Department of Medicine; Department of Medicine, Division of Cardiovascular Medicine
Biomedical Devices and Instrumentation | Cardiology | Cardiovascular Diseases | Health Communication | Telemedicine
BACKGROUND: The Centers for Disease Control and Prevention has estimated that atrial fibrillation (AF) affects between 2.7 million and 6.1 million people in the United States. Those who have AF tend to have a much higher stroke risk than others. Although most individuals with AF benefit from anticoagulation (AC) therapy, a significant majority are hesitant to start it. To add, providers often struggle in helping patients negotiate the decision to start AC therapy. To assist in the communication between patients and providers regarding preferences and knowledge about AC therapy, different strategies are being used to try and solve this problem. In this research study, we will have patients and providers utilize the AFib 2gether app with hopes that it will create a platform for shared decision making regarding the prevention of stroke in patients with AF receiving AC therapy.
OBJECTIVE: The aim of our study is to measure several outcomes related to encounters between patients and their cardiology providers where AFib 2gether is used. These outcomes include usability and perceived usefulness of the app from the perspective of patients and providers. In addition, we will assess the extent and nature of shared decision making.
METHODS: Eligible patients and providers will evaluate the AFib 2gether mobile app for usability and perceived usefulness in facilitating shared decision making regarding understanding the patient's risk of stroke and whether or not to start AC therapy. Both patients and providers will review the app and complete multiple questionnaires about the usability and perceived usefulness of the mobile app in a clinical setting. We will also audio-record a subset of encounters to assess for evidence of shared decision making.
RESULTS: Enrollment in the AFib 2gether shared decision-making study is still ongoing for both patients and providers. The first participant enrolled on November 22, 2019. Analysis and publishing of results are expected to be completed in spring 2021.
CONCLUSIONS: The AFib 2gether app emerged from a desire to increase the ability of patients and providers to engage in shared decision making around understanding the risk of stroke and AC therapy. We anticipate that the AFib 2gether mobile app will facilitate patient discussion with their cardiologist and other providers. Additionally, we hope the study will help us identify barriers that providers face when placing patients on AC therapy. We aim to demonstrate the usability and perceived usefulness of the app with a future goal of testing the value of our approach in a larger sample of patients and providers at multiple medical centers across the country.
TRIAL REGISTRATION: ClinicalTrials.gov NCT04118270; https://clinicaltrials.gov/ct2/show/NCT04118270.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21986.
anticoagulation, anticoagulation education, anticoagulation risk, anticoagulation therapy, atrial fibrillation, atrial flutter, mobile health, mobile phone, shared decision making, stroke risk
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©Alok Kapoor, Andreza Andrade, Anna Hayes, Kathleen Mazor, Carl Possidente, Kim Nolen, Rozelle Hegeman-Dingle, David McManus. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.02.2021. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
DOI of Published Version
Kapoor A, Andrade A, Hayes A, Mazor K, Possidente C, Nolen K, Hegeman-Dingle R, McManus D. Usability, Perceived Usefulness, and Shared Decision-Making Features of the AFib 2gether Mobile App: Protocol for a Single-Arm Intervention Study. JMIR Res Protoc. 2021 Feb 24;10(2):e21986. doi: 10.2196/21986. PMID: 33625361; PMCID: PMC7946587. Link to article on publisher's site
JMIR research protocols
Kapoor A, Andrade A, Hayes A, Mazor KM, Possidente C, Nolen K, Hegeman-Dingle R, McManus DD. (2021). Usability, Perceived Usefulness, and Shared Decision-Making Features of the AFib 2gether Mobile App: Protocol for a Single-Arm Intervention Study. Open Access Publications by UMMS Authors. https://doi.org/10.2196/21986. Retrieved from https://escholarship.umassmed.edu/oapubs/4611
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