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Non-ST Elevation Myocardial Infarction (nSTEMI)NCT03390270

Risk-score Based ICU Triage

An observational study of Non-ST Elevation Myocardial Infarction (nSTEMI), run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Admission with NSTEMI
How many people
462 participants
Where
1 siteUnited States
Study dates
14 Feb 2018to 31 Aug 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients presenting to the Duke University Medical Center Emergency Department with elevated cardiac troponin

Who may be able to join

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

Who cannot join

  • ST segment elevation myocardial infarction
  • Hemodynamically unstable

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke University

    Durham, North Carolina, 27705

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Admission with NSTEMI
Keywords
intensive care units, critical care, risk assessment, electronic health records
Medical subject headings
Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Admission with NSTEMIOther

    All patients admitted to Duke University Hospital with an NSTEMI

Study groups in NCT03390270
Study groupRoleWhat they receive
Patients with NSTEMIAll patients admitted to Duke University Hospital with an NSTEMI
Receives: Other: Admission with NSTEMI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 year

Secondary outcomes (8)
  1. ICU transfer

    Whether a patient initially admitted to a non-ICU setting is transferred to the ICU during the index hospitalization

    Measured: 30 days

  2. 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)

    Measured: 30 days

  3. Death during the index hospitalization

    Element of composite of "complications mandating ICU care"

    Measured: 30 days

  4. Shock during the index hospitalization

    Element of composite of "complications mandating ICU care"; defined by billing codes

    Measured: 30 days

  5. Cardiac arrest during the index hospitalization

    Element of composite of "complications mandating ICU care"; defined by billing codes

    Measured: 30 days

  6. Heart block requiring treatment during the index hospitalization

    Element of composite of "complications mandating ICU care"; defined by billing codes

    Measured: 30 days

  7. Stroke during the index hospitalization

    Element of composite of "complications mandating ICU care"; defined by billing codes

    Measured: 30 days

  8. Respiratory failure during the index hospitalization

    Element of composite of "complications mandating ICU care"; defined by billing codes

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2018
  2. Study start14 Feb 2018
  3. Primary completion31 Aug 2019
  4. Study completion31 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
462 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03390270
Sponsor's protocol ID
Pro00080891
Status last verified
Sep 2019
First submitted
28 Dec 2017
Last updated
30 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Non-ST Elevation Myocardial Infarction (nSTEMI), run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital cost in dollars (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.

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