ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000426280

Ethics application status

Approved

Date submitted

19/12/2017

Date registered

26/03/2018

Date last updated

26/03/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

The Sydney Triage to Admission Risk Tool (START) study: using a data analytics tool to drive early senior decision making and improve patient outcomes in Emergency Departments

Scientific title

The Sydney Triage to Admission Risk Tool (START) study: using a data analytics tool to drive early senior decision making and improve patient outcomes in Emergency Departments

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

The Sydney Triage to Admission Risk Tool (START)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Emergency Department overcrowding

Condition category

Condition code

Emergency medicine

Other emergency care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Using NSW State-wide linked ED data, we have previously derived and internally validated a prediction tool for ED disposition called the Sydney Triage Admission Risk Tool (START). This tool generates a risk score that correlates with a patient’s likelihood of admission or discharge. It can also be used to describe the risk of re-admission within 30 days of ED presentation. Pilot feasibility studies of the START tool indicate a potential Emergency Treatment Performance (ETP) improvement of around 10%.
START will identify patients who are likely to require in-patient admission and streamed directly to a Medical Admissions Unit, or those who can be safely discharged and streamed to a Fast Track Unit or a co-located GP clinic depending on existing models of care at a given hospital. For instance, patients with chronic conditions such as cardiovascular disease often present with complex and co-existing problems that impede timely disposition decisions despite the patient understanding from past experiences, that an admission is required.
The START score will be calculated by a designated trained ED Nurse in the ED Triage room at each of the three study institutions using a paper based form and supported by an online calculator version of START located at http://www.slhd.nsw.gov.au/rpa/start/default.html The score is a weighted sum of categorical variables (age, triage category, presenting problem, mode of arrival, in-patient admission within previous 30 days and time of day) with weightings derived using logistic regression. For patients allocated to the intervention group a copy of the paper START risk scoring checklist will be attached to the clinical notes and also noted in the comments section on the ED electronic patient tracking list (Cerner Firstnet) and will used by the Nurse Unit Manager or patient flow Navigator in ED (NUM1 or equivalent existing senior nursing role in ED), together with the treating clinician, to assist with disposition decisions and patient streaming to various clinical locations including fast track (minor injuries unit) and Hospital in the Home. Details of the scoring system and clinical recommendations are detailed in the above link and summarised below;

Very likely in-patient admission – Bed management to locate appropriate ward bed and senior clinician to notify admitting team of likely admission prior to full assessment and final disposition. This represents around 10% of all presentations
Likely Admission – Bed management to locate appropriate ward bed and await further advice from senior ED medical officer Around 20% of all presentations
Unclear – Await further assessment in ED – around 40% of all patient presentations
Likely discharge – if extended workup likely, prepare admission to short stay unit Around 20% of all patient presentations
Very likely discharge – stream to ambulatory care, fast track unit, hospital in the home or alternative primary care provider. Around 10% of all patient presentations

A two month education and implementation program will occur prior to the trial, educating clinical and bed management staff about the tool, and integration into clinical practice and bed management strategies across the hospitals. Education will involve ED Doctors, Navigators, Nurse Managers, Bed management and nursing administration.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Presentations allocated to control group will receive standard management in ED by clinicians without the assistance of the risk score tool. The study investigator will still score the triage encounter using the risk tool but the results of the risk scoring will not be made known to the clinician or included in the clinical notes.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome is emergency treatment performance (ETP) defined as the proportion of patients with ED length of stay less than four hours and total length of stay (hours) in ED (defined as time from ED arrival time to ED departure time). These are routinely collected using existing patient information systems (FirstNet, Cerner Millenium) and reported by the Sydney Local Health District ED data manager.

Timepoint [1]

ED departure time

Secondary outcome [1]

Process outcomes include disposition time, (time that in-patient admission decision icons were activated by clinicians in the patient tracking system (Firstnet, Collector) or discharge ready icons were activated on patient information system).

Timepoint [1]

Hospital departure date and readmission date

Secondary outcome [2]

Readmission rates within 30 days-assessed through routine patient tracking system in ED ,Firstnet, Cerner.

Timepoint [2]

ED arrival within 30 days

Secondary outcome [3]

In-patient length of stay will also be analysed- this will be assessed through routine patient tracking system in ED ,Firstnet, Cerner.

Timepoint [3]

This will be assessed at participant discharge from hospital

Eligibility

Key inclusion criteria

Eligible adult (age>16 years) patients will be consecutive patients presenting at these hospital Emergency Departments between 1000 and 2100, representing the busiest period of ED activity. The study will be conducted on Monday to Sundays where there is appropriate research staffing availability and senior clinician cover (at least one ED consultant and Navigator or equivalent on duty).

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusions are planned admissions, transfers from other hospitals (where disposition has been pre-determined), and those brought in by police. These represent less than 10% of all ED presentations.

