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Trial registered on ANZCTR


Registration number
ACTRN12623001096640
Ethics application status
Approved
Date submitted
21/09/2023
Date registered
18/10/2023
Date last updated
18/10/2023
Date data sharing statement initially provided
18/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising diagnosis and management of chronic disease in primary care: an implementation study of a clinical decision support software Future Health Today.
Scientific title
Optimising diagnosis and management of chronic kidney disease, diabetes and cardiovascular disease in primary care: an implementation study of a clinical decision support software Future Health Today.
Secondary ID [1] 310635 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic kidney disease 331516 0
diabetes 331517 0
cardiovascular disease 331518 0
Condition category
Condition code
Renal and Urogenital 328248 328248 0 0
Kidney disease
Metabolic and Endocrine 328249 328249 0 0
Diabetes
Cardiovascular 328250 328250 0 0
Coronary heart disease
Stroke 328251 328251 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Future Health Today (FHT) is a newly developed quality improvement and clinical decision support system software designed to overlay General Practice software. This trial involves using the Future Health Today software chronic disease modules for chronic kidney disease, diabetes and cardiovascular disease that have been developed by University of Melbourne and Western Health. The software is designed to aid screening, diagnosis and management of the inter-related cardiometabolic diseases of chronic kidney disease, diabetes and cardiovascular disease.

The software has a point of care tool for use by General Practitioners. It detects information in the electronic record and flags red if the patient being seen is at risk of, has undiagnosed chronic disease or would benefit from medication optimisation. The conditions covered in this trial are cardiovascular disease, chronic kidney disease and diabetes. All recommendations are based on best practice guidelines, for example the Kidney Health Australia clinical guidelines and the Australian General Practice guidelines for diabetes, cardiovascular disease and kidney disease. The point of care tool also has direct links patient information and best practice guidelines. The second component to the software is a quality improvement tool. This enables practices to recall patients who might benefit from screening or diagnosis.

An example: the practice sets up a cohort of patients with diabetes whose screening blood tests are consistent with kidney disease but do not yet have a diagnosis. The practice nurse automates a recall of these patients to see their general practitioner. During a visit the general practitioner notes the Future Health Today red flag. This will prompt them to review for a diagnosis of chronic kidney disease. It will also suggest guideline directed therapies for example an angiotensin converting enzyme inhibitor or angiotensin receptor blocker. The decision to prescribe the medication is at the discretion of the treating doctor. The clinician can also link direct to patient information regarding kidney disease and clinical guidelines.

Practices will be provided with a 1 hour video call demonstration at the start of the trial run by Future Health Today staff at Melbourne University. They are also able to attend monthly drop in software demonstration sessions as required. Participating practices will also be offered a chronic kidney disease education session (anticipated 1 hour in length) facilitated by a nephrologist and renal nurse practitioner and can arrange additional education as required. A nephrologist and renal nurse practitioner are available to practices participating in the study to assist in any clinical questions.

The intervention will run for three years. In addition to clinical outcomes, use of the software via review of software analytics (e.g. clicks into the software) will also be monitored to understand adherence to the intervention and if any changes in outcomes are due to the intervention.
Intervention code [1] 327034 0
Diagnosis / Prognosis
Intervention code [2] 327035 0
Treatment: Other
Intervention code [3] 327036 0
Early detection / Screening
Comparator / control treatment
This is a pre / post implementation trial.

3 years of retrospective pre-implementation usual care general practice data will be collected on trial start date and will be used as the comparator to the three year active trial using Future Health Today Software.
Control group
Historical

Outcomes
Primary outcome [1] 336115 0
Change in number of patients with an appropriately timed kidney health check in patients at risk of kidney disease.
Timepoint [1] 336115 0
3 years of historical electronic medical record data prior to commencement of trial will be analysed yearly, and compared to the three years post-implementation of the Future Health Today (FHT) chronic disease modules (with analysis at end year one, two and three).
Primary outcome [2] 336116 0
Change in total number of patients diagnosed with chronic kidney disease
Timepoint [2] 336116 0
3 years of historical electronic medical record data prior to commencement of trial will be analysed yearly, and compared to the three years post-implementation of the FHT chronic disease modules (with analysis at end of year one, two and three).
Primary outcome [3] 336117 0
Change in number of patients with chronic kidney disease (CKD) on a renin angiotensin inhibitor with at least 12 months follow up following CKD diagnosis.
Timepoint [3] 336117 0
3 years of historical electronic medical record data prior to commencement of trial will be analysed yearly, and compared to the three years post-implementation of the FHT chronic disease modules (with analysis at end of year one, two and three).
Secondary outcome [1] 426879 0
Change in number of patients with CKD achieving the kidney cycle of care.
Timepoint [1] 426879 0
3 years of historical electronic medical record data prior to commencement of trial will be analysed yearly, and compared to the three years post-implementation of the FHT chronic disease modules (with analysis at end of year one, two and three).
Secondary outcome [2] 426880 0
Change in proportion of patients on any antiproteinuric agent, composite of angiotensin converting enzyme inhibitor (ACE inhibitor), angiotensin receptor blocker (ARB), sodium glucose transport protein 2 inhibitor (SGLT2 inhibitor) and mineralocorticoid receptor antagonist (MRA).
Timepoint [2] 426880 0
3 years of historical electronic medical record data prior to commencement of trial will be analysed yearly, and compared to the three years post-implementation of the FHT chronic disease modules (with analysis at end of year one, two and three).
Secondary outcome [3] 426881 0
Change in number of patients who have both type two diabetes mellitus (T2DM) and CKD who are prescribed an SGLT2 inhibitor
Timepoint [3] 426881 0
3 years of historical electronic medical record data prior to commencement of trial will be analysed yearly, and compared to the three years post-implementation of the FHT chronic disease modules (with analysis at end of year one, two and three).
Secondary outcome [4] 426882 0
Change in urinary albumin to creatinine ratio in patients with CKD diagnosis and at least 12 months follow up.
Timepoint [4] 426882 0
3 years of historical electronic medical record data prior to commencement of trial will be analysed yearly, and compared to the three years post-implementation of the Future Health Today chronic disease modules (with analysis at end of year one, two and three). Participants will only be included in this outcome if they have at least 12 months follow up post CKD diagnosis.
Secondary outcome [5] 426883 0
Change in slope of eGFR in patients with a coded diagnosis of CKD compared 2 years prior and 2 years post and adjusted for baseline function. The index date will be CKD diagnosis coded or if CKD already diagnosed at entry into study
Timepoint [5] 426883 0
2 years of historical electronic medical record data prior to index CKD will be analysed yearly and compared to two year post index CKD date. Index CKD date is defined as the date CKD diagnosed if diagnosed during the trial, or start of implementation of FHT if patients had a previous diagnosis.
Secondary outcome [6] 426884 0
Subgroup analysis will be undertaken comparing those with a coded diagnosis of CKD, to those with measured CKD (all patients meeting CKD diagnostic criteria) and possible CKD (patients who have one eGFR or uACR in diagnostic criteria) for the primary and secondary outcomes
Timepoint [6] 426884 0
3 years of historical electronic medical record data prior to commencement of trial will be analysed yearly, and compared to the three years post-implementation of the FHT chronic disease modules (with analysis at end of year one, two and three).
Secondary outcome [7] 426885 0
Change in referral patterns from practices participating in FHT comparing 3 years prior and 3 years active study.
Timepoint [7] 426885 0
3 years of historical electronic medical record data prior to commencement of trial will be analysed yearly, and compared to the three years post-implementation of the FHT chronic disease modules (with analysis at end of year one, two and three).
Secondary outcome [8] 426886 0
Change in pattern of late referrals to nephrology services
Timepoint [8] 426886 0
3 years of historical electronic medical record data prior to commencement of trial will be analysed yearly, and compared to the three years post-implementation of the FHT chronic disease modules (with analysis at end of year one, two and three).
Secondary outcome [9] 427474 0
Change in proportion of patients on an SGLT2 inhibitor.
Timepoint [9] 427474 0
3 years of historical electronic medical record data prior to commencement of trial will be analysed yearly, and compared to the three years post-implementation of the FHT chronic disease modules (with analysis at end of year one, two and three).
Secondary outcome [10] 427475 0
Change in the proportion of patients on an MRA
Timepoint [10] 427475 0
3 years of historical electronic medical record data prior to commencement of trial will be analysed yearly, and compared to the three years post-implementation of the FHT chronic disease modules (with analysis at end of year one, two and three).

