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Trial registered on ANZCTR


Registration number
ACTRN12622001480774
Ethics application status
Approved
Date submitted
27/10/2022
Date registered
25/11/2022
Date last updated
9/05/2024
Date data sharing statement initially provided
25/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation evaluation of the Emergency nurse Protocol Initiating Care—Sydney Triage to Admission Risk Tool (EPIC-START) model of care
Scientific title
Implementation evaluation of the Emergency nurse Protocol Initiating Care—Sydney Triage to Admission Risk Tool (EPIC-START) model of care
Secondary ID [1] 308286 0
MRFF 2017845
Universal Trial Number (UTN)
Trial acronym
EPIC-START
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nurse-initiated emergency care 328070 0
Condition category
Condition code
Emergency medicine 325131 325131 0 0
Other emergency care
Public Health 325239 325239 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EPIC-START model of care, with three components. Implementation of EPIC-START will use a detailed strategy supported with behaviour change and implementation science theory.

Emergency nurse Protocols Initiating Care (EPIC):
A clinical framework to support the earlier delivery of standardised evidence-based nurse-initiated treatment by emergency nurses for 74 EPICs (41 Adult + 33 Paediatric) for the most common emergency department (ED) presentations, for example, there are protocols for abdominal pain, chest pain, mild head injury, asthma, bites and stings, limb fractures, shortness of breath, headache, wound care, and burns. The EPIC protocols were developed by the NSW Agency for Clinical Innovation (NSW ACI) with clinicians and policy stakeholders across NSW with metropolitan, regional and rural input.
Emergency nurses at sites will be trained in the epic protocol use with online and in person training. There will be recognition of prior learning for experienced staff for some of the skills. It is anticipated the training will occur in the months leading up to the implementation date. There will be support with the implementation clinical nurse consultants for each Local Health District (LHD). There will continue to be support post-implementation.
The EPIC protocols will be stored on the NSW ACI website and the staff will be able to enter information relating to the EPIC into the patient medical record.
The EPIC protocols will support the standard care of the patients in ED. It will mean nurses can commence some treatments earlier prior to doctor review. Use of the EPIC protocols should not increase the time it takes to care for a patient. It may take extra time to read the protocols until the staff are more familiar with the protocol use.
NSW ACI will lead the NSW state rollout of EPIC protocols across the rest of the state, with this study evaluating alongside the state rollout. Once implemented it is unlikely that EPIC will be cancelled, though the study may inform changes to the rollout at the state level and small changes to the EPIC protocols themselves.

Sydney Triage to Admission Risk Tool (START): A validated decision support/risk tool at the point of triage. This tool combines the presenting health concern with various other data elements available at the point of triage to estimate a risk of hospital admission or discharge to support senior clinical decisions about streaming and disposition from ED.
Clinical deterioration tool: A clinical deterioration alert system that supports the earlier detection of, and senior medical response to, patients at risk of clinical deterioration in the ED.The clinical deterioration alert system is based on Modified Early Warning Score (MEWS) and Paediatric Early Warning Scores (PEWS) tools. These validated tools estimate the risk of clinical deterioration resulting in death or Intensive Care Unit admission based on vital sign observations routinely recorded by clinicians in electronic medical record (EMR) observation charts with a reported AUROC of 0.83 (95% CI, 0.83-0.84)1. MEWS tool: https://www.mdcalc.com/calc/1875/modified-early-warning-score-mews-clinical-deterioration PEWS tool: https://www.mdcalc.com/calc/3901/pediatric-early-warning-score-pews
The START and clinical deterioration tool will run on the electronic medical record (eMR) with data pulled from the eMR. The system will automatically run based on the observations at triage and highlight patient risk. This will be mainly used by senior medical clinicians, bed managers, in-charge and / or patient flow coordinators. These staff will receive training in the use of the tools prior to implementation.

Evaluation of adherence to the EPIC-START model of care will happen in several ways: medical record audit, surveys with implementers, web-portal analytics, emR reports on usage, post-surveys, implementation logs.

The timeline of the stepped wedge will be dependant on the state rollout and the readiness of the protocols. However we anticipate that there will be a 2 month step between site implementation.
Four Stages of the study (all these phases will be done as a part of this study):
1. Pre-implementation – collect baseline comparison data and identify barriers to implementation
2. Implementation strategy – develop site-specific implementation strategies based on stage 1
3. Implementation
4. Evaluate the implementation – patient, health service, implementation outcomes (cost, fidelity, usability)
Intervention code [1] 324738 0
Treatment: Other
Comparator / control treatment
Standard care - standard care is the usual care that patients receive on admission to an ED before introduction of EPIC-START.
Control group
Active

Outcomes
Primary outcome [1] 332948 0
1. Change in patient length of stay in the ED

Data collected from medical record data (routinely collected)
Timepoint [1] 332948 0
On discharge from ED
Primary outcome [2] 332949 0
Change in time to treatment

