None listed
Conditions
Brief summary
About 65,000 patients annually in New Zealand are assessed with dedicated clinical pathways for possible Acute Myocardial Infarction (AMI), usually because of chest pain. These enable up-to 35% of patients to have AMI ruled-out within 6 hours. These pathways require two blood tests for cardiac troponin (cTn) over two to six hours from Emergency Department (ED) presentation. Newer, laboratory-based, high-sensitivity assays can now measure cTn at low concentrations with high enough precision to allow rule-out of AMI in 31 to 49% of patients by applying a low-concentration decision threshold to a single ‘baseline’ blood test (done on arrival at the ED). Despite the time-efficiencies that this creates, the turnaround-time taken from blood-draw to actioning of the results is an important limitation to rapid decision-making. Time to transport to a central laboratory and prepare a sample for measurement is a significant component of this time. Additionally, since results are not immediately available, there is also delay because the decision-making clinician is busy with other patients when the results become available. A new high-precision point-of-care cardiac (POC) cTn assays using a near-bedside analyser can provide results in ˜15 minutes. Consequently, rule-out of AMI is now possible using a single ‘baseline’ blood-test with TnI-Nx utilising a low-concentration threshold. We hypothesise that implementation of this assay will result in more patients being released earlier from the ED. Aims This is a multi-centre measured implementation project to enable and evaluate a TnI-Nx based strategy across 10 diverse hospital settings. We aim to (a) reduce length of ED and hospital stay and (b) identify optimal knowledge translation strategies needed to support implementation.
Interventions
Brief Title: This is measured implementation of a change in service delivery via a pragmatic multi-centre stepped-wedge cross-sectional implementation design.
Why: Early risk stratification can enable early discharge of low-risk patients.
What: The use of a next generation point-of-care (POC) troponin assay compared with central laboratory based troponin assay. They hypothesis is that the POC assay will enable earlier discharge in low-risk patients because the results are available earlier.
Who
Brief Title: This is measured implementation of a change in service delivery via a pragmatic multi-centre stepped-wedge cross-sectional implementation design. Why: Early risk stratification can enable early discharge of low-risk patients. What: The use of a next generation point-of-care (POC) troponin assay compared with central laboratory based troponin assay. They hypothesis is that the POC assay will enable earlier discharge in low-risk patients because the results are available earlier. Who: Patients presenting to urban EDs with symptoms of possible acute coronary syndrome (ACS). These are patients who routinely have laboratory based troponin tests on presentation to the ED. The nurse or physician determines this on the basis of the presenting complaint which includes chest-pain. The attending nurse draws the clinical bloods and orders the laboratory troponin test. This will occur in both the usual care and intervention arm. The determination of who gets the blood test by the nurse is standard practice and will not change. In the intervention phase they will also place this blood on a point-of-care troponin measurement device to measure the troponin concentration which will be reported to the attending physician ~15 minutes later. There are no additional blood draws. How: Each emergency department will have a minimum 4 month usual care (control) followed by a two month run-in and minimum 4 month intervention phase. The only difference between arms is that the usual-care arm will use a laboratory based troponin assay on the first blood draw whereas the intervention arm will use a point-of-care assay. There will be at least 5 steps with one month in between steps and one or two hospital sites at each step. Where: Emergency departments (EDs)
Sponsors
Dr Martin Than
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged >= 18 years. 2. Patients being assessed using the local hospital clinical pathway for possible acute coronary syndrome
Exclusion criteria
1. Died in ED
Outcome results
None listed