Eligibility
Key inclusion criteria
General practice clinics in the Western Health catchment area (Western suburbs of Melbourne, Australia). All adult patients (over age 18) will be included from participating practices.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients identified as having a transplant or a dialysis patients will be excluded from chronic kidney disease analysis (though will be included in CKD prevalence data).

Study design
Purpose of the study
Diagnosis
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
Other
Other design features
Historical control using 3 years of retrospective pre implementation data immediately prior to trial commencement.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/10/2023
Actual
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314850 0
Government body
Name [1] 314850 0
Western Health
Country [1] 314850 0
Australia
Funding source category [2] 314852 0
Charities/Societies/Foundations
Name [2] 314852 0
National Association of Diabetes Centres Grant, for Diabetes Related Kidney Disease Model of Care. Note grant funded by industry (AstraZeneca) but was selected and will be administered by NADC.
Country [2] 314852 0
Australia
Primary sponsor type
Government body
Name
Western Health
Address
176 Furlong Road St Albans VIC 3021
Country
Australia
Secondary sponsor category [1] 316842 0
None
Name [1] 316842 0
Address [1] 316842 0
Country [1] 316842 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313851 0
University of Melbourne STEMM 2 ethics committee
Ethics committee address [1] 313851 0
Ethics committee country [1] 313851 0
Australia
Date submitted for ethics approval [1] 313851 0
13/07/2023
Approval date [1] 313851 0
31/08/2023
Ethics approval number [1] 313851 0

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

Contacts
Principal investigator
Name 129554 0
A/Prof Craig Nelson
Address 129554 0
Sunshine Hospital, 176 Furlong Road St Albans VIC 3021
Country 129554 0
Australia
Phone 129554 0
+61 03 8345 1348
Fax 129554 0
Email 129554 0
craig.nelson@wh.org.au
Contact person for public queries
Name 129555 0
Hannah Wallace
Address 129555 0
Sunshine Hospital, 176 Furlong Road St Albans VIC 3021
Country 129555 0
Australia
Phone 129555 0
+61 3 8345 6666
Fax 129555 0
Email 129555 0
hannah.wallace@wh.org.au
Contact person for scientific queries
Name 129556 0
Hannah Wallace
Address 129556 0
Sunshine Hospital, 176 Furlong Road St Albans VIC 3021
Country 129556 0
Australia
Phone 129556 0
+61 3 8345 6666
Fax 129556 0
Email 129556 0
hannah.wallace@wh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Researchers will be able to share aggregate data, however individual participant data will not be shared to protect patient privacy. Individual patients have not provided consent (a waiver of consent exists). Aggregate data and analytical code will be able to be shared, after trial publication.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20406Study protocol    Trial investigators anticipate publishing of proto... [More Details]
20407Analytic code    This will be made avaliable after analysis and pub... [More Details]
20408Statistical analysis plan  hannah.wallace@wh.org.au Anticipate publishing of trial protocol. Will also... [More Details]
20409Clinical study report    Will be avaliable post conclusion of trial and ana... [More Details]
20410Ethical approval  hannah.wallace@wh.org.au On request



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.