Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000004268
Ethics application status
Approved
Date submitted
5/12/2017
Date registered
9/01/2018
Date last updated
2/03/2021
Date data sharing statement initially provided
29/04/2019
Date results information initially provided
2/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Atrial Fibrillation Screen, Management And Guideline Recommended Therapy (AF SMART): Implementation in the rural primary care setting
Scientific title
Identifying and managing atrial fibrillation (AF) in rural patients aged 65 years and over by opportunistic screening using a smartphone electrocardiogram in the rural primary setting (AF SMART)
Secondary ID [1] 293508 0
Nil
Universal Trial Number (UTN)
Trial acronym
AF SMART rural
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 305695 0
Condition category
Condition code
Cardiovascular 304915 304915 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ten rural general practices will participate in the intervention-based study. Staff at these practices will attend a one hour training session with a researcher. The session will feature a brief presentation on atrial fibrillation (AF), study protocol, and the use of an approved handheld smartphone electrocardiograph device (iECG) (Kardia Mobile, ARTG Identifier 234417) and the accompanying mobile application (Kardia).

The Kardia device is a portable iECG monitor that attaches to smartphones. It enables a single lead iECG to be taken using the Kardia application on the smartphone after a patient places two fingers on the electrodes.

A flyer advertising the study will be displayed in the general practice reception area, and a laminated copy of the patient participant information statement (PIS) will be available at reception. Screening will be offered by nurses during flu or shingles vaccinations and “co-ordinated chronic care” consultations. Screening will be offered opportunistically by GPs during patient consultations. The GP or nurse will invite the patient to participate and record the patient's oral consent in the clinical record. During screening, the patient will be asked to hold the smartphone ECG for a minimum of thirty seconds to record their heart rhythm. The Kardia application immediately analyses the ECG rhythm for the presence of AF using a validated algorithm, and provides an immediate provisional diagnosis on the smartphone.

The ECG recordings and provisional diagnoses can be directly imported into the general practice’s local server. Staff can download them as PDFs to attach to patient files in the clinical management system. PenCAT software (Pen CS) will be configured to collect de-identified data from electronic patient records. These data include demographic, medication, and diagnostic information. Data presented to the researchers are all de-identified.

For this study the practice nurses will facilitate a general practitioner review for all patients with a provisional diagnosis of AF, if they have no previous known history of this condition. Review of known AF patients’ current management plan is also recommended particularly if they are not being treated by anti-coagulants. The general practitioner will determine subsequent management strategy for both new and known AF patients using an electronic decision-support system (EDS) called HealthTracker-CVD. This system is developed by the George Institute in collaboration with Sydney University. It sits within the practice software (Medical Director or Best Practice) to provide healthcare staff with evidence-based guidelines for optimal therapeutic management of AF.

The screening intervention will commence in 2018 and run for 3-4 months in each practice. Following completion of the intervention, semi-structured interviews will be conducted with selected nurses, practice managers, and general practitioners from each practice to identify barriers and enablers of workflow as well as the usefulness of EDS.
Intervention code [1] 299743 0
Early detection / Screening
Comparator / control treatment
We propose to compare data collected in this study to data collected from our current study (ACTRN12616000850471) in metropolitan Sydney, and the George Institute database of ‘control’ practices with the same data-parameters collected through concurrent studies from May 2012 to May 2017 run by The George Institute using HealthTracker.
Control group
Historical

Outcomes
Primary outcome [1] 304108 0
Composite primary outcome: Implementation success through process measures including proportion of eligible patients screened, fidelity to the protocol, and time taken to complete the intervention (number of eligible patients screened identified from deidentified data extract from practices then divided by the number of patients over 65 years attending the practice during the screening period; process outcomes measured using qualitative process evaluation using semi-structured interviews performed at the end of the screening intervention)..
Timepoint [1] 304108 0
Completion of the screening intervention
Secondary outcome [1] 341001 0
Cost effectiveness analysis (i.e. incremental cost-effectiveness ratio of screening per quality adjusted life year gained, and per stroke avoided– using the basic economic model for AF screening developed and utilised in the SEARCH-AF study with revised figures reflecting 2018 costs).

