Critical Health Assessment and Outcomes Score/Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Critical Illness, Death, Sudden. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
CHAOS is based on the investigator's new and exciting results from pre-clinical and large longitudinal multi-center observational clinical studies of critically ill patients and asymptomatic community-based adults with little or no advanced disease. By integrating approaches from the physical, biological, computational, statistical and clinical sciences, this observational study will test the hypothesis that early diagnosis of subclinical signatures of critical illness encoded within physiological signals complements conventional clinical predictors by providing unique prognostic insight. The primary goal is to reduce mortality, morbidity and complications by early identification of individuals with brewing subclinical critical illness and adverse events before overt clinical presentation (e.g., cardiac arrest, arrhythmias, hemorrhage, respiratory failure, circulatory collapse). This will provide the necessary lead time for healthcare providers to deliver early, more effective and/or preventive therapies. Through innovative approaches, CHAOS also meets the challenge of medical errors to reduce missed diagnosis, misdiagnosis, preventable harm and variability in provider adherence to best practice guidelines. The goal is to validate predictive algorithms and identify subclinical signatures of illness, ranging from asymptomatic adults in the community to very sick patients in the hospital. The overall goal is to make healthcare more precise, effective, efficient, safe and timely while reducing costs, preventable harms and adverse events.
Primary outcome measures
- Time to Mortality [Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]
- Duration of ICU/hospital stay [Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]
Secondary outcome measures (3)
- Rates of critical care transfer [Time frame: through study completion, an average of 1 year]
- Non-fatal adverse events [Time frame: through study completion, an average of 1 year]
- readmission to unit or hospital [Time frame: 30 days]
Eligibility criteria
Inclusion criteria
- All patients age 18-100 years admitted to a bed or OR with telemetry monitoring capability will be included.
Exclusion criteria
- Children (individuals <18 years of age).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Indiana University — Indianapolis
- Johns Hopkins University — Baltimore
- University of Cincinnati — Cincinnati
Identifiers
NCT: NCT02766166 · CR02_2017-5045 (central IRB)