Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001146886
Ethics application status
Approved
Date submitted
26/10/2012
Date registered
30/10/2012
Date last updated
6/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Senior Early Assessment and Streaming Adult Patients using a Senior Work up and Treatment Team (SWAT) in a Tertiary Hospital Emergency Department – a randomised control trial
Scientific title
Senior Early Assessment and Streaming Adult Patients using a Senior Work up and Treatment Team (SWAT) in a Tertiary Hospital Emergency Department: A quasi randomised control trial to assess the effect of a senior early assessment and work up of emergency department length of stay.
Secondary ID [1] 281446 0
Nil
Universal Trial Number (UTN)
U1111-1136-3897
Trial acronym
SWAT study for EDLOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The effect of a Senior Work up and Treatment Team (SWAT) on Emergency Department Length of Stay (EDLOS). 287707 0
Condition category
Condition code
Public Health 288044 288044 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RCT design with shift days randomized to three arms - intervention (SWAT shift), standard care (extra consultant) or control (no consultant). The SWAT shift is the intervention arm in which the consultant will have a specific job role and description aimed at facilitating early assessment and treatment of patients in the Emergency Department (ED). The role of the SWAT doctor is to see patients in an early treatment area, take a very brief history and provide instructions to a nurse and junior doctor for investigations, consults and likely disposition that the patient will need. These can therefor be started earlier than would have happened had they had to wait to be seen by the next available emergency doctor. If the patient requires a bed, monitoring, or further treatment and investigations they will be moved to the appropriate area for this and their care handed over to one of the emergency doctors in that area to continue and follow up on these. This role will exist for and average of two 7 hour shifts per week for 5 months. We have conformed to CONSORT guidelines for RCT and Clustered trials.
Intervention code [1] 285952 0
Early detection / Screening
Intervention code [2] 285964 0
Prevention
Comparator / control treatment
The standard care arm has the consultant assigned as an extra consultant on the floor. He/She is free to see patients in an order of their choosing as well as supervising junior staff and the patients they have seen.They can ask nursing staff and junior staff to order and arrange investigations and consults. This will run over an average of two 7 hour shifts per week for 2 months.
The third arm will involve a non clinical consultant shift where they will not be on the floor seeing patients directly. They will be in the office doing education and administrative activities.
Control group
Active

Outcomes
Primary outcome [1] 288256 0
The primary outcome measured with be Emergency Department Length of Stay. This will be obtained from FIRSTNET, The computer data base used to store all patient information. A print out of all eligible patients will be given each day to Rebecca Davis. This will be done by Sook Lee, out data manager. The print out will have patient Medical Record Number (MRN) but not name. It will be kept in a locked office in the ED and only Rebecca Davis will have access to it. Identifying Medical Record Number (MRN) will be removed and not used on the final data collection excel spreadsheet.
Timepoint [1] 288256 0
This will be measured in hours for each patient who is eligible for the trial. Data will be collected each day. The trial will run for 5 months. Data from the day before will be collected each morning by Rebecca Davis.
Primary outcome [2] 289751 0
National Emergency Access Target (NEAT) time (number of patients seen and discharged within 4 hours)
Timepoint [2] 289751 0
Calculated on emergency admission date and time and discharge date and time from the emergency department for that single presentation
Secondary outcome [1] 299700 0
NEAT time (number of patients seen and discharged within 4 hours).
Time to disposition decision.
This will be obtained from FISRTNET. The computer data base used to store all patient information. A print out of all eligible patients will be given each day to Rebecca Davis. This will be done by Sook Lee, out data manager. The print out will have patient MRN but not name. It will be kept in a locked office in the ED and only Rebecca Davis will have access to it. Identifying MRN will be removed and not used on the final data collection excel spreadsheet.
The MRN is required to link the data on EDLOS to the information on time to disposition on this spreadsheet.
Timepoint [1] 299700 0
This will be measured in hours for each patient who is eligible for the trial. Data will be collected each day. The trial will run for 2 months.
Data from the day before will be collected each morning by Rebecca Davis.

Eligibility
Key inclusion criteria
Age >15 years of age
No immediate need for resuscitation or cardiac monitored bed
Triaged to waiting room, subacute or acute with bed pending Early treatment area (ETA), including patients brought in by ambulance
Presenting between 0930-1700
Minimum age
16 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
mental health patients
paediatric patients
triage category 1 patients
patients requiring immediate treatment where a resuscitation bay is available
Streamed directly to fast track

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)
All patients who fit the inclusion criteria will be enrolled. The patients will not be aware of the intervention at any time. The consultant will be aware once they are randomised to their role.
A random sequence will be generated and group allocation kept in sealed envelopes in a box kept in the ED secretary office. On arrival of a shift the Emergency Consultant rostered to the SWAT shift will take an envelope and be assigned the group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286214 0
Hospital
Name [1] 286214 0
Royal Prince Alfred Hospital
Country [1] 286214 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Level 5
Emergency Department
RPAH
Missenden road
Camperdown NSW
2050
Country
Australia
Secondary sponsor category [1] 285023 0
None
Name [1] 285023 0
Address [1] 285023 0
Country [1] 285023 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288289 0
Ethics Review Committee RPAH Zone
Ethics committee address [1] 288289 0
Ethics committee country [1] 288289 0
Australia
Date submitted for ethics approval [1] 288289 0
10/10/2012
Approval date [1] 288289 0
18/10/2012
Ethics approval number [1] 288289 0
HREC/12/RPAH/434

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

Contacts
Principal investigator
Name 34880 0
Dr Rebecca Davis
Address 34880 0
Royal Prince Alfred Hospital Emergency Department
Level 5
Missenden Road
Camperdown
Country 34880 0
Australia
Phone 34880 0
+61403618860
Fax 34880 0
Email 34880 0
[email protected]
Contact person for public queries
Name 18127 0
Rebecca Davis
Address 18127 0
RPAH Emergency Department
Level 5
RPAH
Missenden Road
Camperdown NSW
2050
Country 18127 0
Australia
Phone 18127 0
61 403618860
Fax 18127 0
Email 18127 0
[email protected]
Contact person for scientific queries
Name 9055 0
Rebecca Davis
Address 9055 0
RPAH Emergency Department
Level 5
RPAH
Missenden Road
Camperdown 2050
Country 9055 0
Australia
Phone 9055 0
61 403618860
Fax 9055 0
Email 9055 0
[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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.