Assessment of Acute Disease to Reduce Imaging Costs



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 99
Updated:10/14/2017
Start Date:January 2010
End Date:February 2013

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Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED

Overtesting for Acute Coronary Syndrome(ACS) and Pulmonary Embolism (PE) in low risk
Emergency Department(ED) patients can increase exposure of nondiseased patients to radiation,
intravenous contrast and anticoagulation. This project addresses question of whether
quantitative Pre-Test Probability(PTP) assessed from two validated web-based computer
algorithms (the project "webtool"), can improve the diagnostic evaluation of adult patients
with charted evidence of chest pain and dyspnea. After a validation phase, the main study
will randomize patients to either the Standard care group or the Intervention group, which
will receive the output of the ACS and PE webtool that includes the PTP estimates of ACS and
PE and one of three recommendations regarding next steps: 1. No further testing, 2. Exclusion
with a biomarker protocol, or 3. Immediate imaging +/- empiric anticoagulation.


I. Inclusion criteria

- Adult (>17 years) ED patient reports a history of chest discomfort and new or worsened
shortness of breath or breathing difficulty, documented in the written history of
present illness or review of systems.

- Patient must understand English or have a certified translator present.

- Physician has ordered or plans to order a 12-lead electrocardiogram.

- Patient indicates the site hospital was his or her "hospital of choice" in the event
of return visit within 14 days.

II. Pre-randomization exclusion criteria

- 12-lead ECG with ST deviation interpreted as acute infarction or ischemia.

- Known diagnosis of acute PE within previous 24 hours (e.g., call back for overread of
a CT scan).

- "Code STEMI" patients (patients with suspected acute myocardial infarction).

- Other obvious condition or diagnosis identified by the emergency physician as
mandating admission (evidence of circulatory shock, severe hypoxemia, decompensated
heart failure, altered mental status, hemorrhage, sepsis syndrome, arrhythmia, trauma,
unstable social or psychiatric situation, stroke, aortic disaster, pneumonia ).

- Myocardial infarction, intracoronary stent placement, or CABG within the previous 30
days.

- Known cocaine use within past 72 hours, based upon patient or laboratory report.

- Referral to the emergency department by a personal physician.

- Patients undergoing voluntary medical clearance for a detox center or any involuntary
court or magistrate order.

- Computer interpretation of the 12-lead ECG containing either "ischemia" or
"infarction".

- Homelessness, out-of-town residence or other condition known to preclude follow-up in
14 days.

- Patients in police custody or currently incarcerated individuals.

- Patients who know they are pregnant or in whom a pregnancy test was drawn as part of
usual care and was found to be positive.

III. Post-randomization exclusions

- Positive urine cocaine test.

- Incarceration within 14 days of enrollment.

- Patient elopement from medical care (i.e., patients who leave against medical advice).
We found this trial at
4
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Charlotte, NC
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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