timeFrame: Following patient physician encounter (within 2 weeks) and 3 months later
measure: Actual Choice
timeFrame: Following patient-physician encounter (within 2 weeks)
measure: Adherence to Chosen Option
timeFrame: Three months following the patient-physician encounter
measure: Decisional Regret Scale (O-Connor - 5 question)
timeFrame: Three months following the patient-physician encounter
measure: Acceptability Scale (O'Connor - 10 question)
timeFrame: Following patient-physician encounter (within 2 weeks)
measure: Physician Nine-item Shared Decision-Making Questionnaire (SDM-Q-9)
timeFrame: Following patient-physician encounter (within 2 weeks)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Matthew T James, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.