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Trial registered on ANZCTR


Registration number
ACTRN12620000233921
Ethics application status
Approved
Date submitted
6/12/2019
Date registered
25/02/2020
Date last updated
25/02/2020
Date data sharing statement initially provided
25/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Atrial Fibrillation Self-Screening, Management and Guideline Recommended Therapy (AF Self SMART)
Scientific title
Determining the feasibility of opportunistic self-screening for atrial fibrillation in general practice among patients aged 65 years and older: Atrial Fibrillation Self-Screening, Management and Guideline Recommended Therapy (AF Self SMART)
Secondary ID [1] 300023 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AF SELF SMART (Atrial Fibrillation Self-Screening, Management and Guideline Recommended Therapy)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atrial fibrillation 315523 0
Condition category
Condition code
Cardiovascular 313805 313805 0 0
Other cardiovascular diseases
Public Health 314135 314135 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of intervention(s) / exposure:
The overall aim is to develop and trial an automated system that can be up-scaled to increase opportunistic screening for atrial fibrillation (AF) among patients aged 65 years or older attending general practices. The project will focus on the development and testing of: automated text message reminders for patients to undertake screening a self-screening station in practices. Development of an automated screening and management process in the general practice environment will reduce the social and economic burden of avoidable stroke.

Primary Objective
To develop a feasible method of opportunistic AF screening in general practice by developing and testing an ECG self-screening station. We propose this intervention could become the mechanism for implementation of Australian and international guidelines recommending opportunistic screening of AF among the 65 and over age group.

Secondary objectives
The study will also assess the effectiveness of implementation of the intervention by examining:
• The proportion of eligible patients attending the practice that undertake self-screening for AF;
• The change in incidence of newly-diagnosed AF before and after the implementation of opportunistic patient self-screening;
• The proportion of guideline-eligible patients with new AF prescribed oral anticoagulant before and after the intervention;
• The acceptability, competing demands, barriers, and enablers of AF self-screening in the general practice environment according to practice staff and patients.

Study design
Initial phase: practice consent, set up, training and education
Practices will be recruited to the study through study advertisement via the local primary health networks (PHNs). We used this mechanism of recruitment in AF SMART. This will comprise obtaining practice-level written informed consent from practice managers of each general practice that adopts the self-screening, and the provision of de-identified patient diagnostic and prescribing data.

Practices will also be provided with posters for the reception area and treatment rooms advising the availability of self-screening in the practice.
Once the IT setup is complete, practice nurses and GPs will receive tailored training on the self-screening procedure and recent developments in the evidence-based management of AF for stroke prevention, highlighting important developments with the introduction of non-vitamin K dependent oral anti-coagulants (NOACs). Education will be structured to be eligible for continuing medical education points and quality improvement points. Our course is currently accredited for GPs for up to 40 Category 1 points for Quality Improvement (QI) clinical audit activities and for practice nurses through the Australian Primary Health Care Nurses Association (APNA), for 1.5 continuing professional development hours.

Pre-intervention and intervention data extraction
PenCAT software will be configured in each practice to collect relevant de-identified data from electronic patient records. These data include demographic, medication, and diagnostic information. Retrospective data extraction of patient electronic medical records for the three months prior to commencement of the project will be undertaken in each practice to enable estimation of new AF diagnosis and prescribing patterns of NOACs prior to the intervention. Identical de-identified data will also be obtained for the three months while the intervention takes place, in order to observe differences in diagnosis and prescribing before and during the intervention.

Self-screening intervention
The self-screening kiosk is a small footprint metal stand on which the FDA and TGA approved Kardia ECG device is mounted with an iPad as the screen. The screening kiosk will be placed in the waiting rooms in a highly visible and patient accessible area. Screening will be offered for 3 months in each practice. All patients aged 65 years visiting the practice for any appointment will be eligible for screening.