SEARCH-AF study:
Lowres, N., Neubeck, L., Salkeld, G., Krass, I., McLachlan, A. J., Redfern, J., ... & Wallenhorst, C. (2014). Feasibility and cost-effectiveness of stroke prevention through community screening for atrial fibrillation using iPhone ECG in pharmacies. The SEARCH-AF study. Thromb Haemost, 111(6), 1167-76.
Timepoint [1] 341001 0
Completion of the screening intervention
Secondary outcome [2] 341003 0
To identify the competing demands, barriers, enablers and assess the level of acceptability according to staff involved in the intervention (measured using qualitative process evaluation using semi-structured interviews with general practice staff performed at the end of the screening intervention).
Timepoint [2] 341003 0
Completion of the screening intervention
Secondary outcome [3] 341004 0
Incidence of new AF in rural screening practices at completion of the intervention compared to metropolitan and control group) (assessed using deidentified data extract from practices, calculated using the number of new AF cases divided by the total number screened with accompanying 95% confidence intervals).
Timepoint [3] 341004 0
Completion of the screening intervention
Secondary outcome [4] 341005 0
The proportion of people screened identified with new AF who are eligible for oral anticoagulants according to guideline (identified using deidentified data extracted from practices, with new AF defined as confirmed positive diagnoses of AF and anticoagulant eligibility defined as those with a CHAD2S2-VASc score = 1 in males or greater than or equal to 2 in all, divided by the total number screened with accompanying 95% confidence intervals)
Timepoint [4] 341005 0
Completion of the screening intervention
Secondary outcome [5] 341061 0
Rates of appropriate treatment in both known and new AF diagnoses with oral anticoagulants and antiplatelets at baseline and at completion of the intervention (compared to metropolitan and control group) (assessed using deidentified data extract from practice; oral anticoagulation eligibility assessed according to CHAD2S2-VASc score = 1 in males or greater than or equal to 2 in all)
Timepoint [5] 341061 0
Completion of the intervention

Eligibility
Key inclusion criteria
Patients aged 65 years and over who are attending the general practice
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Existing diagnosis of atrial fibrillation

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/05/2018
Actual
6/07/2018
Date of last participant enrolment
Anticipated
1/09/2019
Actual
28/06/2019
Date of last data collection
Anticipated
1/09/2020
Actual
3/02/2020
Sample size
Target
3000
Accrual to date
Final
3103
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298127 0
Commercial sector/Industry
Name [1] 298127 0
Pfizer
Country [1] 298127 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
City Rd,
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 297207 0
None
Name [1] 297207 0
Address [1] 297207 0
Country [1] 297207 0
Other collaborator category [1] 279844 0
Other Collaborative groups
Name [1] 279844 0
The George Institute for Global Health
Address [1] 279844 0
Level 5, 1 King Street Newtown NSW, Australia 2042
Country [1] 279844 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299145 0
University of Sydney HREC
Ethics committee address [1] 299145 0
University of Sydney NSW 2006
Ethics committee country [1] 299145 0
Australia
Date submitted for ethics approval [1] 299145 0
20/11/2017
Approval date [1] 299145 0
27/02/2018
Ethics approval number [1] 299145 0
Project No. 2017/1017

Summary
Brief summary
Atrial fibrillation (AF) is the most common heart arrhythmia, affecting 1 in 4 adults worldwide, and at least 240,000 Australians. Prevalence rises with age from approximately 1% of the whole population to 5% in those over 65 years. People with AF are up to seven times more likely to have a stroke than the general population. Almost one in every three strokes is AF-related, and AF-related strokes are likely to be more severe, with a whole of life cost of each stroke estimated at $103,566. However, strokes in AF can be effectively prevented using oral anticoagulants. Unfortunately in Australia oral anticoagulant prescription is only about 60% even in those patients with known AF who are therefore at high risk for stroke. This gap has been difficult to close despite having therapeutic management guidelines.

