A Study to Assess the Effectiveness of an Atrial Fibrillation (AF) Risk Prediction Algorithm and Diagnostic Test in Identifying Patients With AF.

Study Overview
=================
Brief Summary
-----------------
This is a trial to assess the effectiveness of an atrial fibrillation (AF) risk prediction algorithm and diagnostic test for the identification of patients with atrial fibrillation

Official Title
-----------------
A Randomised Controlled Trial for the Identification of Undiagnosed Atrial Fibrillation Patients Using a Machine Learning Risk Prediction Algorithm and Diagnostic Test

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Practice inclusion criteria for the trial are as follows; GP Practices within National Institute for Healthcare Research (NIHR) Clinical Research Network: West Midlands (CRN: WM) CRN: WM GP Practices using EMIS as their electronic medical record system of choice. Patient inclusion criteria for the trial are as follows; Patients registered at a participating practice, aged ≥30 years and without an AF diagnosis. Patients with a valid index date (see Section 3.3) Participant inclusion criteria for participation in the intervention arm are; As above, and who have provided written consent to: attend a research clinic, AF diagnosis check using a 12-lead ECG, and for access to medical records Participant inclusion criteria for participation in further AF remote diagnosis with an AliveCor Heart Monitor are; As above, and those with a negative or indeterminant ECG As above, and those with access to a smartphone Exclusion criteria: Patients <30 years Patients with an existing diagnosis of AF Patients for whom the healthcare professional feels the study is unsuitable

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention arm<br>The AF risk prediction algorithm will be run on patient records within the Egton Medical Information Systems (EMIS) data base, in order to identify patients at risk of developing AF | |
| Control arm<br>Patients may be diagnosed with AF through routine clinical practice only | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with diagnosed Atrial Fibrillation during the research window in control and intervention arms | Prevalence of AF in the research window assessed | From the first collection of patient medical records at the beginning of the trial to the last collection of patient records following the intervention at the end of the trial (Up to 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expected healthcare resource utilisation (Annual maintenance costs related to health states (informed by the primary endpoint), and daily treatment costs (including monitoring)) |  | Up to 6 months | 
| Quality-adjusted life years (QALYs) |  | Up to 6 months | 
| Life years (LYs) |  | Up to 6 months |