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

Emergency Medicine Clinical Trial

— EPOC-BEX-ED  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102216
• Other study ID #: EPOC-BEX-ED
• Status: Completed
• Phase: N/A
• First received: March 16, 2017
• Last updated: August 8, 2017
• Start date: February 13, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2017
• Source: Helen Joseph Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1134
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency Medicine
• Point-of-Care Testing

Intervention

Diagnostic Test:
• iSTAT
iSTAT troponin, INR, CG4+ and Chem8
• CBC
Complete Blood Count
• ECG
ElectroCardioGram
• Lodox
Low dose x-ray

Locations

Country	Name	City	State
South Africa	Helen Joseph Hospital Emergency Department	Johannesburg	Gauteng

Sponsors (4)

Lead Sponsor	Collaborator
Helen Joseph Hospital	Abbott Point of Care, Lodox Systems (Ltd), University of Johannesburg

Country where clinical trial is conducted

South Africa, 

References & Publications (6)

Altman DG, Bland JM. How to randomise. BMJ. 1999 Sep 11;319(7211):703-4. Review. — View Citation

Hoot NR, Aronsky D. Systematic review of emergency department crowding: causes, effects, and solutions. Ann Emerg Med. 2008 Aug;52(2):126-36. doi: 10.1016/j.annemergmed.2008.03.014. Epub 2008 Apr 23. Review. — View Citation

Jarvis P, Davies T, Mitchell K, Taylor I, Baker M. Does rapid assessment shorten the amount of time patients spend in the emergency department? Br J Hosp Med (Lond). 2014 Nov;75(11):648-51. doi: 10.12968/hmed.2014.75.11.648. — View Citation

Stotler BA, Kratz A. Analytical and clinical performance of the epoc blood analysis system: experience at a large tertiary academic medical center. Am J Clin Pathol. 2013 Nov;140(5):715-20. doi: 10.1309/AJCP7QB3QQIBZPEK. — View Citation

Terris J, Leman P, O'Connor N, Wood R. Making an IMPACT on emergency department flow: improving patient processing assisted by consultant at triage. Emerg Med J. 2004 Sep;21(5):537-41. — View Citation

Whiley SP, Alves H, Grace S. Full-body x-ray imaging to facilitate triage: a potential aid in high-volume emergency departments. Emerg Med Int. 2013;2013:437078. doi: 10.1155/2013/437078. Epub 2013 Sep 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)