Many people in the general population are unaware that they have AF, with first diagnosis being made when they are admitted to hospital with a stroke or transient ischaemic attack. The diagnosis of unknown AF can be easily made using a 30 second ECG rhythm strip obtained with a TGA approved smartphone ECG (iECG). Using this device, unknown AF can be identified and treated, thus reducing the number of strokes due to AF. We have previously shown that community screening for AF to prevent stroke is likely to be cost-effective, but the magnitude of the benefit in terms of numbers of strokes prevented, is determined by the proportion of the population screened.

This study therefore explores screening for AF in rural primary care, by performing iECG screening for patients attending their general practice. Screening will be offered by practice nurses during annual influenza vaccination (currently administered to over 70% of patients aged 65 or over in general practice) and during annual chronic care assessments such as Diabetes Cycle of Care and Health Assessment for People Aged 75 and Older. General practitioners will also opportunistically screen patients. This opportunistic method of screening, through its reach, could approximate systematic population screening for AF. Screening will be performed in 10 practices across rural NSW to gauge and efficacy and cost effectiveness of community-based AF screening.
In addition to the handheld iECG device, this study will also implement the electronic decision support software called HealthTracker-CVD. A special AF module has been designed as part of this software to automatically calculate the stroke risk score for patients with AF, and provide individualised advice on evidence-based management of AF. An automated tool such as this available to both general practitioners and practice nurses is ideal to facilitate closing the gap in oral anticoagulant prescription for stroke prevention in patients with diagnosed AF.
Trial website
Trial related presentations / publications
Results paper (quantitative):
Orchard J, Li J, Freedman B, Webster R, Salkeld G, Hespe C, Gallagher R, Patel A, Kamel B, Neubeck L, et al. Atrial Fibrillation Screen, Management, And Guideline-Recommended Therapy in the Rural Primary Care Setting: A Cross-Sectional Study and Cost-Effectiveness Analysis of eHealth Tools to Support All Stages of Screening. J Am Heart Assoc 2020;9:e017080. Available open access from: https://www.ahajournals.org/doi/10.1161/JAHA.120.017080

Results paper (qualitative): Orchard J, Li J, Gallagher R, Freedman B, Lowres N and Neubeck L. Uptake of a primary care atrial fibrillation screening program (AF-SMART): a realist evaluation of implementation in metropolitan and rural general practice. BMC Fam Pract. 2019;20:170. Available open access from: https://bmcfampract.biomedcentral.com/articles/10.1186/s12875-019-1058-9
Public notes

Contacts
Principal investigator
Name 79450 0
Prof Ben Freedman
Address 79450 0
Level 3, Building D17 Charles Perkins Centre
The University of Sydney
NSW
2006
Country 79450 0
Australia
Phone 79450 0
+61 2 9114 2199
Fax 79450 0
Email 79450 0
ben.freedman@sydney.edu.au
Contact person for public queries
Name 79451 0
Mrs Jessica Orchard
Address 79451 0
Level 2, Building D17 Charles Perkins Centre
The University of Sydney
NSW
2006
Country 79451 0
Australia
Phone 79451 0
+ 61 2 8627 1664
Fax 79451 0
Email 79451 0
jessica.orchard@sydney.edu.au
Contact person for scientific queries
Name 79452 0
Mrs Jessica Orchard
Address 79452 0
Level 2, Building D17 Charles Perkins Centre
The University of Sydney
NSW
2006
Country 79452 0
Australia
Phone 79452 0
+ 61 2 8627 1664
Fax 79452 0
Email 79452 0
jessica.orchard@sydney.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
Not permitted by our ethics approval


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1953Study protocol    https://bmjopen.bmj.com/content/8/10/e023130



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Orchard J, Li J, Freedman B, Webster R, Salkeld G,... [More Details]
Study results articleYes Orchard J, Li J, Gallagher R, Freedman B, Lowres N... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAtrial fibrillation screen, management, and guideline-recommended therapy in the rural primary care setting: A cross-sectional study and cost-effectiveness analysis of ehealth tools to support all stages of screening.2020https://dx.doi.org/10.1161/JAHA.120.017080
N.B. These documents automatically identified may not have been verified by the study sponsor.