PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical Decision Aid, Standard Care.
- Who it may be relevant to
- Registry conditions: Heart Failure, Coronary Artery Disease, Peripheral Artery Disease, Ischemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Interventions
- Other Clinical Decision Aid
The clinical decision aid tool will be used at the subject's first visit (Week 0), Week 12 and Week 24. - Other Standard Care
Cardiology clinic visits will take place at the subjects first visit (Week 0), Week 12 and Week 24.
Primary outcome measures
- Medication use [Time frame: Week 0]
- Medication use [Time frame: Week 12]
- Medication use [Time frame: Week 24]
- Imaging surveillance [Time frame: Week 0]
- Imaging surveillance [Time frame: Week 12]
- Imaging surveillance [Time frame: Week 24]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Froedtert & the Medical College of Wisconsin — Milwaukee
Publications
- Brown SA, Chung BY, Doshi K, Hamid A, Pederson E, Maddula R, Hanna A, Choudhuri I, Sparapani R, Bagheri Mohamadi Pour M, Zhang J, Kothari AN, Collier P, Caraballo P, Noseworthy P, Arruda-Olson A; Cardio-Oncology Artificial Intelligence Informatics and Precision Equity (CAIPE) Research Team Investigators. Patient similarity and other artificial intelligence machine learning algorithms in clinical d PMID 36691060
- Brown SA, Fang MZ, Sparapani R, Zhou Y, Osinski K, Taylor B, Yu D, Blessing J, Shah R, Collier P, BagheriMohamadiPour M, Zhang J, Kothari A, Echefu G, Rickards J, Otto C, Sanchez Z, Olson J, Arruda-Olson A, Cheng YC, Cheng F; Cardio-Oncology Artificial Intelligence Informatics and Precision Equity, and Patient Similarity Algorithms in the Prevention of Cardiovascular Toxicity Research Team Investi PMID 41378455
- Brown SA, Hamid A, Pederson E, Bs AH, Maddula R, Goodman R, Lamberg M, Caraballo P, Noseworthy P, Lukan O, Echefu G, Berman G, Choudhuri I; Cardio-Oncology Artificial Intelligence Informatics & Precision Equity (CAIPE) and Patient Similarity Algorithms in the Prevention of Cardiovascular Toxicity (PACT) Research Team Investigators. Simplified rules-based tool to facilitate the application of up-to PMID 37891699
Identifiers
NCT: NCT05377320 · PRO00039290