Early Point-Of-Care Blood Tests, ECG & X-rays in the Emergency Department

Study Overview
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Brief Summary
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The 2015 Abbott Point-of-Care Great Minds Summit in Berlin presented novel research that showed the potential for upfront, point-of-care (POC) blood testing to improve waiting times, costs and patient flow in the Emergency Department (ED). POC testing has become a focus area for enquiry as EDs worldwide look for ways to cope with over-crowding and reduce waiting times. In South African EDs, the target time for patients to be seen is dictated by their triage category. Patients triaged Red (critical) should ideally be seen immediately, Orange within 10 minutes, Yellow within 1 hour and Green within 4 hours of arrival. Whilst patients may initially be evaluated within the above time frames, there may be delays in their final disposition due to time lags in obtaining results from special tests and/or investigations. Traditionally, blood tests and other special investigations such as electrocardiograms (ECG) and radiological investigations (x-rays) take place after the doctor has evaluated the patient. Patients (and doctors) then have to wait for the results of these tests before a decision can be made regarding the patient's final disposition. Instead of sending blood specimens to the laboratory for analysis, POC blood testing refers to selected tests which can be performed in the ED and provide immediate on-site results and thus have the potential to expedite patient management decisions. Similarly, low dose x-ray (LODOX®) is the radiological equivalent of a POC blood test providing a full body x-ray within 19 seconds. LODOX has been evaluated in trauma patients previously but its application as a screening tool for non-trauma patients in the ED has not been properly explored thus far. Electrocardiograms (ECGs) are commonly used in clinical medicine as a POC test to evaluate the heart. Locally, Helen Joseph Hospital ED in Johannesburg has a constant influx of critically ill and injured patients 24 hours a day. The aim of this investigator-initiated, prospective, randomised control trial is to compare and assess the standard workflow pathway currently in use in the ED to a modified pathway that makes use of upfront, early POC tests (blood tests, ECG and/or LODOX) to see if the use of such has any significant effect on costs, waiting times and associated patient flow patterns in the ED.

Detailed Description
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The Helen Joseph Hospital ED has a constant influx of critically ill and injured patients 24 hours a day. On average, 170 - 200 patients are triaged and evaluated per day - approximately 60 000-70000 patients per annum. EDs world-wide are constantly looking for ways to decrease patient over-crowding and waiting times. Suggested solutions have included the hiring of additional personnel, creating observation units, ambulance diversion and triage. Some have even tried to improve patient flow by placing a senior consultant in the triage area. In South African EDs, the South African Triage Scale (SATS) is utilised to assess severity and acuity of patients presenting to the ED. The target time for patients to be seen is dictated by their triage category. Patients triaged Red should ideally be seen immediately, Orange within 10 minutes, Yellow within 1 hour and Green within 4 hours of arrival. Whilst patients may initially be evaluated within these time frames, there may be delays in their final disposition due to time lags in obtaining results from special investigations. Traditionally, investigations in the ED take place after the doctor has evaluated the patient. Patients (and doctors) then have to wait for the results of the investigations. Further decisions on the patients' ultimate disposition (i.e. either discharged home or admitted for inpatient care) are thus contingent upon the results of the investigations. POC blood testing (as opposed to sending blood to the laboratory to be analysed) has been shown to be accurate and assist in expediting patient management by decreasing the turnaround time for results. Low dose x-ray (LODOX®) has been marketed as a quick and easy radiological screening tool for trauma patients that can even be used as a triage tool. The LODOX can produce a full body antero-posterior x-ray image within 19 seconds. It is much quicker and exposes the patient to less radiation than a standard radiograph/x-ray. It can therefore also be categorised as the x-ray equivalent of a POC test. Its use has never been evaluated as a tool for non-trauma patients in the ED. Electrocardiograms (ECGs) are commonly used in clinical medicine as a POC test to evaluate the heart. The aim of this study is therefore to assess whether, individually or in combination, upfront, early POC blood tests, ECGs and/or LODOX can decrease waiting times, reduce costs and improve patient flow in the ED.

Official Title
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An Assessment of the Impact of Enhanced Workflow Patterns Associated With Upfront, Early Point-of-care Testing on Costs, Waiting and Disposition Times in an Emergency Department

Conditions
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Emergency Medicine, Point-of-Care Testing

