Clinical trial NCT02766166: Critical Health Assessment and Outcomes Score/Study
Official title: Critical Health Assessment and Outcomes Score/Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Death, Sudden
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
name: Indiana University
First posted: 2016-05-09
Enrollment: 200000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to the hospital, including ward bed or surgical operating room with telemetry monitoring capability.

Brief summary: 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.


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).

Primary outcomes:
measure: Time to Mortality
timeFrame: 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
measure: Duration of ICU/hospital stay
timeFrame: 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 outcomes:
measure: Rates of critical care transfer
timeFrame: through study completion, an average of 1 year
measure: Non-fatal adverse events
timeFrame: through study completion, an average of 1 year
measure: readmission to unit or hospital
timeFrame: 30 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
References: