Emergency MedicineEPOC-BEX-EDNCT03102216
Early Point-Of-Care Blood Tests, ECG & X-rays in the Emergency Department
A study testing iSTAT, CBC and ECG in people with Emergency Medicine and Point-of-Care Testing, run by Helen Joseph Hospital at 1 site in South Africa.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Medicine, Point-of-Care Testing
- What is being tested?
- iSTAT, CBC and ECG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,134 participants
- Where
- 1 siteSouth Africa
- Study dates
- 13 Feb 2017to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Failure to obtain consent
- Pregnant patients
- Patients who require immediate resuscitation
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Helen Joseph Hospital Emergency Department
Johannesburg, Gauteng, 2006
About this study
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
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.
Read the 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.
- Conditions
- Emergency Medicine, Point-of-Care Testing
- Being tested
- iSTAT, CBC, ECG, Lodox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSTATDiagnostic test
iSTAT troponin, INR, CG4+ and Chem8
CBCDiagnostic test
Complete Blood Count
ECGDiagnostic test
ElectroCardioGram
LodoxDiagnostic test
Low dose x-ray
| Study group | Role | What they receive |
|---|---|---|
| Current workflow pathway | No intervention | 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 |
| Enhanced workflow pathway iSTAT | Experimental | 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. Receives: Diagnostic Test: iSTAT |
| Enhanced workflow pathway iSTAT CBC | Experimental | Patients will receive iSTAT point-of-care troponin, INR, CG4+ and chem8 tests as well as a CBC prior to seeing the doctor. Receives: Diagnostic Test: iSTAT; Diagnostic Test: CBC |
| Enhanced workflow pathway ECG | Experimental | Patients will receive a 12lead, v1R-v6R(right sided ECG leads) and V7-V9 ECG prior to seeing the doctor. Receives: Diagnostic Test: ECG |
| Enhanced workflow pathway Lodox | Experimental | Patients will receive a supine AP and lateral lodox (low dose x-ray) of their chest and abdomen prior to seeing the doctor. Receives: Diagnostic Test: Lodox |
| Enhanced workflow pathway iSTAT ECG | Experimental | 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. Receives: Diagnostic Test: iSTAT; Diagnostic Test: ECG |
| Enhanced workflow pathway iSTAT, CBC ECG | Experimental | 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. Receives: Diagnostic Test: iSTAT; Diagnostic Test: CBC; Diagnostic Test: ECG |
| Enhanced workflow pathway iSTAT lodox | Experimental | Patients will receive iSTAT point-of-care troponin, INR, CG4+ and chem8 tests and Lodox prior to seeing the doctor. Receives: Diagnostic Test: iSTAT; Diagnostic Test: Lodox |
| Enhanced workflow pathway iSTAT CBC Lodox | Experimental | iSTAT point-of-care troponin, INR, CG4+ and chem8 tests; CBC and Lodox prior to seeing the doctor. Receives: Diagnostic Test: iSTAT; Diagnostic Test: CBC; Diagnostic Test: Lodox |
| Enhanced workflow pathway ECG Lodox | Experimental | Patients will receive LODOX and 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor. Receives: Diagnostic Test: ECG; Diagnostic Test: Lodox |
| Enhanced workflow pathway iSTAT ECG Lodox | Experimental | iSTAT point-of-care troponin, INR, CG4+ and chem8 tests; LODOX and 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor Receives: Diagnostic Test: iSTAT; Diagnostic Test: ECG; Diagnostic Test: Lodox |
| Enhanced workflow pathway iSTAT CBC ECG Lodox | Experimental | 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. Receives: Diagnostic Test: iSTAT; Diagnostic Test: CBC; Diagnostic Test: ECG; Diagnostic Test: Lodox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease waiting and disposition times for patients presenting to the Emergency Department
Measurement of waiting and workflow times compared to current workflow pathway
Measured: 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
Measurement of cost implications
Measured: Compare the costs for standard care to costs of point-of-care intervention through study completion (approximately 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start13 Feb 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Emergency MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator-initiated, Prospective, Randomised, Control Trial
- Masking
- None (open label)
- Enrolment
- 1,134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helen Joseph Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Point of Care, University of Johannesburg, Lodox Systems (Ltd)
- Responsible party
- Principal investigator, Dr LN Goldstein, Helen Joseph Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102216
- Sponsor's protocol ID
- EPOC-BEX-ED
- Acronym
- EPOC-BEX-ED
- Status last verified
- Aug 2017
- First submitted
- 16 Mar 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 10480833Hoot 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.
PubMed 18433933Jarvis 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.
PubMed 25383437Stotler 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.
PubMed 24124152Terris 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.
PubMed 15333523Whiley 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.
PubMed 24205438Goldstein 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.
