Risk-score Based ICU Triage

Completed

• Conditions: Non-ST Elevation Myocardial Infarction (nSTEMI)
• Interventions: Other: Admission with NSTEMI

• Registration Number: NCT03390270
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2017-12-28
• Study First Submitted QC: 2017-12-28
• Study First Posted: 2018-01-04
• Study Start: 2018-02-14
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-27
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 462

Inclusion Criteria

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

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Exclusion Criteria

• ST segment elevation myocardial infarction
• Hemodynamically unstable

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with NSTEMI	Admission with NSTEMI	All patients admitted to Duke University Hospital with an NSTEMI

Primary Outcome Measures

Name	Time	Method
Hospital cost in dollars	1 year	Cost of caring for NSTEMI patients at Duke University Hospital in the 1 year prior to roll-out of the risk score versus the 1 year after

Secondary Outcome Measures

Name	Time	Method
Death during the index hospitalization	30 days	Element of composite of "complications mandating ICU care"
Respiratory failure during the index hospitalization	30 days	Element of composite of "complications mandating ICU care"; defined by billing codes
Shock during the index hospitalization	30 days	Element of composite of "complications mandating ICU care"; defined by billing codes
Stroke during the index hospitalization	30 days	Element of composite of "complications mandating ICU care"; defined by billing codes
ICU transfer	30 days	Whether a patient initially admitted to a non-ICU setting is transferred to the ICU during the index hospitalization
Development of complications mandating ICU care during the index hospitalization	30 days	Composite of death or development of shock, cardiac arrest, heart block requiring treatment, stroke, or respiratory failure (as identified by billing codes)
Cardiac arrest during the index hospitalization	30 days	Element of composite of "complications mandating ICU care"; defined by billing codes
Heart block requiring treatment during the index hospitalization	30 days	Element of composite of "complications mandating ICU care"; defined by billing codes

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States