Coordinating Healthcare with Artificial intelligence-supported Technology for Atrial Fibrillation patients (CHAT-AF): Protocol for a Randomised Controlled Trial (Preprint)

Author:

Laranjo LilianaORCID,Shaw TimORCID,Trivedi Ritu,Thomas Stuart,Charlston Emma,Klimis Harry,Thiagalingam AravindaORCID,Kumar Saurabh,Tan Timothy C,Nguyen Tu N,Marschner Simone,Chow ClaraORCID

Abstract

BACKGROUND

Atrial fibrillation (AF) is an increasingly common chronic health condition in which integrated care, that is multidisciplinary and patient-centric, is recommended yet challenging to implement.

OBJECTIVE

The aim of CHAT-AF is to evaluate the feasibility and potential efficacy of a digital intervention (‘AF-Support’) comprising pre-programmed automated phone calls (artificial intelligence conversational technology), texts-messages and emails, and an educational website to support AF patients self-manage their condition and coordinate primary and secondary care follow-up.

METHODS

CHAT-AF is a 6-month randomised controlled trial of adult patients with AF (n=385) allocated in a ratio 4:1 to AF-Support or usual care, with post-intervention semi-structured interviews. The primary outcome is AF-related quality of life, and secondary outcomes include cardiovascular risk factors, outcomes, and health care utilisation. The 4:1 allocation design enables a detailed examination of the feasibility, uptake, and process of implementation of AF-Support. Participants with new or ongoing AF will be recruited from hospitals and specialist-led clinics in Sydney, Australia. ‘AF-Support’ has been co-designed with clinicians, researchers, information technologists and consumers. Automated calls will occur 7 times with the first call triggered to commence 24-48 hours after enrolment. Calls follow a standard flow but are customised to vary depending on patient responses. Calls assess AF symptoms and participant responses will trigger different system responses based on pre-specified protocols including identification of red flags requiring escalation. Randomisation will be done electronically, and allocation concealment will be ensured. Due to the nature of this trial, only outcome assessors and data analysts will be blinded. For the primary outcome, groups will be compared using analysis of covariance adjusted for corresponding baseline values. Randomised trial data analysis will be according to the principle of intention-to-treat and qualitative data will be thematically analysed.

RESULTS

Ethics approval was granted by the Western Sydney Local Health District (WSLHD) Human Ethics Research Committee and recruitment started in December 2020. As of December 2021, 103 patients have been recruited.

CONCLUSIONS

This study will address the gap in knowledge with respect to the role of post-discharge virtual care models to support patients with atrial fibrillation.

CLINICALTRIAL

Registration number: ACTRN12621000174886

Publisher

JMIR Publications Inc.

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