PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Imaging surveillance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Imaging surveillance
时间窗: Week 24
The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.
Medication use
时间窗: Week 24
The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.
次要结局
未报告次要终点
研究者
Yee Chung Cheng
Associate Professor
Medical College of Wisconsin