Risk-score Based ICU Triage

Non-ST Elevation Myocardial Infarction (nSTEMI) Clinical Trial

Official title:

Rational Coronary Care Unit Triage for Stable Patients With NSTEMI: Evaluating the Safety and Costs of a Risk Score-based Triaging System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390270
• Other study ID #: Pro00080891
• Status: Completed
• Start date: February 14, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: September 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non-ST Elevated Myocardial Infarction
• Non-ST Elevation Myocardial Infarction (nSTEMI)

Intervention

Other:
• Admission with NSTEMI
All patients admitted to Duke University Hospital with an NSTEMI

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital cost in dollars	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	1 year
Secondary	ICU transfer	Whether a patient initially admitted to a non-ICU setting is transferred to the ICU during the index hospitalization	30 days
Secondary	Development of complications mandating ICU care during the index hospitalization	Composite of death or development of shock, cardiac arrest, heart block requiring treatment, stroke, or respiratory failure (as identified by billing codes)	30 days
Secondary	Death during the index hospitalization	Element of composite of "complications mandating ICU care"	30 days
Secondary	Shock during the index hospitalization	Element of composite of "complications mandating ICU care"; defined by billing codes	30 days
Secondary	Cardiac arrest during the index hospitalization	Element of composite of "complications mandating ICU care"; defined by billing codes	30 days
Secondary	Heart block requiring treatment during the index hospitalization	Element of composite of "complications mandating ICU care"; defined by billing codes	30 days
Secondary	Stroke during the index hospitalization	Element of composite of "complications mandating ICU care"; defined by billing codes	30 days
Secondary	Respiratory failure during the index hospitalization	Element of composite of "complications mandating ICU care"; defined by billing codes	30 days