Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000146594
Ethics application status
Approved
Date submitted
29/01/2015
Date registered
17/02/2015
Date last updated
16/06/2021
Date data sharing statement initially provided
16/06/2021
Date results information initially provided
16/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot assessment of the feasibility of a notification system for patients with high-risk laboratory abnormalities in acute surgical wards
Scientific title
A pilot assessment of the feasibility of a notification system for patients with high-risk laboratory abnormalities in acute surgical wards
Secondary ID [1] 286069 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-surgical adverse events 294063 0
Condition category
Condition code
Public Health 294362 294362 0 0
Health service research
Surgery 294416 294416 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Using data from the previous study (Loekito et al, Common laboratory tests predict imminent death in ward patients, Resuscitation, 2013;84(3):280-285) we have identified patterns and tests with given sensitivity and specificity that can be used to identify at risk patients. We plan to obtain raw level data generated by the Pathology Lab computers as they come on stream and, subsequent to their acquisition by the CERNER system, deliver them to a server where they can be analyzed by software designed to identify high-risk patterns.

When such a pattern is identified in a patient who is electronically known to be located on the 8th floor, we plan to send an electronic message to a designated pager carried by the Medical Emergency Team (MET) registrar notifying her/him that patient X is at risk.

As an example, if a patient was identified to be at risk of a Medical Emergecny Team (MET) call, the message might take this form “MR John Citizen on ward 8N has major laboratory abnormalities”.

However, because of workload issues, only one in two alerts will be sent to the MET registrar’s pager (approximately 2 alerts/day). Patient's whose alert is sent to the MET registrar's pager will form the intervention group. The MET registrar will then review the participant at the next earliest opportunity. At the review the MET registrar will assess the patient and assess the patient's pathology data. The MET registrar will then make treatment decisions and contact the patient's primary team and modify treatment (if appropriate and agreed) following such discussion. The duration of the intervention period is 12 months.

All data collections on treatment, characteristics and outcomes will be by means of review of scanned medical records after the patient has been discharged.
Intervention code [1] 291057 0
Treatment: Other
Intervention code [2] 291100 0
Prevention
Comparator / control treatment
Using data from the previous study we have identified patterns and tests with given sensitivity and specificity that can be used to identify at risk patients. We plan to obtain raw level data generated by the Pathology Lab computers as they come on stream and, subsequent to their acquisition by the CERNER system, deliver them to a server where they can be analyzed by software designed to identify high-risk patterns.
When such a pattern is identified in a patient who is electronically known to be located on the 8th floor, we plan to send an electronic message to a designated pager carried by the MET registrar notifying her/him that patient X is at risk.

As an example, if a patient was identified to be at risk of a MET call, the message might take this form “MR John Citizen on ward 8N has major laboratory abnormalities”.

However, because of workload issues, only one in two alerts will be sent to the MET registrar’s pager (approximately 2 alerts/day). Patient's whose alert is not sent to the MET registrar's pager will form the control group. Alerts that are not sent to the MET registrar will be stored in the CERNER database and the outcomes of patients identified by members of the research team.

All data collections on treatment, characteristics and outcomes will be by means of review of scanned medical records after the patient has been discharged.
Control group
Active

Outcomes
Primary outcome [1] 294159 0
Mortality - 24 hours
Timepoint [1] 294159 0
At 24 hours after the biochemical alert.
Primary outcome [2] 294160 0
Mortality - 48 hours
Timepoint [2] 294160 0
At 48 hours after the biochemical alert.
Secondary outcome [1] 312646 0
Mortality - Hospital
Timepoint [1] 312646 0
Assessed at time when patient is discharged from hospital
Secondary outcome [2] 312647 0
Length of stay - hospital
Timepoint [2] 312647 0
Hospital admission duration in days
Secondary outcome [3] 312648 0
Intensive Care Unit admission - 24 hours
Timepoint [3] 312648 0
The need for admission to the intensive care unit occuring within 24 hours following a biochemical alert.
Secondary outcome [4] 312649 0
Medical Emergency Team (MET) call - 24 hours
Timepoint [4] 312649 0
Occurence of a medical emergency team (MET) call within the first 24 hours following a biochemical alert.
Secondary outcome [5] 312650 0
Medical Emergency Team (MET) call - 48 hours
Timepoint [5] 312650 0
Occurence of a medical emergency team (MET) call within the first 48 hours following a biochemical alert.
Secondary outcome [6] 312651 0
Intensive Care Unit admission - 48 hours
Timepoint [6] 312651 0
The need for admission to the intensive care unit occuring within 48 hours following a biochemical alert.
Secondary outcome [7] 312824 0
Number of identified alerts per day.
Timepoint [7] 312824 0
The number of alerts generated by the computer-based algorithm during the study period during the 12-month intervention period.
Secondary outcome [8] 312825 0
Number of alerts received by the Medical Emergency Team registrar.
Timepoint [8] 312825 0
Number of alerts received by the Medical Emergency Team registrar during the 12-month intervention period.
Secondary outcome [9] 312906 0
The number of patients seen by the Medical Emergency Team registrar.
Timepoint [9] 312906 0
The number of patients seen by the Medical Emergency Team registrar during the 12-month intervention period.

