Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000578505
Ethics application status
Approved
Date submitted
15/04/2024
Date registered
7/05/2024
Date last updated
7/05/2024
Date data sharing statement initially provided
7/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Endocrinological Dashboard Implementation For the Instigation of Consult Engagement (EDIFICE) on Healthcare-associated Infection Incidence in Adult Inpatients
Scientific title
Effect of Endocrinological Dashboard Implementation For the Instigation of Consult Engagement (EDIFICE) on Healthcare-associated Infection Incidence in Adult Inpatients
Secondary ID [1] 311843 0
None
Universal Trial Number (UTN)
U1111-1306-2613
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Proactive diabetes care
 333375 0
Condition category
Condition code
Metabolic and Endocrine 330069 330069 0 0
Diabetes
Public Health 330314 330314 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An electronic dashboard has been created for the purpose of this study which will be utilised by the endocrine department (consultants and registrars), and randomise patients into three separate arms of intervention. The dashboard will monitor the electronic medical records and randomly allocate patients who meet the following criteria: A single glucose reading above 20mmol/L in the last 24 hours, two glucose readings greater than 15mmol/L in the preceding 24 hours, a blood glucose reading less than 3.0mmol/L.

The three arms of intervention are:
1. Control arm - No active input from the Endocrine service at that time. Standard care will be provided by the home team who will still be able to ask for consultation in keeping with their usual practice.
2. The endocrinology consult service will proactively instigate a bedside consult within 24 hours of enrolment in the study, aiming to optimise glycaemic control. Consulting service will involve endocrinology an consultant and registrar with documentation in the electronic medical record.
3. Virtual arm whereby generic advice is entered into the electronic medical records (EMR) and offer of titration is made to the home team within 24 hours of enrolment in the study. The entry will be made by the endocrinology registrar and will be as detailed below and monitored via the EMR:
• This patient has been identified automatically as part of a clinic study aimed at early identification of in patient dysglycaemia (CALHN HREC No. 17529).
• The following are recommended for patients with hyperglycaemia:
- All patients with should have an HbA1c if not performed within the last 3 months
- Blood glucose concentration should be measured 4-6 hourly whilst an inpatient (ideally pre-meals and pre-bed)
- In general blood glucose target for admitted patients are 5-10 mmol/L but may require alteration based on patient specific factors
- Regular medication should be charted in stable patient tolerating oral intake if clinically appropriate
- If patients are consistently using supplemental insulin for >48hours consider introducing long acting insulin and prandial insulin as required
- If is a new diagnosis of diabetes is made or new injectable diabetes medication has been started, a diabetes nurse educator consult should be sought as early in the admission as practical

If required, the endocrine team can be contacted for formal consultation or remote assistance with insulin titration, this will not occur unless the home team make contact through the usual pathway.
Intervention code [1] 328306 0
Early detection / Screening
Comparator / control treatment
The first arm of the study mentioned above - No active input from the Endocrine service at that time. Standard care will be provided by the home team who will still be able to ask for consultation in keeping with their usual practice.

Standard of care in this setting is management of diabetes by the home team without endocrinology input unless the endocrine team is called for advice or a consult, which is at the discretion of the home team.
Control group
Active

Outcomes
Primary outcome [1] 337990 0
Healthcare-associated infection (HAI) incidence
Timepoint [1] 337990 0
48hours following admission
Secondary outcome [1] 434026 0
Inpatient glycaemic burden
Timepoint [1] 434026 0
Chart review 3 months post discharge
Secondary outcome [2] 434358 0
Length of stay
Timepoint [2] 434358 0
Chart review 3 months post discharge
Secondary outcome [3] 434359 0
Clinical Costing
Timepoint [3] 434359 0
Chart review 3 months post discharge
Secondary outcome [4] 434360 0
Cost of diabetes care package
Timepoint [4] 434360 0
Chart review 3 months post discharge
Secondary outcome [5] 434361 0
Emergency and ambulatory cost
Timepoint [5] 434361 0
Chart review 3 months post discharge
Secondary outcome [6] 434362 0
Treatment cost associated with diabetes related complications
Timepoint [6] 434362 0
Chart review 3 months post discharge
Secondary outcome [7] 434363 0
30-day readmission
Timepoint [7] 434363 0
Chart review 3 months post discharge
Secondary outcome [8] 434364 0
In-hospital mortality
Timepoint [8] 434364 0
Chart review 3 months post discharge
Secondary outcome [9] 434365 0
Diabetes medication on discharge
Timepoint [9] 434365 0
Chart review 3 months post discharge
Secondary outcome [10] 434366 0
Subsequent HbA1c recorded on the medical record in the 3 and 12 months following inclusion in the study
Timepoint [10] 434366 0
Chart review 3 and 12 months post discharge
Secondary outcome [11] 434367 0
Time from adverse glycemic day to endocrine referral
Timepoint [11] 434367 0
Chart review 3 months post discharge

Eligibility
Key inclusion criteria
o (1) Equal to, or greater than 18 years of age
o (2) Admitted to hospital at the Royal Adelaide, The Queen Elizabeth Hospital, Flinders Medical Centre and the Lyell McEwin Hospital after 1 March 2024.
o (3) Has received at least one blood glucose level (BGL) measurement that was recorded in the electronic medical record.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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)
Central randomisation by computer:
o All patients with at least one BGL recorded have the potential to be included in the purpose-built dashboard, which is hosted on a secure SA Health intranet server.
o The patients flagged by the prespecified criteria (a single glucose reading above 20mmol/L in the last 24 hours, two glucose readings greater than 15mmol/L in the preceding 24 hours, a BGL reading less than 3.0mmol/L) will then be randomly assigned
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2024
Actual
Date of last participant enrolment
Anticipated
15/05/2025
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 316189 0
Hospital
Name [1] 316189 0
Royal Adelaide Hospital
Country [1] 316189 0
Australia
Funding source category [2] 316410 0
Hospital
Name [2] 316410 0
Queen Elizabeth Hospital
Country [2] 316410 0
Australia
Funding source category [3] 316411 0
Hospital
Name [3] 316411 0
Lyell McEwin Hospital
Country [3] 316411 0
Australia
Funding source category [4] 316412 0
Hospital
Name [4] 316412 0
Flinders Medical Centre
Country [4] 316412 0
Australia
Primary sponsor type
Individual
Name
Mahesh Umapathysivam
Address
Country
Australia
Secondary sponsor category [1] 318487 0
None
Name [1] 318487 0
Address [1] 318487 0
Country [1] 318487 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315008 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 315008 0
https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
Ethics committee country [1] 315008 0
Australia
Date submitted for ethics approval [1] 315008 0
19/03/2024
Approval date [1] 315008 0
21/03/2024
Ethics approval number [1] 315008 0

Summary
Brief summary
To examine the feasibility and effect of the implementation of a descriptive glycaemic dashboard and proactive endocrinology consult service on glycaemia and glycaemic complications. Patients will be identified via an electronic dashboard with preset criteria of dysglycaemia and randomly assigned to 'standard of care', formal bedside consult, or a default entry on the electronic medical records. We hope to demonstrate that proactive intervention for patients with dysglycaemia will reduce hospital associated infections, as well as a number of other beneficial secondary outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133410 0
Dr Mahesh Umapathysivam
Address 133410 0
Royal Adelaide Hospital, North terrace, Adelaide, SA, 5000
Country 133410 0
Australia
Phone 133410 0
+61 08 7074 2674
Fax 133410 0
Email 133410 0
Mahesh.umapathysivam@sa.gov.au
Contact person for public queries
Name 133411 0
Mahesh Umapathysivam
Address 133411 0
Royal Adelaide Hospital, North terrace, Adelaide, SA, 5000
Country 133411 0
Australia
Phone 133411 0
+61 08 7074 0000
Fax 133411 0
Email 133411 0
Mahesh.umapathysivam@sa.gov.au
Contact person for scientific queries
Name 133412 0
Mahesh Umapathysivam
Address 133412 0
Royal Adelaide Hospital, North terrace, Adelaide, SA, 5000
Country 133412 0
Australia
Phone 133412 0
+61 08 7074 0000
Fax 133412 0
Email 133412 0
Mahesh.umapathysivam@sa.gov.au

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.