NARRATIVE| VOLUME 1, ISSUE 1, P25-27, MARCH 2023
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Open AccessPublished:February 15, 2023DOI:https://doi.org/10.1016/j.mcpdig.2023.01.004
We, a nurse and a laboratory director, share our experience supporting a research study that employed a digital health application and a rapid test for severe acute respiratory syndrome coronavirus 2 and the implications of this approach for health care delivery.
Recently, we (a nurse and a laboratorian) had the opportunity to support a research study that employed a digital health platform and a rapid antigen test for severe acute respiratory syndrome coronavirus 2 that had emergency use authorization for home use by the US Food and Drug Administration. The study was intended to gather additional performance data in support of an emergency use authorization application for a version of the test whereby the patient could take the test at home and then scan the test cartridge with their phone using the digital health application.
In this study, patients were solicited via posters and handouts as they drove through coronavirus disease 2019 testing tents at our hospital campus. Those who agreed to participate parked their car in the parking lot, consented verbally, and signed a tablet for HIPAA consent. They were provided a mobile phone with the digital health application and a rapid antigen test kit. The digital health application provided instructions for collection of anterior nasal swabs and included a countdown timer, which was activated by the patient once they had initiated the test. When the timer was complete, the application automatically started a second countdown timer, which would mark the end of a valid period for test interpretation. The phone prompted the patient to scan the cartridge, and the algorithm interpreted the test and returned the result to the patient. All of this took place in their car, which indicates the simplicity of the approach. After completing the test, the patient was prompted to answer questions about their experience. The patients in the study gave positive feedback, and the study demonstrated that the digital health application could interpret the test results equal to humans.
The study was conducted under institutional review board-approved protocol 20-010688.
A digital-enabled test such the one in our study is an example of an alternative approach to some aspects of ambulatory care.
Rather than patients seeking care from their outpatient primary care providers, emergency department, or urgent care facilities for nonemergency situations, they could perform the test at home along with a symptom checker. The test and symptom information would be interpreted automatically and interfaced with their records. A health care provider could review the information remotely and prescribe any needed care. If the patient or provider has specific concerns or notices warning symptoms, then a virtual care session could be initiated without the patient needing to travel. This approach would be especially convenient for those without transportation or who are caregivers, and it reduces the spread of infectious disease among those who would otherwise take public transit or sit in a waiting room. Over-the-counter tests are for home use and not documented in patients’ charts. Often, a health care provider orders a redundant test to repeat the same test if the patient comes to the office. This is wasteful health care spending. A digitized result also makes automated and anonymous reporting possible for public health. This latter aspect is especially important because when people perform tests at home, reporting is optional. Public health institutions lose accurate data about the volumes of tests and positivity rates, unlike when testing is performed at clinics or hospitals, where reporting is required.
This study is an example of the emerging field of digital research studies. The available tools can enable patients to self-identify as potential subjects, review study information and consent forms, consent digitally, and participate. For some studies, all of this might be possible without intervention by study staff. Digital-enabled research studies may better engage underserved populations because subjects can enroll and participate remotely from wherever they are. In some iterations, the cost of recruitment may drop considerably. The cost impact would be minimal for patients who self-identify as interested but ultimately do not participate. Although this study did not employ all those tools, future iterations are likely to minimize the need for study staff and will effectively “meet” patients wherever they are.
From the nursing perspective, it was intriguing to see how the application and rapid test could empower someone to support their own health more actively. This technology may increase access to health care by reducing the cost of care and/or removing barriers of transportation, childcare, time off work, etc. It could also reduce the number of low-acuity visits for symptoms of respiratory infection or urinary tract infection and, thereby, increase on-site capacity for patients with more complex needs. Health care providers could bill for virtual visits if one is required. As for provision of health care information, the digital health application would have educational material and routine care instructions available based on the patient’s rapid test results and reported symptoms. Health care information would be available 24×7 through the application. Efficient access to reliable information should reduce the nonbillable effort incurred by manually providing information through patient portals.
From the laboratory perspective, home testing has always been a concern. We want patients to have the convenience of prioritizing their own health; yet, we worry about the quality of tests and the ability of patients to perform them correctly, interpret them correctly, and make appropriate decisions afterward. Digital-enabled near-patient testing is a paradigm shift. The instructions packaged with rapid tests are often difficult to read and interpret. Instead, the digital health application can display step-by-step instructions, in full color, with animated gifs or videos, and provide access to technical help if needed.
Automation of the timer for steps and visual interpretation reduces the chance of error. In fact, for a finger-stick blood test, the application can look for the stain of blood in the sample input location of the test cartridge to ensure that it was set up correctly. Even on the front end of the process—which test to take—the digital health application can use patient symptoms and provider input (as well as the prevalence of local diseases) to select the test that is likely to have an impact on care (or no test at all). Lastly, evaluation of some types of new tests would be easier using a digital platform, and digital tools could allow a more complete understanding of the course of common diseases.
Will digital health be able to deliver care or research data at a lower cost? Can it ensure the same or higher quality for certain episodes of care? Could digital tools strengthen or weaken patient-provider relationships? The answers to these questions are yet to be determined, and the success of digital health depends on adoption and integration by health care providers as well as health care consumers having sufficient access to appropriate electronic resources such as smart phones, computers, and high-speed internet. Like any tool that holds powerful potential for improvement, it could also exacerbate existing problems. There is a risk of addition of complexity and logistics to care, loss of personal connection, and lowered quality or decreased efficiency through poor implementation.
In the study that we supported, we saw the potential for how a digital health application could transform traditional over-the-counter tests into tools for provision of increased-quality care. If this type of tool could be implemented at an equal or lower cost to traditional care, it would result in higher-value care
and, thus, support the triple aim of health care.
Digital health platforms provide the potential to reach more patients and connect them to care as well as better represent them in health care studies. Both increased access to health care and representation support health equity, which was recently proposed as the fifth aim of health care.
Potential Competing Interests
T.E.G. reports research support from Mayo Clinic Center for Individualized Medicine and Mayo Clinic Professorship funds: Geraldine Colby Zeiler Professor in Pathology; receiving testing kits from ACON Laboratories; sponsored research support from Safe Health Systems; and potential royalties from Safe Health Systems.
The authors would like to acknowledge the contributions of Kenta Reilly and Kathrine McAulay, PhD, in setting up logistics for the study as well as the hard-working staff of Mayo Clinic in Arizona coronavirus disease 2019 drive-through tents, who worked like the postal service through everything from desert heat to thunderstorms to wildlife encounters and more. Their dedication to patient care cannot be underestimated.
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Published online: February 15, 2023
Grant Support: The work was supported by Mayo Clinic Center for Individualized Medicine, Geraldine Colby Zeiler (Professor in Pathology), Acon Laboratories (reagents), and Safe Health Systems.
© 2023 Published by Elsevier Inc on behalf of Mayo Foundation for Medical Education and Research.