PubMed 31829227
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03102216
- Acronym / sponsor ID
- EPOC-BEX-ED / EPOC-BEX-ED
- Conditions
- Emergency Medicine, Point-of-Care Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,134 participants (actual)
- Lead sponsor
- Helen Joseph HospitalUniversity, hospital or other
- Collaborators
- Abbott Point of Care, University of Johannesburg, Lodox Systems (Ltd)
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
- Model description
- Investigator-initiated, Prospective, Randomised, Control Trial
| Arm | Type | Receives |
|---|---|---|
| Current workflow pathway | No intervention | –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 |
| Enhanced workflow pathway iSTAT | Experimental | Diagnostic Test: iSTATPatients 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 | Experimental | Diagnostic Test: iSTAT, Diagnostic Test: CBCPatients 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 | Experimental | Diagnostic Test: ECGPatients will receive a 12lead, v1R-v6R(right sided ECG leads) and V7-V9 ECG prior to seeing the doctor. |
| Enhanced workflow pathway Lodox | Experimental | Diagnostic Test: LodoxPatients 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 | Experimental | Diagnostic Test: iSTAT, Diagnostic Test: ECGPatients 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 | Experimental | Diagnostic Test: iSTAT, Diagnostic Test: CBC, Diagnostic Test: ECGPatients 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 | Experimental | Diagnostic Test: iSTAT, Diagnostic Test: LodoxPatients 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 | Experimental | Diagnostic Test: iSTAT, Diagnostic Test: CBC, Diagnostic Test: LodoxiSTAT point-of-care troponin, INR, CG4+ and chem8 tests; CBC and Lodox prior to seeing the doctor. |
| Enhanced workflow pathway ECG Lodox | Experimental | Diagnostic Test: ECG, Diagnostic Test: LodoxPatients will receive LODOX and 12lead, v1R-v6R and V7-V9 ECG prior to seeing the doctor. |
| Enhanced workflow pathway iSTAT ECG Lodox | Experimental | Diagnostic Test: iSTAT, Diagnostic Test: ECG, Diagnostic Test: LodoxiSTAT 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 | Experimental | Diagnostic Test: iSTAT, Diagnostic Test: CBC, Diagnostic Test: ECG, Diagnostic Test: LodoxPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Abdominal/epigastric/stomach pain/vomiting
- Psychosis/aggression/hallucinations (see Ethical Considerations)
- Shortness of breath/dyspnoea/cough/chest pain/syncope
- General body pain/weakness
Key exclusion criteria (3 listed)
- Failure to obtain consent
- Pregnant patients
- Patients who require immediate resuscitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iSTATiSTAT troponin, INR, CG4+ and Chem8 | Diagnostic test | Enhanced workflow pathway iSTAT, Enhanced workflow pathway iSTAT CBC, Enhanced workflow pathway iSTAT CBC ECG Lodox, Enhanced workflow pathway iSTAT CBC Lodox, Enhanced workflow pathway iSTAT ECG, Enhanced workflow pathway iSTAT ECG Lodox, Enhanced workflow pathway iSTAT lodox, Enhanced workflow pathway iSTAT, CBC ECG |
| CBCComplete Blood Count | Diagnostic test | Enhanced workflow pathway iSTAT CBC, Enhanced workflow pathway iSTAT CBC ECG Lodox, Enhanced workflow pathway iSTAT CBC Lodox, Enhanced workflow pathway iSTAT, CBC ECG |
| ECGElectroCardioGram | Diagnostic test | Enhanced workflow pathway ECG, Enhanced workflow pathway ECG Lodox, Enhanced workflow pathway iSTAT CBC ECG Lodox, Enhanced workflow pathway iSTAT ECG, Enhanced workflow pathway iSTAT ECG Lodox, Enhanced workflow pathway iSTAT, CBC ECG |
| LodoxLow dose x-ray | Diagnostic test | Enhanced workflow pathway ECG Lodox, Enhanced workflow pathway Lodox, Enhanced workflow pathway iSTAT CBC ECG Lodox, Enhanced workflow pathway iSTAT CBC Lodox, Enhanced workflow pathway iSTAT ECG Lodox, Enhanced workflow pathway iSTAT lodox |
Primary outcome
Decrease waiting and disposition times for patients presenting to the Emergency Department
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)
Measurement of waiting and workflow times compared to current workflow pathway
1 secondary outcome
Decrease the costs of special investigations for patients presenting to the Emergency Department
Time frame: Compare the costs for standard care to costs of point-of-care intervention through study completion (approximately 4 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Results publication: PubMed 10480833Altman 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 publication: PubMed 18433933Hoot 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 publication: PubMed 25383437Jarvis 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 publication: PubMed 24124152Stotler 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 publication: PubMed 15333523Terris 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 publication: PubMed 24205438Whiley 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.
- Derived from this study: PubMed 31829227Goldstein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iSTAT, CBC and ECG in people with Emergency Medicine and Point-of-Care Testing, run by Helen Joseph Hospital at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease waiting and disposition times for patients presenting to the Emergency Department (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03102216, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.