PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study

Study Overview
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Brief Summary
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This is a single-center, double-arm, open-label, randomized feasibility study that will determine whether a novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists, will favorably impact appropriate medication use and cardiac imaging surveillance, and will improve clinician and patient decision-making, perception, and behavior towards cardioprotective medication usage and cardiovascular disease imaging utilization.

Detailed Description
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For this feasibility study, the researchers will create the clinical decision aid and test the central hypothesis that this novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists and will favorably impact appropriate medication use and cardiac imaging surveillance. The hypothesis is supported by preliminary data suggesting that an initial and rudimentary version of the clinical aid increases appropriate medication use and imaging follow-up in cardio-oncology patients. Success will be determined by ≥85% of clinic visits using the clinical decision aid resulting in pursuit of medication use and cardiac imaging surveillance patterns commensurate with recommendations specific to cancer survivors, with overall rates the same or higher than the group without the clinical decision aid, as well as overall favorable patient and physician focus group comments and survey responses.

Official Title
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PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study

Conditions
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Heart Failure, Coronary Artery Disease, Peripheral Artery Disease, Ischemia, Hypertension, Diabetes Mellitus, Cardiomyopathies, Cardiotoxicity

Intervention / Treatment
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* Other: Clinical Decision Aid
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years with a history of cancer. Have not previously visited a cardiologist to assess cardiovascular risk after cancer diagnosis. Clinically at intermediate, high, or very high risk for cardiovascular diseases determined based on imprecise clinical risk models, such as those used for cardiac dysfunction. Ability to understand a written informed consent form, and willing to sign it prior to study registration. Exclusion Criteria: Patient <18 years. Without a personal history of cancer. Existing cardiomyopathy diagnosed after cancer diagnosis. Documented cognitive impairment. Patient or patient representative who is unable and unwilling to sign the informed consent form.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical Decision Aid Group<br>In this group, physicians will use standard care plus the clinical decision aid. | Other: Clinical Decision Aid<br>* The clinical decision aid tool will be used at the subject's first visit (Week 0), Week 12 and Week 24.<br>|
| Control Group<br>In this group, physicians will use standard care only. | Other: Standard Care<br>* Cardiology clinic visits will take place at the subjects first visit (Week 0), Week 12 and Week 24.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication use | The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject. | Week 0 | 
| Medication use | The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject. | Week 12 | 
| Medication use | The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject. | Week 24 | 
| Imaging surveillance | The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject. | Week 0 | 
| Imaging surveillance | The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject. | Week 12 | 
| Imaging surveillance | The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject. | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical decision aid, cancer, cardiac dysfunction, cardio-oncology, artificial intelligence, machine learning, adverse events