Data collected from medical record data (routinely collected)
Timepoint [2] 332949 0
Time receives first treatment in ED
Primary outcome [3] 332950 0
Change in time to analgesia

Data collected from medical record data (routinely collected)
Timepoint [3] 332950 0
Time of analgesia first receive in ED
Secondary outcome [1] 415284 0
Change in patient / carer experience in ED.
Composite - Either the patient or their carer (eg for patients <18 years, cognitively incapable) will complete the survey
The patient or carer will either complete a survey independantly or will be assisted via telephone call by one of the site research nurses to complete the survey.
To assess patient experience two instruments will be used, the Australian Hospital Patient Experience Question Set (AHPEQS) and Schmidt's Perceptions of Nursing Care Survey (SPNCS)
Timepoint [1] 415284 0
Within 2 weeks of discharge from the ED
Secondary outcome [2] 415288 0
Change to costs in ED.

Data collected from medical record data (routinely collected)
Timepoint [2] 415288 0
Cumulative data will be assessed at the conclusion of the study using admission information.

Eligibility
Key inclusion criteria
Emergency patient presentations
Data will be collected via medical records and other routinely collected data including patient presentation information and costing data.
Inclusions:
- All patients presenting to the emergency department during the collection period for each cluster
- Adult and paediatric patients are included
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients that are direct transfers/admissions from other sites are excluded
- Patients will be excluded if they require immediate resuscitation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a stepped wedge randomised control trial

Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation of cluster using computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This project will incorporate an effectiveness-implementation hybrid design that will consist of: a stepped wedge cluster randomised controlled trial (SW-cRCT) supported with implementation frameworks to test the implementation strategy and the outcomes of the intervention.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample Patient Survey (recruiting)
Overall, 63% of patients/carers rated their experience with ED care as “very good” in 2019-20. We will need to survey 120 ED patients/carers at each data collection time point per cluster/LHD, totally 1920 across the study, to detect a 5% change in “very good” satisfaction rating when assuming ICC 0.05 for a two-sided test (80% power; ??<5%).

We used a standard deviation of 5.4 hours on ED LOS based on our previous study of over 67000 ED presentations in NSW 32. When assuming an intraclass correlation coefficient (ICC) of 0.05, the number of ED presentations required per data collection time point at each cluster (LHD; Figure 1) is 1420 to detect a one-hour change in ED LOS for a two-sided test (80% power; ??<5%). With 5 data collection time points per cluster (LHD), the total number of ED presentations required is 28,400.

For each outcome of interest, data collected across all measurement periods and all study data collection time points will be used in the analyses comparing intervention status (pre versus post). Analyses will apply the intention-to-treat principle. Patient data will be analysed according to the status of the study EDs (i.e. pre or post intervention) where patients were presented and treated. Outcomes will be assessed at the patient-level using mixed effect models, considering correlation of patient presentation within ED and LHD (cluster) and multiple presentations for the same patient, with adjustment for potential confounding factors. For example, for ED LOS analysis we will adjust for patient characteristics, e.g. age and gender and clinical characteristic, e.g. number of laboratory tests ordered. The mixed models will also incorporate fixed terms for intervention status and measurement time points (including baseline). The analyses will include multiple time points pre and post the intervention. The study design will allow us to determine temporal changes in system effectiveness, e.g. to determine if ED LOS continue to decrease over time.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2023
Actual
27/11/2023
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
1920
Accrual to date
343
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312534 0
Government body
Name [1] 312534 0
Australian Department of Health (MRFF)
Country [1] 312534 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 314136 0
None
Name [1] 314136 0
Address [1] 314136 0
Country [1] 314136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311867 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 311867 0
Ethics committee country [1] 311867 0
Australia
Date submitted for ethics approval [1] 311867 0
25/10/2022
Approval date [1] 311867 0
14/12/2022
Ethics approval number [1] 311867 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122654 0
Prof Kate Curtis
Address 122654 0
RC Mills Building
University of Sydney
Camperdown NSW 2006
Country 122654 0
Australia
Phone 122654 0
+61410314818
Fax 122654 0
Email 122654 0
Kate.curtis@sydney.edu.au
Contact person for public queries
Name 122655 0
Sarah Kourouche
Address 122655 0
RC Mills Building
University of Sydney
Camperdown NSW 2006
Country 122655 0
Australia
Phone 122655 0
+61 286278895
Fax 122655 0
Email 122655 0
sarah.kourouche@sydney.edu.au
Contact person for scientific queries
Name 122656 0
Sarah Kourouche
Address 122656 0
RC Mills Building
University of Sydney
Camperdown NSW 2006
Country 122656 0
Australia
Phone 122656 0
+61411350035
Fax 122656 0
Email 122656 0
sarah.kourouche@sydney.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
Sharing of IPD will be dependent upon the conditions of the ethical approval


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.