Text message notification is an effective means for GP practices to communicate with patients in the target age range, with greater than 80% of Australians aged 65 years and older using a smartphone. It is standard practice that patients register their mobile phone number with the GP surgery, with the option to opt out of practice text message reminders and broadcast text messages. A maximum of one broadcast text message about the study will be sent per patient.

Text message reminders will only be employed in practices that already utilise text message communication with patients. Two methods of SMS text message notifications will be used to prompt patients to self-screen, with eligible patients only receiving one notification of the availability to self-screen.
• Prompt to screen sent with appointment reminder text messages.
Appointment reminder messages are routine for most general practices and are often sent the day prior to a scheduled appointment. Each practice has their unique appointment reminder message text and format. In AF-Self SMART a brief message advising of the availability of AF self-screening will be added to the standard appointment reminder text message. A QR code may also be added to the text message. This is a uniquely-generated bar code that will be used to register the patient’s details at the screening kiosk.

Text message broadcasts advising of the commencement of flu vaccination have become commonplace in general practices. Similar to that described for the appointment reminder text messages, a brief message about the availability of AF screening +/- a QR code will be appended to the practices’ standard broadcast message.

A participation information statement will be available at both the reception desk and the self-screening booth detailing the aims of the study, risks and benefits of participation and assurance of data confidentiality. Informed patient consent will be implied from patient completion of the screening protocol. This method of informed consent is likely to maximise participation of both practices and patients, thereby facilitating the development of a protocol of screening that can be up-scaled for opportunistic general practice-based screening, which is the ultimate purpose of this study, to provide maximum efficacy in detecting AF among the 65 and older age group.

At the self-screening kiosk patients will either scan their QR-code or manually enter their name and date of birth. The screening software will prompt them to touch the ECG transducer for 30 seconds for recording of the ECG. Identical to the approved AF SMART study, the ECG is then automatically interpreted by a software algorithm that has been shown to reliably and validly detect AF. The results are then instantly available to the GP and nurse via the Kardia-Pro app and may be entered into patient’s investigation reports in their medical file. During the patient’s appointment with the GP or nurse, the outcome of the ECG will be reviewed or patients will be recalled to the practice if the screening station detects an abnormal or indeterminate ECG. If AF is confirmed, the GP will review the patient and determine appropriate management.

Protocol for each of the automated ECG diagnoses:
• Protocol if a patient receives “Possible AF” diagnosis
The patient will be prompted to discuss this with their medical practitioner during their allotted appointment time, or the patient will be recalled to the practice for a follow-up appointment. Further investigation is at the GP’s discretion, although a 12-lead ECG is recommended to confirm all new AF diagnoses.

• Protocol if a patient receives “Unclassified” diagnosis
The patient will be prompted to discuss this with their medical practitioner during their allotted appointment time, or the patient will be recalled to the practice for a follow-up appointment. Depending on individual patient’s history and ECG, a 12-lead ECG may be recommended but follow-up is at the GP’s discretion. There are a number of conditions that can lead to this particular diagnosis (e.g. sinus tachycardia/bradycardia, left bundle branch block) which may or may not be clinically significant.

• Protocol if a patient receives “Normal” diagnosis
No further action is required.

Process evaluation
Individual semi-structured interviews will take place with practice managers, reception staff, nurses, doctors and eligible patients. Participants will be randomly selected from each practice, and we will aim to interview the practice manager and at least two each of reception staff, doctors, nurses and patients per practice. Interview participants will be given detailed information about the aims of the study, the risks and benefits of participation and participant confidentiality prior to the commencement of interviews and will be asked to sign a consent form. Interviews will take 10-20 minutes to complete.



