Feasibility and Pilot Testing of "My Heart and CKD" Online Shared Decision Aid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Calgary
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Decision aid
Other interventionDecision aid for use by physicians and patients with CKD when deciding upon an invasive vs a conservative approach to management of coronary artery disease.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Decision aid interventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Following patient-physician encounter (within 2 weeks)2
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.
Time frame
Following patient-physician encounter (within 2 weeks)3
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
Time frame
Following patient-physician encounter (within 2 weeks)4
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
Time frame
Following patient-physician encounter (within 2 weeks)Secondary outcomes
1
Preferred Choice
The patient's inclination towards a preferred choice of treatment with invasive versus conservative management
Time frame
Following patient physician encounter (within 2 weeks) and 3 months later2
Actual Choice
Whether invasive or optimal medical therapy was actually chosen by the patient and physician.
Time frame
Following patient-physician encounter (within 2 weeks)3
Adherence to Chosen Option
Whether the treatment received (invasive or medical therapy) remained the same as the initially chosen option
Time frame
Three months following the patient-physician encounter4
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
Time frame
Three months following the patient-physician encounterSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Calgary
Lead sponsor
University of Alberta
Collaborator
Alberta Health services
Collaborator
Source ClinicalTrials.gov