Viewing Study NCT03102216



Ignite Creation Date: 2024-05-06 @ 9:54 AM
Last Modification Date: 2024-10-26 @ 12:21 PM
Study NCT ID: NCT03102216
Status: COMPLETED
Last Update Posted: 2017-08-09
First Post: 2017-03-16

Brief Title: Early Point-Of-Care Blood Tests ECG X-rays in the Emergency Department
Sponsor: Helen Joseph Hospital
Organization: Helen Joseph Hospital

Study Overview

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
Status: COMPLETED
Status Verified Date: 2017-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EPOC-BEX-ED
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 andor 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 patients 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 andor 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 ie 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 radiographx-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 andor LODOX can decrease waiting times reduce costs and improve patient flow in the ED

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None