Clinical trial NCT06272942: An Observational Study to Identify New Health Problems Arising After an Intensive Care Unit Admission in People With Acute Respiratory Distress Syndrome in the United States
Official title: Identifying Post ICU Morbidity in Patients With ARDS in the United States
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Post Intensive Care Syndrome (PICS)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-02-22
Enrollment: 140000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients in Optum Claims data with acute respiratory distress syndrome (ARDS) admitted to an intensive care unit (ICU) from January 1, 2016 until October 1, 2022.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* continuous coverage of at least 365 days (\>= 1 year) pre-index date for the cohort
* age \>= 18 years
* not seen outside the healthcare system

Exclusion Criteria:

* none

Primary outcomes:
measure: Morbidity
timeFrame: at 1,3,6 and 12 month pre- and post- index hospital admission
measure: Post ICU Syndrome-related morbidity
timeFrame: at 12 months post- index hospital admission
measure: Incident morbidity
timeFrame: at 1, 3, 6 and 12 months post- index hospital admission
measure: Post ICU Syndrome-related incident morbidity
timeFrame: at 1, 3, 6 and 12 months post- index hospital admission
measure: Difference in prevalence rates pre versus post index hospitalization
timeFrame: at 1, 3, 6 and 12 months post- index hospital admission
measure: Average total healthcare costs based on healthcare billing data in the one year post index ICU admission
timeFrame: at 12 months post- index hospital admission
Secondary outcomes:
Other outcomes:
measure: Exploratory, descriptive difference in ranking of PICS domain comorbidity ratios observed for ARDS (ICU admissions) versus pneumonia (non ICU admissions).
timeFrame: At 1, 3, 6 and 12 months post-index admission
Locations:
city: Whippany
country: United States
facility: Bayer
state: New Jersey
Study officials:
References: