What Is the Evidence Supporting the Use of Mobile Health Technologies in Palliative Care?

Introduction and Scope of the Problem

There has been explosive growth in the creation and use of mobile technologies for health care in the past 10 years, accompanying exponential growth in access to mobile technology. The global mobile health market is anticipated to surpass $100 billion in 2021, a fivefold increase from 2016 figures. While 96% of Americans own a cellular phone, fewer Americans (81%) own smartphones, with significant variation based on age, level of income, and rural geography. Worldwide, there were more than 7 billion mobile phone subscriptions in 2015, with 70% of those in low- or middle-income countries where people may be more likely to have access to a mobile phone than to clean water or electricity. Widespread access to these technologies creates important opportunities to impact patient and caregiver access to health care, especially for seriously ill patients and their loved ones, who may be isolated not only by geography and/or finances but also by decreased functional status, burden of travel to multiple appointments, and need for in-home care service.

Mobile health (mHealth) is a dynamic term which the National Institutes of Health (NIH) defines as “the use of mobile and wireless devices (cellphones, tablets, etc.) to improve health outcomes, health care services, and health research.” This chapter focuses on the evidence base for mHealth using strategies that are patient facing.

The three mHealth strategies with the most research include communication (via text, image, audio, and/or video), applications (software on phones and tablets), and activity trackers, which can be a stand-alone wearable device as well as activity-monitoring software embedded into smartphones. The IQVIA Institute in 2017 reported 318,000 health-related applications, with ongoing rapid growth in numbers. Enthusiasm for mHealth is driven in part by the need for disruptive solutions to unsustainable health care spending, and the everlasting (and sometimes unfulfilled) promise of technology to improve our quality of life. There is evidence that mHealth strategies can improve access to care, increase access to health information, and promote positive behavior change to impact health outcomes. These benefits can be particularly important for those who are isolated—whether that be geographically, socio-economically, or functionally due to illness. While the potential for good is evident, the impact of mHealth on patient outcomes outside of small research studies is overwhelmed by the hundreds of thousands of non-evidence-based applications available. The commercial market has adapted and grown faster than the mHealth research sector, leaving a gap in our understanding and a need for continued focus on standardization, regulation, and outcomes research to guide best practice.

The Evolution of mHealth and the “Research–Market Divide”

High-quality mHealth applications should bring together evidence-based interventions and software design/formatting for end-user accessibility and functionality. The market availability of mental wellness applications demonstrates the divide between commercially available applications and those which utilize evidence-based interventions. A 2020 review of such applications revealed a total of 1,009 psychosocial wellness and stress management applications available on the iOS and Android app stores. Of these, only 21 of the applications were supported by original research, with a total of 25 efficacy studies and 10 feasibility studies. Only one application, Headspace ( https://www.headspace.com/ ), had multiple efficacy studies associated. The Anxiety and Depression Association of America recognized this disparity and developed PsyberGuide ( https://onemindpsyberguide.org/ ), a collaboration with Northwestern University to provide app reviews and information to the public and health professionals to facilitate identification of high-quality applications and integrate them into their work. As mHealth continues to grow across all areas of medicine, providers must be vigilant to integrate tools with a strong evidence base.

Having high-quality scientific content for an mHealth app is not enough, though. If the design is not usable, the end user (patient or clinician) is unlikely to remain engaged. Xcertia, a nonprofit organization founded by the American Medical Association (AMA) and partner IT organizations, has developed mHealth App Guidelines for usability, privacy, content, security, design, and operability ( https://www.allianceni.org/xcertia ). App developers who have sought Xcertia approval may then use the Xcertia design and logo as evidence of fidelity to the standards. Another tool for assessment of app quality is the Mobile App Rating Scale (MARS), describing an application’s engagement, functionality, aesthetics, and information quality, with 23 subcategory questions under those clusters. The mean scores in those categories are combined for a global mean app quality MARS score.

The infrastructure for regulation is present and evolving in some areas of mHealth technology. Since 2013, the Food and Drug Administration (FDA) has used a medical device regulatory framework to oversee and approve more complex mHealth products (e.g., remote cardiac monitors, diabetes management systems, remote vital sign monitors, and picture archiving systems). These are classified based on patient risk and required need for regulatory oversight. A 2018 review of FDA mHealth app products revealed 189 products, 70% of which were classified as prescription and 23% as over the counter. In 2019, the 21st Century CURES Act clarified that the FDA is barred from regulating low-risk mHealth apps that focus on promoting wellness or education, not aiming to diagnose or treat disease. For example, an mHealth app could help with self-esteem but not treat an anxiety disorder. The FDA clarifies that an app may refer to a disease or condition if the aim is to reduce the risk of chronic disease or help in living well with a chronic disease.

To facilitate movement of information between different varieties of devices, electronic health records (EHR), and cloud exchanges, application development must adhere to standards for interoperability, to ensure that different interfaces allow for effective, solvent information exchange. Fast Healthcare Interoperability Resources (FHIR) has been recognized as the gold standard for such interoperability, such that in 2020, the Centers for Medicare & Medicaid Services (CMS) issued the Interoperability and Patient Access Final Rule, requiring use of FHIR by many CMS regulated payers by 2021.

The AMA Digital Health Research Report, published in 2019, showed that physicians have multiple motivations to use mHealth applications, including patient adherence, patient safety, work efficiency, diagnostic ability, patient–physician relationship, and patient convenience. Requirements for implementation include integration into the EHR, equivalence to traditional care, being covered by malpractice insurance, and having reimbursement potential. The report also links to a Digital Health Implementation Playbook to aid clinicians in incorporating these tools into their practice.

It is upon this background of explosive development and still-emerging regulatory infrastructure that we explore the current state of the evidence base for mHealth generally and in the provision of palliative care and hospice specifically. The current evidence base is strongest in areas of practice other than hospice and palliative care, but with important lessons for these fields. This chapter highlights the ability of this disruptive technology to fundamentally impact patient communication, patient-reported outcomes, and patient access to care and connection with their health care providers.