Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001131448
Ethics application status
Approved
Date submitted
11/03/2016
Date registered
19/08/2016
Date last updated
19/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a hospital-wide multimodal intervention on Emergency Department crowding, function and outcomes at Canberra Hospital and Health Services
Scientific title
Prospective Observational study of the effects of a hospital-wide intervention on process, flow and outcomes in the Emergency Department at Canberra Hospital and Health Services
Secondary ID [1] 288745 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergency 297987 0
Condition category
Condition code
Public Health 298143 298143 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Previously planned multimodal hospital wide intervention comprising:
1. Changes to admission, discharge and bed management processes to reduce the load of admitted patients waiting for inpatient beds in the Emergency Department
2. Physical rebuild of the Emergencty Department to increase available space and improve flow
3. Alteration in Emergency Department staffing, roles and administration
These changes began in late 2015 and the study period will be calendar years 2016 and 2017. Observations will be gathered from hospital clinical information systems and patient notes as necessary
Intervention code [1] 294179 0
Not applicable
Comparator / control treatment
Retrospective Controls from the previous 3 years - calendar years 2013-2015
Control group
Historical

Outcomes
Primary outcome [1] 297650 0
Hours per week when number of patients in Emergency department who are waiting for inpatient beds exceeds 10. This is derived from the Emergency Department information system.
Timepoint [1] 297650 0
Calendar years 2016 and 2017 (ie Dec 31)
Primary outcome [2] 297651 0
Achievement of the National Emergency Access target (NEAT - a four hour target). This is defined as the proportion of all patients who spend less that four hours in the Emergency Department. It is derived from the Emergency Department information system.
Timepoint [2] 297651 0
Calendar Years 2016 and 2017 (ie Dec 31)
Primary outcome [3] 298983 0
Mortality in Hospital (assessed from hospital information system, access to individual notes not required)
Timepoint [3] 298983 0
10 days and 60 days from leaving ED and at end of hospital admission
Secondary outcome [1] 321691 0
Standard Emergency Department Indicators of process and flow as defined by the Australasian College for Emergency Medicine and the Australian Council on Healthcare Standards: Proportion of patients starting treatment within appropriate time threshold for their triage category derived from ED information system
Timepoint [1] 321691 0
Calendar Years 2016 and 2017 (ie Dec 31)
Secondary outcome [2] 321692 0
Standard Emergency Department Indicators of process and flow as defined by the Australasian College for Emergency Medicine and the Australian Council on Healthcare Standards: Proportion of patients admitted to hospital derived from ED information system
Timepoint [2] 321692 0
Calendar Years 2016 and 2017 (ie Dec 31)
Secondary outcome [3] 321693 0
Inpatient Length of stay after leaving Emergency department, derived from hospital inpatient information system (individual inpatient notes not required)
Timepoint [3] 321693 0
Calendar Year 2016 (ie Dec 31)
Secondary outcome [4] 321694 0
Readmission Rate at 14 days, derived from hospital inpatient information system (individual inpatient notes not required)
Timepoint [4] 321694 0
Calendar Years 2016 and 2017 (ie Dec 31)
Secondary outcome [5] 324116 0
Time from arrival to administration of antibiotics in patients with blood culture proven sepsis, derived from review of relevant patient notes
Timepoint [5] 324116 0
Calendar Years 2016 and 2017 (ie Dec 31)
Secondary outcome [6] 325817 0
Standard Emergency Department Indicators of process and flow as defined by the Australasian College for Emergency Medicine and the Australian Council on Healthcare Standards: Proportion of patients who do not wait to be seen derived from ED information system
Timepoint [6] 325817 0
Calendar Years 2016 and 2017 (ie Dec 31)

Eligibility
Key inclusion criteria
All presentations to the Emergency department
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Comparison of Mean, median, and proportion as appropriate with standard statistical tests. In-hospital mortality is approximately 1% of Emergency patients at 10 days. Power calculation suggests that to detect a 20% change in mortality requires a minimum of 44000 cases (alpha 0.o5, power 0.8), or approximately eight months in this Emergency Department. Study design was extended to 12 months for controls and intervention in order to account for seasonal factors

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/08/2016
Date of last participant enrolment
Anticipated
31/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 5428 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 12914 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 293099 0
University
Name [1] 293099 0
Australian National University Medical School
Country [1] 293099 0
Australia
Primary sponsor type
Individual
Name
Prof Drew Richardson
Address
Emergency Medicine
The Canberra Hospital
Garran ACT
2605
Country
Australia
Secondary sponsor category [1] 291888 0
None
Name [1] 291888 0
Address [1] 291888 0
Country [1] 291888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294602 0
ACT Health Research Ethics Committee
Ethics committee address [1] 294602 0
Ethics committee country [1] 294602 0
Australia
Date submitted for ethics approval [1] 294602 0
11/03/2016
Approval date [1] 294602 0
24/05/2016
Ethics approval number [1] 294602 0
ETHLR.16.079

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

Contacts
Principal investigator
Name 64326 0
Prof Drew Richardson
Address 64326 0
Emergency Medicine
The Canberra Hospital
Yamba Dr
Garran
ACT 2605
Country 64326 0
Australia
Phone 64326 0
+61 2 6244 2418
Fax 64326 0
+61 2 6244 2594
Email 64326 0
[email protected]
Contact person for public queries
Name 64327 0
Drew Richardson
Address 64327 0
Emergency Medicine
The Canberra Hospital
Yamba Dr
Garran
ACT 2605
Country 64327 0
Australia
Phone 64327 0
+61 2 6244 2418
Fax 64327 0
+61 2 6244 2594
Email 64327 0
[email protected]
Contact person for scientific queries
Name 64328 0
Drew Richardson
Address 64328 0
Emergency Medicine
The Canberra Hospital
Yamba Dr
Garran
ACT 2605
Country 64328 0
Australia
Phone 64328 0
+61 2 6244 2418
Fax 64328 0
+61 2 6244 2594
Email 64328 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
SourceTitleYear of PublicationDOI
EmbaseEffects of a hospital-wide intervention on emergency department crowding and quality: A prospective study.2017https://dx.doi.org/10.1111/1742-6723.12771
N.B. These documents automatically identified may not have been verified by the study sponsor.