Implementing Individualized Patient Reported Outcome Measures in Routine Care of Patients With Co… (NCT06164457) | Clinical Trial Compass
RecruitingNot Applicable
Implementing Individualized Patient Reported Outcome Measures in Routine Care of Patients With Coronary Artery Disease
Canada200 participantsStarted 2024-06-08
Plain-language summary
Investigators recently developed the APPROACH electronic patient reported outcome (ePROM) Survey and Clinician Report tools to collect individual results from online quality of life and health status surveys for patients with coronary heart disease, and report them back to their treating clinicians. This pilot interventional study uses a pre-post design to assess whether implementing the ePROM system into routine care is feasible and acceptable to patients and physicians, and to inform feasibility for a larger clinical trial. Specifically, the investigators aim to evaluate use of the ePROM Patient Survey and Clinician Report among eligible outpatients with known or suspected coronary artery disease and their cardiologists. Additionally, the investigators aim to determine if the use of the APPROACH ePROMs Clinician Report in routine medical encounters is acceptable (based on administrative burden, ease of use, and time required) to patients and clinicians, and supports effective communication for management of symptoms of coronary artery disease.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Patient Inclusion Criteria:
* age at least 40 years.
* either (i) known coronary artery disease (defined as a history of myocardial infarction, percutaneous or surgical coronary revascularization, or documentation of obstructive coronary artery disease on previous invasive or CT angiography) or (ii) suspected coronary artery disease (defined as stable angina or anginal equivalent symptoms) as the reason for referral to a cardiologist.
* Able to communicate in English or be willing to have an English-speaking family member or friend assist with survey completion.
* Access to the internet, valid email address, and a web-enabled device, for survey completion.
* Upcoming outpatient visit with a study cardiologist in the next 14-28 day
Exclusion criteria:
\- N/A, all inclusion criteria must be met to participate
Physician Inclusion Criteria: We will recruit 4 cardiologists to participate, 2 each from Alberta Health Services Edmonton and Calgary zones, including both academic and community practice settings. To be eligible, cardiologists will need to have an active outpatient practice including moderate to high volumes of patients being assessed and managed for coronary artery disease, and to be willing to commit to participating in all aspects of the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ePROM usage metrics
Timeframe: Usage metrics will be collected during the intervention period (~4 months)
2
Acceptability of the Clinician Report to clinicians
Timeframe: Post-visit surveys will be completed following every patient visit during the intervention period (~4 months), the exit interview will occur at the end of the intervention period.
3
Acceptability and utility of the ePROM Patient Survey and Clinician Report to patients
Timeframe: Patients will complete a post-visit survey following each visit during both the control and intervention period (~8 months).