Atrial Fibrillation Self-Screening, Management and Guideline Recommended Therapy (AF Self SMART)

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.