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)

Trial is unblinded and allocation will not be concealed from participants. However allocation will be concealed from study investigators using a computer generated number sequence in an opaque sealed envelope drawn at the start of each study investigation day.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Consecutive days of the week during the study interval will be randomly allocated by date using a computer generated number sequence in an opaque sealed envelope drawn at the start of the day by the study investigator.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Unit of randomisation will be by day of the week

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Statistical Analysis
The hypothesis will be that patients allocated to the intervention groups are associated with improved ETP (Emergency Treatment Performance - proportion of patients with length of stay less than four hours) and reduced length of stay in ED. Descriptive statistics will be used to compare proportions and means between groups and multi-level modelling used to account for day of week randomisation, seasonal differences and differences in admission practices across three sites.

Pre-specified Subgroups
Pre specified subgroups will be patients over the age of 75 years (older patients are thought to benefit more from this patient flow concept) and patients admitted under various clinical services – respiratory, cardiology, geriatrics, gastrointestinal and surgery. A subgroup of patients presenting with cardiovascular complaints (e.g. chest pain, shortness of breath) will also be analysed, given that patient flow principles, rapid observation units and similar models of care are critical to timely chest pain evaluation in ED.

Sample Size Calculation
A total of 6000 presentations will need to be analysed assuming exclusions are factored. This will provide enough power to detect a 7% improvement in the primary outcome (proportion of patients with ED length of stay less than 4 hours) in the main study analysis and with sufficient power for subgroup analyses of older patients (n=1500, representing around 25% of all presentations) and cardiovascular presentations, with a power of 0.80 and a two tailed alpha of 0.05. (See power calculation below). The current ETP performance at RPA sits around 65-70%. Results of an interim pilot study validating START score suggest that this level of ETP improvement is feasible. Assuming around 5 presentations are allocated and studied each hour at each site, 30 hours a week, an estimated six months of active recruitment is required (accounting for research staff availability and after hours).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

3/09/2018

Actual

Date of last participant enrolment

Anticipated

5/04/2019

Actual

Date of last data collection

Anticipated

3/05/2019

Actual

Sample size

Target

6000

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

Canterbury Hospital - Campsie

Recruitment hospital [3]

Concord Repatriation Hospital - Concord

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

2194 - Campsie

Recruitment postcode(s) [3]

2139 - Concord

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Sydney Local Health District

Address [1]

Missenden Road 2050 NSW

Country [1]

Australia

Primary sponsor type

Government body

Name

Agency for Clinical Innovation

Address

67 Albert Street
Chatswood 2067 NSW

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Research Ethics Committee (RPAH zone)

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

25/10/2016

Ethics approval number [1]

HREC/16/RPAH/521

Summary

Brief summary

Emergency Departments in NSW and across Australia continue to face significant challenges relating to overcrowding and access block. These conditions are projected to deteriorate as the number of patients needing emergency treatment, particularly older patients with cardiovascular presentations (chest pain, shortness of breath) and other chronic medical conditions, continue to increase. The people of NSW urgently need innovative solutions, as part of an overall strategy, to improve ED patient flow and access to timely care.
Decisions regarding hospital admission or discharge are critical to ED functioning, meeting patient expectations, resource management and patient outcomes. These disposition decisions are typically made after a series of nursing and medical assessments, which for many patients take several hours. This can cause patient dissatisfaction and increased anxiety, especially for patients with chronic conditions 
The aim of this project is to facilitate earlier disposition decision making in patients’ journeys through the hospital system in order to reduce ED length of stay, allow patients to access acute medical care earlier and ultimately reduce the burden of ED overcrowding. 
We propose to implement and evaluate the clinical effectiveness of a novel disposition decision support tool based on State-wide data analysis. It is designed to be used by emergency clinicians at the earliest time possible in patient care to significantly improve timeliness and appropriateness of disposition decision making. 
The project will be undertaken as a pragmatic randomised control trial and process evaluation at facilities within Sydney Local Health District, with a plan to implement across other LHDs in collaboration with the NSW Agency for Clinical Innovation and E-Health NSW. It is one of twelve priority areas for action identified by the current New South Wales Government (https://www.nsw.gov.au/premiers-priorities ) and most importantly, will bring data analytics to the bedside in order to improve ED patient processes and outcomes for the future.

Trial website

https://www.slhd.nsw.gov.au/rpa/start/default.html

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Michael Dinh

Address

Royal Prince Alfred Hospital
Camperdown
Missenden Road 2050 NSW

Country

Australia

Phone

+61295150040

Fax

[email protected]

Contact person for public queries

Name

Anja Ebker-White

Address

Royal Prince Alfred Hospital
Camperdown
Missenden Road 2050 NSW

Country

Australia

Phone

+61295150040

Fax

[email protected]

Contact person for scientific queries

Name

Anja Ebker-White

Address

Royal Prince Alfred Hospital
Camperdown
Missenden Road NSW 2050

Country

Australia

Phone

+61295150040

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		https://bmcemergmed.biomedcentral.com/track/pdf/10... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Extending the Sydney Triage to Admission Risk Tool (START+) to predict discharges and short stay admissions.	2018	https://dx.doi.org/10.1136/emermed-2017-207227

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically