ACCESS HCM: Real World Evidence for Artificial-Intelligence-assisted Screening and Access to Care for HCM - A Multi-Site Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Viz.ai, Inc.
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Clinical characteristics of Viz HCM AI screening on HCM diagnosis
研究概览
简要总结
To describe the clinical, economic, and population characteristics of newly diagnosed, previously diagnosed, and suspected patients evaluated by Viz HCM. HCM is underdiagnosed in the community and AI algorithms have been developed as screening tools. However, it is not well understood how to best integrate AI screening tools and their potential impact.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Clinical characteristics of Viz HCM AI screening on HCM diagnosis
时间窗: Up to 3 years
To describe the clinical characteristics of patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Clinical characteristics of Viz HCM AI screening on treatment plans.
时间窗: Up to 3 years
To describe the clinical characteristics of treatment plans for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Population evaluation for access to care by socioeconomic status at the time of diagnosis.
时间窗: Up to 3 years
To describe HCM access to care by socioeconomic status at the time of diagnosis.
Clinical characteristics of Viz HCM AI screening on medical workup.
时间窗: Up to 3 years
To describe the clinical characteristics of medical workup for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Clinical characteristics of Viz HCM AI screening on closed care pathways
时间窗: Up to 3 years
To describe the clinical characteristics of closed care pathways (patients diagnosed who receive treatment) for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Population evaluation for access to care by clinical stage of HCM at time of diagnosis.
时间窗: Up to 3 years
Population evaluation for access to care by clinical stage of HCM at time of diagnosis.
Healthcare utilization and health economic outcomes- medical clinic visits
时间窗: Up to 3 years
To describe healthcare utilization and economic outcomes as captured by medical clinic visits, associated testing (e.g., echocardiogram, cardiac MRI, laboratory and genetic screening), hospitalization, and ICD placement for primary and secondary prevention for sudden cardiac death.
Health economics outcome as captured by associated testing modalities
时间窗: Up to 3 years
To describe healthcare utilization and economic outcomes as captured by associated testing
Health economics outcome as captured by hospitalization data
时间窗: Up to 3 years
To describe healthcare utilization and economic outcomes as captured by hospitalization data
Health economics outcome as captured by ICD placement data
时间窗: Up to 3 years
To describe healthcare utilization and economic outcomes as captured by ICD placement for primary and secondary prevention for sudden cardiac death.
次要结局
- Implementation science - number of active users over time(Up to 2 years)
- Implementation science - percentage of alerts viewed(Up to 2 years)
- Implementation science - reasons for user-indicated actions, where documented(Up to 2 years)