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
- 终止
- 发起方
- Viz.ai, Inc.
- 入组人数
- 17
- 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
- •All Cohorts
- •Patients aged 18+ years at time of arrival to healthcare facility
- •Patients with a resting 12-lead digital electrocardiogram (ECG) that is flagged by Viz HCM for HCM suspicion
- •Additional cohort-specific criteria:
- •Cohort 1 - Newly Diagnosed Patients
- •Patients have been diagnosed with HCM after the Viz HCM implementation
- •Written informed consent is obtained prior to data collection
- •Cohort 2 - Previously Diagnosed Patients ● Prior diagnosis of HCM as evidenced by clinical diagnosis documentation prior to Viz HCM implementation
- •Cohort 3 - Suspected and Not Diagnosed Patients
- •● Patients did not receive sufficient clinical workup for HCM diagnosis confirmation
- •Cohort 4 - Unlikely HCM ● Patient ECG moved to 'Unlikely HCM' group within Viz by site study staff following HCM alert review
- •Cohort 5 - Alerts Not Reviewed
- •● HCM alert not reviewed by site study staff during study enrollment period
排除标准
- 未提供
研究组 & 干预措施
Cohort 1- Newly Diagnosed Patients
This cohort will consist of individuals who are newly diagnosed with HCM after the site began using Viz HCM. These patients will serve as a key population to assess the AI tool's impact on diagnoses, timeliness, and subsequent initiation of treatment. Data collected will include pre-diagnostic clinical indicators, diagnostic pathways, and treatment decisions following diagnosis. This cohort will begin to describe patient access to care and the clinical outcomes following a new HCM diagnosis in an AI-augmented clinical workflow.
干预措施: Viz HCM (Device)
Cohort 2 - Previously Diagnosed Patients
Patients in this cohort will have an existing diagnosis of HCM prior to the start of using Viz HCM. This group will allow for the evaluation of how the AI tool may influence ongoing management strategies, such as treatment adjustments, monitoring practices, risk stratification, and clinical outcomes. The cohort will also help assess whether the AI tool facilitates optimization of care by identifying missed opportunities or previously unrecognized complications.
干预措施: Viz HCM (Device)
Cohort 3 - Suspected and Not Diagnosed Patients
This cohort will include patients who were suspected by Viz HCM users of having underlying HCM, but clinical work-up sufficient to produce a diagnosis of HCM (including imaging and/or genetic testing) did not occur within the data collection period. Data collected will focus on diagnostic pathways, attempts made to coordinate care, and categorical barriers to care.
干预措施: Viz HCM (Device)
Cohort 4 - Unlikely HCM
This cohort will look at a subset of randomly selected patients who are suspected by Viz HCM of having underlying HCM but are moved to the subgroup 'Unlikely HCM' within the Viz app/web by a clinician. After 1 year of study enrollment, a list will be created by Viz and shared with study teams for collection of additional minimal data including age, sex, reason for unlikely HCM (via chat), demographics (race, ethnicity) and reason for ECG.
干预措施: Viz HCM (Device)
Cohort 5 - Alerts Not Reviewed
This cohort will look at a subset of randomly selected patients who are suspected by Viz HCM of having underlying HCM, but the alert is never reviewed by a clinician. After 1 year of study enrollment, a list will be created by Viz and shared with study teams for collection of additional minimal data including age, sex, demographics (race, ethnicity) and reason for ECG.
干预措施: Viz HCM (Device)
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 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.
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.
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.
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
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)