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

Primary Purpose

Emergency Medicine, Point-of-Care Testing

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
iSTAT
CBC
ECG
Lodox
Sponsored by
Helen Joseph Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Emergency Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helen Joseph Hospital Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Current workflow pathway

Enhanced workflow pathway iSTAT

Enhanced workflow pathway iSTAT CBC

Enhanced workflow pathway ECG

Enhanced workflow pathway Lodox

Enhanced workflow pathway iSTAT ECG

Enhanced workflow pathway iSTAT, CBC ECG

Enhanced workflow pathway iSTAT lodox

Enhanced workflow pathway iSTAT CBC Lodox

Enhanced workflow pathway ECG Lodox

Enhanced workflow pathway iSTAT ECG Lodox

Enhanced workflow pathway iSTAT CBC ECG Lodox

Arm Description

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

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.

Patients will receive iSTAT point-of-care troponin, INR, CG4+ and chem8 tests as well as a CBC prior to seeing the doctor.

Patients will receive a 12lead, v1R-v6R(right sided ECG leads) and V7-V9 ECG prior to seeing the doctor.

Patients will receive a supine AP and lateral lodox (low dose x-ray) of their chest and abdomen prior to seeing the doctor.

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.

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.

Patients will receive iSTAT point-of-care troponin, INR, CG4+ and chem8 tests and Lodox prior to seeing the doctor.

iSTAT point-of-care troponin, INR, CG4+ and chem8 tests; CBC and Lodox prior to seeing the doctor.

Patients will receive LODOX and 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor.

iSTAT point-of-care troponin, INR, CG4+ and chem8 tests; LODOX and 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor

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.

Outcomes

Primary Outcome Measures

Decrease waiting and disposition times for patients presenting to the Emergency Department
Measurement of waiting and workflow times compared to current workflow pathway

Secondary Outcome Measures

Decrease the costs of special investigations for patients presenting to the Emergency Department
Measurement of cost implications

Full Information

First Posted
March 16, 2017
Last Updated
August 8, 2017
Sponsor
Helen Joseph Hospital
Collaborators
Abbott Point of Care, University of Johannesburg, Lodox Systems (Ltd)
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1. Study Identification

Unique Protocol Identification Number
NCT03102216
Brief Title
Early Point-Of-Care Blood Tests, ECG & X-rays in the Emergency Department
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helen Joseph Hospital
Collaborators
Abbott Point of Care, University of Johannesburg, Lodox Systems (Ltd)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Medicine, Point-of-Care Testing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Investigator-initiated, Prospective, Randomised, Control Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Current workflow pathway
Arm Type
No Intervention
Arm Description
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
Arm Title
Enhanced workflow pathway iSTAT
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced workflow pathway iSTAT CBC
Arm Type
Experimental
Arm Description
Patients will receive iSTAT point-of-care troponin, INR, CG4+ and chem8 tests as well as a CBC prior to seeing the doctor.
Arm Title
Enhanced workflow pathway ECG
Arm Type
Experimental
Arm Description
Patients will receive a 12lead, v1R-v6R(right sided ECG leads) and V7-V9 ECG prior to seeing the doctor.
Arm Title
Enhanced workflow pathway Lodox
Arm Type
Experimental
Arm Description
Patients will receive a supine AP and lateral lodox (low dose x-ray) of their chest and abdomen prior to seeing the doctor.
Arm Title
Enhanced workflow pathway iSTAT ECG
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced workflow pathway iSTAT, CBC ECG
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced workflow pathway iSTAT lodox
Arm Type
Experimental
Arm Description
Patients will receive iSTAT point-of-care troponin, INR, CG4+ and chem8 tests and Lodox prior to seeing the doctor.
Arm Title
Enhanced workflow pathway iSTAT CBC Lodox
Arm Type
Experimental
Arm Description
iSTAT point-of-care troponin, INR, CG4+ and chem8 tests; CBC and Lodox prior to seeing the doctor.
Arm Title
Enhanced workflow pathway ECG Lodox
Arm Type
Experimental
Arm Description
Patients will receive LODOX and 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor.
Arm Title
Enhanced workflow pathway iSTAT ECG Lodox
Arm Type
Experimental
Arm Description
iSTAT point-of-care troponin, INR, CG4+ and chem8 tests; LODOX and 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor
Arm Title
Enhanced workflow pathway iSTAT CBC ECG Lodox
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
iSTAT
Intervention Description
iSTAT troponin, INR, CG4+ and Chem8
Intervention Type
Diagnostic Test
Intervention Name(s)
CBC
Intervention Description
Complete Blood Count
Intervention Type
Diagnostic Test
Intervention Name(s)
ECG
Intervention Description
ElectroCardioGram
Intervention Type
Diagnostic Test
Intervention Name(s)
Lodox
Intervention Description
Low dose x-ray
Primary Outcome Measure Information:
Title
Decrease waiting and disposition times for patients presenting to the Emergency Department
Description
Measurement of waiting and workflow times compared to current workflow pathway
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)
Secondary Outcome Measure Information:
Title
Decrease the costs of special investigations for patients presenting to the Emergency Department
Description
Measurement of cost implications
Time Frame
Compare the costs for standard care to costs of point-of-care intervention through study completion (approximately 4 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Helen Joseph Hospital Emergency Department
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2006
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10480833
Citation
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.
Results Reference
result
PubMed Identifier
18433933
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.
Results Reference
result
PubMed Identifier
25383437
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.
Results Reference
result
PubMed Identifier
24124152
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.
Results Reference
result
PubMed Identifier
15333523
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.
Results Reference
result
PubMed Identifier
24205438
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.
Results Reference
result
PubMed Identifier
31829227
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.
Results Reference
derived

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

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