The goal of this proposal is to improve the quality and value of care for patients with acute chest pain by investigating the potential impact of point-of-care (POC) high sensitivity cardiac troponin (hs-cTn) testing in the Emergency Department (ED) and exploring how best to integrate POC hs-cTnl into ED risk stratification workflows. The study hypothesizes that the Abbott i-STAT POC hs-cTnI assay will decrease time-to-result (TTR) and ED length of stay (LOS), while increasing ED revenue for patients with acute chest pain compared to a strategy of central laboratory hs-cTnI testing.
Use of point-of-care (POC) testing in the Emergency Department (ED) has been previously established as a method to reduce the time-to-disposition-decision (TTD) making for emergency physicians, which in-turn can reduce ED length of stay (LOS) and time-to-treatment (TTT) of time sensitive conditions, such as myocardial infarctions (MIs). Recently, new POC high sensitivity cardiac troponin I (hs-cTnI) assays have been developed which offer similar diagnostic performance to traditional central lab hs-cTnI testing. However, data examining POC hs-cTnI measurement in U.S. ED settings are limited. In particular, studies have yet to evaluate the potential impact of POC hs-cTnI implementation on time to troponin result (TTR), time-to-last-troponin-result (TTLT), time-to-disposition-decision (TTD), time-to-treatment (TTT), and ED LOS. In addition, limited data exists on how best to implement POC hs-cTnI into ED clinical practice, such as whether POC hs-cTnI measures should be paired with a risk score or incorporated into an accelerated diagnostic protocol. This record is a prospective multisite observational cohort study of 600 adult ED patients with symptoms suggestive of acute coronary syndrome and without ST-segment elevation myocardial infarction (STEMI) across 3 EDs. Participants, accrued under a waiver of informed consent, will undergo a standard-of-care evaluation for possible acute coronary syndrome (ACS) in the ED including blood testing for hs-cTnI (Beckman Coulter) completed in a central laboratory. During the study period all ED patients with chest pain will have an extra lithium heparin blood sample obtained for each troponin test ordered and collected in the ED (typically 2, but this may range from 1-3 troponin measures), which will be used for immediate hs-cTnI measurement by research personnel using an Abbott i-STAT Alinity. Clinicians will be blinded to the POC hs-cTnI results and will base clinical decisions on central laboratory hs-cTn measures. Blood draw times, result times for point-of-care (POC) and central laboratory measures, patient ED arrival, patient ED bedded, ED disposition decision times, and ED discharge times will be recorded on all patients. Following each POC hs-cTnI measurement the treating attending physician will be surveyed regarding whether a negative or positive POC result would change ED disposition or treatment including time stamps to determine estimated TTD, ED LOS and TTT for the POC hs-cTnI measurement strategy. Data from these surveys will be compared to actual TTD, ED LOS and treatment times based on the central laboratory hs-cTnI measurement strategy.
Study Type
OBSERVATIONAL
Enrollment
600
During the study period all ED patients with chest pain will have an extra lithium heparin blood sample obtained for each troponin test ordered and collected in the ED (typically 2, but this may range from 1-3 troponin measures), which will be used for immediate hs-cTnI measurement by research personnel using an Abbott i-STAT POC device.
Carolinas Medical Center
Charlotte, North Carolina, United States
High Point Medical Center
High Point, North Carolina, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Time-to-result (TTR) of hs-cTnI
Defined as the time from blood collection to result time of the hs-cTnI assay, as recorded by research staff for the Abbott i-STAT POC device and by the electronic health record for central lab Beckman Coulter Access 2 hs-cTnI measures. TTR will be collected for each troponin test ordered and collected in the Emergency Department (typically two tests per patient).
Time frame: Index visit to Hour 24
Time-to-last-troponin-result (TTLT)
Defined as the time from ED arrival to the result time of the last hs-cTnI measure in the ED (by the POC and central lab strategies).
Time frame: Index visit to Hour 24
Time-to-disposition decision (TTD)
Defined as the time from the patient being bedded in the ED to provider decision on disposition (discharge vs admission).
Time frame: Index visit to Hour 24
ED length of stay (LOS)
Defined as the time from ED arrival to disposition (discharged, admitted, observation unit, left against medical advice, transfer, etc.).
Time frame: Index visit to Hour 72
ED Revenue amount
Calculate the associated ED revenue generated based on an average of $550 in revenue per bed-hour.
Time frame: Index visit to Month 6
Time-to-treatment (TTT)
Defined by the time from the patient being bedded in the ED to the provider's decision to initiate treatment for patients with a Type 1 Non-ST-Segment Elevation Myocardial Infarction (NSTEMI) diagnosis (e.g., heparin drip).
Time frame: Index visit to Hour 24
Number of Myocardial Infarctions (MI)
Number of Myocardial Infarctions (MI)
Time frame: Baseline and Week 1
Number of Cardiac Deaths
Number of Cardiac Deaths
Time frame: Baseline and Day 30
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