Clinical trial NCT03390270: Risk-score Based ICU Triage
Official title: Rational Coronary Care Unit Triage for Stable Patients With NSTEMI: Evaluating the Safety and Costs of a Risk Score-based Triaging System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-ST Elevation Myocardial Infarction (nSTEMI)
Keywords: intensive care units
critical care
risk assessment
electronic health records
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the Duke University Medical Center Emergency Department with elevated cardiac troponin

Brief summary: The investigators have created a new risk score that predicts whether initially stable patients with myocardial infarctions (heart attacks) will require intensive care while they are in the hospital. To evaluate how well this risk score works, the investigators plan to calculate this risk score for every patient that comes to the hospital with a heart attack, provide the risk score to the emergency room doctor treating the patient, and determine whether each patient required intensive care while they were in the hospital. The investigators will then evaluate whether giving emergency room doctors access to this risk score reduced costs of taking care of heart attack patients compared with previous years.

Detailed description: Multiple recent studies have demonstrated considerable between-hospital variability in ICU utilization for stable patients with NSTEMI and a lack of association between higher hospital-level ICU utilization and short-term mortality. Moreover, severity of illness, as measured by a traditional in-hospital mortality risk score, has only a trivial correlation with ICU utilization. A minority of initially stable patients with NSTEMI (\~15%) deteriorates clinically while hospitalized and requires ICU care for management of cardiac arrest, shock, arrhythmias requiring pacing, stroke, or respiratory failure. Across a variety of conditions outcomes are better when patients are admitted directly to the ICU from the emergency department (ED) rather than transferred in after admission. However, the cost of caring for patients in the ICU is substantially more than the cost of caring for these patients in a non-ICU environment. Furthermore, treating patients that do not require intensive care in the ICU exposes them to unnecessary risks of ICU care, including medication errors, adverse procedural outcomes, delirium, and excessive noise. Reducing ICU utilization for stable patients with NSTEMI may reduce costs and improve patient satisfaction.

Using data from a nationally-representative registry enrolling patients with acute MI, the investigators developed the ACTION ICU risk score. Incorporating demographic, clinical, and laboratory data obtained routinely in the ED work-up of patients with suspected acute MI, the ACTION ICU risk score calculates the risk of in-hospital complications mandating ICU care for initially stable patients with NSTEMI. Complications mandating ICU care were defined as death, shock (cardiogenic or otherwise), cardiac arrest, high degree heart block requiring pacemaker placement, respiratory failure, or stroke. The risk score's c-statistic was 0.72, indicating good discrimination. Importantly, it identified \> 50% of patients as being at \< 10% risk of in-hospital complications mandating ICU care.

However, the clinical and financial implications of using this score to guide ICU triage in routine clinical practice are unknown, and the risk score has not been prospectively validated.

The investigators will create a calculator for the electronic health record that automatically calculates the ACTION ICU risk score for all patients with NSTEMI, as identified by their initial troponin value. Once the score is calculated, it will provide the score, and the patient's risk of clinical deterioration to the ED physician, along with a recommendation for where patients at that risk should be treated. The ED physician, working with the cardiologist on call, will then decide where the patient should be treated.

After one year, each patient for whom the score was calculated will be identified by a query of the electronic medical record. From the electronic medical record, the investigators will identify whether the patient was initially admitted to the ICU or to a non-ICU unit, whether the patient was transferred to the ICU during their hospital course, and whether the patient had clinical complications mandating ICU care (death, shock, cardiac arrest, heart block requiring pacemaker, stroke, or respiratory failure). The investigators will also compare total hospital costs for caring for NSTEMI patients before and after roll-out of the ACTION ICU score electronic medical record plug-in. Study completion will be defined by the last date of data extracted from the medical records for these patients.

Eligibility criteria: Inclusion Criteria:

* Presents to DUMC with elevated cardiac troponin
* Identified by ED physician as having myocardial infarction

Exclusion Criteria:

* ST segment elevation myocardial infarction
* Hemodynamically unstable

Primary outcomes:
measure: Hospital cost in dollars
timeFrame: 1 year
Secondary outcomes:
measure: ICU transfer
timeFrame: 30 days
measure: Development of complications mandating ICU care during the index hospitalization
timeFrame: 30 days
measure: Death during the index hospitalization
timeFrame: 30 days
measure: Shock during the index hospitalization
timeFrame: 30 days
measure: Cardiac arrest during the index hospitalization
timeFrame: 30 days
measure: Heart block requiring treatment during the index hospitalization
timeFrame: 30 days
measure: Stroke during the index hospitalization
timeFrame: 30 days
measure: Respiratory failure during the index hospitalization
timeFrame: 30 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Alexander Fanaroff, MD
role: PRINCIPAL_INVESTIGATOR
References: