Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000334606
Ethics application status
Approved
Date submitted
9/03/2023
Date registered
31/03/2023
Date last updated
13/04/2024
Date data sharing statement initially provided
31/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Equitable access to full blood examination testing at the point of care in remote primary health
Scientific title
The effect of access to point-of-care full blood examination testing on time to treatment for sepsis in Northern Territory primary health care settings
Secondary ID [1] 309136 0
2016006
Universal Trial Number (UTN)
Trial acronym
SPOCTrial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 329235 0
Condition category
Condition code
Infection 326191 326191 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immediate full blood examination (FBE) test results will be implemented into 21 participating remote primary health care centres of the Northern Territory for 6 months via a Point-of-Care (POC) device registered with the therapeutic Goods Administration (TGA) to provide a new model of care for patients with suspected sepsis. As such, the interventions being assessed are:
a) a new model of care
b) a novel POC FBE testing device

The new model of care in which FBE results are available immediately to assist in identifying cases of suspected sepsis (without septic shock) will be implemented into participating health centres. Implementation will occur over a 1 month period, after 6 months of data collection in the usual care arm, where laboratory-based FBE results or no FBE results are used. The intervention period will extend 6 months after the implementation month.
The new model of care will be implemented by embedding FBE POC testing into existing clinical pathways and workflows, including the existing NT Health Primary Health Care Adult Sepsis Recognition and Management Pathway (and the equivalent Paediatric Pathway) and various protocols within in the CARPA (Central Australian Rural Practitioners Association) Standard Treatment Manual for remote and rural practice where FBE (or subset analytes such as WBC and Hb) are required or recommended.
The new model will be communicated to health centres and health care staff participants via information sessions with relevant health care staff and flyers that will be available within participating health centres. Changes to relevant clinical protocols will be distributed to participants via the NT Health AMSANT standard distribution systems for nursing and AHP clinicians. NT Health Rural Medical Practitioners (RMPs), Duty Medical Officers (DMOs) and Medical Retrieval and Consultation Centre (MRaCC) will be informed using their standard clinical update procedures. These communication channels will also be utilised to keep health care staff aware of the trial’s participating health centres.
Protocol modifications and flyers will be developed with the study’s clinical advisors (Clinical Lead Remote Health, Clinical Lead Haematology, and Clinical Lead Sepsis) in collaboration with the Project Manager and Project Coordinator. They will be delivered by the Project Manager, Project Coordinator, Research Support personnel or Clinical Lead Remote Health in FBE POC testing device operator training sessions and/or at standalone information sessions.
A POC connectivity system will be utilised to monitor POC FBE use at participating sites, with the Project Coordinator reviewing FBE testing rates on a weekly basis. Where there are any issues with the use, or lack of use, of the FBE POC device, the Project Coordinator will communicate with the Governance Committee, which will have representation from Administering Organisations of each participating site, who will collaboratively decide upon the best strategy to address the issue and facilitate communication with the participating site. Additionally, the Project Manager and/or Clinical Lead Remote Health will perform a regular audit of clinical cases to monitor the adherence to the new model of care.

For the novel POC FBE testing device intervention, the HemoScreen will be implemented and installed into participating health centres, where possible, by the Project Manager, Project Coordinator and/or local research support personnel. If an in-person installation visit is not possible, local health care staff will be talked through device setup via videoconference.
During the installation visit an initial information and operator training session will be held for all nominated health care staff (doctors, nurses, Aboriginal Health Practitioners/Workers). This session will cover all key aspects of technical and operational use of the device. Practical competency of the staff to use the device and achieve an appropriate test result will be assessed via their performance of quality control testing. After the initial on-site training session, training for any further staff will be provided online/via teleconference and in-person where requested. Methods and materials for training will be consistent with those developed by the Flinders University International Centre for Point-of-Care Testing and will comply with the National Pathology Accreditation Advisory Council (NPAAC) Guidelines for POC testing.
After initial competency is achieved, and post the 6 months intervention period, ongoing training will be provided to POC FBE device operators and/or POC FBE test requestors using a novel case-based learning method for POC testing. Case-based learning modules will be provided using a learning management system (LMS) at 1-3 month intervals throughout the remainder of the study.
A POC connectivity system will be utilised to monitor POC FBE use at participating sites, with the Project Coordinator and/or local research support personnel reviewing FBE tests, errors and quality testing on a weekly basis to ensure device fidelity.
Implementation of the POC FBE device will not change any aspect of patient care related to FBE testing. Patients will have blood drawn via capillary (for Hb) or venous (for FBE) methods consistent with usual care. Instead of the sample being tested via the usual method, it will be tested on the HemoScreen™ POC testing device. As such, sample collection for the POC FBE test will be in place of either laboratory FBE sample collection and/or capillary POC Hb sample collection. In addition, if the patients’ blood is to be also sent to the laboratory for further/additional testing, the same vial of blood collected for the POC FBE test can be sent to the laboratory. Therefore, an additional blood draw will not be required, and usual care will remain unchanged.
Intervention code [1] 325585 0
Early detection / Screening
Intervention code [2] 325718 0
Treatment: Devices
Comparator / control treatment
Six months of data collection will occur in the usual care arm (where laboratory-based FBE results requiring approximately 2 days wait for results or no FBE results are used as delayed results are impractical) prior to the intervention(s) will be implemented into participating health centres. Implementation will occur over a 1 month period, and intervention data will be collected for 6 months post the implementation phase.
Control group
Active

Outcomes
Primary outcome [1] 334067 0
Time to treatment with antibiotics measured from medical records.
Timepoint [1] 334067 0
From time of presentation to time of treatment with antibiotics within 6 months of intervention implementation at the site.
Secondary outcome [1] 419262 0
Incidence of septic shock as assessed from medical records.
Timepoint [1] 419262 0
At 6 months after the intervention implementation at the site.
Secondary outcome [2] 419263 0
Number of medical evacuations for suspected sepsis as assessed from medical records.
Timepoint [2] 419263 0
At 6 months after the intervention implementation at the site.
Secondary outcome [3] 420272 0
Calculating the different between resource use and costs from primary care and hospital medical records and cost-benefit of the new model of care from outcome data. Annualised costs of the POC FBE device and other resources associated with implementation will be estimated from data collected alongside the study implementation of the POC FBE device. The cost of lab-based FBE testing and health care for sepsis will be calculated, including test ordering and care provided by participating clinics, evacuations and hospital admissions (reports on evacuations and hospital admissions are recorded in patient information system). Required cost parameters will be sourced in collaboration with partner organisation NT Health. The cost model will estimate the expected difference in costs associated with the care of sepsis between an intervention and a usual care patient, to which the estimated POC FBE implementation cost per sepsis patient will be added.
Timepoint [3] 420272 0
At 6 months after the intervention implementation at the site.

Eligibility
Key inclusion criteria
Patients diagnosed with sepsis after presenting at a participating health centre.
Minimum age
2 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patient that initially presents to a primary health care centre that does not have a FBE POC testing device and is referred to a nearby primary health care centre that does have a FBE POC testing device.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stepped wedge cluster randomised trial of 21 participating sites randomised into 4 clusters of 5 sites per cluster (6 sites in last cluster to mitigate the risk of site attrition in earlier clusters) via a computer-generated list of random numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Non-concealed allocation of 21 participating sites.
Randomised into 4 clusters of 5 sites per cluster (6 sites in last cluster to mitigate the risk of site attrition in earlier clusters) via a computer-generated list of random numbers.
Sequential crossover of clusters from control to intervention until all clusters are exposed.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To estimate the expected power of the trial to detect statistically significant improvements in the primary outcome (time to treatment initiation) the expected number of sepsis cases in the trial was estimated using data reported by a prospective cohort study that reported an aggregate rate of 11.8 hospital admissions for community acquired sepsis per 1,000 population per year across the Top End of the NT and a rate of 40.8 for Indigenous people (who comprised 27% of the catchment population).[1] The average community size served by remote primary healthcare centres is 900 (70% Indigenous peoples).[2] From these data, over 1,100 cases of community acquired sepsis leading to hospitalisations are expected across the study clinics over the 2.5-year time horizon of the trial. This is a conservative figure as not all cases of sepsis will be hospitalised. The power calculation is based on the primary outcome of time to treatment with antibiotics. A pilot extraction of data for 30 patients from the PCIS demonstrated a mean of 140 minutes’ time gap with standard deviation of 129 minutes between initial presentation to IV antibiotics in the standard care. A sample of 20 clusters in a complete stepped-wedge cluster-randomized design with 4 steps, with 5 cluster(s) switching from control to treatment at each step, with an average of 11 participants per cluster per time period (for a total sample size of 1,100 participants) achieves 90% power to detect a difference between means of 41 minutes (e.g., an average of 140 minutes in control group and 99 minutes in intervention group). The test statistic used is the two-sided Wald Z-Test. The assumed intra cluster correlation (ICC) is 0.050, and the significance level of the test is set to 0.05. One additional site, giving 21 participating sites in total, has been added to mitigate the risk of site attrition in earlier clusters.

1. Davis JS, Cheng AC, McMillan M, et al. Sepsis in the tropical Top End of Australia’s Northern Territory: disease burden and impact on Indigenous Australians. Med J Aust. 2011;194:519-24.

2. Australian Bureau of Statistics (2016) Estimates of Aboriginal and Torres Strait Islander Australians [ww.abs.gov.au/statistics/people/aboriginal-and-torres-strait-islander-peoples/estimates-aboriginal-and-torres-strait-islander-australians/latest-release], accessed 11 February 2022.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
28/02/2027
Actual
Sample size
Target
1100
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NT

Funding & Sponsors
Funding source category [1] 313339 0
Government body
Name [1] 313339 0
NHMRC 2021 Medical Research Future Fund Primary Health Care Research
Country [1] 313339 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 315083 0
None
Name [1] 315083 0
Not applicable.
Address [1] 315083 0
Not applicable.
Country [1] 315083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312561 0
Human Research Ethics Committee of NT Health and Menzies School of Health Research
Ethics committee address [1] 312561 0
John Mathews Building
Royal Darwin Hospital Campus
Rocklands Drive Casuarina NT 0810
Ethics committee country [1] 312561 0
Australia
Date submitted for ethics approval [1] 312561 0
05/04/2023
Approval date [1] 312561 0
26/06/2023
Ethics approval number [1] 312561 0
2023-4597

Summary
Brief summary
The full blood examination (FBE) test is the most requested pathology test in Australia, and yet, remote Northern Territory (NT) communities do not have timely and reliable access to this fundamental test. This project aims to improve patient access to full blood examination (FBE) testing in remote primary care facilities through implementing a novel point-of-care (POC) FBE testing device (Therapeutic Goods Administration [TGA] Approved) and its delivery model in the NT using a stepped wedge cluster-randomised trial in 21 primary health care centres. The delivery model will primarily be evaluated for its clinical and cost-effectiveness in the early treatment of sepsis. Other conditions to be explored in a include anaemia, chronic kidney disease and respiratory infections.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125094 0
Dr Brooke Spaeth
Address 125094 0
Level 3, Health Sciences Building,
Flinders University
BEDFORD PARK SA 5041
Country 125094 0
Australia
Phone 125094 0
+61 0882017792
Fax 125094 0
Email 125094 0
brooke.spaeth@flinders.edu.au
Contact person for public queries
Name 125095 0
Dr Brooke Spaeth
Address 125095 0
Level 3, Health Sciences Building,
Flinders University
BEDFORD PARK SA 5041
Country 125095 0
Australia
Phone 125095 0
+61 0882017792
Fax 125095 0
Email 125095 0
brooke.spaeth@flinders.edu.au
Contact person for scientific queries
Name 125096 0
Dr Brooke Spaeth
Address 125096 0
Level 3, Health Sciences Building,
Flinders University
BEDFORD PARK SA 5041
Country 125096 0
Australia
Phone 125096 0
+61 0882017792
Fax 125096 0
Email 125096 0
brooke.spaeth@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This research involves participating primary health care services located in remote Northern Territory communities, which primarily service Aboriginal and Torres Strait Islander peoples, as such, due to cultural, ethical, and sensitivity considerations, IPD will not be made publicly available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.