Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000983202
Ethics application status
Approved
Date submitted
9/04/2018
Date registered
12/06/2018
Date last updated
13/04/2021
Date data sharing statement initially provided
15/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
PHenotyping Outcomes for clinical Care, QUality and Service
Scientific title
PHenotyping Outcomes for clinical Care, QUality and Service in Flinders Medical Centre patients.
Secondary ID [1] 294395 0
Nil known
Universal Trial Number (UTN)
U1111-1211-2009
Trial acronym
PHOCQUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial infarction 307126 0
Heart failure 307127 0
Atrial fibrillation 307128 0
Condition category
Condition code
Cardiovascular 306237 306237 0 0
Other cardiovascular diseases
Cardiovascular 306241 306241 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
20
Target follow-up type
Years
Description of intervention(s) / exposure
No patient level clinical interventions will be undertaken within the scope of this project. Clinical phenotyping and monitoring of outcome will be conducted parallel to clinical care, but clinicians will not have visibility of the phenotyping process so as not to influence clinical care. The department will continue to provide standard care as per normal practice. Information regarding performance of the system and the clinical cardiology unit will be reported to the Department of Cardiology leadership and governance. Any changes from standard care would come under the aegis of either normal changes in clinical care, or a separate research study with separate HREC approval sought, and any consequent conditions abided by including full informed consent

Phase/stage 1 will use retrospective data only to define and validate electronic phenotypes for arrhythmia (i.e. atrial fibrillation), heart failure (i.e. systolic and diastolic heart failure) and acute coronary syndromes (i.e. myocardial infarction). It will also establish the processes for routine ongoing data-linkage based on unique identifiers held within health datasets and will refine processes for de-identification. No re-identification of data and direct patient contact will be required. No intervention will be conducted for these retrospective patients, and a full waiver of consent has been requested. Only the patient record initially comprising of data from databases that are local to FMC and those that produce aggregate data of a minimum standard, from 2006 onwards, will be used within this retrospective component and no additional patient contact will be sought. Data collection will include information pertinent to patient admissions, discharges, diagnosis, investigations, interventions, procedures, management, pharmacological therapy, outcomes, risk factors and stratification, demographics, social determinants of health and any associated relevant clinical or administrative data.

Phase/stage 2 will build on the data-linkage and de-identification processes of Phase/stage 1 but, using prospective participant data, will incorporate the phenotypic templates into prospective clinical quality registries of acute coronary syndromes, heart failure and arrhythmia. Prospective participant hospital presentation records will be utilised to further refine and validate the phenotypes to ensure the fidelity of the phenotype templates in an ongoing manner. Departmental care will be at the discretion of the treating clinical teams. All clinical assessments shall occur as per standard clinician discretion, both in method, timing, frequency, and scope, given the observational nature of this study. Clinical data is to be recorded either as per standard care or directly into the PHOCQUS database as determined by data variable.
Intervention code [1] 300686 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305249 0
The primary endpoint will be the diagnostic precision (sensitivity and specificity) of the electronically derived phenotype of myocardial infarction.
Timepoint [1] 305249 0
Database study: patient data collection relevant to primary endpoint ongoing for minimum of 20 years. Diagnostic precision will be regularly assessed during stage 1 and 2.
Primary outcome [2] 306125 0
The primary endpoint will be the diagnostic precision (sensitivity and specificity) of the electronically derived phenotype of atrial fibrillation.
Timepoint [2] 306125 0
Database study: patient data collection relevant to primary endpoint ongoing for minimum of 20 years. Diagnostic precision will be regularly assessed during stage 1 and 2.
Primary outcome [3] 306126 0
The primary endpoint will be the diagnostic precision (sensitivity and specificity) of the electronically derived phenotype of heart failure.
Timepoint [3] 306126 0
Database study: patient data collection relevant to primary endpoint ongoing for minimum of 20 years. Diagnostic precision will be regularly assessed during stage 1 and 2.
Secondary outcome [1] 346535 0
Patient reported outcomes as measured by health-related quality of life questionnaire (EQ-5D).
Timepoint [1] 346535 0
EQ5D will be administered to a random subgroup of participants 1 year after initial contact with the cardiology department. Participants will be selected at random based on their unique trial-allocated identification number .

Eligibility
Key inclusion criteria
1. Adult participants who have been admitted to FMC from 2006, regardless of diagnosis and cardiac investigations, noting that the study methodology requires the sampling of patients with and without clinical suspicion of the cardiovascular diseases under question within the retrospective audit as these patients contribute the true negative/false positive patient cohort for sensitivity/specificity analysis.

2. Prospective participants or their legally authorised representatives are capable of providing informed consent, which includes compliance with the requirements and restrictions listed in the opt-out consent form (ICF) and in the study protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prospective participants are excluded from the study if they notify Flinders Cardiology Research that they choose to either withdraw or opt-out of consent. Prior enrolment/participation in this study in not exclusionary.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Approximately 1,000,000 hospital presentation records will be screened retrospectively to achieve training and validation datasets. We will use a training dataset of 20,000 hospital separations and corresponding ED presentations across the 3 main diagnostic groups (myocardial infarction, heart failure and atrial fibrillation), and use a validation dataset of 50,000 hospital separations randomly selected from the administrative process. The diagnoses of interest account for approximately 7% of hospital separations. This is anticipated to yield 1400 cardiac diagnosis (~500 myocardial infarction, ~500 heart failure, and ~400 atrial fibrillation) in the training dataset and 3500 cardiac diagnoses (~1250 myocardial infarction, ~1250 heart failure, and ~1000 atrial fibrillation). PHOCQUS data will be evaluated for individual, cohort and system-related risk factors for those relevant to developing phenotypical templates.
Stratification, covariate selection, data reduction through principal components analysis or factor analysis, natural language processing for narrative records and other statistical approaches will be utilized as appropriate. Incremental development of the evolving phenotype specification will employ standard receiving operating characteristic methodology, as well as net reclassification improvement and integrated discrimination improvement methodologies, using the clinically determined diagnosis of myocardial infarction, atrial fibrillation and heart failure as the “gold standards”. Exploratory analyses using Bayesian logistic regression methods will be undertaken using smaller “sub-datasets” to examine the predictive utility of employing prior probability of the specific cardiovascular diagnoses in order to improve the diagnostic performance on small datasets. Standard descriptive statistics such as mean and SD or median and range will be reported for continuous variables and proportions will be reported for categorical variables. Means and proportions will be compared using t-tests, chi-square tests or fishers exact test as appropriate. Statistical significance will be ascertained at p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2018
Actual
21/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1150000
Accrual to date
80000
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 10423 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 22116 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 299030 0
University
Name [1] 299030 0
Flinders University
Country [1] 299030 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
1 Sturt Rd, Bedford Park
South Australia 5042
Country
Australia
Secondary sponsor category [1] 298265 0
None
Name [1] 298265 0
None
Address [1] 298265 0
Country [1] 298265 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299965 0
SA Department for Health and Wellbeing Human Research Ethics Committee
Ethics committee address [1] 299965 0
Ethics committee country [1] 299965 0
Australia
Date submitted for ethics approval [1] 299965 0
10/05/2018
Approval date [1] 299965 0
07/08/2018
Ethics approval number [1] 299965 0

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

Contacts
Principal investigator
Name 82110 0
Prof Derek Chew
Address 82110 0
Flinders Medical centre,
1 Flinders Drive, Bedford Park 5042
South Australia
Country 82110 0
Australia
Phone 82110 0
+61884042001
Fax 82110 0
Email 82110 0
derek.chew@flinders.edu.au
Contact person for public queries
Name 82111 0
Erin Morton
Address 82111 0
Department of Cardiovascular Medicine
Flinders Medical centre,
1 Flinders Drive, Bedford Park 5042
South Australia
Country 82111 0
Australia
Phone 82111 0
+61882045836
Fax 82111 0
Email 82111 0
erin.morton@flinders.edu.au
Contact person for scientific queries
Name 82112 0
Erin Morton
Address 82112 0
Department of Cardiovascular Medicine
Flinders Medical centre,
1 Flinders Drive, Bedford Park 5042
South Australia
Country 82112 0
Australia
Phone 82112 0
+61882045836
Fax 82112 0
Email 82112 0
erin.morton@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Will be considered in future.


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.