Critical Health Assessment and Outcomes Score/Study

NCT02766166 | Recruiting

• 1 other identifier: CR02_2017-5045 (central IRB)
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Critical Illness; Death, Sudden

Outcome Measures

Primary Outcomes (2)

• Time to Mortality

  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

  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 (3)

• Rates of critical care transfer

  through study completion, an average of 1 year

• Non-fatal adverse events

  through study completion, an average of 1 year

• readmission to unit or hospital

  30 days

Study Arms (2)

Predictive Monitoring

No Predictive Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted to the hospital, including ward bed or surgical operating room with telemetry monitoring capability.

You may qualify if:

• All patients age 18-100 years admitted to a bed or OR with telemetry monitoring capability will be included.

You may not qualify if:

• Children (individuals \<18 years of age).

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Cincinnati: collaborator
• Indiana University: collaborator

Study Sites (3)

Indiana University

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21205, United States

NOT YET RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267-0542, United States

RECRUITING

MeSH Terms

Conditions

Critical Illness; Death, Sudden

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death

Central Study Contacts

Deeptankar DeMazumder, MD, PhD

CONTACT

513-558-1035; DDeMazu@iu.edu

Deeptankar DeMazumder, MD, PhD

CONTACT

513-558-1035; Deeptankar@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 9, 2016
• Study Start: September 1, 2019
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 10, 2022

Record last verified: 2022-09

Locations

US (3)