Identifying Post ICU Morbidity in Patients With ARDS in the United States
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- Bayer
- 入组人数
- 140,000
- 试验地点
- 1
- 主要终点
- Difference in prevalence rates pre versus post index hospitalization
研究概览
简要总结
This is an observational study in which data already collected from people with acute respiratory distress syndrome (ARDS) admitted to an intensive care unit (ICU) are studied.
ARDS is a life-threatening condition in which fluid builds up in the lungs making breathing difficult.
In observational studies, only observations are made without participants receiving any advice or any changes to health care.
People who are admitted to ICU for serious illnesses, like ARDS, often experience new health problems during and after their ICU stays. These health problems that may include physical, mental, and/or emotional disorders, are called post-intensive care syndrome (PICS). Identifying these new health problems early can help people by timely treatments and care.
In this study, researchers want to identify any health problems that arise after ICU admission in people with ARDS in the United States (US). To do this, researchers will collect information on health problems, treatments, medicines, and healthcare visits in people with ARDS, 1 year before and after an ICU admission.
They will then look to see whether the health problems are in areas that have been described as the post intensive care syndrome (PICS).
In addition, they will measure healthcare related costs in the one year after admission and compare it to the one year prior to admission.
Researchers will also compare this information with data collected for people with pneumonia who did not require ICU admission. This will help them to identify any new health problems arising due to ICU stays.
The data will come from participants' medical claims information stored in the Optum Clinformatics Data Mart database from 2016 to 2022. The claims data will only be collected for people in the US.
Researchers will collect data from participants admitted to ICU for ARDS for a maximum of 1 year before and after their stay.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •continuous coverage of at least 365 days (>= 1 year) pre-index date for the cohort
- •age >= 18 years
- •not seen outside the healthcare system
排除标准
- 未提供
结局指标
主要结局
Difference in prevalence rates pre versus post index hospitalization
时间窗: at 1, 3, 6 and 12 months post- index hospital admission
Average total healthcare costs based on healthcare billing data in the one year post index ICU admission
时间窗: at 12 months post- index hospital admission
Average total healthcare costs will be based on healthcare billing data in the one year post index ICU admission.
Post ICU Syndrome-related morbidity
时间窗: at 12 months post- index hospital admission
PICS-related morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization. PICS stands for post intensive care unit syndrome.
Incident morbidity
时间窗: at 1, 3, 6 and 12 months post- index hospital admission
Incident morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
Post ICU Syndrome-related incident morbidity
时间窗: at 1, 3, 6 and 12 months post- index hospital admission
PICS-related incident morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
Morbidity
时间窗: at 1,3,6 and 12 month pre- and post- index hospital admission
Morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
次要结局
未报告次要终点
