A Multicenter Study of the Impact of a COPD Identification and Referral System on Patient Follow Up and Outcomes After an Acute COPD Exacerbation Resulting in an Emergency Department Visit or Hospitalization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Viz.ai, Inc.
- 入组人数
- 485
- 试验地点
- 6
- 主要终点
- To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 30 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
研究概览
简要总结
The goal of this study is to evaluate the impact of implementing an AI-enabled clinical workflow tool (Viz COPD) on respiratory specialist follow up and clinical outcomes after an acute exacerbation.
详细描述
Time perspective: This study will collect data prospectively for the Experimental cohort and retrospectively for the Control cohort. There is also an Exploratory cohort which will collect retrospective and prospective data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40 years or older at the time of arrival to the emergency department.
- •Patients with a clinical diagnosis of COPD who present to the emergency department for a moderate or severe COPD exacerbation.
- •A moderate exacerbation is defined as an acute exacerbation requiring either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics.
- •A severe exacerbation is defined as an acute exacerbation requiring hospitalization, or observation for >24 hours in emergency department/urgent care facility or resulting in death.
- •Patients on dual (LABA/LAMA, LABA/ICS, LAMA/ICS) or triple (LABA/LAMA/ICS) long-acting bronchodilator inhalers.
排除标准
- •Patients on bronchodilator inhaler monotherapy.
- •Patients leaving against medical advice or expiring during hospitalization.
- •Patients with tracheostomy.
- •Patients with advanced cancer.
- •Patients who have received a lung transplant.
- •Discharge to hospice care.
- •Transfer to another hospital.
研究组 & 干预措施
Experimental Cohort
Prospective patients presenting to sites after implementation of the digital health tool.
Control Cohort
Retrospective patients who presented to the same study sites under the standard of care clinical workflow before implementation of the digital health tool
Exploratory Cohort
Patients who had no prior respiratory specialist follow up before implementation of the digital health tool and are re-assessed for follow up after implementation of the digital health tool.
结局指标
主要结局
To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 30 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
时间窗: From time of exacerbation to 30 days after discharge
Proportion of patients with a respiratory specialist follow-up visit within 30 days after discharge in the experimental cohort compared to the control cohort.
To assess the effect of a digital health tool implementation on time to respiratory specialist follow-up after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
时间窗: Up to 1 year
Time from discharge to respiratory specialist follow-up visit in the experimental cohort compared to the control cohort.
次要结局
- To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 90 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.(Enrollment to 90 days after discharge)
- To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year(Enrollment through 1 year after discharge)
- To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year.(Enrollment through 1 year after discharge)
- To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation.(Enrollment to 90 days after discharge)
- To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.(Enrollment to 1 year post discharge)
- To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.(Enrollment through 90 days after discharge)
- To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.(Enrollment through 90 days after discharge)
- To compare the rate of cardiovascular events in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 30 days(Enrollment through 30 days after discharge)
- To compare the rate of cardiovascular events in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year(Enrollment through 1 year after discharge)
- To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 30 days(Enrollment through 30 days after discharge)
- To assess the impact of a digital health tool implementation on achieving pharmacological treatment that is consistent with the GOLD treatment recommendations after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.(Enrollment through 90 days)