Interviews will focus on a detailed process evaluation of the screening procedure with an emphasis on issues for up-scaling the screening for opportunistic self-screening at GP practices. For patients, the process evaluation discussions will occur on the same day as undertaking the ECG self-screening and consultation with their GP. These interviews will focus on the appropriateness of text message prompts to screen, the acceptability of the self-screening process including the screening interface, and any barriers and facilitators patients experienced whilst undertaking self-screening. Interviews with practice staff will focus on the acceptability of the self-screening process, the integration of the screening prompts and decision support tools in the practice workflow, and any barriers or facilitators to self-screening that they encountered.
Intervention code [1] 316296 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator will be the incidence of newly-diagnosed atrial fibrillation among patients aged 65 years and over in the three months of the atrial fibrillation self-screening intervention. The historical data of the AF diagnosis rates will be obtained from retrospective data extractions covering the three months prior to commencement of the study. These data extractions will be performed at each GP practice at the commencement of the intervention.
Control group
Historical

Outcomes
Primary outcome [1] 322212 0
Feasibility will be determined by the proportion of eligible patients aged 65 years and older without any prior diagnosis of AF that complete opportunistic self-screening for atrial fibrillation per practice, as identified by PEN CAT data extraction of practice electronic medical records.
Timepoint [1] 322212 0
For the 3 months after the commencement of the self-screening intervention.
Secondary outcome [1] 377751 0
The total number of patients aged 65 years or older attending the practice for appointments during the three month self-screening intervention period assessed by PEN CAT data extraction of electronic medical records;
Timepoint [1] 377751 0
For the 3 months after the commencement of the self-screening intervention.
Secondary outcome [2] 378826 0
The number identified with ECGs showing possible AF and or unclassified traces during the three month intervention period assessed by PEN CAT data extraction of electronic medical records;
Timepoint [2] 378826 0
For the 3 months after commencement of the self-screening intervention.
Secondary outcome [3] 378827 0
The incidence of new diagnosis of AF in the three months prior and the three months after the intervention assessed by PEN CAT data extraction of electronic medical records
Timepoint [3] 378827 0
For the three months before the start of the self-screening intervention and the three months of the self-screening intervention.
Secondary outcome [4] 378828 0
CHA2DS2-VASc score of all those identified with AF during the intervention period assessed by PEN CAT data extraction of electronic medical records.
Timepoint [4] 378828 0
For the 3 months after commencement of the self-screening intervention
Secondary outcome [5] 378829 0
Comparison of medications initiated among patients with newly-diagnosed AF compared to the Heart Foundation of Australia guideline recommendations in the three months prior to and the three months of the duration of the intervention assessed by PEN CAT data extraction of electronic medical records;
Timepoint [5] 378829 0
For the three months before the start of the self-screening intervention and the three months of the self-screening intervention.
Secondary outcome [6] 378830 0
Appropriateness of SMS text message screening prompts, ascertained by open questions in the the face-to-face process evaluation interviews with patients and practice staff.
Timepoint [6] 378830 0
For practice staff the timepoint that will be of reference will be the 3 months after the commencement of the self-screening intervention, for patients the timepoint of reference will just be their screening experience which will have occurred on the day of the interview.
Secondary outcome [7] 378831 0
Acceptability of the self-screening process as described by patients in the face-to-face process evaluation interviews with patients. .
Timepoint [7] 378831 0
For practice staff the timepoint that will be of reference will be the 3 months after the commencement of the self-screening intervention, for patients the timepoint of reference will just be their screening experience which will have occurred on the day of the interview.
Secondary outcome [8] 378832 0
Barriers and facilitators to self-screening elicited by patients and practice staff in process evaluation interviews ascertained by open questions in the the face-to-face process evaluation interviews. .
Timepoint [8] 378832 0
For practice staff the timepoint that will be of reference will be the 3 months after the commencement of the self-screening intervention, for patients the timepoint of reference will just be their screening experience which will have occurred on the day of the interview.
Secondary outcome [9] 378833 0
Issues with integration of self-screening in the practice work flow as per practice staff elicited by open-ended questions in the face-to-face process evaluation interviews. .
Timepoint [9] 378833 0
For practice staff the timepoint that will be of reference will be the 3 months after the commencement of the self-screening intervention, for patients the timepoint of reference will just be their screening experience which will have occurred on the day of the interview.

