Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000357954
Ethics application status
Approved
Date submitted
27/02/2020
Date registered
12/03/2020
Date last updated
15/09/2022
Date data sharing statement initially provided
12/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Critical Care Outreach Consultant pilot audit
Scientific title
Effect of a critical care outreach consultant on the outcomes of at-risk and deteriorating hospitalized patients
Secondary ID [1] 300667 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
In-hospital at-risk and deteriorating ward patients
 316466 0
Condition category
Condition code
Public Health 314823 314823 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
Introduction of an intensive care specialist to provide pre-emptive review of emergency department patients who may require intensive care unit admission and to be a senior decision maker to provide oversight of ward-based medical emergency team (MET) reviews. This will involve clinical review, medical imaging and blood tests as dictated by the intensive care clinicians as part of usual care. The frequency of review will vary between patients. It will vary from a single review to multiple reviews in a single day. The duration of follow-up will also be governed by the treating clinicians. This may vary from one day to daily reviews until hospital discharge. The frequency of review will be dictated by the patients perceived risk status and response to treatment.
Intervention code [1] 316995 0
Not applicable
Comparator / control treatment
Timeliness of admission of Emergency Department patients and Medical Emergency Team call to the intensive care unit during their admission to the Austin Hospital during April 2019 - March 2020..
Control group
Historical

Outcomes
Primary outcome [1] 323055 0
Timeliness of admission of Emergency Department patients to the intensive care unit. This will be determined by measuring the interval between the date and time of patient triage in the emergency department and the date and time of ICU admission. Both of these dates and times are routinely collected in a hospital administrative system called Medtrack.
Timepoint [1] 323055 0
Time between Emergency Department triage and admission to the intensive care unit
Primary outcome [2] 323056 0
Timeliness of admission of Medical Emergency Team call patients to the intensive care unit.
This will be determined by measuring the interval between the date and time of patient triage in the emergency department and the date and time of ICU admission. Both of these dates and times are routinely collected in a hospital administrative system called Medtrack.
Timepoint [2] 323056 0
Time between first Medical Emergency Team call and admission to the intensive care unit
Secondary outcome [1] 380622 0
Acute Physiology and Chronic Health III Score as an assessment of severity of illness
Timepoint [1] 380622 0
On admission to intensive care unit admission for the patient's index hospital admission
Secondary outcome [2] 380623 0
Proportion of patients who have two or more medical emergency team calls. on medical emergency team calls are routinely collected on an electronic system called Risk-Man VHIMS. The proportion of patients who have two or more medical emergency team calls will be measured by dividing the number of patients who have more than one medical emergency team call review during the same admission (multiple medical emergency team patients) by the total number of patients who have received a medical emergency team call.
Timepoint [2] 380623 0
Within index hospital admission
Secondary outcome [3] 380624 0
Length of hospital admission. This will be assessed by the difference between the date and time of hospital discharge and the date and time of hospital admission
Timepoint [3] 380624 0
Duration in days of hospital admission for the index hospital admission
Secondary outcome [4] 380625 0
Length of stay in the intensive care unit. This will be assessed by the difference between the date and time of Intensive care discharge and the date and time of Intensive care admission.
Timepoint [4] 380625 0
Duration in days of intensive care unit admission for the index hospital admission
Secondary outcome [5] 380626 0
Intensive care unit mortality
Timepoint [5] 380626 0
Death of a patient occuring in the intensive care unit during the index hospital admission
Secondary outcome [6] 380627 0
Hospital mortality
Timepoint [6] 380627 0
Death of a patient occuring in the hospital during the index hospital admission
Secondary outcome [7] 401810 0
Medical emergency team call activations per 1000 admissions.
Medical record review.
Timepoint [7] 401810 0
During hospital admission for the study period.

Eligibility
Key inclusion criteria
Patients aged greater than or equal to 18 years of age
Admitted to the intensive care unit from the emergency department
Admitted to the intensive care unit following medical emergency team call
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Did not get admitted to the intensive care unit from the emergency department or following a medical emergency team call,

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Comparison of proportions with chi-squared
Comparison of median (IQR) timelines with Mann-Whitney U test
Analysis will occur for the period where the intervention is applied
Interrupted time-series analysis will also be conducted to take into account the effects of secular trends or changes over time that were occurring independent of the introduction of the critical care outreach consultant role

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/04/2020
Actual
20/04/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
520
Accrual to date
50
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16006 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 29515 0
3084 - Heidelberg
Recruitment postcode(s) [2] 29516 0
3084 - Banyule

Funding & Sponsors
Funding source category [1] 305092 0
Hospital
Name [1] 305092 0
Austin Hospital
Country [1] 305092 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 305468 0
Individual
Name [1] 305468 0
Associate Professor Daryl Jones
Address [1] 305468 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country [1] 305468 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305482 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 305482 0
Ethics committee country [1] 305482 0
Australia
Date submitted for ethics approval [1] 305482 0
14/02/2020
Approval date [1] 305482 0
05/03/2020
Ethics approval number [1] 305482 0
Audit/20/Austin/23

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

Contacts
Principal investigator
Name 100518 0
A/Prof Daryl Jones
Address 100518 0
Department of Intensive Care
Level 2, Austin Tower
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 100518 0
Australia
Phone 100518 0
+61 3 9496 5057
Fax 100518 0
+61 3 9496 3932
Email 100518 0
[email protected]
Contact person for public queries
Name 100519 0
Dr Glenn Eastwood
Address 100519 0
Department of Intensive Care
Level 2, Austin Tower
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 100519 0
Australia
Phone 100519 0
+61 3 9496 4835
Fax 100519 0
+61 3 9496 3932
Email 100519 0
[email protected]
Contact person for scientific queries
Name 100520 0
Daryl Jones
Address 100520 0
Department of Intensive Care
Level 2, Austin Tower
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 100520 0
Australia
Phone 100520 0
+61 3 9496 5057
Fax 100520 0
+61 3 9496 3932
Email 100520 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is confidential information of patients admitted to Austin Health and information is obtained under the 'audit' framework.


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.