Intervention / Treatment
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* Diagnostic Test: iSTAT
* Diagnostic Test: CBC
* Diagnostic Test: ECG
* Diagnostic Test: Lodox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consenting adult patients older than 18 years old, with the one of the symptom groups below, that present to Helen Joseph Hospital ED, who do not require immediate resuscitation i.e. not triaged red. This will be performed during weekdays only. Presenting symptom groups: Abdominal/epigastric/stomach pain/vomiting Psychosis/aggression/hallucinations (see Ethical Considerations) Shortness of breath/dyspnoea/cough/chest pain/syncope General body pain/weakness Overdose Exclusion Criteria: Failure to obtain consent Pregnant patients Patients who require immediate resuscitation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Investigator-initiated, Prospective, Randomised, Control Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Current workflow pathway<br>In the Current (normal) Workflow Pathway, after a patient is triaged, they are reviewed by the doctor. It is routine for the doctor to then order diagnostic tests/investigations that include blood tests, which are analysed at the laboratory, x-rays, which are performed in the Radiology department, and an ECG, which is performed by an ECG technician. Once the results of those tests are ready, the doctor will then review the patient a second time with all the results. The decision for patient disposition will then be made | |
| Experimental: Enhanced workflow pathway iSTAT<br>Patients will receive i-STAT point-of-care troponin, INR (International Normalised Ratio), CG4(blood gas analysis) and chem8 tests prior to seeing the doctor. | Diagnostic Test: iSTAT<br>* iSTAT troponin, INR, CG4+ and Chem8<br>|
| Experimental: Enhanced workflow pathway iSTAT CBC<br>Patients will receive iSTAT point-of-care troponin, INR, CG4+ and chem8 tests as well as a CBC prior to seeing the doctor. | Diagnostic Test: iSTAT<br>* iSTAT troponin, INR, CG4+ and Chem8<br>Diagnostic Test: CBC<br>* Complete Blood Count<br>|
| Experimental: Enhanced workflow pathway ECG<br>Patients will receive a 12lead, v1R-v6R(right sided ECG leads) and V7-V9 ECG prior to seeing the doctor. | Diagnostic Test: ECG<br>* ElectroCardioGram<br>|
| Experimental: Enhanced workflow pathway Lodox<br>Patients will receive a supine AP and lateral lodox (low dose x-ray) of their chest and abdomen prior to seeing the doctor. | Diagnostic Test: Lodox<br>* Low dose x-ray<br>|
| Experimental: Enhanced workflow pathway iSTAT ECG<br>Patients will receive iSTAT point-of-care troponin, INR, CG4+ and chem8 tests as well as 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor. | Diagnostic Test: iSTAT<br>* iSTAT troponin, INR, CG4+ and Chem8<br>Diagnostic Test: ECG<br>* ElectroCardioGram<br>|
| Experimental: Enhanced workflow pathway iSTAT, CBC ECG<br>Patients will receive iSTAT point-of-care troponin, INR, CG4+ and chem8 tests, CBC and 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor. | Diagnostic Test: iSTAT<br>* iSTAT troponin, INR, CG4+ and Chem8<br>Diagnostic Test: CBC<br>* Complete Blood Count<br>Diagnostic Test: ECG<br>* ElectroCardioGram<br>|
| Experimental: Enhanced workflow pathway iSTAT lodox<br>Patients will receive iSTAT point-of-care troponin, INR, CG4+ and chem8 tests and Lodox prior to seeing the doctor. | Diagnostic Test: iSTAT<br>* iSTAT troponin, INR, CG4+ and Chem8<br>Diagnostic Test: Lodox<br>* Low dose x-ray<br>|
| Experimental: Enhanced workflow pathway iSTAT CBC Lodox<br>iSTAT point-of-care troponin, INR, CG4+ and chem8 tests; CBC and Lodox prior to seeing the doctor. | Diagnostic Test: iSTAT<br>* iSTAT troponin, INR, CG4+ and Chem8<br>Diagnostic Test: CBC<br>* Complete Blood Count<br>Diagnostic Test: Lodox<br>* Low dose x-ray<br>|
| Experimental: Enhanced workflow pathway ECG Lodox<br>Patients will receive LODOX and 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor. | Diagnostic Test: ECG<br>* ElectroCardioGram<br>Diagnostic Test: Lodox<br>* Low dose x-ray<br>|
| Experimental: Enhanced workflow pathway iSTAT ECG Lodox<br>iSTAT point-of-care troponin, INR, CG4+ and chem8 tests; LODOX and 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor | Diagnostic Test: iSTAT<br>* iSTAT troponin, INR, CG4+ and Chem8<br>Diagnostic Test: ECG<br>* ElectroCardioGram<br>Diagnostic Test: Lodox<br>* Low dose x-ray<br>|
| Experimental: Enhanced workflow pathway iSTAT CBC ECG Lodox<br>Patients will receive iSTAT point-of-care troponin, INR, CG4+ and chem8 tests; CBC, LODOX and 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor. | Diagnostic Test: iSTAT<br>* iSTAT troponin, INR, CG4+ and Chem8<br>Diagnostic Test: CBC<br>* Complete Blood Count<br>Diagnostic Test: ECG<br>* ElectroCardioGram<br>Diagnostic Test: Lodox<br>* Low dose x-ray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease waiting and disposition times for patients presenting to the Emergency Department | Measurement of waiting and workflow times compared to current workflow pathway | From patient Arrival in the Emergency Department until disposition (i.e. until the decision to admit or discharge the patient is made) through study completion (approximately 4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease the costs of special investigations for patients presenting to the Emergency Department | Measurement of cost implications | Compare the costs for standard care to costs of point-of-care intervention through study completion (approximately 4 months) |