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Набор скоро начнётся NCT05377320

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

— Наблюдательное Heart Failure Coronary Artery Disease Peripheral Artery Disease Ischemia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Clinical Decision Aid, Standard Care.
Кому может быть актуально
Состояния в реестре: Heart Failure, Coronary Artery Disease, Peripheral Artery Disease, Ischemia. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Clinical Decision Aid
    The clinical decision aid tool will be used at the subject's first visit (Week 0), Week 12 and Week 24.
  • Другое Standard Care
    Cardiology clinic visits will take place at the subjects first visit (Week 0), Week 12 and Week 24.

Первичные конечные точки

  • Medication use [Срок оценки: Week 0]
  • Medication use [Срок оценки: Week 12]
  • Medication use [Срок оценки: Week 24]
  • Imaging surveillance [Срок оценки: Week 0]
  • Imaging surveillance [Срок оценки: Week 12]
  • Imaging surveillance [Срок оценки: Week 24]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Froedtert & the Medical College of Wisconsin — Milwaukee

Публикации

  • 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

Идентификаторы

NCT: NCT05377320 · PRO00039290

Первоисточники (государственные реестры)

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