None listed
Conditions
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. 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. The current study therefore explores screening for AF in primary care, by performing iECG screening during annual influenza vaccination currently administered to over 70% of patients aged 65 years and over in general practice. This opportunistic method of screening, through its reach, would approximate systematic population screening for AF. Screening will be performed in a small number of practices in this pilot study to optimize the process and inform any refinement of a larger scale study of implementation. The pilot will also ensure the tools are ready for the larger implementation study.
Interventions
Five General practices will participate in the pilot intervention. Nurses at the participating practices will attend a two-hour training session with a trained cardiac nurse specialist. The practice nurse will receive training regarding the research protocol and the use of an approved handheld ECG monitoring device (AliveCor Heart Monitor, ARTG Identifier 208100). This is a special cover that attaches to smartphones, and enables a single lead ECG to be taken using an application on the phone (iE
Five General practices will participate in the pilot intervention. Nurses at the participating practices will attend a two-hour training session with a trained cardiac nurse specialist. The practice nurse will receive training regarding the research protocol and the use of an approved handheld ECG monitoring device (AliveCor Heart Monitor, ARTG Identifier 208100). This is a special cover that attaches to smartphones, and enables a single lead ECG to be taken using an application on the phone (iECG). Practice nurses will use the ECG device to screen for AF during the period of observation of the patient after the administration of the annual flu shot in general practice. The patient will be asked to hold the smartphone ECG for approximate one minute, to record their heart rhythm. The smartphone 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 recording and provisional diagnosis are directly imported into the general practice software and attached to the patient notes. The nurse will facilitate a general practitioner review for all patients with a provisional diagnosis of AF, if they have no previous known history of AF. The general practitioner will review the patient and determine subsequent management. The screening intervention will run for the entire 2015 flu-vax period, approximately 2-3 months in total. Following completion of the intervention, structured interviews will be conducted with the participating nurses, practice managers and a selection of general practitioners from each practice to determine the barriers and enablers of the screening intervention and thereby inform refinement of the larger scale intervention.
Sponsors
University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients aged 65 years and over, who are eligible for an annual flu shot. A convenience sample of General Practice will be selected from those who respond to the expression of interest for participation in the pilot study. General practices will need to offer annual flu-vaccination administered by a practice nurse, and need to have onsite wi-fi and a computerized patient management system to be considered eligible for participation. The first 5 eligible practices that respond to the expression of interest will be recruited to the study.
Exclusion criteria
Insufficient cognitive capacity to understand the consent process
Outcome results
None listed