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
1 other identifier
interventional
1,134
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 13, 2017
CompletedFirst Submitted
Initial submission to the registry
March 16, 2017
CompletedFirst Posted
Study publicly available on registry
April 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedAugust 9, 2017
August 1, 2017
5 months
March 16, 2017
August 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Decrease the costs of special investigations for patients presenting to the Emergency Department
Compare the costs for standard care to costs of point-of-care intervention through study completion (approximately 4 months)
Study Arms (12)
Current workflow pathway
NO INTERVENTIONIn 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
Enhanced workflow pathway iSTAT
EXPERIMENTALPatients will receive i-STAT point-of-care troponin, INR (International Normalised Ratio), CG4(blood gas analysis) and chem8 tests prior to seeing the doctor.
Enhanced workflow pathway iSTAT CBC
EXPERIMENTALPatients will receive iSTAT point-of-care troponin, INR, CG4+ and chem8 tests as well as a CBC prior to seeing the doctor.
Enhanced workflow pathway ECG
EXPERIMENTALPatients will receive a 12lead, v1R-v6R(right sided ECG leads) and V7-V9 ECG prior to seeing the doctor.
Enhanced workflow pathway Lodox
EXPERIMENTALPatients will receive a supine AP and lateral lodox (low dose x-ray) of their chest and abdomen prior to seeing the doctor.
Enhanced workflow pathway iSTAT ECG
EXPERIMENTALPatients 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.
Enhanced workflow pathway iSTAT, CBC ECG
EXPERIMENTALPatients 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.
Enhanced workflow pathway iSTAT lodox
EXPERIMENTALPatients will receive iSTAT point-of-care troponin, INR, CG4+ and chem8 tests and Lodox prior to seeing the doctor.
Enhanced workflow pathway iSTAT CBC Lodox
EXPERIMENTALiSTAT point-of-care troponin, INR, CG4+ and chem8 tests; CBC and Lodox prior to seeing the doctor.
Enhanced workflow pathway ECG Lodox
EXPERIMENTALPatients will receive LODOX and 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor.
Enhanced workflow pathway iSTAT ECG Lodox
EXPERIMENTALiSTAT point-of-care troponin, INR, CG4+ and chem8 tests; LODOX and 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor
Enhanced workflow pathway iSTAT CBC ECG Lodox
EXPERIMENTALPatients 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.
Interventions
iSTAT troponin, INR, CG4+ and Chem8
Complete Blood Count
ElectroCardioGram
Low dose x-ray
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Failure to obtain consent
- Pregnant patients
- Patients who require immediate resuscitation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helen Joseph Hospitallead
- Abbott Point of Carecollaborator
- University of Johannesburgcollaborator
- Lodox Systems (Ltd)collaborator
Study Sites (1)
Helen Joseph Hospital Emergency Department
Johannesburg, Gauteng, 2006, South Africa
Related Publications (7)
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.
PMID: 10480833RESULTHoot 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.
PMID: 18433933RESULTJarvis 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.
PMID: 25383437RESULTStotler 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.
PMID: 24124152RESULTTerris 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.
PMID: 15333523RESULTWhiley 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.
PMID: 24205438RESULTGoldstein 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.
PMID: 31829227DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head: Department of Emergency Medicine
Study Record Dates
First Submitted
March 16, 2017
First Posted
April 5, 2017
Study Start
February 13, 2017
Primary Completion
June 30, 2017
Study Completion
June 30, 2017
Last Updated
August 9, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share