Clinical trial NCT03102216: Early Point-Of-Care Blood Tests, ECG & X-rays in the Emergency Department
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergency Medicine
Point-of-Care Testing
Lead sponsor: Helen Joseph Hospital
Sponsor class: OTHER
Collaborators: name: Abbott Point of Care
name: University of Johannesburg
name: Lodox Systems (Ltd)
First posted: 2017-04-05
Enrollment: 1134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigator-initiated, Prospective, Randomised, Control Trial
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decrease waiting and disposition times for patients presenting to the Emergency Department
timeFrame: 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 outcomes:
measure: Decrease the costs of special investigations for patients presenting to the Emergency Department
timeFrame: Compare the costs for standard care to costs of point-of-care intervention through study completion (approximately 4 months)
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Helen Joseph Hospital Emergency Department
state: Gauteng
Study officials:
References:
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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.
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. doi: 10.1136/emj.2002.003913.
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.
citation: 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.