Eligibility
Key inclusion criteria
Key inclusion criteria: Five to eight practices in urban Sydney will be recruited to the study. The practices will be required to:

• Meet IT software requirements, including the installation of Top Bar and the clinical audit software PenCAT;
• WiFi; and
• Use either Best Practice or Medical Director as the practice electronic patient record management system.

Practices will provide written informed consent to participate in the study and must be willing to comply with the study protocol.

Patient eligibility
Eligible patients aged 65 years or older presenting to the general practice for any health practitioner appointment, including annual flu vaccination, shingles vaccination, chronic care assessment, will be eligible for AF self screening if they meet the following inclusion criteria:
• Aged 65 years or older, and
• No recorded diagnosis of AF.

Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with severe medical conditions (i.e. terminal illness) or who are physically or intellectually unable to undertake the screening procedure will be excluded from the study.

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
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size estimation

This study aims to recruit five to eight urban general practices. Each practice is expected to have approximately 300 patients utilising self-screening during the three-month study period, but numbers will vary between sites, dependant on the size of the practice. As the primary objective of this study is to develop and test the tools and protocols for ECG self-screening, a formal power calculation to inform sample size is not possible for this endpoint. Five to eight practices will provide a sufficient cross-sectional sample to test implementation of the self-screening stations and will provide relevant information required to scale the protocol for opportunistic screening in general practice.

Population to be analysed

Pre-intervention data extraction
The retrospective data extraction will focus on all patients aged 65 years or older without a previous diagnosis of AF presenting for an appointment to the practice. Those with a new diagnosis of AF over the period will be identified, and data on medications prescribed to these patients will be extracted.

Self-screening intervention
The total number of in-scope patients (i.e. 65 years or older with no previous AF diagnosis) presenting to the practice for an appointment over the duration of the self-screen intervention will be determined. Those with newly diagnosed AF will be identified, and information on medication prescription will be extracted.

Analysis plan

Quantitative analyses

The PenCAT data extraction would be obtained retrospectively for the three months prior to the commencement of the self-screen intervention. During the intervention the PenCAT data extraction will be collected at the end of months 1, 2 and 3. Interim extracts will be used to provide feedback to practices, with only the extract at the end of the study (comprising of the full three months of the intervention) being used for analysis.

Data preparation
• In the dataset for analysis, we will exclude anyone who was screened but ineligible (e.g. pre-existing diagnosis of AF or aged less than 65 years);
• CHA2DS2-VASc score will be calculated for all patients with a diagnosis of AF.


Descriptive analyses will occur both at the individual practice level and all practices pooled together.

Analyses of pre-intervention data
• Total number of in-scope patients 65 years or older actively attending the practice;
• Total number of patients newly identified with AF in the pre-intervention period;
• The rate of AF detection (per 1000 patients);
• CHA2DS2-VASc score for all patients with a new diagnosis of AF during the pre-intervention period;
• Medications prescribed for those patients with newly diagnosed AF (i.e. warfarin/other vitamin K antagonists, aspirin, other anti-platelets, new oral anticoagulants);
• Comparison of AF treatment compared to the new Cardiac Society of Australia and New Zealand (CSANZ) and Heart Foundation guidelines and the European Society of Cardiology recommendations.

Analyses of intervention data
• Total number of in-scope patients 65 years or older actively attending the practice;
• Total number of in-scope patients completing AF self-screening;
• Total number of patients identified with ECGs with ‘possible AF’ or ‘unclassifiable’;
• Total number of patients identified with AF after medical review;
• The rate of AF detection (per 1000 patients);
• CHA2DS2-VASc score for all patients with a new diagnosis of AF;
• Medications prescribed for those patients with newly diagnosed AF (i.e. warfarin/other vitamin K antagonists, non-Vitamin K dependent oral anticoagulants, aspirin, other anti-platelets);
• Comparison of AF treatment new Cardiac Society of Australia and New Zealand (CSANZ) and Heart Foundation of Australia guidelines and the European Society of Cardiology recommendations.

