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Completed

NCT Number: NCT03102216

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helen Joseph Hospital Emergency Department

Johannesburg, Gauteng, 2006, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iSTAT

Diagnostic Test

iSTAT troponin, INR, CG4+ and Chem8

CBC

Diagnostic Test

Complete Blood Count

ECG

Diagnostic Test

ElectroCardioGram

Lodox

Diagnostic Test

Low dose x-ray

Primary outcomes

  1. Decrease waiting and disposition times for patients presenting to the Emergency Department

    Time frame: 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)

    Measurement of waiting and workflow times compared to current workflow pathway

Secondary outcomes

  1. Decrease the costs of special investigations for patients presenting to the Emergency Department

    Time frame: Compare the costs for standard care to costs of point-of-care intervention through study completion (approximately 4 months)

    Measurement of cost implications

Sponsors and collaborators

Lead sponsor

Helen Joseph Hospital

Other

Collaborators

  • Abbott Point of Care
  • Lodox Systems (Ltd)
  • University of Johannesburg

Registry information

Official study title

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

Acronym: EPOC-BEX-ED

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 5, 2017
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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