Coordinating Health Care With Artificial Intelligence-Supported Technology for Patients With Atrial Fibrillation: Protocol for a Randomized Controlled Trial.

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

Objective: The aim of Coordinating Health Care With Artificial Intelligence-Supported Technology in AF is to evaluate the feasibility and potential efficacy of a digital intervention (AF-Support) comprising preprogrammed automated telephone calls (artificial intelligence conversational technology), SMS text messages, and emails, as well as an educational website, to support patients with AF in self-managing their condition and coordinate primary and secondary care follow-up.

Methods: Coordinating Health Care With Artificial Intelligence-Supported Technology in AF is a 6-month randomized controlled trial of adult patients with AF (n=385), who will be allocated in a ratio of 4:1 to AF-Support or usual care, with postintervention semistructured interviews. The primary outcome is AF-related quality of life, and the secondary outcomes include cardiovascular risk factors, outcomes, and health care use. The 4:1 allocation design enables a detailed examination of the feasibility, uptake, and process of the implementation of AF-Support. Participants with new or ongoing AF will be recruited from hospitals and specialist-led clinics in Sydney, New South Wales, Australia. AF-Support has been co-designed with clinicians, researchers, information technologists, and patients. Automated telephone calls will occur 7 times, with the first call triggered to commence 24 to 48 hours after enrollment. Calls follow a standard flow but are customized to vary depending on patients' responses. Calls assess AF symptoms, and participants' responses will trigger different system responses based on prespecified protocols, including the identification of red flags requiring escalation. Randomization will be performed electronically, and allocation concealment will be ensured. Because of the nature of this trial, only outcome assessors and data analysts will be blinded. For the primary outcome, groups will be compared using an analysis of covariance adjusted for corresponding baseline values. Randomized trial data analysis will be performed according to the intention-to-treat principle, and qualitative data will be thematically analyzed.

Results: Ethics approval was granted by the Western Sydney Local Health District Human Ethics Research Committee, and recruitment started in December 2020. As of December 2021, a total of 103 patients had been recruited.

Conclusions: This study will address the gap in knowledge with respect to the role of postdischarge digital care models for supporting patients with AF.

Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621000174886; https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12621000174886.

International Registered Report Identifier (irrid): DERR1-10.2196/34470.