Qualitative analyses

A detailed process evaluation using mixed methods will be undertaken to evaluate the ECG self-screening process. Transcriptions of the semi-structured interviews will be analysed thematically by several members of the research team. Realist evaluation will be used to analyse the patient and practice acceptability of the self-screening process, the barriers/enablers to screening and how screening fits into the workflow of the practice. The research team will discuss and refine the analysis to reach a final consensus on the main themes in terms of barriers and enablers.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304477 0
Commercial sector/Industry
Name [1] 304477 0
Bristol Myers Squibb
Address [1] 304477 0
4 Nexus Ct, Mulgrave VIC 3170
Country [1] 304477 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Level 3, Administration Building (F23), University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 304746 0
Other
Name [1] 304746 0
Heart Research Institute
Address [1] 304746 0
7 Eliza St
Newtown NSW 2042
Country [1] 304746 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304908 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 304908 0
Level 3, Administration Building (F23)
University of Sydney NSW 2006
Ethics committee country [1] 304908 0
Australia
Date submitted for ethics approval [1] 304908 0
04/04/2019
Approval date [1] 304908 0
03/06/2019
Ethics approval number [1] 304908 0
2019/382
Ethics committee name [2] 304915 0
University of Notre Dame Human Research Ethics Committee
Ethics committee address [2] 304915 0
PO Box 944
Broadway
NSW 2007
Ethics committee country [2] 304915 0
Australia
Date submitted for ethics approval [2] 304915 0
14/10/2019
Approval date [2] 304915 0
31/10/2019
Ethics approval number [2] 304915 0
0191455

Summary
Brief summary
Atrial fibrillation (AF) is a heart-beat irregularity that is often asymptomatic to patients and increases the risk of stroke. This project will develop and test an automated ECG self-screening station that will be put in GP waiting rooms to detect AF among patients 65 years of age and older. Patient self-screening will be integrated within the workflow and software of GP practices. We propose that this intervention could become the mechanism for widespread implementation of the new Australian and international AF screening and management guidelines, and thereby contribute to the greater prevention of avoidable strokes in Australia.
Trial website
Trial related presentations / publications
Public notes
Presentations arising from the project:

Giskes K, Lowres N, Orchard J, Hespe C, Freedman B. Atrial fibrillation self-screening, guideline and recommended therapy (AF SELF SMART). Australasian Association of Academic Primary Care (AAAPC) conference, Adelaide, 10 July 2019.

Giskes K. Automated self-screening for AF in general practice. GP 19 conference, Adelaide, 24 October 2019.

Contacts
Principal investigator
Name 98614 0
Prof Ben Freedman
Address 98614 0
Heart Research Institute/University of Sydney
7 Eliza St
Newtown
NSW 2042
Country 98614 0
Australia
Phone 98614 0
+61 02 82088900
Fax 98614 0
Email 98614 0
ben.freedman@sydney.edu.au
Contact person for public queries
Name 98615 0
Dr Katrina Giskes
Address 98615 0
Heart Research Institute/University of Sydney
7 Eliza St
Newtown
NSW 2042
Country 98615 0
Australia
Phone 98615 0
+61 02 82088900
Fax 98615 0
Email 98615 0
katrina.giskes@sydney.edu.au
Contact person for scientific queries
Name 98616 0
Dr Katrina Giskes
Address 98616 0
Heart Research Institute/University of Sydney
7 Eliza St
Newtown
NSW 2042
Country 98616 0
Australia
Phone 98616 0
+61 02 82088900
Fax 98616 0
Email 98616 0
katrina.giskes@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
What supporting documents are/will be available?
No other documents available
Summary results
No Results