Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000019606
Ethics application status
Approved
Date submitted
7/12/2022
Date registered
10/01/2023
Date last updated
7/06/2023
Date data sharing statement initially provided
10/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
BANDAIDS CDSS: Digital solutions for heart failure best practice care.
Scientific title
The efficacy of digital solutions for heart failure best practice care.
Secondary ID [1] 308295 0
None
Universal Trial Number (UTN)
Trial acronym
BANDAIDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure with reduced ejection fraction (left ventricular ejection fraction (LVEF) less than or equal to 40% or described as at least “moderately” impaired).
 328082 0
Condition category
Condition code
Cardiovascular 325139 325139 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BANDAID digital health solution is comprised of a Clinical Decision Support System (CDSS). Physicians will enter in specific patient in-puts into the CDSS, a web-application that will aide in the identification of recommended therapies in hospital inpatients. This will be presented as a list of the guideline-recommended treatments for the clinician to review, indicate if they prescribed the therapy, and why or why not. The CDSS is implemented within 24h of patient admission to hospital and 24h prior to discharge. Use of the CDSS takes approximately 5 minutes and this web application has been specifically developed for this study.
Intervention code [1] 324749 0
Treatment: Other
Comparator / control treatment
The real-time audit using the CDSS will be compared to a retrospective audit of the same institution, of prescribing practice prior to introduction of the CDSS, to evaluate the effect of the CDSS application on clinician prescribing practice. The retrospective audit period is 6-months prior to CDSS implementation.

There is no control for the e-TIP intervention.
Control group
Historical

Outcomes
Primary outcome [1] 332964 0
The absolute difference in the proportion of patients receiving guideline recommended therapies at discharge in the real-time audit, compared with rates documented in the retrospective audits. Source of information is the medical record.
Timepoint [1] 332964 0
Baseline (time of patient discharge from hospital).
Secondary outcome [1] 415349 0
Utilisation of evidence-based therapies post-discharge compared to guideline recommendations in each audit. Source of information is the medical record.
Timepoint [1] 415349 0
6 months post-discharge.
Secondary outcome [2] 415350 0
Number of HFrEF hospital re-admissions. Source of information is the medical record.
Timepoint [2] 415350 0
6 months post-discharge.
Secondary outcome [3] 415351 0
Number of HFrEF hospital re-admissions and cardiovascular deaths, as a composite outcome. Source of information is the medical record.
Timepoint [3] 415351 0
6 months post-discharge.
Secondary outcome [4] 415352 0
Number of cardiovascular hospitalisations. Source of information is the medical record.
Timepoint [4] 415352 0
6 months post-discharge.
Secondary outcome [5] 415353 0
All-cause mortality. Source of information is the medical record.
Timepoint [5] 415353 0
6 months post-discharge.

Eligibility
Key inclusion criteria
Adults, aged 18 years and older, admitted to a participating centre, with a diagnosis of HFrEF confirmed by evidence of left ventricular ejection fraction (LVEF) less than or equal to 40% (or described as at least moderately impaired).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inpatients being managed with palliative intent, or who did not survive admission
2. List of discharge medications unavailable

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study aims to recruit 500 participants in the real-time study. With 500 participants followed for an average of 6 months, the study offers more than 88% power at 2P=0.05 to detect absolute improvements in adherence rates with any recommendation of 10% or more in the cohort (i.e., from 80% to 90%). Comparisons of hospital re-admission rates for heart failure will be undertaken between the real-time audit cohort and the retrospective audit cohort. A reduction in re-admission rates from 18% to 11.5% or lower would be identified with more than 83% power at 2P=0.05. 500 participants will be recruited to the retrospective audit.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312545 0
Government body
Name [1] 312545 0
Medical Research Future Fund
Country [1] 312545 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
NHMRC Clinical Trials Centre
92-94 Parramatta Road,
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 314612 0
None
Name [1] 314612 0
Address [1] 314612 0
Country [1] 314612 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311872 0
Sydney Local Health District HREC
Ethics committee address [1] 311872 0
Ethics committee country [1] 311872 0
Australia
Date submitted for ethics approval [1] 311872 0
06/12/2022
Approval date [1] 311872 0
22/05/2023
Ethics approval number [1] 311872 0

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

Contacts
Principal investigator
Name 122674 0
Prof Anthony Keech
Address 122674 0
NHMRC Clinical Trials Centre
92-94 Parramatta Road
Camperdown NSW 2050
Country 122674 0
Australia
Phone 122674 0
+61 2 9562 5000
Fax 122674 0
Email 122674 0
[email protected]
Contact person for public queries
Name 122675 0
Anthony Keech
Address 122675 0
NHMRC Clinical Trials Centre
92-94 Parramatta Road
Camperdown NSW 2050
Country 122675 0
Australia
Phone 122675 0
+61 2 9562 5000
Fax 122675 0
Email 122675 0
[email protected]
Contact person for scientific queries
Name 122676 0
Anthony Keech
Address 122676 0
NHMRC Clinical Trials Centre
92-94 Parramatta Road
Camperdown NSW 2050
Country 122676 0
Australia
Phone 122676 0
+61 2 9562 5000
Fax 122676 0
Email 122676 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 6-month trial is funded by an incubator grant and will be extended to a larger randomised controlled trial (RCT) if the results provide evidence of intervention effectiveness. Given this, IPD data will not be shared from this trial but this would be considered if it were to progress to a larger RCT.


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.