Early Point-Of-Care Blood Tests, ECG & X-rays in the Emergency Department (EPOC-BEX-ED)

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

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.

Study Overview

• Status: Completed
• Conditions: Emergency Medicine; Point-of-Care Testing
• Intervention / Treatment: Diagnostic test: iSTAT; Diagnostic test: CBC; Diagnostic test: ECG; Diagnostic test: Lodox

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2006
      • Helen Joseph Hospital Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Current workflow pathway; 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; 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; iSTAT troponin, INR, CG4+ and Chem8
Experimental: Enhanced workflow pathway iSTAT CBC; 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; iSTAT troponin, INR, CG4+ and Chem8; Diagnostic test: CBC; Complete Blood Count
Experimental: Enhanced workflow pathway ECG; Patients will receive a 12lead, v1R-v6R(right sided ECG leads) and V7-V9 ECG prior to seeing the doctor.	Diagnostic test: ECG; ElectroCardioGram
Experimental: Enhanced workflow pathway Lodox; 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; Low dose x-ray
Experimental: Enhanced workflow pathway iSTAT ECG; 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; iSTAT troponin, INR, CG4+ and Chem8; Diagnostic test: ECG; ElectroCardioGram
Experimental: Enhanced workflow pathway iSTAT, CBC ECG; 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; iSTAT troponin, INR, CG4+ and Chem8; Diagnostic test: CBC; Complete Blood Count; Diagnostic test: ECG; ElectroCardioGram
Experimental: Enhanced workflow pathway iSTAT lodox; Patients will receive iSTAT point-of-care troponin, INR, CG4+ and chem8 tests and Lodox prior to seeing the doctor.	Diagnostic test: iSTAT; iSTAT troponin, INR, CG4+ and Chem8; Diagnostic test: Lodox; Low dose x-ray
Experimental: Enhanced workflow pathway iSTAT CBC Lodox; iSTAT point-of-care troponin, INR, CG4+ and chem8 tests; CBC and Lodox prior to seeing the doctor.	Diagnostic test: iSTAT; iSTAT troponin, INR, CG4+ and Chem8; Diagnostic test: CBC; Complete Blood Count; Diagnostic test: Lodox; Low dose x-ray
Experimental: Enhanced workflow pathway ECG Lodox; Patients will receive LODOX and 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor.	Diagnostic test: ECG; ElectroCardioGram; Diagnostic test: Lodox; Low dose x-ray
Experimental: Enhanced workflow pathway iSTAT ECG Lodox; 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; iSTAT troponin, INR, CG4+ and Chem8; Diagnostic test: ECG; ElectroCardioGram; Diagnostic test: Lodox; Low dose x-ray
Experimental: Enhanced workflow pathway iSTAT CBC ECG Lodox; 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; iSTAT troponin, INR, CG4+ and Chem8; Diagnostic test: CBC; Complete Blood Count; Diagnostic test: ECG; ElectroCardioGram; Diagnostic test: Lodox; Low dose x-ray

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Helen Joseph Hospital
• Collaborators: University of Johannesburg; Abbott Point of Care; Lodox Systems (Ltd)

Publications and helpful links

General Publications

• Altman DG, Bland JM. How to randomise. BMJ. 1999 Sep 11;319(7211):703-4. doi: 10.1136/bmj.319.7211.703. No abstract available.
• 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.
• 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.
• 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.
• 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. doi: 10.1136/emj.2002.003913.
• 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.
• Goldstein LN, Wells M, Vincent-Lambert C. The cost-effectiveness of upfront point-of-care testing in the emergency department: a secondary analysis of a randomised, controlled trial. Scand J Trauma Resusc Emerg Med. 2019 Dec 11;27(1):110. doi: 10.1186/s13049-019-0687-2.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: EPOC-BEX-ED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No