Eligibility
Key inclusion criteria
All patients admitted to the acute surgical ward of the Austin Hospital.
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 of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Identification of patients is achieved via central randomisation by a computer using a pre-specified algorithm of pathology data. Allocation is concealed as the MET registrar who receives the alert will only know of the active alerts and not the control alerts.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computerised sequence generation will ensure 1:1 randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline and outcome variables will be compared using Chi-square tests for equal proportion, Student’s t-test for normally distributed outcomes and Wilcoxon rank-sum tests
otherwise. Multivariate models adjusting for baseline imbalances and known covariates will be performed using logistic regression. A p-value of 0.05 will be considered to be statistically significant. Kaplan-Meier plot and and Cox-proportional hazards modelling will be performed as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/07/2014
Actual
23/07/2014
Date of last participant enrolment
Anticipated
Actual
19/11/2020
Date of last data collection
Anticipated
Actual
19/11/2020
Sample size
Target
205
Accrual to date
Final
205
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3369 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 9159 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 290655 0
Hospital
Name [1] 290655 0
Austin Health - Anaesthesia Intensive Care Trust Fund
Country [1] 290655 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Austin Health
145 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 289347 0
Individual
Name [1] 289347 0
Professor Rinaldo Bellomo
Address [1] 289347 0
Austin Hospital
Department of Intensive Care
145 Studley Road
Heidelberg VIC 3084
Country [1] 289347 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292286 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 292286 0
Austin Health
145 Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 292286 0
Australia
Date submitted for ethics approval [1] 292286 0
08/02/2011
Approval date [1] 292286 0
15/06/2011
Ethics approval number [1] 292286 0
H2011/04296

Summary
Brief summary
In a previous audit, we retrospectively studied 418,897 batches of tests in 42,701 patients for a total of 2.5 million individual measurements of nine laboratory results (Loekito et al, Common laboratory tests predict imminent death in ward patients, Resuscitation 2013; 84(3):280-285). We identified simple laboratory abnormalities (e.g. high plasma urea, low blood bicarbonate level, low albumin), which either alone, but even more so when clustered together in particular pattern were associated with a higher risk of poor outcome (MET call, ICU admission or death) by the following calendar day. This finding suggested that, using routinely measure laboratory results, we might be able to identify those patients, who are at high risk of such outcomes and that, we might, therefore, be in a position to notify the ward where these patients are located of such increased risk. In this pilot study, we plan to extend our assessment the feasibility of such a notification system following a pilot study approved by the Human Research Ethics Committee in 2011.

Specifically, we plan to continuously scan the raw data emerging form the pathology lab computers with focus on the 8th floor wards. Then, using a computerized risk identification system based on our retrospective analysis, we plan to identify patterns of laboratory data that identify patients at high risk of the above adverse outcomes by the next calendar day.

Once such identification has been achieved, we plan to send every second notification to a dedicated pager carried by the Medical Emergency Team (MET) registrar, who will then visit the patient, review his/her laboratory results, contact the primary team to inform them of the laboratory concerns and modify treatment (if appropriate and agreed) following such discussion . Such notification will occur electronically by automated messages sent to the pager.

The purpose of the pilot study is to assess: 1. How many notifications such a system would generate per day for the 8th floor wards; 2. Whether such a system can reliably deliver such notifications; 3. How many at risk patients are identified by such a system and how many are missed per month; 4. The outcome of patients identified by such a system.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 290 290 0 0
/AnzctrAttachments/367857(v29-01-2015-13-22-20)-20141208 - Austin Approval LNR14Austin407.pdf
Attachments [2] 300 300 0 0
/AnzctrAttachments/367857-Austin_NDSAC_Activation of biochemical alerts_HREC approval letter_150611.pdf

Contacts
Principal investigator
Name 54486 0
Prof Rinaldo Bellomo
Address 54486 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 54486 0
Australia
Phone 54486 0
+61 3 9496 5992
Fax 54486 0
+ 61 3 9496 3932
Email 54486 0
[email protected]
Contact person for public queries
Name 54487 0
A/Prof Glenn Eastwood
Address 54487 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 54487 0
Australia
Phone 54487 0
+61 3 9496 4835
Fax 54487 0
+61 3 9496 3932
Email 54487 0
[email protected]
Contact person for scientific queries
Name 54488 0
Prof Rinaldo Bellomo
Address 54488 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 54488 0
Australia
Phone 54488 0
+61 3 9496 5992
Fax 54488 0
+61 3 9496 3932
Email 54488 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Resuscitation 133 (2018) 167-172 https://doi.org/... [More Details]
Plain language summaryNo The use of routine biochemical results may assist ... [More Details]

Documents added automatically
No additional documents have been identified.